Scolaris Content Display Scolaris Content Display

انجام دیلاتاسیون متناوب توسط خود فرد در مدیریت بیماری تنگی مجرای ادرار در مردان

Contraer todo Desplegar todo

Referencias

منابع مطالعات واردشده در این مرور

Afridi 2010 {published data only}

Afridi NG, Khan M, Nazeem S, Hussain A, Ahmad S, Aman Z. Intermittent urethral self dilatation for prevention of recurrent stricture. Journal of Postgraduate Medical Institute 2010;24(3):239‐43.

Bodker 1992 {published data only}

Bodker A, Ostri P, Rye‐Andersen J, Edvardsen L, Struckmann J. Treatment of recurrent urethral stricture by internal urethrotomy and intermittent self‐catheterization: a controlled study of a new therapy. Journal of Urology 1992;148(2 Pt 1):308‐10.

Harriss 1994 {published data only}

Harriss DR, Beckingham IJ, Lemberger RJ, Lawrence WT. Long‐term results of intermittent low‐friction self‐catheterization in patients with recurrent urethral strictures. British Journal of Urology 1994;74(6):790‐2.

Hosseini 2008 {published data only}

Hosseini J, Kaviani A, Golshan AR. Clean intermittent catheterization with triamcinolone ointment following internal urethrotomy. Urology Journal 2008;5(4):265‐8.

Husmann 2006 {published data only}

Husmann DA, Rathbun SR. Long‐term followup of visual internal urethrotomy for management of short (less than 1 cm) penile urethral strictures following hypospadias repair. Journal of Urology 2006;176(4 Pt 2):1738‐41.

Khan 2011 {published data only}

Khan S, Khan RA, Ullah A, ul Haq F, ur Rahman A, Durrani SN, et al. Role of clean intermittent self catheterisation (CISC) in the prevention of recurrent urethral strictures after internal optical urethrotomy. Journal of Ayub Medical College, Abbottabad : JAMC 2011;23(2):22‐5.

Kjaergaard 1994 {published data only}

Kjaergaard B, Walter S, Bartholin J, Andersen JT, Nohr S, Beck H, et al. Prevention of urethral stricture recurrence using clean intermittent self‐catheterization. British Journal of Urology 1994;73(6):692‐5.

Matanhelia 1995 {published data only}

Matanhelia SS, Salaman R, John A, Matthews PN. A prospective randomized study of self‐dilatation in the management of urethral strictures. Journal of the Royal College of Surgeons of Edinburgh 1995;40(5):295‐7.

Ngugi 2007 {published data only}

Ngugi PM, Kassim A. Clean intermitent catheterisation in the management of urethral strictures. East African Medical Journal 2007;84(11):522‐4.

Sallami 2011 {published data only}

Sallami S, Mouine Y, Rhouma SB, Cherif K, Dahmani A, Horchani A. Clean intermittent catheterization following urethral stricture surgery using a low friction catheter versus conventional plastic catheter: a prospective, randomized trial [online]. UroToday International Journal2011; Vol. 4, issue 1.

Tammela 1993 {published data only}

Tammela TL, Permi J, Ruutu M, Talja M. Clean intermittent self‐catheterization after urethrotomy for recurrent urethral strictures. Annales Chirurgiae et Gynaecologiae ‐ Supplementum 1993;206:80‐3.

منابع مطالعات خارج‌شده از این مرور

Kaisary 1985 {published data only}

Kaisary AV. Postoperative care following internal urethrotomy. Urology 1985;26(4):333‐6.

Khalid 2007 {published data only}

Khalid M, Sanaullah, Ahmad M, Hussain K, Husain S. Clean intermittent self dilatation as an adjunct to optical urethrotomy for rehabilitation of anterior urethral stricture. Pakistan Postgraduate Medical Journal 2007;18(1):11‐3.

Suhail 2011 {published data only}

Suhail MA, Memon S‐U, Shaikh U. The comparative role of optical urethrotomy with and without clean intermittent self catheterization (CISC) in urethral stricture. Medical Forum Monthly 2011;22(11):13.

Tunc 2002 {published data only}

Tunc M, Tefekli A, Kadioglu A, Esen T, Uluocak N, Aras N. A prospective, randomized protocol to examine the efficacy of postinternal urethrotomy dilations for recurrent bulbomembranous urethral strictures. Urology 2002;60(2):239‐44.

Ahmed 1998

Ahmed A, Kalayi GD. Urethral stricture at Ahmadu Bello University Teaching Hospital, Zaria. East African Medical Journal 1998;75(10):582‐5.

Guyatt 2008

Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck‐Ytter Y, Alonso‐Coello P, Schünemann HJ, GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336(78650):924‐6.

Higgins 2003

Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analyses. BMJ 2003;327(7414):557‐60.

Higgins 2011

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

Jackson 2011

Jackson MJ, Sciberras J, Mangera A, Brett A, Watkin N, N'Dow J, et al. Defining a patient‐reported outcome measure for urethral stricture surgery. European Urology 2011;60(1):60‐8.

Lauritzen 2009

Lauritzen M, Greis G, Sandberg A, Wedren H, Ojdeby G, Henningsohn L. Intermittent self‐dilatation after internal urethrotomy for primary urethral strictures: a case‐control study. Scandanavian Journal of Urology and Nephrology 2009;42:220‐5.

Lawrence 1988

Lawrence WT, MacDonagh RP. Treatment of urethral stricture disease by internal urethrotomy followed by intermittent 'low‐friction' self‐catheterization: preliminary communication. Journal of the Royal Society of Medicine 1988;81(3):136‐9.

Lefebvre 2011

Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

Lumen 2009

Lumen N, Hoebeke P, Willemsen P, De Troyer B, Pieters B, Oosterlinck W. Etiology of urethral stricture disease in the 21st century. Journal of Urology 2009;182(3):983‐7.

Mundy 2010

Mundy AR, Andrich DE. Urethral strictures. BJU International 2010;107(1):6‐26.

Reference Manager 2012

Reference Manager Professional Edition Version 12. New York: Thomson Reuters2012.

Santucci 2007

Santucci RA, Joyce GF, Wise M. Male urethral stricture disease. Journal of Urology 2007;177(5):1667‐74.

Schulz 2010

Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Medicine 2010;8:18. [PUBMED: 20334633]

Wong 2012

Wong SS W, Aboumarzouk OM, Narahari R, O'Riordan A, Pickard R. Simple urethral dilatation, endoscopic urethrotomy, and urethroplasty for urethral stricture disease in adult men. Cochrane Database of Systematic Reviews 2012, Issue 12. [DOI: 10.1002/14651858.CD006934.pub3]

Yu‐Hung Lin 2006

Yu‐Hung Lin, William Ji‐Sien Huang, Kuang‐Kuo Chen. Using stainless steel chopstick for self‐performing urethral sounding in preventing recurrence of anterior urethral stricture. Journal of the Chinese Medical Association 2006;69(4):189‐92.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Afridi 2010

Methods

Full text.

July 2004 ‐ June 2008.

Objective: find out the role of intermittent self‐dilatation for the prevention of recurrent urethral stricture.

Quasi‐randomisation: alternate allocation.

Statistical methods: not described.

Participants

Pakistan.

146 men with anterior urethral stricture.

Age: not stated.

Exclusions: posterior urethral stricture; post‐urethroplasty; stricture; unable to perform intermittent self‐dilatation; >3 strictures; stricture >4cm; obliterative urethral stricture; para‐urethral abscess; fistula.

Interventions

Group A (n = 73): optical urethrotomy

Group B (n = 73): optical urethrotomy then intermittent self‐dilatation for 5 months

Outcomes

PROs: no

Health economic: no

Adverse events: no

Acceptability: no

Recurrence rate:

Number of men with urethral stricture 8 months after optical urethrotomy.

Definition of recurrence: urethrogram.

Group A : 42/73

Group B: 26/73

Notes

intermittent self‐dilatation programme: daily for 4 weeks; alternate days for 4 weeks; every 3 days for 4 weeks; weekly for 8 weeks.

Withdrawals: nil.

Subgroups: first versus recurrent stricture; stricture length; aetiology

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Quote: 'divided into two groups on alternate basis.'

Allocation concealment (selection bias)

High risk

Quote: 'divided into two groups on alternate basis.'

Blinding (performance bias and detection bias)
All outcomes

High risk

Not stated.

Impossible to blind participants.

Outcome assessors probably not blind.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data.

Selective reporting (reporting bias)

Low risk

Expected outcomes reported.

Funding/COI

Unclear risk

No statement.

Bodker 1992

Methods

Full text.

Objective: find the effect of treatment of recurrent urethral stricture by optical urethrotomy followed by intermittent self‐dilatation for 3 months.

States randomised; no details.

Statistical methods: Chi2.

Participants

Denmark.

61 men with recurrent anterior urethral stricture.

Age: range 18‐87; Median: Observation 76; Intervention 70

Exclusions: prostatic urethral stricture, bladder cancer.

Interventions

Observation (n = 33): optical urethrotomy

Intervention (n = 28): optical urethrotomy then intermittent self‐dilatation for 3 months

Outcomes

PROs: no

Health economic: no

Adverse events:

Intervention: 2/28 urethral haemorrhage; Observation: nil reported.

Acceptability: no

Recurrence rate:

Number of men with recurrent urethral stricture 1 year after optical urethrotomy.

Definition of recurrence: flow rate < 10ml/s.

Observation: 23/28

Intervention: 18/23

Time to recurrence:

Median time after optical urethrotomy:

Observation: 4 (range 2‐12) months

Intervention: 7 (range 5‐15) months

Notes

intermittent self‐dilatation programme: twice weekly for 1 month then weekly for 2 months

Withdrawals:

Observation: 3 death, 1 DNA

Intervention: 2 bleeding, 2 death, 1 DNA

Subgroups: no.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Abstract states 'randomized to undergo internal urethrotomy'; thereafter described as allocated to groups.

Allocation concealment (selection bias)

High risk

Probably not done.

Blinding (performance bias and detection bias)
All outcomes

High risk

Not stated.

Impossible to blind participants.

Outcome assessors probably not blind.

Incomplete outcome data (attrition bias)
All outcomes

High risk

2 men in intervention group withdrawn owing to haemorrhage should have been evaluated for recurrence.

Selective reporting (reporting bias)

Low risk

Expected outcomes reported.

Funding/COI

Unclear risk

No statement.

Harriss 1994

Methods

Full text.

1985‐89.

Objective: ascertain the duration of intermittent self‐dilatation required to allow stabilization of urethral strictures following urethrotomy.

Randomisation: odd/even hospital number.

Statistical methods: Chi2 with Yates' correction; Wilcoxon signed rank test.

Participants

UK.

101 men with recurrent urethral stricture.

Age: range 24‐78, median 67.

Exclusions: nil (states all men with the disease attending the department)

Interventions

Group 1: optical urethrotomy then intermittent self‐dilatation for 6 months

Group 2: optical urethrotomy then intermittent self‐dilatation for 3 years (intended).

Outcomes

PROs: no

Health economic: no

Adverse events:

Not stratified by group: overall: 21 death, 6 UTI, 'several' haematuria.

Acceptability:

No objective assessment. Quote 'most patients ... took to the procedure very easily.'

Recurrence rate:

Number of men with recurrent urethral stricture.

Census time point unclear; follow‐up range 24‐78 months.

Definition of recurrence: cystoscopy.

Group 1 (6 months): 19/48

Group 2A (12‐36 months): 4/28

Group 2B (> 36 months): 0/10

Time to recurrence: no

Notes

intermittent self‐dilatation programme: twice weekly for 1 month then weekly.

Withdrawals:

8/21 men who died of 'unrelated disease' in the study period with insufficient follow‐up, 7 DNA (Group 1 = 3; Group 2 = 4)

Protocol not followed: significant deviation from intended 36‐month programme of intermittent self‐dilatation in Group 2 owing to death, administrative error and patient preference.

Subgroups: no.

10 men on permanent intermittent self‐dilatation after optical urethrotomy = zero recurrence.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Odd/even hospital number.

Allocation concealment (selection bias)

High risk

Odd/even hospital number.

Blinding (performance bias and detection bias)
All outcomes

High risk

Not stated. Probably not done.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Number of patients withdrawn sufficient to introduce clinically relevant bias.

Selective reporting (reporting bias)

High risk

Narrative presentation of results; post‐hoc analysis; variable follow‐up and time point of recurrence not stated.

Funding/COI

Unclear risk

No statement.

Hosseini 2008

Methods

Full text.

Objective: evaluate intermittent self‐dilatation in combination with triamcinolone gel for lubrication of the catheter after optical urethrotomy.

Double‐blind, placebo‐controlled trial.

Randomisation: random numbers table.

Statistical methods: Chi2, Student's t test.

Participants

Iran.

70 male participants with urethral stricture.

Age: range 10‐80; Mean: intervention 37.7; Control 34.5

Exclusions: complete urethral obstruction; stricture > 1.5 cm.

Interventions

Control (n = 35): optical urethrotomy then intermittent self‐dilatation with water‐based lubricant for 6 months.

Intervention (n=35): optical urethrotomy then intermittent self‐dilatation with 1 ml 1% triamcinolone gel for 6 months.

Outcomes

PROs: no

Health economic: no

Adverse events:

Not objectively reported. Metaquote: 'no febrile UTIs or complications specific to Triamcinolone.'

Acceptability:

No objective assessment. Quote 'all of the patients who completed the prescribed CISC program considered the method fully acceptable.'

Recurrence rate:

Number of men with recurrent urethral stricture 12 months after optical urethrotomy.

Definition of recurrence: cystoscopy.

Control: 15/34

Intervention: 9/30

P = 0.24

Time to recurrence: no

Notes

intermittent self‐dilatation: daily week 1, alternate days week 2, twice weekly week 3, weekly week 4, every 2 weeks for 1 month, monthly for 3 months.

Withdrawals:

Control: 1 DNA

Intervention: 5 DNA

Subgroups: no.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Refers to random table. Probably done.

Allocation concealment (selection bias)

High risk

Not described. Probably not done.

Blinding (performance bias and detection bias)
All outcomes

Low risk

Quotes: 'the patient and the physicians involved in the research project were blind to the type of the lubricants' which were 'packed in similar tubes.'

Incomplete outcome data (attrition bias)
All outcomes

High risk

Imbalance in numbers across intervention groups possibly related to outcome and sufficient to introduce clinically relevant bias in intervention effect estimate.

Selective reporting (reporting bias)

Low risk

Expected outcomes reported.

Funding/COI

Unclear risk

No statement.

Husmann 2006

Methods

Full text.

1986‐2005.

Objective: to answer the question 'does post‐op intermittent self‐dilatation influence long term results of optical urethrotomy?'

States randomised; no details.

Statistical methods: Chi2

Participants

USA.

72 men with < 1cm pendulous penile urethral stricture following hypospadias repair.

Age: not stated, presumed adults, conclusion refers to follow‐up through adulthood.

Exclusions: meatal or bulbar stricture.

Interventions

Control: optical urethrotomy (n = 37)

Intervention: optical urethrotomy then intermittent self‐dilatation for 3 months (n = 35)

Outcomes

PROs: no

Health economic: no

Adverse events: no

Acceptability: no

Recurrence rate:

Number of men with recurrent urethral stricture 2 years after optical urethrotomy.

Definition of recurrence: re‐intervention.

Control: 28/37

Intervention: 27/35

Time to recurrence: no

Notes

intermittent self‐dilatation programme: daily.

Withdrawals: not reported.

Subgroups: type of hypospadias repair: tubularised graft, tubularised flap, onlay flap, urethral plate.

Authors' conclusion: addition of intermittent self‐dilatation following optical urethrotomy has no benefit for preventing stricture recurrence [in men who have had hypospadias surgery].

Note: patients recruited over 19‐year period.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quotes: 'randomized to treatment based on 1 of 4 types of initial hypospadias repair'; 'arbitrarily assigned to treatment.' Probably not done.

Allocation concealment (selection bias)

High risk

Randomised according to type of hypospadias repair.

Probably not done.

Blinding (performance bias and detection bias)
All outcomes

High risk

Not stated.

Impossible to blind participants.

Outcome assessors probably not blind.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Number randomised not stated. Reports only patients that completed the study.

Selective reporting (reporting bias)

Unclear risk

Unclear. Presents analysis that was not pre‐specified.

Funding/COI

Unclear risk

No statement.

Khan 2011

Methods

Full text.

June 2007 ‐ June 2010.

Objective: determine the role of intermittent self‐dilatation in the prevention of recurrence of urethral stricture after optical urethrotomy; study the frequency of postoperative complications and tolerability of intermittent self‐dilatation.

States randomised; no details.

Participants

Pakistan.

60 men with anterior urethral stricture.

Age: range 20‐38; mean Control 37.3, Treatment 42.5

Exclusions: prostate or bladder cancer, inability to learn intermittent self‐dilatation.

Interventions

Control: optical urethrotomy (n = 30)

Treatment: optical urethrotomy then intermittent self‐dilatation for 1 year (n = 30)

Outcomes

PROs: no.

Health economic: no.

Adverse events:

Control: 3 UTI; 1 epididymitis

Treatment: 4 UTI, zero epididymitis.

Acceptability: no objective assessment. Quote 'All of the patients who completed the prescribed CISC program considered the method fully acceptable.'

Recurrence rate:

Number of men with recurrent urethral stricture 12 months after optical urethrotomy.

Definition of recurrence: cystoscopy.

Control: 12/26

Treatment: 4/22

P < 0.01

Time to recurrence: no

Notes

intermittent self‐dilatation: twice a day for 1 week, once a day for 4 weeks, then weekly for one year.

Withdrawals:

Control: 4 (2 DNA, 1 emigration, 2 symptomatic declined cystoscopy)

Treatment: 8 (4 DNA, 1 death, 3 unable to perform intermittent self‐dilatation)

Subgroups: no.

Large sections of this paper including the results are described verbatim in Kjaergaard 1994; numbers similar.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote 'randomly divided into treatment group and control group.'

Insuffucient information to make judgement.

Allocation concealment (selection bias)

High risk

Not stated. Probably not done.

Blinding (performance bias and detection bias)
All outcomes

High risk

Not stated.

Impossible to blind participants.

Outcome assessors probably not blind.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Number of participants withdrawn from treatment arm enough to impact effect estimate.

Selective reporting (reporting bias)

Low risk

Expected outcomes reported.

Funding/COI

Unclear risk

Not stated.

Kjaergaard 1994

Methods

Full text.

August 1987 ‐ August 1991.

Objective: investigate the effect of intermittent self‐dilatation on the prevention of urethral stricture after optical urethrotomy.

States randomised.

Statistical methods: Life‐table, logrank, Fisher's exact test.

Participants

Denmark.

55 men with anterior urethral stricture.

Age: range 28‐85 (median 68)

Exclusions: prostate or bladder cancer, inability to learn intermittent self‐dilatation.

Interventions

Control: optical urethrotomy (n = 24)

Treatment: optical urethrotomy then intermittent self‐dilatation for 1 year (n = 31).

Outcomes

PROs: no

Health economic: no

Adverse events:

Number of men with positive urine culture or epididymitis

Control: 5/22

Treatment: 1/21

P = 0.4

Acceptability:

Not objectively assessed. Quote 'All of the patients who completed the prescribed CIC programme considered the method fully acceptable.'

Recurrence rate:

Number of men with recurrent urethral stricture 12 months after optical urethrotomy.

Definition of recurrence: cystoscopy.

Control: 15/22

Treatment: 4/21

P < 0.01

Notes

intermittent self‐dilatation programme: weekly.

Withdrawals:

Control: 2 (2 protocol violation)

Treatment: 10 (4 DNA, 1 death, 1 rUTI, 4 unable to perform intermittent self‐dilatation)

Subgroups: no.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Method of randomisation is unclear. Insufficient detail to make a judgement.

Allocation concealment (selection bias)

High risk

Not stated. Probably not done.

Blinding (performance bias and detection bias)
All outcomes

High risk

Not stated. Probably not done.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Number of participants withdrawn from treatment arm enough to impact effect estimate.

Selective reporting (reporting bias)

High risk

Pre‐stated outcomes not reported: time to recurrence; second year data.

Funding/COI

Unclear risk

Astra Meditec Limited, Denmark supplied LoFric catheters for this study.

Matanhelia 1995

Methods

Full text.

1989‐1991.

No stated objective.

States randomly allocated; no details.

Statistical methods: Log rank x2

Participants

UK.

51 men with anterior urethral stricture.

Age: not stated.

Exlcusions: not stated.

Interventions

Control: optical urethrotomy (n = 21)

Treatment: optical urethrotomy then intermittent self‐dilatation for 3 months (n = 23)

Outcomes

PROs: no

Health economic: no

Adverse events:

Zero UTI intermittent self‐dilatation arm. Quote 'none developed urinary tract infections.'

Acceptability:

No objective assessment. Quote 'patients generally found the procedure acceptable.'

Recurrence rate:

Number of men with recurrent urethral stricture 12 months after optical urethrotomy.

Definition of recurrence: flow rate < 12 ml/s.

Control: 8/21

Treatment: 6/23

Time to recurrence: no

Notes

intermittent self‐dilatation programme: twice daily for 2 weeks, daily for 3 weeks, twice weekly for 3 weeks, weekly for 4 weeks.

Withdrawals:

7 (6 DNA, 1 death); not stratified by arm.

Subgroups:

First or recurrent stricture.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: 'Patients were randomly allocated.' No further details.

Allocation concealment (selection bias)

High risk

Not described. Probably not done.

Blinding (performance bias and detection bias)
All outcomes

High risk

Not stated. Probably not done.

Incomplete outcome data (attrition bias)
All outcomes

High risk

6/51 patients entered into the trial did not attend follow‐up, allocation unspecified. Sufficient to impact on intervention effect.

Selective reporting (reporting bias)

High risk

No pre‐stated objective. UTI data incompletely reported.

Funding/COI

Unclear risk

Not stated.

Ngugi 2007

Methods

Full text.

October 1998 ‐ June 1999.

Objective: compare clean intermittent self catheterisation and urethral dilation with sounds in the management of recurrent urethral strictures.

Randomised study; random number sequence generated by computer.

Statistical methods: Chi2, Fisher's exact test.

Participants

Kenya.

49 male patients with recurrent urethral stricture.

Age: range 15‐75; mean Control 40.0, Treatment 40.7

Exclusions: none stated.

Interventions

Control (Group B): dilatation with sounds at 1, 3 and 6 months (n = 22)

Treatment (Group A): intermittent self‐dilatation for 6 months (n = 27)

Outcomes

PROs: quality of life; non‐validated questionnaire; at 1, 3 and 6 months.

Respectively:

Control: 6/22, 15/17, 12/15 unhappy

Treatment: 0/25, 3/25, 3/20 unhappy

P = 0.01, 0.01, 0.12

Health economic: no

Adverse events:

No objective assessment. Quote 'higher rate of infection in the dilatation group at 3 and 6 months.'

Acceptability: no.

Recurrence rate: no.

Flowrate:

At baseline (preoperative), 1, 3 and 6 months.

Respectively:

Control mean: 9.9 ± 10.7, 8.2 ± 3.9, 5.4 ± 3.4, 7.7 ± 2.7 ml/s

Treatment mean: 11.7 ± 10.9, 18.9 ± 9.9, 18.9 ± 9.8, 18.6 ± 11.5 ml/s

P = 0.80, 0.0002, 0.0002, 0.002

Notes

intermittent self‐dilatation programme: twice daily.

Withdrawals: unclear: states 13 and 10 lost to follow‐up at 3 and 6 months respectively, does not tally with results table.

Subgroups: no

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random number sequence generated by computer. Probably done.

Allocation concealment (selection bias)

High risk

Not described. Probably not done.

Blinding (performance bias and detection bias)
All outcomes

High risk

No details. Probably not done.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Flowrate means and unspecified measure of dispersion given. Quality of Life (QoL) data missing for 14/49 patients at 6 months. Report states n = 10 and 13 lost to follow‐up at 3 and 6 months respectively.

Selective reporting (reporting bias)

High risk

Non‐specific pre‐stated objective. QoL Likert‐type scale stated in methods but not presented in results.

Funding/COI

Unclear risk

Not stated.

Sallami 2011

Methods

Full text.

August 2005 ‐ February 2008.

Objective: compare intermittent self‐dilatation after optical urethrotomy for urethral stricture using a low‐friction hydrophilic catheter (LoFric) or standard Nelaton polyvinyl chloride (PVC) catheter.

States block randomisation.

Statistical methods: Life table, log rank, Chi2.

Participants

Tunisia.

62 men with anterior or posterior urethral stricture < 2cm.

Age: range 21‐86; mean Control 60.9, Treatment 62

Exclusions: prostate or bladder cancer, patients requiring antibiotic prophylaxis, need for CISC for bladder drainage, incapable of following study protocol.

Interventions

Control: optical urethrotomy then intermittent self‐dilatation with Nelaton catheter (n = 31).

Treatment: optical urethrotomy then intermittent self‐dilatation with LoFric catheter (n = 31).

Outcomes

PROs:

Ease of use after 6 catheter insertions: 5‐item VAS non‐validated questionnaire (trouble, convenience, pain, comfort, general opinion).

Mean pain, comfort and opinion scores favoured LoFric; trouble and convenience NS.

Health economic: no

Adverse events:

Control: 7 (1 prostatitis, 2 bleeding, 4 positive urine culture)

Treatment: 1 positive urine culture

Acceptability:

Number of men who considered the treatment acceptable.

Means of assessment of acceptability to patients not described.

Control: 7/28

Treatment 30/31

Recurrence rate:

Definition of recurrence: flow rate < 14 ml/s

Number of men with recurrent urethral stricture 2 years after optical urethrotomy.

Control: 7/28

Treatment: 2/31

P = 0.15

Time to recurrence: no.

Notes

intermittent self‐dilatation programme: twice monthly for 3 months then monthly for 1 year

Witdrawals: n = 3 Nelaton arm (1 DNA, 2 rUTI).

Authors conclude: LoFric catheter significantly increased the degree of comfort and satisfaction and decreased the feeling of pain when the catheter was removed or inserted, when compared with a conventional PVC catheter.

Note: Results state only 10/31 in treatment arm able to perform intermittent self‐dilatation at home without problems.

Subgroups: no.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

States block randomisation. No further details.

Allocation concealment (selection bias)

High risk

Not stated. Probably not done.

Blinding (performance bias and detection bias)
All outcomes

High risk

Not stated. Probably not done.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

3 control group patients withdrawn (2 UTI, 1 DNA); none from the treatment group.

Selective reporting (reporting bias)

High risk

Time to first recurrence analysis stated in Methods but not reported in Results.

Results conflict with statement that only 10/31 in treatment arm able to perform intermittent self‐dilatation at home without problems.

Funding/COI

Unclear risk

Not stated.

Tammela 1993

Methods

Full text.

Objective: compare the effect of treatment of urethral stricture by optical urethrotomy followed by intermittent self‐dilatation for 6 versus 12 months.

Randomised study; method of randomisation not described.

Statistical methods: Student's t test, Chi2.

Participants

Finland.

49 men with recurrent urethral stricture.

Age: mean Group A 58, Group B 62

Exlcusions: prostate or bladder cancer, scarred prostatic urethra; inadequate vision, dexterity, mental capacity.

Interventions

Group A: optical urethrotomy and intermittent self‐dilatation for 12 months (n = 24).

Group B: optical urethrotomy and intermittent self‐dilatation for 6 months (n = 25).

Outcomes

PROs: no.

Health economic: no.

Adverse events:

Asymptomatic bacteruria n = 10/48

Symptomatic bacteruria n = 2/48

Acceptability: 1/48 unable to perform intermittent self‐dilatation.

Recurrence rate:

Number of men with recurrent urethral stricture 1 year after optical urethrotomy

Definition of recurrence: need for further treatment.

Group A: 3/24

Group B: 2/24

All recurrences occurred > 6 months therefore number of men with recurrent urethral stricture 6 months ‐ 1 year after optical urethrotomy:

Group A (intermittent self‐dilatation): 3/24

Group B (no intermittent self‐dilatation): 2/24

Flowrate:

3, 6, 9 and 12 months after optical urethrotomy.

Group A mean: 18 ± 7, 17 ± 9, 17 ± 3, 18 ± 6 ml/s

Group B mean: 17 ± 6, 17 ± 7, 14 ± 7, 12.5 ± 3 ml/s

At 12 months p < 0.05

Notes

intermittent self‐dilatation: twice weekly for 1 month then weekly.

Withdrawals: n = 1 (Group B) unable to perform intermittent self‐dilatation at home.

Subgroups: no.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

States randomised into 2 groups. No further details.

Allocation concealment (selection bias)

High risk

Not stated. Probably not done.

Blinding (performance bias and detection bias)
All outcomes

High risk

Not stated. Probably not done.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Means and SD presented only.

Selective reporting (reporting bias)

Low risk

Expected outcomes reported.

Funding/COI

Unclear risk

Not stated.

Abbreviations

CISC clean intermittent self‐catherisation

CONSORT Consolidated Standards of Reporting Trials

DNA did not attend

ISD intermittent self‐dilatation

LUTS lower urinary tract symptoms

NS Not statistically‐significant

PRO patient‐reported outcome

PROM patient‐reported outcome measure

PVC polyvinyl chloride

QALY quality‐adjusted life year

QoL quality of life

rUTI recurrent urinary tract infection

VAS visual analogue scale

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Kaisary 1985

Full text.

Evaluates technique called 'hydraulic self‐dilatation' (manual occlusion of the meatus during voiding) following optical urethrotomy.

Not intermittent self‐dilatation.

Khalid 2007

Abstract only. Full text sought from author and publisher and not available.

Probably observational case series of optical urethrotomy plus intermittent self‐dilatation.

Probably non‐randomised study.

Suhail 2011

Abstract only. Full text sought from author and publisher and not available.

Evaluates optical urethrotomy versus optical urethrotomy then intermittent self‐dilatation. Described as comparative cross‐sectional study. Participants 'divided into groups.'

Probably non‐randomised study.

Tunc 2002

Full text.

Optical urethrotomy alone versus serial urethral dilatation performed by a surgeon.

Not intermittent self‐dilatation.

Data and analyses

Open in table viewer
Comparison 1. ISD versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Recurrent urethral stricture Show forest plot

6

404

Risk Ratio (M‐H, Random, 95% CI)

0.70 [0.48, 1.00]

Analysis 1.1

Comparison 1 ISD versus no treatment, Outcome 1 Recurrent urethral stricture.

Comparison 1 ISD versus no treatment, Outcome 1 Recurrent urethral stricture.

2 Adverse events Show forest plot

2

91

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.11, 3.26]

Analysis 1.2

Comparison 1 ISD versus no treatment, Outcome 2 Adverse events.

Comparison 1 ISD versus no treatment, Outcome 2 Adverse events.

2.1 Urinary tract infection/bacteriuria

2

91

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.11, 3.26]

Open in table viewer
Comparison 2. One programme of ISD versus another

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Recurrent urethral stricture Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

Analysis 2.1

Comparison 2 One programme of ISD versus another, Outcome 1 Recurrent urethral stricture.

Comparison 2 One programme of ISD versus another, Outcome 1 Recurrent urethral stricture.

1.1 Short duration versus long duration of treatment

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 3. One device for ISD versus another

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Recurrent urethral stricture (type of catheter) Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

Analysis 3.1

Comparison 3 One device for ISD versus another, Outcome 1 Recurrent urethral stricture (type of catheter).

Comparison 3 One device for ISD versus another, Outcome 1 Recurrent urethral stricture (type of catheter).

1.1 LoFric vs PVC

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2 Recurrent urethral stricture (catheter lubrication) Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

Analysis 3.2

Comparison 3 One device for ISD versus another, Outcome 2 Recurrent urethral stricture (catheter lubrication).

Comparison 3 One device for ISD versus another, Outcome 2 Recurrent urethral stricture (catheter lubrication).

2.1 Triamcinolone gel versus water‐based lubricant

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3 Adverse events Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

Analysis 3.3

Comparison 3 One device for ISD versus another, Outcome 3 Adverse events.

Comparison 3 One device for ISD versus another, Outcome 3 Adverse events.

PRISMA study flow diagram
Figuras y tablas -
Figure 1

PRISMA study flow diagram

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 ISD versus no treatment, Outcome 1 Recurrent urethral stricture.
Figuras y tablas -
Analysis 1.1

Comparison 1 ISD versus no treatment, Outcome 1 Recurrent urethral stricture.

Comparison 1 ISD versus no treatment, Outcome 2 Adverse events.
Figuras y tablas -
Analysis 1.2

Comparison 1 ISD versus no treatment, Outcome 2 Adverse events.

Comparison 2 One programme of ISD versus another, Outcome 1 Recurrent urethral stricture.
Figuras y tablas -
Analysis 2.1

Comparison 2 One programme of ISD versus another, Outcome 1 Recurrent urethral stricture.

Comparison 3 One device for ISD versus another, Outcome 1 Recurrent urethral stricture (type of catheter).
Figuras y tablas -
Analysis 3.1

Comparison 3 One device for ISD versus another, Outcome 1 Recurrent urethral stricture (type of catheter).

Comparison 3 One device for ISD versus another, Outcome 2 Recurrent urethral stricture (catheter lubrication).
Figuras y tablas -
Analysis 3.2

Comparison 3 One device for ISD versus another, Outcome 2 Recurrent urethral stricture (catheter lubrication).

Comparison 3 One device for ISD versus another, Outcome 3 Adverse events.
Figuras y tablas -
Analysis 3.3

Comparison 3 One device for ISD versus another, Outcome 3 Adverse events.

Summary of findings for the main comparison. Intermittent self‐dilatation compared to no treatment for males after urethral stricture surgery

Intermittent self‐dilatation compared to no treatment for males after urethral stricture surgery

Population: males after urethral stricture surgery
Intervention: intermittent self‐dilatation
Comparison: no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

No treatment

Intermittent self‐dilatation

Recurrent urethral stricture
Follow‐up: 8‐24 months

618 per 1000

433 per 1000
(297 to 618)

RR 0.7
(0.48 to 1)

404
(6 studies)

⊕⊝⊝⊝
very low1,2,3

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Downgraded by two for risk of bias: all six trials comprising the quantitative synthesis were judged high risk of bias in two or more domains.
2 Downgraded by two for inconsistency: the point estimates of the effect size vary widely; the statistical test for heterogeneity is highly significant (P = 0.003), and the I2 is large (72%).
3 Downgraded by two for imprecision: the total number of events was less than 300 and the 95% confidence interval of the effect size is 0.48 to 1.00 (> 50% and includes the line of no effect).

Figuras y tablas -
Summary of findings for the main comparison. Intermittent self‐dilatation compared to no treatment for males after urethral stricture surgery
Comparison 1. ISD versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Recurrent urethral stricture Show forest plot

6

404

Risk Ratio (M‐H, Random, 95% CI)

0.70 [0.48, 1.00]

2 Adverse events Show forest plot

2

91

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.11, 3.26]

2.1 Urinary tract infection/bacteriuria

2

91

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.11, 3.26]

Figuras y tablas -
Comparison 1. ISD versus no treatment
Comparison 2. One programme of ISD versus another

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Recurrent urethral stricture Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.1 Short duration versus long duration of treatment

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 2. One programme of ISD versus another
Comparison 3. One device for ISD versus another

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Recurrent urethral stricture (type of catheter) Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.1 LoFric vs PVC

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2 Recurrent urethral stricture (catheter lubrication) Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

2.1 Triamcinolone gel versus water‐based lubricant

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3 Adverse events Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

Figuras y tablas -
Comparison 3. One device for ISD versus another