Non-surgical treatment for women with pelvic organ prolapse and bowel-emptying problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Pelvic organ prolapse can produce anatomical changes that contribute to difficulty with bowel emptying, and surgery is often recommended but not always possible. This Phase 3 interventional study delivers a multimodal conservative program combining tibial neuromodulation, biofeedback therapy, targeted pelvic floor muscle training, and dietary modification for women with rectocele grade I–II and functional defecatory disorders confirmed by high-resolution anorectal manometry. Participants will undergo baseline physiological testing and symptom assessment, receive the combined therapies, and be followed for changes in anorectal function and symptoms. The study aims to determine whether treating the functional component can reduce symptoms and potentially avoid or delay surgical intervention.

Why it matters

Who can join: the full rules

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

Where it's running

• Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
  Moscow, Russia Recruiting
• Federal Research Center of Coloproctology
  Moscow, Russia Recruiting

Study contacts

• Study coordinator: Sergey Morozov, MD, PhD
• Email: morosoffsv@mail.ru
• Phone: +79104681801

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.