Actively Recruiting
Evaluation of Complex (Physical Therapy and Diet) Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Led by Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology · Updated on 2025-08-03
100
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
Sponsors
F
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Lead Sponsor
S
State Scientific Centre of Coloproctology, Russian Federation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a complex conservative treatment for women with pelvic organ prolapse who experience functional defecatory disorders. Pelvic organ prolapse involves a structural problem that can lead to difficulty with bowel movements and is often treated with surgery. However, surgery is not always possible, and the study aims to see if non-surgical therapies can improve symptoms in patients with mild to moderate prolapse. The study tests several treatments including biofeedback therapy, tibial neuromodulation, pelvic floor muscle training, and diet modification. Biofeedback therapy helps patients learn to control pelvic muscles using special devices, while tibial neuromodulation uses electrical stimulation on a nerve in the leg to improve anal sphincter function. Pelvic floor muscle training involves exercises taught by healthcare providers and continued at home for six months with online monitoring. Diet changes focus on fiber, vitamins, and hydration to support bowel function. Participants will be monitored over six months with assessments including stool frequency and form, difficulty with bowel emptying, and measures of anal muscle pressure and function. Researchers will use questionnaires and anorectal tests to evaluate changes. The study includes careful monitoring of treatment adherence and safety, with the goal of understanding how these combined therapies affect bowel function in women with pelvic organ prolapse.
CONDITIONS
Brief Title
Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to participate with signed informed consent
- Female participants aged 18 to 70 years
- Diagnosis of rectocele grade I or II, or rectocele grade I or II with internal rectal invagination
- Functional defecatory disorders confirmed by complex examination including high-resolution anorectal manometry
You will not qualify if you...
- Rectocele grade III
- Internal genital prolapse
- History of abdominal or pelvic surgery affecting bowel motility (except uncomplicated appendectomy or laparoscopic cholecystectomy)
- Gynecological surgery impacting rectal sensory or reservoir function
- History of major cardiovascular events or current conditions increasing risk with study participation
- Starting new medications influencing rectal motility, sensory function, muscle tone, or contractility
- Inability to understand or follow study procedure instructions
- General condition deemed ineligible by investigator discretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive conservative treatment for functional defecatory disorders including biofeedback therapy, tibial neuromodulation, pelvic floor muscles training, and diet modification as per their assigned group.
Regular visits for therapy sessions and online monitoring during home training
Trial Site Locations
Total: 2 locations
1
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Moscow, Russia, 115446
Actively Recruiting
2
Federal Research Center of Coloproctology
Moscow, Russia
Actively Recruiting
Research Team
S
Sergey Morozov, MD, PhD
O
Oksana Fomenko, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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