PENILE NON-ABLATIVE RADIOFREQUENCY IN URINARY INCONTINENCE POST-PROSTATECTOMY: PRELIMINARY DATA OF A PILOT STUDY

Mamede C1, Mamede T2, Teles A3, Quibervile A3, Cerqueira M3, Oliveira dos Santos C1, Barros D4, Sodré D3, Santana L2, Coutinho J2, Piason L2, Pavie M5, Vieira M2, Dourado N6, Sodré P7, Godoy Januário P8, Matos R9, Velame R8, Ferreira R2, Gomes T10, Sevani Maggitti V2, Lordelo P2

Research Type

Clinical

Abstract Category

Male Stress Urinary Incontinence (Post Prostatectomy Incontinence)

Abstract 359
Open Discussion ePosters
Scientific Open Discussion Session 5
Wednesday 27th September 2023
12:55 - 13:00 (ePoster Station 2)
Exhibit Hall
Conservative Treatment Male Incontinence Rehabilitation
1. Escola Bahiana de Medicina e Saúde Pública - EBMSP; Instituto Patricia Lordelo - IPL; Universidade do Estado da Bahia - UNEB, 2. Escola Bahiana de Medicina e Saúde Pública - EBMSP; Instituto Patricia Lordelo - IPL, 3. Instituto Patricia Lordelo - IPL, 4. Escola, 5. Escola Bahiana de Medicina e Saúde Pública - EBMSP; Instituto Patricia Lordelo - IPL; Universidade Salvador - UNIFACS, 6. Instituto Patricia Lordelo - IPL; Centro Universitário - UniFTC Salvador, 7. Instituto Patricia Lordelo - IPL; Universidade do Estado da Bahia, 8. Instituto Patricia Lordelo - IPL; Universidade do Estado da Bahia - UNEB, 9. Escola Bahiana de Medicina e Saúde Pública - EBMSP; Instituto Patricia Lordelo - IPL; Centro Universitário - UniFTC Salvador, 10. Escola Bahiana de Medicina e Saúde Pública - EBMSP; Instituto Patricia Lordelo - IPL; Universidade do Salvador - UNIFACS
Presenter
Links

Poster

Abstract

Hypothesis / aims of study
Radiofrequency (RF) is a resource that is characterized by emitting and generating radiation in the electromagnetic spectrum, producing heat by conversion that stimulates an ionic transmission mechanism that leads to increased circulation. We hypothesize that, once this current is applied to the penis, it would provide an improvement in the production of collagen and elastin in the male urethra, which may favor the improvement of voiding function. Based on this, we aim to assess the effect of the non-ablative RF in the voiding function and quality of life of prostatectomized men.
Study design, materials and methods
This is a pilot study with preliminary data. Men aged between 20 and 80 years with complaints of urinary loss after prostatectomy were admitted. Thus, men with less than six months of prostatectomy surgery, history of neurological disease, uncontrolled diabetes mellitus, uncontrolled arterial hypertension, Peyronie's disease, psychiatric disease, as well as those who had anatomical malformations in the genital region or with penile prostheses were excluded. 

In this context, once the informed consent form was signed, the patient was evaluated by a trained researcher and answered a questionnaire with sociodemographic data and basic anamnesis. Then, in a private and individualized room, the participants were instructed to complete the ICIQ-SF questionnaire (International Consultation on Incontinence Questionnaire - Short Form) which is a self-administered questionnaire that assesses the impact of urinary incontinence (UI) on the quality of life and points out the qualification of urinary loss; this instrument is composed of four questions that assess the frequency, severity and impact of UI. In addition, it contains a group of eight questions related to the causes or situations of UI experienced by patients. The maximum score on the ICIQ-SF is 21 points, and each of the three questions can have a score ranging from 0 to 10. There is no universally accepted cut-off point for the ICIQ-SF. However, some studies established a cutoff point to define the presence or absence of urinary incontinence. In the ICIQ-SF, the higher the score, the worse the urinary incontinence and the worse the impact on the person's quality of life.

The SF-36 (The Medical Outcomes Study 36-item Short-Form Health Survey) is a generic health assessment questionnaire that consists of 36 items, encompassed in 8 scales or components: functional capacity (10 items), physical aspects (4 items), pain (2 items), general health status (5 items), vitality (4 items), social aspects (2 items), emotional aspects (3 items), mental health (5 items) and one more question of comparative evaluation between current health conditions and that of a year ago. It evaluates both the negative aspects of health (illness or disease) and the positive aspects (well-being). The score for each domain can vary from 0 to 100, the lower the score in any domain indicates worse health-related quality of life, and the higher scores indicate better health-related quality of life. There is no universally accepted cut-off point in this instrument.

The protocol of the study was: total of 12 sessions of non-ablative RF (IBRAMED, Amparo, São Paulo, Brazil), performed twice a week, with the temperature varying from 39°C till 41°C for two minutes in each side (left and right) of the penis. The patient was positioned in dorsal decubitus, the dispersive plate was covered with disposable transparent PVC film, patient’s penis was positioned on top of the plate and the active capacitive electrode was coated with non-lubricated preservative and water-based gel was added inside and outside of it. 

After the treatment was complete, the patient answered again the ICIQ-SF and SF-36.
Results
According to the data in Table 1, the sample is composed of patients with a mean age of 64.7 years, in terms of skin color, most declared themselves brown (50%). Singles and widowers are the majority each group is formed by 33.3%. Regarding schooling, the majority have incomplete primary education with 66.7%.

In table 2, it is possible to see a median decrease of 1.5 point in the ICIQ-SF, with one patient losing urine less often than before and another patient not losing it at all anymore. The median impact in quality of life also diminished 1.0 point. According to SF-36, the general median score health-related quality of life of the patients got worse.
Interpretation of results
The analysis of the preliminary data indicates that there is a slight tendency of improvement in the urinary incontinence of the patients after the application of non-ablative RF on the penis, but not showing positive difference in SF-36. Despite that, in a closer analysis of the SF-36, it is possible to see that general health and social functioning domains had an increased score.

Non-ablative RF is a technique that uses radiofrequency energy to stimulate collagen and elastin production to improve tissue function, which can help to reduce urinary incontinence.[1] There is some evidence in the literature of benefits of this technique in women through the vaginal canal and in men via the rectum, to reach the bladder neck level and membranous urethra.[1,2] However, the application via rectum can be uncomfortable and surrounded by prejudice for men and their masculinity. In view of this, there is a need to bring new approaches to the treatment of post-prostatectomy urinary incontinence. In the present study, the ICIQ-SF was used as the main instrument to assess the impact of urinary incontinence, In the descriptive analysis, an improvement was observed in the three questions of the ICIQ-SF because of that we can hypothesize that penile non-ablative RF can benefit some patients with post-prostatectomy urinary incontinence. 

Despite the potential benefits of non-ablative RF in the management of urinary incontinence,[1-3] its application to the penis needs to be better understood due to the specificity of the male urethra, which is very different from the female urethra, mainly in length, being five to six times longer. Urethral length should be a resisting factor for urine leakage, but in men with post-prostatectomy urinary incontinence this mechanism does not prevent urine leakage due to the scarf in the bladder neck, inner sphincter lesion and possible nerve lesion.[1,3] Perhaps if the RF could reach also the membranous urethra – not only  the spongy urethra - results could be better.
Concluding message
Although the results showed a small positive clinical change in our sample, we believe that RF applied in this modality deserves new, better designed studies so that there is a better understanding of its clinical effects and that it can contribute to the management of urinary incontinence post-prostatectomy.
Figure 1 Table 1: Sociodemographic data of the research group.
Figure 2 Table 2: Data collected from the ICIQ-SF and SF-36 at assessment and reassessment.
References
  1. Sodré DSM, Sodré PRS, Brasil C, Teles A, Dória M, Café LE, et al. New concept for treating urinary incontinence after radical prostatectomy with radiofrequency: phase 1 clinical trial. Lasers in Medical Science [Internet]. 2019 Dec 1;34(9):1865–71. Available from: https://pubmed.ncbi.nlm.nih.gov/30989457/2.
  2. Lordelo P, Boas AV, 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(05):1–7. https://doi.org/10.1590/S1677-5538.IBJU.2016.0621.
  3. 3. Boellaard TN , Hagens MJ , Veerman H, Yakar D , Mertens LS, Heijmink SWTJ et al. Prostate MRI for Improving Personalized Risk Prediction of Incontinence and Surgical Planning: The Role of Membranous Urethral Length Measurements and the Use of 3D Models. Life (Basel). 2023 Mar 19;13(3):830. doi: 10.3390/life13030830.
Disclosures
Funding Company IBRAMED. the company OMNI Diagnostics Solutions by Image, which provided the ultrasound equipment for the development of the research; the company FLUKKA, which provided the medication for the development of the research; Secretaria Municipal de Saúde de Salvador - Service Provision Agreement No. 460/2021; Instituto Patricia Lordelo-IPL; Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-CAPES; Conselho Nacional de Desenvolvimento Científico e Tecnológico-CNPQ; Clinical Trial Yes Public Registry No RCT No Subjects Human Ethics Committee 5544 - Escola Bahiana de Medicina e Saúde Publica - FBDC Helsinki Yes Informed Consent Yes
09/06/2025 04:32:58