Técnicas, estrategias y diseños de sondas intermitentes para el tratamiento de las afecciones vesicales crónicas
Appendices
Appendix 1. Glossary of terms
| Aseptic technique | In healthcare, an aseptic technique is a set of specific practices and procedures used to ensure that susceptible sites (e.g. open wounds or insertion sites of invasive devices) or sterile equipment/devices (e.g. catheters) are not contaminated with microorganisms during a procedure (Loveday 2014). It is used in healthcare when undertaking bladder catheterisation procedures. |
| Catheter design | Different sizes, lengths, tips, presentation (e.g. protective sleeve, pre‐lubrication, integrated collection bag) and coatings |
| Catheter materials | The base material of the catheter (e.g. PVC, PVC‐free, latex), and the presence or not of a bonded coating (e.g. hydrophilic) |
| Multiple‐use catheter | A sterile or clean uncoated catheter, which may be re‐used after decontaminating |
| Clean technique | A clean technique is used for intermittent self‐catheterisation, where a sterile or clean (multiple‐use) catheter is inserted with clean, ungloved hands and with or without a cleansing solution (soap and water, or water alone) and clean or sterile lubricant.
|
| Hydrophilic‐ coated catheter | A type of catheter with a slippery coating designed to ease catheter insertion and may (according to the manufacturers) reduce urethral trauma and UTI. The most common hydrophilic coating is either supplied ready to use, or requires the addition of water at the time of use to form a lubricious layer. |
| Sterile catheter | Sterile single‐use catheter |
| Symptomatic UTI | The presence of symptoms or signs compatible with UTI (not including odorous or cloudy urine alone) with no other identified source of infection along with ≥103 CFU/mL of 1 bacterial species in a single catheter urine specimen (IDSA 2009) |
| Uncoated catheter | Typically clear PVC, uncoated catheters are packed singly in sterile packaging. They may be supplied pre‐lubricated, used with a separate lubricant or with just water to aid insertion. |
Appendix 2. Search of the Cochrane Incontinence Specialised Register
The Cochrane Incontinence Specialised Register was searched using the Group's own keyword system. The search terms used are given below:
topic.urine.incon*
AND
(design.cct* OR design.rct*)
AND
intvent.mech.cath*
All searches were of the keyword field of EndNote 2018.
PRISMA study flow diagram
'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.
Comparison 1: Aseptic versus clean technique, Outcome 1: Symptomatic UTI
Comparison 2: Single‐use catheter (sterile) versus multiple‐use catheter (clean), Outcome 1: Symptomatic UTI
Comparison 3: Hydrophilic‐coated catheter (single‐use) versus uncoated catheter (single use), Outcome 1: Symptomatic UTI
Comparison 3: Hydrophilic‐coated catheter (single‐use) versus uncoated catheter (single use), Outcome 2: Adverse effects: number with urethral trauma/bleeding
Comparison 3: Hydrophilic‐coated catheter (single‐use) versus uncoated catheter (single use), Outcome 3: Satisfaction
| Aseptic technique compared to clean technique for long‐term bladder management | ||||||
| Patient or population: long‐term bladder management | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with clean technique | Risk with aseptic technique | |||||
| Number with symptomatic UTI Follow‐up: 12 months | Study population | RR 1.20 | 36 | ⊕⊕⊝⊝ | 75 more per 1000 people will have symptomatic UTI with aseptic technique (173 fewer to 623 more) | |
| 375 per 1000 | 450 per 1000 | |||||
| Adverse effects (urethral trauma/bleeding/haematuria) | Not reported | |||||
| Participant‐assessed outcome(satisfaction) | Not reported | |||||
| Participant‐assessed outcome(preference) | Not reported | |||||
| Cost‐effectiveness | Not reported | |||||
| *The risk in the intervention group (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). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Downgraded two levels for imprecision: few participants | ||||||
| Single‐use (sterile) catheter compared to multiple‐use (clean) catheter for long‐term bladder management | ||||||
| Patient or population: long‐term bladder management | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with multiple‐use (clean) catheter | Risk with Single‐use (sterile) catheter | |||||
| Number with symptomatic UTI1 Follow‐up: range two to four months | Study population | RR 0.98 | 97 | ⊕⊕⊝⊝ | 6 fewer per 1000 people will have symptomatic UTI with single‐use catheter (144 fewer to 237 more) | |
| 320 per 1000 | 314 per 1000 | |||||
| Participant‐assessed outcome(satisfaction) | Not reported | |||||
| Participant‐assessed outcome(preference) | Not reported | |||||
| Adverse effects (urethral trauma/bleeding/haematuria): Follow‐up to 2 months | One study reported zero adverse events in both arms. | |||||
| Cost‐effectiveness | Not reported | |||||
| *The risk in the intervention group (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). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Included one cross‐over study; data used from first treatment period only (22 participants) 2 Downgraded two levels due to serious imprecision: few participants and wide 95% CI consistent with possible benefit and possible harm | ||||||
| Hydrophilic‐coated catheter compared to uncoated catheter for long‐term bladder management | ||||||
| Patient or population: long‐term bladder management | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with uncoated | Risk with Hydrophilic‐coated | |||||
| Number with symptomatic UTI Follow‐up: range two to 12 months | Study population | RR 0.89 | 98 | ⊕⊕⊝⊝ | 80 fewer per 1000 people will have symptomatic UTI with hydrophilic‐coated catheter (225 fewer to 101 more) | |
| 725 per 1000 | 645 per 1000 | |||||
| Adverse effects (urethral trauma/bleeding/haematuria) Follow‐up: range two to 12 months
| Study population | RR 1.37 | 400 | ⊕⊕⊕⊝ | 74 more per 1000 people will have urethral trauma, bleeding or haematuria with hydrophilic‐coated catheter (2 more to 174 more) | |
| 200 per 1000 | 274 per 1000 | |||||
| Participant‐assessed outcome (satisfaction) (higher score = greater satisfaction) Follow‐up: 6 months | The mean participant‐assessed score for satisfaction (higher score = greater satisfaction) was 8.6 in the uncoated catheter group | MD 0.7 higher | ‐ | 114 | ⊕⊝⊝⊝ |
|
| Participant‐assessed outcome (preference) Follow‐up: 20 sets of each catheter used | One cross‐over trial, reported greater preference for a hydrophilic‐coated catheter (19/29) compared to an uncoated catheter (10/29). | ‐ | 29 |
|
| |
| Cost‐effectiveness | Not reported | |||||
| *The risk in the intervention group (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). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Downgraded one level due to serious risk of bias: outcomes could have been influenced by lack of blinding. 2 Downgraded one level due to serious imprecision: small sample sizes 3 Downgraded one level due to serious risk of performance, detection and attrition bias 4 Downgraded one level due to serious risk of performance and attrition bias 5 Downgraded two levels due to very serious imprecision: few participants | ||||||
| Study | Intervention | Comparator |
| Comparison one: aseptic technique versus clean technique | ||
| Sterile: single‐use catheter | Clean: multiple‐use catheter | |
| Sterile: single‐use catheter | Clean: multiple‐use catheter | |
| Sterile: single‐use catheter | Clean: single‐use catheter | |
| Sterile: Single‐use catheter with an integrated bag | Clean: multiple‐use catheter | |
| Comparison two: single‐use catheter (sterile) versus multiple‐use catheter (clean) | ||
| Single‐use (hydrophilic‐coated) | Multiple‐use (uncoated) Clean catheters re‐used for one week | |
| Single‐use (uncoated) | Multiple‐use Number of re‐uses not described | |
| Single‐use (uncoated) | Multiple‐use Number of re‐uses not described | |
| Single‐use (uncoated) | Multiple‐use Number of re‐uses not described | |
| Single‐use (hydrophilic‐coated) | Multiple‐use (uncoated) Clean catheters re‐used for one day | |
| Comparison three: hydrophilic‐coated catheter versus uncoated catheter | ||
| Single‐use coated | Single‐use uncoated | |
| Single‐use coated | Single‐use uncoated | |
| Single‐use coated | Single‐use uncoated | |
| Single‐use coated | Single‐use uncoated | |
| Single‐use coated | Multiple‐use uncoated | |
| Single‐use coated | Single‐use uncoated | |
| Single‐use coated | Single‐use uncoated | |
| Single‐use coated | Single‐use uncoated | |
| Single‐use coated | Multiple‐use uncoated | |
| Comparison four: one catheter length versus another catheter length | ||
| Short‐ength hydrophilic‐coated catheter | Standard‐length (various designs) | |
| Short‐length hydrophilic‐coated catheter | Standard‐length hydrophilic‐coated catheter | |
| Short‐length hydrophilic‐coated catheter | Standard‐length (various designs) | |
| Short‐length (30 cm) uncoated, pre‐lubricated closed system with integrated collection bag | Standard‐length (40 cm) uncoated, pre‐lubricated closed system with integrated collection bag | |
| Short‐length hydrophilic‐coated catheter | Standard‐length hydrophilic‐coated catheter | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Symptomatic UTI Show forest plot | 1 | 36 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.20 [0.54, 2.66] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Symptomatic UTI Show forest plot | 2 | 97 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.98 [0.55, 1.74] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Symptomatic UTI Show forest plot | 2 | 98 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.89 [0.69, 1.14] |
| 3.2 Adverse effects: number with urethral trauma/bleeding Show forest plot | 4 | 430 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.37 [1.01, 1.87] |
| 3.3 Satisfaction Show forest plot | 1 | 114 | Mean Difference (IV, Fixed, 95% CI) | 0.70 [0.19, 1.21] |
