Radiofrequency for the treatment of stress urinary incontinence in female: Randomized Clinical Trial

Brasil C1, Teles A1, Lemos N2, Basto Brito M1, Liony C1, Matos J C1, Dória M1, Leony J C1, Lemos L1, Campos R1, Lordelo P1

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 279
Female Incontinence
Scientific Podium Short Oral Session 16
Thursday 30th August 2018
09:27 - 09:35
Hall C
Conservative Treatment New Devices Stress Urinary Incontinence Female Clinical Trial
1. Pelvic Floor Care Center (CAAP), Bahiana School of Medicine and Public Health, 2. University of Toronto
Presenter
C

Cristina Brasil

Links

Abstract

Hypothesis / aims of study
Stress urinary incontinence (SUI) is defined as any involuntary loss of urine in exertion, sneezing or coughing, which affects about 14% to 50% of the female population. Radiofrequency (RF) is a new therapeutic possibility that may aid in one of the pathophysiological mechanisms of SUI which is the decrease of collagen in the urethral walls. Thus, the objective of this study was to verify clinical response, quality of life, sexual function and satisfaction with non-ablative radiofrequency treatment for stress urinary incontinence in women.
Study design, materials and methods
This is a randomized clinical trial. We included women with SUI (Pad Test> 1g), muscle function ³3 on the OXFORD scale, age range between 30 to 59 years and patients at the Center of Attention to the Pelvic Floor. After the consent, an initial evaluation was made composed by anamnesis, voiding diary, muscle function evaluation (PERFECT), 1 hour Pad Test, and the application of the Female Sexual Function Index (FSFI), the SF-36 questionnaire and the King's Health Questionnaire (KING). The women were randomized into two groups, the radiofrequency group (GR) in which 5 sessions of non-ablative monopolar RF were performed in the external urethral meatus (Figure 1), with a temperature of 39-41ºC for 2 minutes, and the control group (CG) that followed the same protocol, however the RF was switched off and coated with heated glycerin. Both performed home exercises. After a week of the last session of RF were reassessed the Pad Test, questionnaires, muscle function, voiding diary and questioned the participants satisfaction with the treatment.
Results
The sample consisted of 13 women in the GR and 9 in the CG, in which they presented homogeneity in sociodemographic and clinical characteristics. There was a reduction in the variability of urinary loss in GR (p = 0.04) with a magnitude of the effect by Cohen's D of 0.960. In the GR, a reduction in urinary loss was observed through voiding diary (p = 0.025), increase of strength, endurance, resistance and fastness of the PERFECT scheme (p <0.05 for all) and positive impact of King questionnaire in the physical, social limitation domains, and severity of symptoms (p <0.05). There was no change in sexual function and quality of life by SF-36. The 11 (88%) GR women reported that they very satisfied.
Interpretation of results
The present study demonstrates a decrease in urinary loss with the use of non-ablative monopolar radiofrequency (RF) in the urethral external meatus, and consequent satisfaction with the treatment of SUI in the short term, without adverse effects. 
The criteria used to evaluate the RF clinical response in the short term were Pad Test of one hour, frequency of urinary loss mentioned by the three-day urinary diary and muscle function. All outcomes showed a clinical improvement in RG, indicating a new therapeutic possibility and without adverse effects.
Concluding message
Non-ablative radiofrequency in urethral external meatus has been proving to be beneficial in the short-term response of SUI treatment, with reduction of urinary loss and improvement of muscle function. RF had no impact on the general quality of life but in the specific quality of life, it presented positive impacts on the physical, social limitation and reduction of the severity of the symptoms. Women treated with RF were satisfied with the treatment.
Figure 1
References
  1. Lordelo P, Vilas Boas A, Sodré D, Lemos A, Tozetto S, Brasil C. New concept for treating female stress urinary incontinence with radiofrequency. Int Braz J Urol. 2017 Sep-Oct;43(5):896-902. doi: 10.1590/S1677-5538.IBJU.2016.0621
  2. Dillon B, Dmochowski R. Radiofrequency for the treatment of stress urinary incontinence in women. Curr Urol Rep. 2009; 10(5):369-74
Disclosures
<span class="text-strong">Funding</span> Foundation for Research Support of the State of Bahia <span class="text-strong">Clinical Trial</span> Yes <span class="text-strong">Registration Number</span> NCT02617797 <span class="text-strong">RCT</span> Yes <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> Committee of Ethics and Research of the Escola Bahiana de Medicina e Saúde Pública <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes