Effects of Hypopressive Exercises on Urinary Incontinence and Erectile Dysfunction After Radical … (NCT07101731) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Hypopressive Exercises on Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy
Turkey (Türkiye)30 participantsStarted 2024-06-01
Plain-language summary
This randomized controlled trial investigates the effects of hypopressive exercises on urinary incontinence and erectile dysfunction in men following radical prostatectomy. Participants will be randomly assigned to one of two groups: a control group receiving home-based pelvic floor muscle exercises and an experimental group receiving both pelvic floor muscle exercises and supervised hypopressive exercises twice per week. The study aims to determine whether the addition of hypopressive techniques, which target coordinated activation of the pelvic floor and abdominal muscles without increasing intra-abdominal pressure, offers greater improvements in urinary and sexual function. Primary outcomes include pelvic floor muscle strength and endurance, while secondary outcomes include urinary incontinence severity, erectile function, and quality of life.
Who can participate
Age range
55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Male individuals diagnosed with prostate cancer who have undergone radical prostatectomy
* Experiencing both urinary incontinence and erectile dysfunction
* Age \> 55 years
* A score of 24 or higher on the Mini-Mental State Examination (MMSE)
* Literate (able to read and write)
* Willingness to participate in the study (signed informed consent)
* Ability to voluntarily contract pelvic floor muscles
* Ability to cooperate with the assessments and interventions used in the study
Exclusion Criteria
* History of urinary incontinence before surgery
* Congenital abnormalities of the urinary system
* Presence of neurological disorders
* History of transurethral resection of the prostate (TURP)
* Diagnosis of chronic obstructive pulmonary disease (COPD) and/or chronic restrictive pulmonary disease
* History of inguinal hernia
* Previous or current history of radiation therapy
* Surgical or postoperative complications that prevent early physiotherapy intervention (e.g., urinary tract infection, bladder neck stenosis)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in urinary incontinence severity measured by 1-hour Pad Test
Timeframe: Baseline and 8 weeks
2
Change in pelvic floor muscle strength measured by Modified Oxford Scale
Timeframe: Baseline and 8 weeks
3
Change in pelvic floor muscle endurance measured in seconds