Low-temperature heat via the urethra to treat women with urinary leakage

Review question

We studied the question of whether using low-temperature heat via the urethra is safe and helps women with involuntary urinary leakage. We looked for randomised studies comparing this treatment with no treatment or with other treatment forms.

Background

Involuntary urinary leakage is a troubling problem that many women face. Many types of treatment are available to help these women, such as changes in behaviour and different types of surgery. Low-temperature heat via the urethra is a newer form of treatment that can be used to treat women in the office rather than in the operating room. How well this treatment works and how safe it is are not well understood.

Study characteristics

We searched for all randomised controlled trials that studied this form of treatment up to December 2014. We found only one trial of 173 women who were troubled by urinary leakage. On average, these women were 50 years of age. Through random assignment, two-thirds of them were treated with low-temperature heat via the urethra; the others did not receive this treatment. Researchers followed these women for 12 months. The makers of this treatment paid for the study.

Key results

No information revealed whether more or fewer women complained of urinary leakage at 12 months, or whether there was a difference in the number of women having repeat surgery. The study did not show that quality of life was improved. Evidence was insufficient to show whether there was a difference in serious or minor side effects.

Quality of the evidence

Using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach, we found no evidence for the question of whether low-temperature heat via the urethra changed the number of women who leaked. We found low-quality evidence related to serious side effects, minor side effects and quality of life when compared with no treatment because data were limited and the study was poorly conducted. We found no evidence on whether this treatment changed the number of women who underwent another surgery. Because we did not find studies that compared this treatment with other treatments, we do not know whether this treatment results in better or worse outcomes.

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.

Read the full 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 strategy: 

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.

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