The Effects of Neuromuscular Electrical Stimulation in Individuals With Urinary Incontinence After Prostatectomy
Primary Purpose
Urinary Incontinence
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation application
Sham neuromuscular electrical stimulation application
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 in the urology clinic
- Being over 40 years old
- Volunteering to participate in the study
Exclusion Criteria:
- Severe cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients ect.)
- Those with sensory loss
- Presence of ongoing urinary infection
- Only urgency urinary incontinence
- Having a pacemaker
- Active cancer treatment (radiotherapy, chemotherapy),
- Those who have undergone Transurethral Prostatectomy (TUR-P) surgery
- Those who have a problem that interferes with cooperation and understanding
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
NMES group
Sham group
Arm Description
Neuromuscular electrical stimulation (NMES) will be applied with INNOVO brand (Atlantic Therapeutics, Galway, Ireland) device for 30 minutes 3 days a week during 4 weeks
Sham group will be applied from the same device (INNOVO brand (Atlantic Therapeutics, Galway, Ireland)), for 3 days a week for 30 minutes during 4 weeks, but no current will be given from the device.
Outcomes
Primary Outcome Measures
Urinary incontinence severity
Urinary incontinence severity will be assess 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 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)
Patients' subjective perception of 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)).
Patient 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))
Full Information
NCT ID
NCT05236088
First Posted
February 2, 2022
Last Updated
February 2, 2022
Sponsor
Ankara Yildirim Beyazıt University
1. Study Identification
Unique Protocol Identification Number
NCT05236088
Brief Title
The Effects of Neuromuscular Electrical Stimulation in Individuals With Urinary Incontinence After Prostatectomy
Official Title
The Effects of Neuromuscular Electrical Stimulation in Individuals With Urinary Incontinence After Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
March 2023 (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 neuromuscular electric stimulation on urinary symptoms, quality of life, sexual function, perception of improvement and patient satisfaction in individuals with post-prostatectomy urinary incontinence
Detailed Description
One of the two most common complications after prostatectomy surgeries is urinary incontinence (UI) and the other is erectile dysfunction. There are conservative and surgical treatment options in post-prostatectomy urinary incontinence. One of the conservative treatment options is neuromuscular electrical stimulation application. Since electrical stimulation applications, used in the treatment of post-prostatectomy urinary incontinence, are usually given together with other treatment protocols, there are limitations in clearly demonstrating the effects of neuromuscular electrical stimulation on post-prostatectomy urinary incontinence.
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
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NMES group
Arm Type
Experimental
Arm Description
Neuromuscular electrical stimulation (NMES) will be applied with INNOVO brand (Atlantic Therapeutics, Galway, Ireland) device for 30 minutes 3 days a week during 4 weeks
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
Sham group will be applied from the same device (INNOVO brand (Atlantic Therapeutics, Galway, Ireland)), for 3 days a week for 30 minutes during 4 weeks, but no current will be given from the device.
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulation application
Intervention Description
It was applied with INNOVO brand (Atlantic Therapeutics, Galway, Ireland) device. It was applied for 30 minutes 3 days a week during 4 weeks
Intervention Type
Device
Intervention Name(s)
Sham neuromuscular electrical stimulation application
Intervention Description
Sham group will be applied from the same device, again 3 days a week for 30 minutes during 4 weeks, but no current will be given from the device.
Primary Outcome Measure Information:
Title
Urinary incontinence severity
Description
Urinary incontinence severity will be assess 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 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
Patients' subjective perception of 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
Patient 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)
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male with post-prostatectomy urinary incontinence
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 in the urology clinic
Being over 40 years old
Volunteering to participate in the study
Exclusion Criteria:
Severe cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients ect.)
Those with sensory loss
Presence of ongoing urinary infection
Only urgency urinary incontinence
Having a pacemaker
Active cancer treatment (radiotherapy, chemotherapy),
Those who have undergone Transurethral Prostatectomy (TUR-P) surgery
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
The Effects of Neuromuscular Electrical Stimulation in Individuals With Urinary Incontinence After Prostatectomy
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