Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy
1 other identifier
interventional
40
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedStudy Start
First participant enrolled
July 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2022
CompletedJune 27, 2022
June 1, 2022
3 months
June 22, 2022
June 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
change from baseline at 4 weeks
Secondary Outcomes (6)
Presence of urinary incontinence symptoms
change from baseline at 4 weeks
Life quality
change from baseline at 4 weeks
Sexual function
change from baseline at 4 weeks
Perception of Subjective Improvement
after treatment (4th week)
Patients Satisfaction
after treatment (4th week)
- +1 more secondary outcomes
Study Arms (2)
Electrical stimulation (ES) group
EXPERIMENTALES group will be given additional external electrical stimulation to the lifestyle advices.
Control group
EXPERIMENTALControl group will be given only lifestyle advices .
Interventions
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.
The lifestyle advices include fluid consumption, diet, weight control, constipation, smoking, etc.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seyda Toprak Celenay
Ankara Yildirim Beyazıt University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
June 22, 2022
First Posted
June 27, 2022
Study Start
July 15, 2022
Primary Completion
October 15, 2022
Study Completion
December 15, 2022
Last Updated
June 27, 2022
Record last verified: 2022-06