Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Orga… (NCT04547816) | Clinical Trial Compass
RecruitingPhase 3
Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Russia100 participantsStarted 2020-07-01
Plain-language summary
This study is planned to evaluate the efficacy of complex conservative treatment (including tibial neuromodulation, biofeedback therapy, special pelvic floor training and diet modification) in women with pelvic organ prolapse
Who can participate
Age range
18 Years – 70 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:
* Willingness to participate (signed informed consent form)
* Females with rectocele I-II grade or rectocele I-II grade and internal rectal invagination and functional defecatory disorders (per Rome IV guidelines) confirmed on the basis of complex examination including high-resolution anorectal manometry
Exclusion Criteria:
* rectocele III grade;
* internal genitals prolapse;
* history of abdominal or pelvic surgery that may impact bowel motility (excluding non-complicated appendectomy or laparoscopic cholecystectomy);
* gynecological surgery that may influence sensory or reservoir function of rectum;
* history of major cardiovascular events, or presence of current conditions that in case of participation of the patient in the study may put her at risk of exacerbation or complication;
* start of any new concomitant medication with mechanisms of action that influence rectal motility, sensory function, muscle tone and/or contractility
* inability to understand and/or follow the instructions to perform all the procedures required per protocol
* general condition of the patient that make her ineligible by the discretion of the investigator
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
Mean stool frequency
Timeframe: A week
2
Mean stool form value
Timeframe: A week
3
Mean defecation with difficult bowel emptying
Timeframe: a week
4
Change of KESS scale points
Timeframe: at the end-point, 6 months after enrolment
5
Change in Scale of bowel evacuatory function assessment
Timeframe: at the end-point, 6 months after enrolment
6
Average anal resting pressure
Timeframe: at the end-point, 6 months after enrolment
7
Maximum absolute anal squeeze pressure
Timeframe: at the end-point, 6 months after enrolment
8
Average absolute anal squeeze pressure
Trial details
NCT IDNCT04547816
SponsorFederal State Budgetary Scientific Institution