Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy
Primary Purpose
Urinary Incontinence
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ES and lifestyle advices
Lifestyle advices
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Electrical stimulation (ES) group
Control group
Arm Description
ES group will be given additional external electrical stimulation to the lifestyle advices.
Control group will be given only lifestyle advices .
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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".
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)
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))
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))
Compliance with Lifestyle Advices
Compliance of patients to the lifestyle advices will be evaluated using a 100-mm visual analog scale.
Full Information
NCT ID
NCT05432869
First Posted
June 22, 2022
Last Updated
June 22, 2022
Sponsor
Ankara Yildirim Beyazıt University
1. Study Identification
Unique Protocol Identification Number
NCT05432869
Brief Title
Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy
Official Title
Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 15, 2022 (Anticipated)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electrical stimulation (ES) group
Arm Type
Experimental
Arm Description
ES group will be given additional external electrical stimulation to the lifestyle advices.
Arm Title
Control group
Arm Type
Experimental
Arm Description
Control group will be given only lifestyle advices .
Intervention Type
Other
Intervention Name(s)
ES and lifestyle advices
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Lifestyle advices
Intervention Description
The lifestyle advices include fluid consumption, diet, weight control, constipation, smoking, etc.
Primary Outcome Measure Information:
Title
Urinary incontinence severity
Description
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.
Time Frame
change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Presence of urinary incontinence symptoms
Description
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.
Time Frame
change from baseline at 4 weeks
Title
Life quality
Description
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".
Time Frame
change from baseline at 4 weeks
Title
Sexual function
Description
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)
Time Frame
change from baseline at 4 weeks
Title
Perception of Subjective Improvement
Description
Patients' subjective perception of improvement will be questioned with a 4-point Likert scale (worse (1), same (2), better (3) and completely cured (4))
Time Frame
after treatment (4th week)
Title
Patients Satisfaction
Description
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))
Time Frame
after treatment (4th week)
Title
Compliance with Lifestyle Advices
Description
Compliance of patients to the lifestyle advices will be evaluated using a 100-mm visual analog scale.
Time Frame
after treatment (4th week)
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male with urinary incontinence after prostatectomy
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyda Toprak Celenay
Phone
+90312 906 1000
Email
sydtoprak@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda Toprak Celenay
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy
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