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

Evaluation of Complex (Physical Therapy and Diet) Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse

This will test whether a combined non-surgical program—tibial nerve stimulation, biofeedback, pelvic floor exercises, and diet changes—can improve bowel-emptying symptoms in women with mild-to-moderate pelvic organ prolapse.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology (Academic / other)
• Locations: 2 sites (Moscow and 1 other locations)
• Trial ID: NCT04547816 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women with grade I–II rectocele (with or without internal rectal intussusception) who meet Rome IV criteria for functional defecatory disorders and have confirmation on high-resolution anorectal manometry are the intended participants.

Not a fit: Women with grade III rectocele, significant internal genital prolapse, prior abdominal or gynecologic surgeries that affect bowel function, major cardiovascular disease, or those starting medications that alter rectal motility are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If effective, the treatment could reduce constipation and straining, improve quality of life, and help some women avoid or postpone surgery.

How similar studies have performed: Prior studies of biofeedback and tibial neuromodulation have shown benefit for functional defecation disorders in general, but combining these approaches specifically in women with anatomical prolapse has been less well tested.

Eligibility criteria

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 this trial is running

Moscow and 1 other locations

• 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

Conditions Pelvic Floor Prolapse; Functional Constipation; Rectocele; pelvic floor prolapse; conservative treatment; functional disorders of defecation; rectocele; diet modification