Urethral injection therapy for urinary incontinence in women

Vivienne Kirchin; Tobias Page; Phil E Keegan; Kofi OM Atiemo; June D Cody; Samuel McClinton; Patricia Aluko

doi:10.1002/14651858.CD003881.pub4

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Referencias

References to studies included in this review

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References to other published versions of this review

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estudios excluidos
estudios en curso
otras referencias

Keegan PE, Atiemo K, Cody JD, McClinton S, Pickard R. Periurethral injection therapy for urinary incontinence in women. Cochrane Database of Systematic Reviews 2007, Issue 3. [DOI: 10.1002/14651858.CD003881.pub2]

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

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Anders 2002

Methods	RCT. Follow‐up of mean 54 months
Participants	A: GAX‐collagen (26) B: Macroplastique™ (34). 60/60 women, mean age 76 years (range 45‐88 years) Included: women considered unfit for surgery A:10/26 B:9/34, women who had previous failed continence surgery A:16/26 B:25/34. These women had undergone a mean 2.1 (range 1‐4) of continence procedures. Excluded: women with detrusor instability, voiding difficulties, recurrent urinary tract infection, gross vaginal prolapse. SUI was due to sphincter deficiency.
Interventions	A: glutaraldehyde cross‐linked collagen is a purified bovine dermal collagen cross‐linked with glutaraldehyde and dispersed in phosphate‐buffered physiological saline. B: Macroplastique™ consists of textured silicone particles suspended in a liquid gel (polyvinylpyrrolidone) The injections were performed periurethrally for both A and B. Women were offered a max 3 injections.
Outcomes	Injection required to achieve max benefit Median (IQR) pad test loss at 12 months Mean volume injected (mL) Number failed after injection, King's QOL.
Notes	Willcoxon sign rank test and Mann Witney U tests used.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear

Andersen 2002

Methods	RCT. 52 women. Follow‐up at a mean of 32.3 months. All patients ISD, Leak point pressure < 90.
Participants	A: Durasphere (25) B: Contigen (21)
Interventions	A: Durasphere contains pyrolytic carbon‐coated zirconium oxide beads. B: Contigen consists of bovine collagen. Both agents (A, B) were injected transurethrally. Mean volume of A used was 4.5 mL. Mean volume of B used was 4.2 mL.
Outcomes	Numbers not cured at a mean of 32.3 months A:15/25; B: 18/21 Numbers not improved A: 5/25; B: 8/21 as assessed by Stamey continence grading system
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Researcher not surgeon

Bano 2005

Methods	RCT 50 patients Follow‐up 6 weeks and 6 months
Participants	A: Permacol™ (25) B: Macroplastique™ (25) Mean age 61 years (range: 28‐80) 6/25 of Permacol™ patients had undergone previous anti‐incontinence surgery. 2/25 of Macroplastique™ patients had a previous pubovaginal sling and 1 had a colposuspension. Inclusion and exclusion criteria was not stated.1 Macroplastique™ patient died due to medical reasons. 1 Permacol™ patient withdrew from study.
Interventions	A: Permacol™ is porcine collagen B: Macroplastique™ consists of silicone particles. 21/25 Permacol™ patients were injected periurethrally, the rest were injected transurethrally. Macroplastique™ was injected using the Macroplastique™ injection system which uses a transurethral approach. Mean volume of Permacol™ was 8 mL. Mean volume of Macroplastique™ was 5 mL.
Outcomes	At 6 months Improvement in Stamey grade A; 14/24 B;10/24 Improvement as assessed by Kings College questionnaire A;14/24 B; 7/24 Patients dry A: 15/24; B: 9/24 Urinary retention A: 2/25; B: 3/25. Urge incontinence A: 1/25; B: 1/25
Notes	No statistical analysis was carried out
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear

Corcos 2005

Methods	RCT (multicentre). 12 months follow‐up
Participants	133 women with SUI. A: collagen (66); B: open surgery (67). A: 2/66; B:13/67 refused intervention. Results reported for A: 64; B: 54.
Interventions	A: (64) submucosal urethral injection, 1‐4 injections in 6 months, follow‐up started after last injection. B: (54) option of BNS (6), Sling (24) or Burch (24).
Outcomes	Numbers not cured or improved at 12 months A:40/64 B:15/54. IIQ questionnaire score mean(SD) A:45.2(18.4) B:41.6(17.6). Numbers not satisfied A:15/64 B:14/54. Complications A:36 B:84 events.
Notes	BNS or IIQ abbreviations not explained in study. No description of inclusion or exclusion criteria. Unsure if women's characteristics in groups are similar.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear
Blinding (performance bias and detection bias) All outcomes	High risk	Not blinded and patients and doctors would be aware which treatment had been given

Dmochowski 2004

Methods	RCT (multicentre). 253 total, 237 women randomised. Results presented for 168 women at 12 months follow up for primary effectiveness. Adverse events for 253 patients.
Participants	Included: women diagnosed with urodynamic SUI confirmed by clinical urodynamic evaluation. Mean age for both groups 61 years. All patients had failed previous incontinence treatment, 46% failing at least one surgery.
Interventions	A: Uryx™ is an injectable solution of ethylene vinyl alcohol copolymer (EVOH) dissolved in dimethyl sulphoxide (DMSO) carrier. Upon contact with an aqueous environment, such as the submucosal tissues of the urethra, the DMSO solvent diffuses away, resulting in precipitation of the polymer, which forms a cohesive spongy mass creating a bulking effect. Uryx™ hand‐injected through a fine 25 g needle. B: Contigen™ is cross‐linked bovine collagen. Maximum of 3 treatments in 90 days allowed,
Outcomes	Mean total volume injected per patient. A: 4.7 cc; B: 7.2 cc. Efficacy was assessed at 12 months following last treatment using pad weight and Stamey test. I‐QOL also used.
Notes	No description of participant characteristics (age, parity, BMI).
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear
Other bias	Unclear risk	Funded by Genyx medical, Inc. manufacturer of Uryx™

Ghoniem 2009

Methods	RCT, multicentre.
Participants	260 randomised, 247 studied, women with SUI primarily intrinsic sphincter deficiency, failed conservative treatments. Mean age 61 years. 24% had prior surgery.
Interventions	Macroplastique™ versus Contigen™. Repeat treatment allowed after 3 months.
Outcomes	Stamey grade, pad weight and IQOL score 12 months after surgery primary outcome measure. decrease in baseline IQOL of at least 1 Stamey grade at 12 months
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	High risk
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Patient blinded; physician unaware; unclear who completed assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	12 patients who withdrew and 1 patient wrongly treated were excluded from analysis. At 12 months 51 patients were considered as discontinued as lost to follow‐up.
Selective reporting (reporting bias)	Low risk

Kuhn 2008

Methods	RCT
Participants	30 elderly women with stress incontinence.
Interventions	Transurethral mid‐urethral collage injection versus bladder neck injection.
Outcomes	VAS, residual urine, urethral resting pressure and functional urethral length, cough test and flowmetry.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Computer assisted
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Follow‐up performed by different team but had access to operation notes

Lee 2001

Methods	RCT (double‐blind, placebo‐controlled). Of the 68 women randomised: 1 = lost to follow‐up; 8 = withdrew; 2 = desired change treatment; 1 = death from fat embolism; 1 = death. Follow‐up at 3, 6, 9, 12, 18 and 24 months.
Participants	A: Autologous fat (35) B: Saline (33) Results reported for A: 27/35; B: 29/33. Mean age (SD) A: 57.2 (11.6); B: 56.9 (12.3). Groups are similar in terms of parity, history of incontinence surgery, baseline continence questionnaire score, pad test weight, maximum urethral closure pressure, leak point pressure. Included: women with SUI. Excluded: women receiving co‐interventions such as HRT, weight reduction or Kegel exercises, diagnosis causing incontinence such as bladder instability.
Interventions	A: periurethral autologous fat injection, under local anaesthesia and intravenous sedation, about 30 cc fat harvested from anterior abdominal wall or buttock, bulking agent placed at bladder neck and proximal urethra.
Outcomes	Numbers not cured or improved at < 1‐year follow‐up A: 21/27; B: 23/29. Pad weight (g), mean (SD) A:14.8 (20.1); B: 18.56 (27.6). Continence questionnaire score, mean (SD) A: 10.9 (4.5); B:12.2 (4.6). Complications A: 29/91; B:11/98 procedures. Number of injections required to achieve max benefit (1) A: 0; B: 0, (2) A: 1; B: 0, (3) A: 26; B: 29. Mortality A: 1/27; B: 0/29.
Notes	Statistical methods used are not described,
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Lightner 2001

Methods	RCT (multicentre, controlled, double‐blind) 355 women randomised and followed up for mean 14 months (range 9‐30 months), 235 women completed 12 months follow‐up for whom results are reported.
Participants	Included: women diagnosed with SUI due to ISD. All women had abdominal leak pressure < 90 cm H₂O. Excluded: positive skin results with test injections of bovine collagen and beta‐glucan.
Interventions	A: Durasphere (pyrolytic carbon‐coated zirconium oxide beads suspended in a carrier gel, prepackaged syringes with 1.0 mL Durasphere and 18‐guage needle delivery device were used, B: bovine collagen (Contigen™ bard collagen implant) women underwent injections according to the manufacturer's instructions.
Outcomes	Mean number of injections required to achieve maximum benefit A: 1.69; B: 1.55. Mean volume injected (mL) A: 4.83 mL; B: 6.23 mL. Mean change in pad weight test at 12 months A: 19.3 g; B: 15.5 g (not significant difference).
Notes	Continence data are reported for 235 women completing 12 months follow‐up (mean 14 months, range 9‐30). Adverse events reported for all 355 women, mean 11 months follow‐up (range 1‐26).
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear

Lightner 2009

Methods	Evaluator blinded prospective RCT Zuidex™ Implacer vs Contigen™ , follow‐up greater than 1 year from last treatment.
Participants	344 women with urodynamically confirmed stress incontinence (ALP <100 cm/H₂O) at 23 North American sites
Interventions	Zuidex™ via Implacer device (227) Contigen™ under endoscopic guidance (117); 2 re‐treatments within initial 3 month period allowed
Outcomes	Primary outcome ‐ proportion of women who achieved ≥ 50% reduction in urinary leakage on provocation testing at baseline compared with 12 months post‐last treatment. Stamey grading, 24‐hour pad test, micturition chart and patient global assessment of incontinence problems.
Notes	Outcome at 12 months from last treatment failed to show that non‐cystoscopically injected Zuidex™ (implacer) was equivalent to Contigen™ injected endoscopically.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No comments made
Allocation concealment (selection bias)	High risk	Operator visually informed of the randomisation result
Blinding (performance bias and detection bias) All outcomes	Unclear risk	States evaluator blinded but does not describe who did evaluation and if operative note was removed from medical records, patient blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Multiple imputations and hot deck procedure Last observation carried forward
Selective reporting (reporting bias)	High risk	Selective reporting of secondary outcome measures ‐ 24‐hour pad test results and QOL scores not mentioned
Other bias	Unclear risk	Primary outcome data missing for 38% of ZI group and 28% of CE group due to premature withdrawal or protocol violation

Maher 2005

Methods	RCT, prospective 45 women. Follow‐up at 6 months and 1 year. Telephone questionnaire follow‐up at mean 62 months ( range 43‐71 months).
Participants	Included women with SUI and ISD diagnosed by a maximal urethral closure pressure < 20 cm H₂O who failed to respond to conservative treatment. Excluded those who required prolapse surgery, had undergone sling procedure or were unsuitable for anaesthesia. A: Macroplastique™ (23); B: pubovaginal sling (22). Median age in A = 65; B = 63.
Interventions	A: Macroplastique™ consists of silicone particles B: the pubovaginal sling is surgically placed for suburethrally for treatment of SUI
Outcomes	Subjectively cured A: 17/22; B: 19/21. Patients satisfied A:13/22; B: 17/21. Objectively cured A: 2/22; B: 17/21. Median SUDI score A: 14; B: 11. Median SIIQ score A: 5; B: 9. Median 1‐hour pad test A: 5; B: 2. At mean 62 months reported success A: 21%; B: 69%, satisfaction A: 29%; B: 69%.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear

Mayer 2007

Methods	Prospective single‐blind RCT
Participants	296 women with stress incontinence (ISD with or without hypermobility) and no previous urethral bulking.
Interventions	CaHA versus collagen soft tissue augmentation of the sphincter; up to 5 injections were allowed in the first 6 months.
Outcomes	Improvement in Stamey urinary incontinence scale by one or more grades at 12 months after initial injection; results available in 231 patients at 12 months.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation tables
Allocation concealment (selection bias)	High risk
Blinding (performance bias and detection bias) All outcomes	Low risk	Surgeon not blinded however ancillary clinical research staff obtaining follow‐up data unaware of treatment assignment.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Only 54% (296) of 545 eligible patients participated in study and of these only 231 (78%) had 12‐month Stamey scores available. Only these 231 were evaluated. No details are given regarding the "un‐evaluable" patients to show that they are comparable. Later mentions a separate intention‐to‐treat analysis but is not specific about how this was done.
Selective reporting (reporting bias)	Low risk	All primary and secondary outcome measures reported.
Other bias	Unclear risk	13 CaHA and 15 collagen women received periurethral rather than transurethral injections, study sponsored by bioform medical manufacturer of Coaptite (CaHA).

Schulz 2004

Methods	RCT (prospective) 12‐month follow‐up
Participants	Included: 40 women with GSI (36/40) or mixed incontinence with a minor and controlled urge component (4/40), no significant differences between groups for any preoperative measurements. Excluded those with UTI, bladder capacity < 250 mL or PVR > 100 mL, neurogenic bladder, Grade 3 cystocoele, uterine prolapse or rectocoele, those taking alpha agonist or antagonist, those previously received radiation to urethra, previous bulking agent therapy, pregnancy or intention to get pregnant during the study period and life expectancy < 15 months.
Interventions	A: (20) periurethral route of injection; B: (20) transurethral route of injection. Average volume of injection A: 3.9 mL; B 3.5 mL.
Outcomes	Number not cured or improved A: 16/17; B: 14/17. Average pad weight A: 4.1 g; B: 6.3 g. QOL score A: 34; B: 27. Retention A: 6/20; B: 1/20. Number of patients with more than one injections A: 10/20; B: 12/20.
Notes	Loss to follow‐up A: 3/20; B: 2/20 (1/20 became pregnant and withdrew from study).
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

ter Meulen 2009

Methods	Prospective RCT
Participants	47 recruited, 45 women treated with stress incontinence caused by urethral hypermobility and non‐successful conservative treatment.
Interventions	MPQ injections versus pelvis floor muscle exercise and home‐training programme.
Outcomes	Follow‐up at 3 months for both groups and at 12 months for MPQ group. Pad test, number of pads used Frequency volume chart, Physician and patient cure self assessment
Notes	Repeat MPQ at 3 months if requested by patient or clinically indicated. Further follow‐up of this group at 3 and 12 months following repeat treatment. 5 years taken to recruit to study.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	High risk
Blinding (performance bias and detection bias) All outcomes	High risk
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Intention‐to‐treat with missing values are imputed by general mean substitution. 47 patients recruited 45 treated, 1 excluded due to not fulfilling inclusion criteria, 1 patient included twice.
Selective reporting (reporting bias)	High risk	12‐month follow‐up for one group only.
Other bias	Unclear risk	Study sponsored by uroplasty BV, makers of Macroplastique™ and Macroplastique™ implantation system.

ALP = alkaline phophatase; BMI = body mass index; GAX‐collagen = Glutaraldehyde cross‐linked collagen; GSI = genuine stress incontinence; HRT = Hormone Replacement Therapy; IIQ = Incontinence Impact Questionnaire; IQR = Inter Quartile Range; ISD = Intrinsic Sphincter Deficiency; PVR = postvoid residual; MPQ = Macroplastique™; QoL = quality of life; RCT = randomised controlled trial; SD = standard deviation; SUDI = Short Urinary Distress Inventory; SUI = Stress Urinary Incontinence; VAS = visual analogue scale.

Characteristics of excluded studies [ordered by study ID]

Ir a:

estudios incluidos
estudios en curso

Study	Reason for exclusion
Anonymous 2004	Pre‐marketing approval letter
Anonymous 2006	Pre‐marketing approval letter
Carr 2009	No control arm (randomisation was to different doses of active treatment)
Currie 1997	Case report
Haab 1997	Non‐randomised study
Imamoglu 2008	Study participants male
Kuznetsov 2000	Non‐randomised study
Plotti 2008	Letter to editor
Radley 1999	Non‐randomised study
Strasser 2007	Study withdrawn by publishers
Truzzi 2004	Not relevant to this review

Characteristics of ongoing studies [ordered by study ID]

Ir a:

estudios incluidos
estudios excluidos

Anonymous 2003b

Trial name or title	Collagen versus Macroplastique™
Methods
Participants	Unknown
Interventions	Collagen versus Macroplastique™
Outcomes	Unknown
Starting date	Unknown ‐ already ongoing at July 2003
Contact information
Notes	Investigational device exemption (IDE) data being prepared for publication.

Cardozo 2002

Trial name or title	Comparative study of the efficacy, acceptability, morbidity and cost‐effectiveness of the 'Tension Free Vaginal Tape' and the periurethral injection of collagen in the management of recurrent stress incontinence
Methods
Participants	Plan to recruit 56 participants
Interventions	Periurethral collagen injection versus TVT^TM
Outcomes	Unknown
Starting date	Started recruiting in September 2001.
Contact information
Notes	At 25 January 2005 still ongoing ‐ current status uncertain.

Courtney‐Watson 2002

Trial name or title	Comparison of two surgical methods for curing stress incontinence (recurrent)
Methods
Participants	Inclusion criteria included low UCP
Interventions	Macroplastique™ versus TVT^TM
Outcomes	Unknown
Starting date	2002
Contact information
Notes	Trial stopped due to difficulty recruiting. Planned to recruit 30 participants to each arm but randomised under 15 participants.

Henalla 2003

Trial name or title	A randomised clinical trial for the evaluation of two implantation sites for Macroplastique™ bladder neck implants using the Macroplastique™ implantation system
Methods
Participants	Women with urodynamically proven Genuine Stress Incontinence.
Interventions	Comparing implantation sites
Outcomes	Unknown
Starting date	April 1999
Contact information
Notes	Study now finished. Awaiting publication.

TVT^TM = Tension Free Vaginal Tape; UCP = urethral closure pressure.

Data and analyses

Open in table viewer

Comparison 1. Urethral injection therapy versus no treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number not improved (worse or unchanged) within first year Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.1 Comparison 1 Urethral injection therapy versus no treatment, Outcome 1 Number not improved (worse or unchanged) within first year.
1.1 periurethral autologous fat vs saline	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Pad weight test Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.2 Comparison 1 Urethral injection therapy versus no treatment, Outcome 2 Pad weight test.
2.1 periurethral autologous fat vs saline	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Disease‐specific measures Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.3 Comparison 1 Urethral injection therapy versus no treatment, Outcome 3 Disease‐specific measures.
3.1 periurethral autologous fat vs saline	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Number of patients requiring more than 1 treatment to achieve maximum benefit Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.4 Comparison 1 Urethral injection therapy versus no treatment, Outcome 4 Number of patients requiring more than 1 treatment to achieve maximum benefit.
4.1 periurethral autologous fat vs saline	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Peri‐ and postoperative complication Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.5 Comparison 1 Urethral injection therapy versus no treatment, Outcome 5 Peri‐ and postoperative complication.
5.1 periurethral autologous fat vs saline	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Serious morbidity (such as pulmonary embolism) or mortality Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.6 Comparison 1 Urethral injection therapy versus no treatment, Outcome 6 Serious morbidity (such as pulmonary embolism) or mortality.
6.1 periurethral autologous fat vs saline	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Open in table viewer

Comparison 2. Urethral injection therapy versus conservative management

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number not cured (worse, unchanged or improved) at 3 months Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.1 Comparison 2 Urethral injection therapy versus conservative management, Outcome 1 Number not cured (worse, unchanged or improved) at 3 months.
2 Number not improved (worse or unchanged) at 3 months Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.2 Comparison 2 Urethral injection therapy versus conservative management, Outcome 2 Number not improved (worse or unchanged) at 3 months.
3 Disease‐specific measures Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.3 Comparison 2 Urethral injection therapy versus conservative management, Outcome 3 Disease‐specific measures.
4 Peri‐ and postoperative complication Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.4 Comparison 2 Urethral injection therapy versus conservative management, Outcome 4 Peri‐ and postoperative complication.
4.1 retention	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Open in table viewer

Comparison 3. Urethral injection therapy versus other surgical managements

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number not cured (subjectively) within first year Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.1 Comparison 3 Urethral injection therapy versus other surgical managements, Outcome 1 Number not cured (subjectively) within first year.
1.1 macroplastique vs pubovaginal sling	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Number not cured (objectively) within first year Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.2 Comparison 3 Urethral injection therapy versus other surgical managements, Outcome 2 Number not cured (objectively) within first year.
2.1 collagen vs surgery	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 macroplastique vs pubovaginal sling	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Presence of urinary urgency and urge incontinence Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.3 Comparison 3 Urethral injection therapy versus other surgical managements, Outcome 3 Presence of urinary urgency and urge incontinence.
3.1 collagen vs surgery	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Disease‐specific measures Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.4 Comparison 3 Urethral injection therapy versus other surgical managements, Outcome 4 Disease‐specific measures.
4.1 collagen vs surgery	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Numbers not satisfied Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.5 Comparison 3 Urethral injection therapy versus other surgical managements, Outcome 5 Numbers not satisfied.
5.1 collagen vs surgery	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.2 macroplastique vs pubovaginal sling	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Open in table viewer

Comparison 4. One material for injectable treatment versus another material for injectable treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number not cured (worse, unchanged ) within first year Show forest plot	5		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 4.1 Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 1 Number not cured (worse, unchanged ) within first year.
1.1 carbon particles vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 Silicone particles vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.3 Ethylene vinyl alcohol copolymer vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.4 Permacol vs silicone particles	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.5 Dextranomer/hyaluronic acid versus collagen <2g leakage on pad test	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Number not cured (worse, unchanged ) after first year Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 4.2 Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 2 Number not cured (worse, unchanged ) after first year.
2.1 Carbon particles versus collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 CaHa versus collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Number not improved (worse or unchanged) within first year Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 4.3 Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 3 Number not improved (worse or unchanged) within first year.
3.1 silicone particles vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 calcium hydroxylapatite versus collagen	0		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 Permacol vs silicone at 6 months using stamey grade	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.4 permacol vs silicone at 6 months using KCQ	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.5 Zuidex versus Contigen using 50% reduction in leak on provocation	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.6 Zuidex vs collagen improvement of one or more Stamey grade	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Number not improved (worse or unchanged) after first year Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 4.4 Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 4 Number not improved (worse or unchanged) after first year.
4.1 Carbon particles versus collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 CaHa versus collagen ‐ improved	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.3 CaHa versus collagen ‐ significant improvement	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Presence of urge incontinence Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 4.5 Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 5 Presence of urge incontinence.
5.1 Permacol vs silicone particles	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Pad weight test Show forest plot	4		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 4.6 Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 6 Pad weight test.
6.1 carbon particles vs collagen	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.2 CaHa versus collagen	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.3 Silicone particles vs collagen	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.4 Dexranomer/hyaluronic acid versus collagen	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Number of treatment required to achieve maximum benefit Show forest plot	2	699	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
Open in figure viewer Analysis 4.7 Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 7 Number of treatment required to achieve maximum benefit.
7.1 carbon particles vs collagen	1	355	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.2 Zuidex vs collagen	1	344	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
8 Number of patients requiring more than 1 treatment to achieve maximum benefit Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 4.8 Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 8 Number of patients requiring more than 1 treatment to achieve maximum benefit.
8.1 silicone particles vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
8.2 Zuidex versus collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
9 Total volume injected Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 4.9 Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 9 Total volume injected.
9.1 Silicon vs collagen	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
9.2 Zuidex vs collagen	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10 Peri‐ and post‐ operative complication Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 4.10 Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 10 Peri‐ and post‐ operative complication.
10.1 CaHa particles vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.2 Zuidex vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
11 Voiding difficulties postoperatively and long‐term (hypercontinence) Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 4.11 Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 11 Voiding difficulties postoperatively and long‐term (hypercontinence).
11.1 CaHa versus collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
11.2 permacol vs silicone particles	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
12 New urinary symptoms (urge incontinence) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 4.12 Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 12 New urinary symptoms (urge incontinence).
12.1 CaHa vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
13 Injection site complications Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 4.13 Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 13 Injection site complications.
13.1 Zuidex versus collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Open in table viewer

Comparison 5. One route of injection versus another route of injection

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number not cured (worse, unchanged or improved) within first year Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 5.1 Comparison 5 One route of injection versus another route of injection, Outcome 1 Number not cured (worse, unchanged or improved) within first year.
1.1 periurethral injection vs transurethral injection	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 bladder neck versus mid‐urethral	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Urinary retention Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 5.2 Comparison 5 One route of injection versus another route of injection, Outcome 2 Urinary retention.
2.1 periurethral vs transurethral injection	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 bladder neck vs mid‐urethral	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Figure 1

PRISMA Study flow diagram ‐ showing the flow of literature through the review process

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Analysis 1.1

Comparison 1 Urethral injection therapy versus no treatment, Outcome 1 Number not improved (worse or unchanged) within first year.

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Analysis 1.2

Comparison 1 Urethral injection therapy versus no treatment, Outcome 2 Pad weight test.

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Analysis 1.3

Comparison 1 Urethral injection therapy versus no treatment, Outcome 3 Disease‐specific measures.

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Analysis 1.4

Comparison 1 Urethral injection therapy versus no treatment, Outcome 4 Number of patients requiring more than 1 treatment to achieve maximum benefit.

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Analysis 1.5

Comparison 1 Urethral injection therapy versus no treatment, Outcome 5 Peri‐ and postoperative complication.

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Analysis 1.6

Comparison 1 Urethral injection therapy versus no treatment, Outcome 6 Serious morbidity (such as pulmonary embolism) or mortality.

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Analysis 2.1

Comparison 2 Urethral injection therapy versus conservative management, Outcome 1 Number not cured (worse, unchanged or improved) at 3 months.

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Analysis 2.2

Comparison 2 Urethral injection therapy versus conservative management, Outcome 2 Number not improved (worse or unchanged) at 3 months.

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Analysis 2.3

Comparison 2 Urethral injection therapy versus conservative management, Outcome 3 Disease‐specific measures.

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Analysis 2.4

Comparison 2 Urethral injection therapy versus conservative management, Outcome 4 Peri‐ and postoperative complication.

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Analysis 3.1

Comparison 3 Urethral injection therapy versus other surgical managements, Outcome 1 Number not cured (subjectively) within first year.

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Analysis 3.2

Comparison 3 Urethral injection therapy versus other surgical managements, Outcome 2 Number not cured (objectively) within first year.

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Analysis 3.3

Comparison 3 Urethral injection therapy versus other surgical managements, Outcome 3 Presence of urinary urgency and urge incontinence.

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Analysis 3.4

Comparison 3 Urethral injection therapy versus other surgical managements, Outcome 4 Disease‐specific measures.

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Analysis 3.5

Comparison 3 Urethral injection therapy versus other surgical managements, Outcome 5 Numbers not satisfied.

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Analysis 4.1

Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 1 Number not cured (worse, unchanged ) within first year.

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Analysis 4.2

Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 2 Number not cured (worse, unchanged ) after first year.

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Analysis 4.3

Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 3 Number not improved (worse or unchanged) within first year.

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Analysis 4.4

Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 4 Number not improved (worse or unchanged) after first year.

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Analysis 4.5

Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 5 Presence of urge incontinence.

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Analysis 4.6

Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 6 Pad weight test.

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Analysis 4.7

Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 7 Number of treatment required to achieve maximum benefit.

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Analysis 4.8

Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 8 Number of patients requiring more than 1 treatment to achieve maximum benefit.

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Analysis 4.9

Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 9 Total volume injected.

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Analysis 4.10

Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 10 Peri‐ and post‐ operative complication.

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Analysis 4.11

Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 11 Voiding difficulties postoperatively and long‐term (hypercontinence).

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Analysis 4.12

Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 12 New urinary symptoms (urge incontinence).

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Analysis 4.13

Comparison 4 One material for injectable treatment versus another material for injectable treatment, Outcome 13 Injection site complications.

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Analysis 5.1

Comparison 5 One route of injection versus another route of injection, Outcome 1 Number not cured (worse, unchanged or improved) within first year.

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Analysis 5.2

Comparison 5 One route of injection versus another route of injection, Outcome 2 Urinary retention.

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Comparison 1. Urethral injection therapy versus no treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number not improved (worse or unchanged) within first year Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.1 periurethral autologous fat vs saline	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Pad weight test Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

2.1 periurethral autologous fat vs saline	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Disease‐specific measures Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.1 periurethral autologous fat vs saline	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Number of patients requiring more than 1 treatment to achieve maximum benefit Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 periurethral autologous fat vs saline	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Peri‐ and postoperative complication Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5.1 periurethral autologous fat vs saline	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Serious morbidity (such as pulmonary embolism) or mortality Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6.1 periurethral autologous fat vs saline	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. Urethral injection therapy versus no treatment

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Comparison 2. Urethral injection therapy versus conservative management

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number not cured (worse, unchanged or improved) at 3 months Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Number not improved (worse or unchanged) at 3 months Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 Disease‐specific measures Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4 Peri‐ and postoperative complication Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 retention	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 2. Urethral injection therapy versus conservative management

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Comparison 3. Urethral injection therapy versus other surgical managements

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number not cured (subjectively) within first year Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.1 macroplastique vs pubovaginal sling	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Number not cured (objectively) within first year Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.1 collagen vs surgery	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 macroplastique vs pubovaginal sling	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Presence of urinary urgency and urge incontinence Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.1 collagen vs surgery	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Disease‐specific measures Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.1 collagen vs surgery	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Numbers not satisfied Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5.1 collagen vs surgery	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.2 macroplastique vs pubovaginal sling	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 3. Urethral injection therapy versus other surgical managements

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Comparison 4. One material for injectable treatment versus another material for injectable treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number not cured (worse, unchanged ) within first year Show forest plot	5		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.1 carbon particles vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 Silicone particles vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.3 Ethylene vinyl alcohol copolymer vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.4 Permacol vs silicone particles	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.5 Dextranomer/hyaluronic acid versus collagen <2g leakage on pad test	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Number not cured (worse, unchanged ) after first year Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.1 Carbon particles versus collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 CaHa versus collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Number not improved (worse or unchanged) within first year Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.1 silicone particles vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 calcium hydroxylapatite versus collagen	0		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 Permacol vs silicone at 6 months using stamey grade	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.4 permacol vs silicone at 6 months using KCQ	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.5 Zuidex versus Contigen using 50% reduction in leak on provocation	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.6 Zuidex vs collagen improvement of one or more Stamey grade	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Number not improved (worse or unchanged) after first year Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 Carbon particles versus collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 CaHa versus collagen ‐ improved	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.3 CaHa versus collagen ‐ significant improvement	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Presence of urge incontinence Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5.1 Permacol vs silicone particles	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Pad weight test Show forest plot	4		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

6.1 carbon particles vs collagen	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.2 CaHa versus collagen	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.3 Silicone particles vs collagen	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.4 Dexranomer/hyaluronic acid versus collagen	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Number of treatment required to achieve maximum benefit Show forest plot	2	699	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]

7.1 carbon particles vs collagen	1	355	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.2 Zuidex vs collagen	1	344	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
8 Number of patients requiring more than 1 treatment to achieve maximum benefit Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

8.1 silicone particles vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
8.2 Zuidex versus collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
9 Total volume injected Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

9.1 Silicon vs collagen	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
9.2 Zuidex vs collagen	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10 Peri‐ and post‐ operative complication Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

10.1 CaHa particles vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.2 Zuidex vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
11 Voiding difficulties postoperatively and long‐term (hypercontinence) Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

11.1 CaHa versus collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
11.2 permacol vs silicone particles	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
12 New urinary symptoms (urge incontinence) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

12.1 CaHa vs collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
13 Injection site complications Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

13.1 Zuidex versus collagen	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 4. One material for injectable treatment versus another material for injectable treatment

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Comparison 5. One route of injection versus another route of injection

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number not cured (worse, unchanged or improved) within first year Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.1 periurethral injection vs transurethral injection	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 bladder neck versus mid‐urethral	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Urinary retention Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 periurethral vs transurethral injection	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 bladder neck vs mid‐urethral	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 5. One route of injection versus another route of injection

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Referencias

References to studies included in this review

Anders 2002 {published data only}

Andersen 2002 {published data only}

Bano 2005 {published data only}

Corcos 2005 {published data only}

Dmochowski 2004 {published data only}

Ghoniem 2009 {published data only}

Kuhn 2008 {published data only}

Lee 2001 {published data only}

Lightner 2001 {published data only}

Lightner 2009 {published data only}

Maher 2005 {published data only}

Mayer 2007 {published data only}

Schulz 2004 {published data only}

ter Meulen 2009 {published data only}

References to studies excluded from this review

Anonymous 2004 {published data only}

Anonymous 2006 {published data only}

Carr 2009 {published data only}

Currie 1997 {published data only}

Haab 1997 {published data only}

Imamoglu 2008 {published data only}

Kuznetsov 2000 {published data only}

Plotti 2008 {published data only}

Radley 1999 {published data only}

Strasser 2007 {published data only}

Truzzi 2004 {published data only}

References to ongoing studies

Anonymous 2003b {published data only}

Cardozo 2002 {published data only}

Courtney‐Watson 2002 {published data only}

Henalla 2003 {published data only}

Additional references

Berman 1997

Bezerra 2001

Birnbaum 2004

Chaliha 1995

Chong 2011

Clarke 2003

Dean 2006

Dmochowski 2002

Glazener 2001

Glazener 2004

Higgins 2005

Hurtado 2009

Kilonzo 2004

Kunkle 2015

Lapitan 2005

Lightner 2002

Oremus 2003

Silva 2011

Subak 2008

Sèbe 2011

Wagner 1998

Walsh 1998

Ware 1992

Wyman 1987

Zigmond 1983

References to other published versions of this review

Keegan 2007

Kirchin 2012

Pickard 2003

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Characteristics of ongoing studies [ordered by study ID]

Data and analyses

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Instituciones a las que se accedió previamente

Usuarios institucionales

Instituciones a las que se accedió previamente

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