Back to resultsEffects of External Electric Stimulating in Individuals With Urinary Incontinence After Prostatectomy
Primary Purpose
Urinary Incontinence
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ES application
Sham 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 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
ES group
Sham group
Arm Description
External neuromuscular electrical stimulation was applied to the patients in supine position. It was applied for 30 minutes 3 days a week for 8 weeks. This stimulation consists of a total of eight external electrodes, including 2 sheaths wrapped around the thigh area and 4 electrodes for each leg. Electrodes were placed on the anterior and posterior proximal thighs, buttocks, and outside of the hips. The treatment protocol was applied with symmetrical biphasic current at a frequency of 50 Hertz (Hz), with stimulation and rest periods of 5 seconds of contraction and 5 seconds of rest.
In the Sham group, for 45 minutes, 2 days a week, a vacuum electrode was connected from combined vacuum electrotherapy device over the pelvis and thigh, and only vacuum was applied while the patient was in the supine position, and no current was given from the applied device.
Outcomes
Primary Outcome Measures
Pad Test
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.
UI symptoms
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
Secondary Outcome Measures
Life quality
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).
Sexual Function
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).
Evaluation of Subjective Improvement Perception
The subjective improvement of UI symptoms pf the patients after treatment was evaluated using a 4-item Likert-type scale.
Evaluation of Treatment Satisfaction
After the 8-week treatment program, the patients' satisfaction with the treatment for UI was evaluated using a 5-item Likert-type scale.
Full Information
NCT ID
NCT05127447
First Posted
November 17, 2021
Last Updated
November 17, 2021
Sponsor
Ataturk Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05127447
Brief Title
Effects of External Electric Stimulating in Individuals With Urinary Incontinence After Prostatectomy
Official Title
Effects of External Electric Stimulating in Individuals With Urinary Incontinence After Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk Training and Research Hospital
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 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.
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
Model Description
Participants will be randomly divided into two groups (such as ES and sham groups)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ES group
Arm Type
Experimental
Arm Description
External neuromuscular electrical stimulation was applied to the patients in supine position. It was applied for 30 minutes 3 days a week for 8 weeks. This stimulation consists of a total of eight external electrodes, including 2 sheaths wrapped around the thigh area and 4 electrodes for each leg. Electrodes were placed on the anterior and posterior proximal thighs, buttocks, and outside of the hips. The treatment protocol was applied with symmetrical biphasic current at a frequency of 50 Hertz (Hz), with stimulation and rest periods of 5 seconds of contraction and 5 seconds of rest.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
In the Sham group, for 45 minutes, 2 days a week, a vacuum electrode was connected from combined vacuum electrotherapy device over the pelvis and thigh, and only vacuum was applied while the patient was in the supine position, and no current was given from the applied device.
Intervention Type
Device
Intervention Name(s)
ES application
Intervention Description
Electrical stimulation (ES) application will be given to the ES group
Intervention Type
Other
Intervention Name(s)
Sham application
Intervention Description
Only vacuum was applied and no current was given from the applied device
Primary Outcome Measure Information:
Title
Pad Test
Description
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.
Time Frame
change from baseline at 8 weeks
Title
UI symptoms
Description
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
Time Frame
change from baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Life quality
Description
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).
Time Frame
change from baseline at 8 weeks
Title
Sexual Function
Description
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).
Time Frame
change from baseline at 8 weeks
Title
Evaluation of Subjective Improvement Perception
Description
The subjective improvement of UI symptoms pf the patients after treatment was evaluated using a 4-item Likert-type scale.
Time Frame
after treatment (8th week)
Title
Evaluation of Treatment Satisfaction
Description
After the 8-week treatment program, the patients' satisfaction with the treatment for UI was evaluated using a 5-item Likert-type scale.
Time Frame
after treatment (8th week)
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Participants 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 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
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 Electric Stimulating in Individuals With Urinary Incontinence After Prostatectomy
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