Skip to main content
Clinical Trials/NCT05432869
NCT05432869
Unknown
Not Applicable

Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy

Ankara Yildirim Beyazıt University0 sites40 target enrollmentJuly 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
Ankara Yildirim Beyazıt University
Enrollment
40
Primary Endpoint
Urinary incontinence severity
Last Updated
3 years ago

Overview

Brief Summary

The aim of this study is to investigate the effects of external electrical stimulation applied on the thigh on urinary symptoms, quality of life, sexual function, perception of subjective improvement and satisfaction in men with urinary incontinence after prostatectomy

Detailed Description

The most common complication after prostatectomy surgeries is urinary incontinence. There are conservative and surgical treatment options in post-prostatectomy urinary incontinence. One of the conservative treatment options is electrical stimulation application. Electrical stimulation with the intraanal probe in men is painful and uncomfortable. And also there are few studies, demonstrating the effects of electrical stimulation on urinary incontinence after prostatectomy in the literature.

Registry
clinicaltrials.gov
Start Date
July 15, 2022
End Date
December 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Ankara Yildirim Beyazıt University
Responsible Party
Principal Investigator
Principal Investigator

seyda toprak celenay

associate professor

Ankara Yildirim Beyazıt University

Eligibility Criteria

Inclusion Criteria

  • Being a male individual with stress or stress-dominant mixed urinary incontinence symptoms after undergoing prostatectomy surgery
  • Being over 40 years old
  • Not having residual cancerous tissue
  • Volunteering to participate in the study

Exclusion Criteria

  • Having serious cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients, etc.)
  • Having sensory loss
  • Having an ongoing urinary infection
  • Having only urgency urinary incontinence
  • Using a pacemaker
  • Receiving active cancer treatment (radiotherapy, chemotherapy)
  • Those who have a problem that interferes with cooperation and understanding

Outcomes

Primary Outcomes

Urinary incontinence severity

Time Frame: change from baseline at 4 weeks

Urinary incontinence severity will be assessed with a 1-hour pad test. This amount; less than 2 grams is considered normal, 2-10 grams is mild, 10-50 grams is moderate, and over 50 grams is severe stress urinary incontinence.

Secondary Outcomes

  • Compliance with Lifestyle Advices(after treatment (4th week))
  • Presence of urinary incontinence symptoms(change from baseline at 4 weeks)
  • Sexual function(change from baseline at 4 weeks)
  • Perception of Subjective Improvement(after treatment (4th week))
  • Life quality(change from baseline at 4 weeks)
  • Patients Satisfaction(after treatment (4th week))

Similar Trials