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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
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    June 22, 2022
    Last Updated
    June 22, 2022
    Sponsor
    Ankara Yildirim Beyazıt University
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    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

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

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