Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse

NCT04547816 | Recruiting Phase 3 DMC

• 1 other identifier: DGH-SSCC1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Pelvic Floor Prolapse; Functional Constipation; Rectocele

Keywords

pelvic floor prolapse; conservative treatment; functional disorders of defecation; rectocele; diet modification; biofeedback therapy; tibial neuromodulation

Outcome Measures

Primary Outcomes (11)

• Mean stool frequency

  clinical outcome

  A week

• Mean stool form value

  clinical outcome, assessed with the use of the Bristol stool scale (BSS)

  A week

• Mean defecation with difficult bowel emptying

  patient-reported outcome, clinical

  a week

• Change of KESS scale points

  A specialized validated questionnaire will be used before treatment and at the end of the study. "Change" is to be assessed as percentage decline from baseline values.

  at the end-point, 6 months after enrolment

• Change in Scale of bowel evacuatory function assessment

  A specialized validated questionnaire will be used before treatment and at the end of the study. "Change" is to be assessed as percentage decline from baseline v

  at the end-point, 6 months after enrolment

• Average anal resting pressure

  Values obtained during HR anorectal manometry

  at the end-point, 6 months after enrolment

• Maximum absolute anal squeeze pressure

  Values obtained during HR anorectal manometry

  at the end-point, 6 months after enrolment

• Average absolute anal squeeze pressure

  Values obtained during HR anorectal manometry

  at the end-point, 6 months after enrolment

• Average incremental anal squeeze pressure

  Values obtained during HR anorectal manometry

  at the end-point, 6 months after enrolmentat the end-point, 6 months after enrolment

• Residual push pressure

  Values obtained during HR anorectal manometry

  at the end-point, 6 months after enrolment

• Push relaxation percentage

  Values obtained during HR anorectal manometry

  at the end-point, 6 months after enrolment

Study Arms (3)

biofeedback and tibial neuromodulation (BFB+TNM)

EXPERIMENTAL

Procedure: Biofeedback therapy; Procedure: Tibial neuromodulation

BFB+TNM + pelvic floor muscles training (PFMT)

EXPERIMENTAL

Procedure: Biofeedback therapy; Procedure: Tibial neuromodulation; Behavioral: Pelvic floor muscles training

BFB+TNM+PFMT+diet modification

EXPERIMENTAL

Procedure: Biofeedback therapy; Procedure: Tibial neuromodulation; Behavioral: Pelvic floor muscles training; Behavioral: Diet modification

Interventions

Biofeedback therapy PROCEDURE

Biofeedback therapy is a procedure when the patient is taught to make proper squeezing by adequate increase of intra-abdominal and rectal pressures and relaxation of the muscles of the pelvic floor. This procedure is widely described and is to be performed with the use of devices registered for this purpose Urostim and WPM Solar, MMS, the Netherlands

Also known as: BFB

BFB+TNM + pelvic floor muscles training (PFMT); BFB+TNM+PFMT+diet modification; biofeedback and tibial neuromodulation (BFB+TNM)

Tibial neuromodulation PROCEDURE

TNM is a standard procedure that is previously described as an effective method to treat functional insufficiency of the anal sphincter. It acts on the lumbosacral nerve plexus with an electric current through the posterior tibial nerve of one of the patient's limbs. For the study purpose a registered device for electric therapy (BioBravo, MTR Plus Vertriebs GmbH, Germany) is to be used.

Also known as: TNM

BFB+TNM + pelvic floor muscles training (PFMT); BFB+TNM+PFMT+diet modification; biofeedback and tibial neuromodulation (BFB+TNM)

Pelvic floor muscles training BEHAVIORAL

PFMT is a complex of 5 exercises aimed to make functional training of pelvic floor muscles. This complex does not require additional equipment. It may be performed at home. The patients will be trained to perform this complex of exercises by a healthcare provider. The complex of physical therapy consists of a single basic exercise for training coordinated muscle tension of abdominal wall and relaxation of the pelvic floor muscles, and 4 exercises to increase the contractility of pelvic floor muscles without additional involvement of the muscles of the abdominal wall. This allows to coordinate and consciously control the contraction and relaxation of the pelvic diaphragm. Initial course of training is 10 working days. Than patients continue the intervention for 6 months at home with online monitoring of the correctness and regularity of training.

Also known as: PFMT

BFB+TNM + pelvic floor muscles training (PFMT); BFB+TNM+PFMT+diet modification

Diet modification BEHAVIORAL

Diet modification play an important role in the regulation of colonic transit and defecation. Dietary factors may act through faecal bulk by additional stimulation of mechanoreceptors of the rectum. At the same time, adequate intake of vitamins (for example, B12) may improve electric conductivity of nerves and thus impact the tone of pelvic floor muscles. Among other factors known to affect functional state of pelvic floor muscles and colonic transit are dietary fibers, adequate intake of water, regular meal intake. For the study purposes, it is planned to provide standard recommendation based on the national recommended daily allowances according to patients' sex, age and physical activity level.

Also known as: DM

BFB+TNM+PFMT+diet modification

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology: lead
• State Scientific Centre of Coloproctology, Russian Federation: collaborator
• Ministry of Health, Russian Federation: collaborator
• Ministry of Science and Higher Education, Russian Federation: collaborator

Study Sites (2)

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Moscow, 115446, Russia

RECRUITING

Federal Research Center of Coloproctology

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Rectocele

Interventions

Biofeedback, Psychology; Diet Therapy

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Nutrition Therapy

Central Study Contacts

Sergey Morozov, MD, PhD

CONTACT

+79104681801; morosoffsv@mail.ru

Oksana Fomenko, MD, PhD

CONTACT

+79164817323; oksana671@yandex.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After randomization eligible subjects are to receive one of the treatment option described in the Model Description according to the order placed in a closed envelope which is to be opened by person who perform biofeedback (BFT) and tibial neuromodulation (TNM). The investigator responsible for the study conduction, clinical assessment and high-resolution anorectal manometry measurements is not supposed to get the information about the number of procedures (BFT+TNM; or BFT+TNM + pelvic floor muscles training (PFMT); or BFT+TNM + PFMT + diet modification (DM)) that a certain subject receives
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Random assignment to one of the groups depending on the treatment options: 1. biofeedback and tibial neuromodulation 2. biofeedback and tibial neuromodulation + pelvic floor muscles training 3. biofeedback and tibial neuromodulation + pelvic floor muscles training + diet modification

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 14, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: within 2 years after study completion
• Access Criteria: per request

Locations

RU (2)