Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Recruiting now · Phase 3
Conditions studied: Pelvic Floor Prolapse, Functional Constipation, Rectocele
In brief
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
Key facts
- Study ID
- NCT04547816
- Run by
- Federal State Budgetary Scientific Institution
- People needed
- 100
- Starts
- 2020-07-01
- Expected to finish
- 2026-05-31
- Last updated by the study team
- 2025-08-03
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology — Moscow, Russia (enrolling)
- Federal Research Center of Coloproctology — Moscow, Russia (enrolling)
Full record on ClinicalTrials.gov
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