Comparison of the Efficacy of Perineal and Anal Electrical Stimulation in Patients with Urinary Incontinence After Radical Prostatectomy

October 31, 2024 updated by: Necmettin Yildiz, Pamukkale University

Comparison of the Efficacy of Perineal and Anal Electrical Stimulation in Patients with Urinary Incontinence After Radical Prostatectomy. a Prospective Randomised Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-80 years old
  • Men with RP with incontinence over >50 g/24 h and no residual cancer after RP on pathological examination
  • Men within 1 month to 1 year after catheter removal
  • Willingness to complete and do the QoL scale.
  • Understanding procedures, benefits, and possible side effects.
  • Being able to give written, informed consent.

Exclusion Criteria:

  • UI history before RP.
  • History of conservative treatment after RP including ES.
  • Prolonged indwelling urethral catheterization (more than 15 days).
  • Previous urological surgery history.
  • Men receiving radiotherapy.
  • Presence of urethral stricture and urinary tract infection.
  • Heart failure, presence of a pacemaker, implanted defibrillator.
  • Transurethral resection of the prostate due to benign prostatic hyperplasia.
  • Use of drugs that may affect bladder function (antimuscarinic, duloxetine, tricyclic antidepressant, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: PFME
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
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.
Experimental: Group 2: PFME + Anal ES
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
Anal ES was applied 3 days a week, 20 minutes a day, for a total of 24 sessions for 8 weeks.
Experimental: Group 3: PFME + Perineal 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
Perineal ES was applied 3 days a week, 20 minutes a day, for a total of 24 sessions for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of incontinence
Time Frame: 8 weeks
The 24-hour pad test was carried out to evaluate urinary loss.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of sexual function - International Index of Erectile Function (IIEF)
Time Frame: 6 weeks
Sexual functions
6 weeks
Incontinence episodes
Time Frame: 8 weeks
Patients with a 50% or greater reduction in incontinence episodes were consider improvement
8 weeks
Three-day Bladder Diary
Time Frame: 8 weeks
It was used "frequency of voiding", "incontinence episodes", "nocturia", "number of pads" from data collected with a 3-day bladder diary.
8 weeks
Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
Time Frame: 8 weeks
The IIQ-7 scale which has great validity in studies was used to assess the patient's QoL associated with incontinence problem
8 weeks
Level of Anxiety and Depression - Hospital Anxiety and Depression Scale (HAD)
Time Frame: 8 weeks
Anxiety and Depression
8 weeks
Treatment satisfaction - Likert scale (1-5 )
Time Frame: 8 weeks
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)
8 weeks
Treatment Success (Continence rate)
Time Frame: 8 weeks
Patients with ≤8 gr in 24-hour pad test measurement will be considered "continent"
8 weeks
Cure (Dry) and Improvement Rate
Time Frame: 8 weeks
the absence of will be evaluated as "dryness"
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Study Director: Necmettin YILDIZ Prof., Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Estimated)

November 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PamukkaleU.ftr-NYıldız-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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