New concept for treating urinary incontinence after radical prostatectomy with radiofrequency: phase 1 clinical trial
To describe the clinical response and side effects of radiofrequency treatment in patients with urinary incontinence after radical prostatectomy. This is a phase 1 clinical trial with 10 men up to 65 years of age who had urinary incontinence after radical prostatectomy, post void residual volume < 50 ml verified by ultrasonography, pad test ≥ 1 g, and PSA < 0.2 ng/ml. pad test and self-administered questionnaires were used to assess clinical response. Scales were used to measure treatment satisfaction and improvement in symptoms. Participants underwent five sessions of 2 min of non-ablative endoanal radiofrequency (41 °C). The evaluated co-primary endpoints were urinary incontinence volume and urinary symptoms, analyzed by the Wilcoxon nonparametric test; residual volume, and self-reports to assess safety. The participants’ mean age was 57.5 ± 4.9. The initial pad test score was 6.5 g (1.7–50.0) with a final score of 2.0 g (0.0–9.0) (p < 0.01). Ultrasonography showed no alteration of residual volume. A decrease of urinary loss was found in nine patients, three of them showed a complete resolution of urinary loss. A decrease in irritative micturition symptoms was found as well, but no improvement in the quality of life was shown. Regarding treatment satisfaction, two patients were neutral, six satisfied, and two very satisfied. Limitations included pain while the endoanal electrode was inserted. Four patients indicated pain during treatment, but overall results were positive. The reduction of urinary loss and irritative micturition symptoms increased patients’ satisfaction scores, without improving their perception of quality of life.
KeywordsProstatectomy Radiofrequency Urinary incontinence
Government agency – FAPESB (Fundação de Amparo à Pesquisa do Estado da Bahia) by PRONEM 010/2014.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
All procedures performed were in accordance with the ethical standards of the institutional and/or national research committee and with the Declaration of Helsinki of 1964 and its later amendments or comparable ethical standards. The study was approved by the Research Ethics Committee of the Bahiana School of Medicine and Public Health (CAAE: 58851916.9.0000.5544) and registered at ClinicalTrials.gov (NTR: 03048799) as a randomized clinical trial preceded by a pilot study.
Informed consent was obtained from the patients included in the study.
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