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. 2015 Mar 18;2015(3):CD010217.
doi: 10.1002/14651858.CD010217.pub2.

Transurethral radiofrequency collagen denaturation for the treatment of women with urinary incontinence

Diana Kang  1 , Julia Han, Molly M Neuberger, M Louis Moy, Sheila A Wallace, Pablo Alonso-Coello, Philipp Dahm
Affiliations

Transurethral radiofrequency collagen denaturation for the treatment of women with urinary incontinence

Diana Kang et al. Cochrane Database Syst Rev. .

Abstract

Background: Transurethral radiofrequency collagen denaturation is a relatively novel, minimally invasive device-based intervention used to treat individuals with urinary incontinence (UI). No systematic review of the evidence supporting its use has been published to date.

Objectives: To evaluate the efficacy of transurethral radiofrequency collagen denaturation, compared with other interventions, in the treatment of women with UI.Review authors sought to compare the following.• Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment.• Transurethral radiofrequency collagen denaturation versus conservative physical treatment.• Transurethral radiofrequency collagen denaturation versus mechanical devices (pessaries for UI).• Transurethral radiofrequency collagen denaturation versus drug treatment.• Transurethral radiofrequency collagen denaturation versus injectable treatment for UI.• Transurethral radiofrequency collagen denaturation versus other surgery for UI.

Search methods: We conducted a systematic search of the Cochrane Incontinence Group Specialised Register (searched 19 December 2014), EMBASE and EMBASE Classic (January 1947 to 2014 Week 50), Google Scholar and three trials registries in December 2014, along with reference checking. We sought to identify unpublished studies by handsearching abstracts of major gynaecology and urology meetings, and by contacting experts in the field and the device manufacturer.

Selection criteria: Randomised and quasi-randomised trials of transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, conservative physical treatment, mechanical devices, drug treatment, injectable treatment for UI or other surgery for UI in women were eligible.

Data collection and analysis: We screened search results and selected eligible studies for inclusion. We assessed risk of bias and analysed dichotomous variables as risk ratios (RRs) with 95% confidence intervals (CIs) and continuous variables as mean differences (MDs) with 95% CIs. We rated the quality of evidence using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach.

Main results: We included in the analysis one small sham-controlled randomised trial of 173 women performed in the United States. Participants enrolled in this study had been diagnosed with stress UI and were randomly assigned to transurethral radiofrequency collagen denaturation (treatment) or a sham surgery using a non-functioning catheter (no treatment). Mean age of participants in the 12-month multi-centre trial was 50 years (range 22 to 76 years).Of three patient-important primary outcomes selected for this systematic review, the number of women reporting UI symptoms after intervention was not reported. No serious adverse events were reported for the transurethral radiofrequency collagen denaturation arm or the sham treatment arm during the 12-month trial. Owing to high risk of bias and imprecision, we downgraded the quality of evidence for this outcome to low. The effect of transurethral radiofrequency collagen denaturation on the number of women with an incontinence quality of life (I-QOL) score improvement ≥ 10 points at 12 months was as follows: RR 1.11, 95% CI 0.77 to 1.62; participants = 142, but the confidence interval was wide. For this outcome, the quality of evidence was also low as the result of high risk of bias and imprecision.We found no evidence on the number of women undergoing repeat continence surgery. The risk of other adverse events (pain/dysuria (RR 5.73, 95% CI 0.75 to 43.70; participants = 173); new detrusor overactivity (RR 1.36, 95% CI 0.63 to 2.93; participants = 173); and urinary tract infection (RR 0.95, 95% CI 0.24 to 3.86; participants = 173) could not be established reliably as the trial was small. Evidence was insufficient for assessment of whether use of transurethral radiofrequency collagen denaturation was associated with an increased rate of urinary retention, haematuria and hesitancy compared with sham treatment in 173 participants. The GRADE quality of evidence for all other adverse events with available evidence was low as the result of high risk of bias and imprecision.We found no evidence to inform comparisons of transurethral radiofrequency collagen denaturation with conservative physical treatment, mechanical devices, drug treatment, injectable treatment for UI or other surgery for UI.

Authors' conclusions: It is not known whether transurethral radiofrequency collagen denaturation, as compared with sham treatment, improves patient-reported symptoms of UI. Evidence is insufficient to show whether the procedure improves disease-specific quality of life. Evidence is also insufficient to show whether the procedure causes serious adverse events or other adverse events in comparison with sham treatment, and no evidence was found for comparison with any other method of treatment for UI.

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Conflict of interest statement

D Kang: none known.

J Han: none known.

MM Neuberger: none known.

ML Moy: none known.

SA Wallace: none known.

P Alonso‐Coello: none known.

P Dahm: none known.

Figures

1
1
Study flow diagram.
2
2
Forest plot of comparison: 1 Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, outcome: 1.2 Disease‐specific quality of life: number of women with an I‐QOL score improvement greater than or equal to 10 points at 12 months.
3
3
Forest plot of comparison: 1 Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, outcome: 1.3 Clinician observations: objective measurement of incontinence: change in leak point pressure at 12 months.
4
4
Forest plot of comparison: 1 Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, outcome: 1.4 Other adverse event: pain/dysuria: dysuria.
5
5
Forest plot of comparison: 1 Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, outcome: 1.6 Other adverse event: de novo urinary retention: urinary retention.
6
6
Forest plot of comparison: 1 Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, outcome: 1.8 Other adverse event: haematuria.
1.1
1.1. Analysis
Comparison 1 Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, Outcome 1 Serious adverse events.
1.2
1.2. Analysis
Comparison 1 Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, Outcome 2 Disease‐specific quality of life: number of women with an I‐QOL score improvement ≥ 10 points at 12 months.
1.3
1.3. Analysis
Comparison 1 Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, Outcome 3 Clinician observations: objective measurement of incontinence: change in leak point pressure at 12 months.
1.4
1.4. Analysis
Comparison 1 Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, Outcome 4 Other adverse event: pain/dysuria: dysuria.
1.5
1.5. Analysis
Comparison 1 Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, Outcome 5 Other adverse event: (new) detrusor overactivity: overactive bladder symptoms.
1.6
1.6. Analysis
Comparison 1 Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, Outcome 6 Other adverse event: de novo urinary retention: urinary retention.
1.7
1.7. Analysis
Comparison 1 Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, Outcome 7 Other adverse event: urinary tract infection.
1.8
1.8. Analysis
Comparison 1 Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, Outcome 8 Other adverse event: haematuria.
1.9
1.9. Analysis
Comparison 1 Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, Outcome 9 Other adverse event: hesitancy.
See this image and copyright information in PMC

Update of

References

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References to other published versions of this review

Dahm 2012
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Publication types