Obesity on the Efficacy of Bilateral Tibial Nerve Stimulation (NCT07390682) | Clinical Trial Compass
CompletedNot Applicable
Obesity on the Efficacy of Bilateral Tibial Nerve Stimulation
Egypt60 participantsStarted 2026-02-15
Plain-language summary
Obstructed defecation syndrome (ODS) is a common functional bowel disorder characterized by difficulty in stool evacuation. Bilateral posterior tibial nerve stimulation (BT PTNS) has emerged as a noninvasive, safe, and effective therapeutic option for functional ODS, improving symptom severity and quality of life.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
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:
* Diagnosis of functional obstructed defecation (Rome IV criteria).
* Able to provide informed consent.
* BMI ≥30 kg/m² (obese group) or BMI \<30 kg/m² (non-obese group).
Exclusion Criteria:
* Organic causes of constipation (e.g., colorectal cancer, inflammatory bowel disease).
* Previous pelvic floor surgery.
* Neurological disorders affecting bowel function.
* Pregnancy or lactation.
* Current use of other neuromodulation therapies.
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 symptom severity measured by the Modified Obstructed Defecation Score (MODS).
Timeframe: Within 6 weeks of treatment.
2
Change in quality of life measured by the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL).
Timeframe: Within 6 weeks of treatment.
Trial details
NCT IDNCT07390682
SponsorGeneral Committee of Teaching Hospitals and Institutes, Egypt