The Effects of Neuromuscular Electrical Stimulation in Individuals With Urinary Incontinence After Prostatectomy
February 2, 2022 updated by: seyda toprak celenay, Ankara Yildirim Beyazıt University
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
Study Overview
Status
Not yet recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
36 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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NMES group
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
|
It was applied with INNOVO brand (Atlantic Therapeutics, Galway, Ireland) device.
It was applied for 30 minutes 3 days a week during 4 weeks
|
|
Sham Comparator: Sham group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urinary incontinence severity
Time Frame: change from baseline at 4 weeks
|
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.
|
change from baseline at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of urinary incontinence symptoms
Time Frame: change from baseline at 4 weeks
|
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
Time Frame: change from baseline at 4 weeks
|
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
Time Frame: change from baseline at 4 weeks
|
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
|
|
Patients' subjective perception of improvement
Time Frame: after treatment (4th week)
|
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)
|
|
Patient satisfaction
Time Frame: after treatment (4th week)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2022
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
March 1, 2023
Study Registration Dates
First Submitted
February 2, 2022
First Submitted That Met QC Criteria
February 2, 2022
First Posted (Actual)
February 11, 2022
Study Record Updates
Last Update Posted (Actual)
February 11, 2022
Last Update Submitted That Met QC Criteria
February 2, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/02/02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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