Actively Recruiting
Efficacy of Conservative 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
308 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
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
CONDITIONS
Official 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 and sign informed consent
- Female with rectocele grade I-II or rectocele grade I-II with internal rectal invagination
- Functional defecatory disorders confirmed by Rome IV guidelines and 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 affecting rectal sensory or reservoir function
- History of major cardiovascular events or current conditions posing risk during study participation
- Starting new medications affecting rectal motility, sensory function, muscle tone, or contractility
- Inability to understand or follow study procedures
- General condition deemed ineligible by investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
O
Oksana Fomenko, MD, PhD
CONTACT
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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