Actively Recruiting

Phase 3
Age: 18Years - 70Years
FEMALE
ID04547816

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

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

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
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 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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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