Effect of Pelvic Floor Down-training on Women With Idiopathic Overactive Bladder (NCT06662565) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Pelvic Floor Down-training on Women With Idiopathic Overactive Bladder
Egypt30 participantsStarted 2024-10-31
Plain-language summary
This study will be conducted to investigate the effect of pelvic floor down-training on women with idiopathic overactive bladder
Who can participate
Age range
30 Years – 45 Years
Sex
FEMALE
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:
* Multiparous woman with idiopathic OAB (2-3 times) who diagnosed by physician and confirmed by the urodynamic study.
* Woman with high rectal resting tone measured by pressure biofeedback.
* Woman diagnosed with constipation according to the Rome IV criteria and Bristol score.
* Ages ranging from 30 to 45 years.
* BMI from 25-29.9 Kg/m2
Exclusion Criteria:
Women will be excluded from the study if they have:
* Severe OAB as measured by the overactive bladder symptom score for severity
* Postmenopausal women (a point in time 12 months after a woman's last period.)
* Any abnormalities around the bladder, such as bladder cancer, bladder calculus, interstitial cystitis, or endometriosis.
* Untreated urinary tract infections.
* Psychological or mental health problems.
* Pregnancy and lactation
* A history of previous pelvic surgery.
* Are receiving any pharmacological treatment at the time of the study.
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
Rectal resting pressure
Timeframe: 8 weeks
2
Rectal bearing pressure
Timeframe: 8 weeks
3
Overactive Bladder Symptom Score (OABSS):
Timeframe: 8 weeks
4
Assessment of overactive bladder symptoms
Timeframe: 8 weeks
5
Assessment of quality of life
Timeframe: 8 weeks
6
Constipation scoring system
Timeframe: 8 weeks
7
Five-item score for obstructed defecation syndrome (ODS-S)