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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Other: ES and lifestyle advices
* Other: Lifestyle advices


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrical stimulation (ES) group<br>ES group will be given additional external electrical stimulation to the lifestyle advices. | Other: ES and lifestyle advices<br>* The lifestyle advices include fluid consumption, diet, weight control, constipation, smoking, etc. External electrical stimulation will be applied for 30 minutes 3 days a week during 4 weeks. Electrodes were placed on the thighs.<br>|
| Experimental: Control group<br>Control group will be given only lifestyle advices . | Other: Lifestyle advices<br>* The lifestyle advices include fluid consumption, diet, weight control, constipation, smoking, etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary incontinence severity | 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. | change from baseline at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of urinary incontinence symptoms | Urinary incontinence symptoms will be assessed with International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF). It consists of 6 questions in total and the total score is 3., 4., 5. It is obtained by adding the scores they get from the questions. A low score in the scale indicates that urinary incontinence symptoms are less. | change from baseline at 4 weeks | 
| Life quality | Life quality will be assessed with King Health Questionnaire. The questionnaire, consisting of thirty-two items, consists of 2 parts. In the first part, there are 2 questions questioning the general health perception and incontinence effect, and 19 questions dividing the quality of life into 7 areas (role limitations, physical limitations, social limitations, personal relationships, emotional problems, sleep/energy disorders, symptom severity measurement). In the second part, there are 11-item complaint severity scales that evaluate the presence and severity of urinary symptoms. While the best score that can be obtained on the complaint severity scale is 0, the worst score is 30, the best score that can be obtained for all King Health Questionnaire subsections is 0 and the worst score is 100. | change from baseline at 4 weeks | 
| Sexual function | Sexual function will be assessed with International Index of Erectile Function-5. It includes 5 main topics; erectile function, orgasm function, sexual desire, sexual intercourse satisfaction and general satisfaction are questioned with a total of 5 questions. Each question gets a score between 0-5. Total score; severe (5-7), moderate (8-11), mild-moderate (12-16), mild (17-21), no erectile dysfunction (22-25) | change from baseline at 4 weeks | 
| Perception of Subjective Improvement | Patients' subjective perception of improvement will be questioned with a 4-point Likert scale (worse (1), same (2), better (3) and completely cured (4)) | after treatment (4th week) | 
| Patients Satisfaction | Patient satisfaction will be questioned with a 5-point Likert scale (not at all satisfied (1), dissatisfied (2), undecided (3), satisfied (4), very satisfied (5)) | after treatment (4th week) | 
| Compliance with Lifestyle Advices | Compliance of patients to the lifestyle advices will be evaluated using a 100-mm visual analog scale. | after treatment (4th week) |