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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Other: ES and lifestyle advices; Other: Lifestyle advices

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrical stimulation (ES) group; ES group will be given additional external electrical stimulation to the lifestyle advices.	Other: ES and lifestyle advices; 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.
Experimental: Control group; Control group will be given only lifestyle advices .	Other: Lifestyle advices; The lifestyle advices include fluid consumption, diet, weight control, constipation, smoking, etc.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2022
• Primary Completion (Anticipated): October 15, 2022
• Study Completion (Anticipated): December 15, 2022

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: 2022/06/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No