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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05432869
• Other study ID #: 2022/06/22
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: June 2022
• Source: Ankara Yildirim Beyazit University
• Contact: Seyda Toprak Celenay
• Phone: +90312 906 1000
• Email: sydtoprak[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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.
• Lifestyle advices
The lifestyle advices include fluid consumption, diet, weight control, constipation, smoking, etc.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)