Actively Recruiting

Phase 3
Age: 18Years - 70Years
FEMALE
NCT04547816

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

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here