An interventional study of PFME and PFME + Anal ES in Prostatectomy and Urinary Incontinence, sponsored by Pamukkale University. Not yet recruiting at 1 site in Turkey. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by Pamukkale University · Not applicable, Interventional, and Other
Radical prostatectomy (RP) is a common procedure for the treatment of prostate cancer. However, postoperative urinary incontinence (UI) is an important reason for morbidity. UI negatively affects the quality of life in 30-50% of patients, especially in the early period (3 weeks to 6 months). However, it takes approximately 1 year to achieve continence (1).
Conservative treatment methods include pelvic floor muscle exercises (PFME) with or without biofeedback (BF), anal and perineal electrical stimulation (ES), magnetic stimulation (MS), compression (penile clamps), lifestyle changes and combinations of these methods (2).
ES artificially stimulates the pudendal nerve and its branches to cause direct and reflex responses of the urethral and periurethral striated muscles in women. ES also inhibits detrusor overactivity (3,4). There is conflicting evidence as to whether the addition of ES to treatment increases the efficacy of PFME alone in patients with UI after RP (Level of evidence:1b), (5). However, ES may benefit PFME for up to six months (Level of evidence: 2b), (5). Non-neurogenic male incontinence guidelines recommend PFME alone or in combination with BF and/or ES for men undergoing RP to accelerate improvement of UI (5).
Many studies have shown that anal ES alone (1,7,8) or in combination with PFME (4,9,10,11) is more effective than untreated (4,7,9,11) or placebo ES (8,12). There are only two randomised controlled trials in the literature evaluating the efficacy of perineal ES in patients with UI after RP (13,14). In the study by Yıldız et al. (13), the group receiving perineal ES and the control group receiving no treatment were compared in patients who developed UI after RP. The results showed that incontinence severity, incontinence episodes, quality of life and anxiety parameters improved significantly in the 8th week in the group receiving perineal ES compared to the control group. In the study by Pané-Alemany et al. (14), a group receiving perianal ES and a group receiving anal ES were compared in patients who developed UI after RP. In the study, it was shown that the efficacy of the two treatments was not statistically different.
Our study is the first prospective randomised controlled trial to evaluate the efficacy of perineal and anal ES added to PFME in patients with UI after RP. The aim of this study was to evaluate the efficacy of perineal ES and anal ES added to PFME on clinical parameters related to UI, quality of life and sexual functions, depression and anxiety. In addition, patients' preparation time for stimulation, treatment satisfaction and discomfort levels will be evaluated.
The research will be conducted at Pamukkale University Physical Medicine and Rehabilitation (PMR) Department, Urogynecological Rehabilitation Unit between November 2024 and January 2025.
The study included 93 patients (described in detail in the statistics section) who accepted the treatment among the male patients who applied to Pamukkale University FTR Polyclinic with the complaint of UI after RP or who were referred to the Urogynecological Rehabilitation Unit by the Urology outpatient clinic and who met the inclusion criteria. Patients will be informed about the content, purpose and application of the study and their written consent will be obtained.
At the beginning of the study, age, height, weight, education level, occupation, marital status, previous operations, systemic diseases, alcohol, tea, coffee, coffee, cigarette use and medications will be questioned in patients who applied to Pamukkale University FTR Polyclinic or Urology Polyclinic with the complaint of UI after RP and referred to the Urogynecological Rehabilitation Unit. The type of UI (stress, urge, mixed, drip) will be determined in all patients participating in the study.
Patients will be advised to continue their medical treatments for reasons other than incontinence during the treatment period. No lifestyle modification recommendations regarding urinary function will be given during the treatment period and participants will be instructed not to change their habits during the 8-week period of the study.
Ninety-three male patients who meet the inclusion and exclusion criteria after RP will be randomly divided into three groups using a random number table. The first group will receive PFME, the second group will receive PFME + anal ES, and the third group will receive PFME + perineal ES.
Group 1: PFME Group 2: PFME + anal ES Group 3: PFME + perineal ES
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's planned enrollment of 93 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
The patients were instructed to do as an home exercise program in first 2 weeks, 5 s contraction and 10 s relaxation, including two sets of 5 repetition daily, in following 2 weeks 10 s contraction and 20 s relaxation, including two sets of 10 repetition daily, and after 4 weeks, 10 s contraction and 20 s relaxation including three sets of 10 repetition daily in three different position (lying, sitting, and standing). So in the first 2 weeks 30 contractions daily, in following 2 weeks 60 contractions daily and upward 4th weeks, 90 contractions daily with progressively increasing intensity was done. All patients were asked to mark the exercise at a daily home schedule. Patients who did not complete more than 20% of the list according to the daily home program were excluded from the study.
Other: PFME
Anal ES was applied in the lithotomy position by means of a combined electrotherapy (stimulation) device with anal electrodes. Anal ES was applied 3 days a week, 20 minutes a day, for a total of 24 sessions for 8 weeks. Stimulation parameters were 50 Hz frequency, 5-10 s work-rest cycle and 300 µs pulse amplitude. Symmetrical biphasic pulse wave was given in the range of 1-100 mA (according to the patient's discomfort level feedback). In this procedure, it was applied with an anal probe placed in the anal region. Patients did not perform voluntary contractions during ES. Anal probes were used separately for each patient. Anal ES sessions were performed by an investigator participating in the study. Men who missed any treatment session for the stimulation group were excluded from the study.
Other: PFME + Anal ES
Perineal ES was applied in the lithotomy position by means of a combined electrotherapy (stimulation) device with surface electrodes. Anal ES was applied 3 days a week, 20 minutes a day, for a total of 24 sessions for 8 weeks. Stimulation parameters were 50 Hz frequency, 5-10 s work-rest cycle and 300 µs pulse amplitude. Symmetrical biphasic pulse wave was given in the range of 1-100 mA (according to the patient's discomfort level feedback). In this procedure, five surface electrodes with a diameter of 2 cm will be used, four electrodes symmetrically in the perianal region and one electrode in the leg (ground-neutral electrode). Patients will not perform voluntary contractions during ES. Surface electrodes will be used separately for each patient. Perineal ES sessions were performed by an investigator participating in the study. Men who missed any treatment session for the stimulation group were excluded from the study.
Other: PFME + Perineal ES
All patients were asked to mark the exercise at a daily home schedule. Patients who did not complete more than 20% of the list according to the daily home program were excluded from the study.
Anal ES was applied 3 days a week, 20 minutes a day, for a total of 24 sessions for 8 weeks.
Perineal ES was applied 3 days a week, 20 minutes a day, for a total of 24 sessions for 8 weeks.
Severity of incontinence
The 24-hour pad test was carried out to evaluate urinary loss.
Time frame: 8 weeks
Incontinence episodes
Patients with a 50% or greater reduction in incontinence episodes were consider improvement
Time frame: 8 weeks
Three-day Bladder Diary
It was used "frequency of voiding", "incontinence episodes", "nocturia", "number of pads" from data collected with a 3-day bladder diary.
Time frame: 8 weeks
Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
The IIQ-7 scale which has great validity in studies was used to assess the patient's QoL associated with incontinence problem
Time frame: 8 weeks
Level of sexual function - International Index of Erectile Function (IIEF)
Sexual functions
Time frame: 6 weeks
Level of Anxiety and Depression - Hospital Anxiety and Depression Scale (HAD)
Anxiety and Depression
Time frame: 8 weeks
Treatment satisfaction - Likert scale (1-5 )
The patients evaluated the change of their urinary incontinence on a 5-point Likert scale (5, very satisfied; 4, satisfied; 3, equally satisfied and unsatisfied; 2, unsatisfied; 1, very unsatisfied)
Time frame: 8 weeks
Treatment Success (Continence rate)
Patients with ≤8 gr in 24-hour pad test measurement will be considered "continent"
Time frame: 8 weeks
Cure (Dry) and Improvement Rate
the absence of will be evaluated as "dryness"
Time frame: 8 weeks
Plan to share: No
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Pamukkale University