Effects of External Electric Stimulating in Individuals With Urinary Incontinence After Prostatectomy

Not Applicable

• Conditions: Urinary Incontinence

• Registration Number: NCT05127447
• Lead Sponsor: Ataturk Training and Research Hospital

Brief Summary

The aim of this study is to investigate effects of external electric stimulating in individuals with urinary incontinence after prostatectomy.

Detailed Description

Urinary incontinence (UI) is common in men after prostotectomy, and patients' quality of life is adversely affected. In addition, electric stimulation (ES) can be played an important role in the management of UI . However, there are limitations in clearly demonstrating the effects of ES on men with UI after prostatectomy.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-11-17
• Last Update Submitted: 2021-11-17
• Study First Posted: 2021-11-19
• Last Update Posted: 2021-11-19
• Study Start: 2021-12
• Primary Completion: 2022-07
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Being a male individual with stress or stress-dominant mixed UI symptoms after undergoing prostatectomy surgery for prostate cancer in the urology clinic
• Being over 40 years old
• Being 24 and over with Mini Mental Test results in individuals over 65 years of age.
• 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)
• Lack of evaluation parameters
• Not continuing the treatment regularly

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
UI symptoms	change from baseline at 8 weeks	The ICIQ_SF is a UI questionnaire that evaluates symptom type and severity. 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
Pad Test	change from baseline at 8 weeks	A 1-hour pad test will be applied. Beginning with an empty bladder, a pre-weighed sanitary napkin will be inserted into the underwear. The patient will be asked to drink 500 ml of water within 15 minutes and then remain active for half an hour. Then, various activities will be made to the patient to provoke involuntary urine leakage with a full bladder. weight will be measured.

Secondary Outcome Measures

Name	Time	Method
Life quality	change from baseline at 8 weeks	Life quality will be assessed with King's Health Questionnaire (KHQ).This questionnaire consists of two parts and 32 items.. The minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health).
Evaluation of Treatment Satisfaction	after treatment (8th week)	After the 8-week treatment program, the patients' satisfaction with the treatment for UI was evaluated using a 5-item Likert-type scale.
Evaluation of Subjective Improvement Perception	after treatment (8th week)	The subjective improvement of UI symptoms pf the patients after treatment was evaluated using a 4-item Likert-type scale.
Sexual Function	change from baseline at 8 weeks	Evaluation of sexual functions will be evaluated with International Index of Erectile Function IIEF-5 (IIEF-5), which is one of the most commonly used forms in men presenting with sexual complaints. 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).