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

Phase 3

Recruiting

• Conditions: Rectocele; Pelvic Floor Prolapse; Functional Constipation
• Interventions: Procedure: Biofeedback therapy; Procedure: Tibial neuromodulation; Behavioral: Pelvic floor muscles training; Behavioral: Diet modification

• Registration Number: NCT04547816
• Lead Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

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

Detailed Description

Pelvic organ prolapse is a condition with impaired anatomic structure, which may result in defecatory disorders and usually considered as an indication for surgery. However, operation is not always possible. Existing data suggest that functional component may also be possible, despite on the anatomic impairment. The aim of the study is to evaluate the effect of complex conservative treatment of functional defecatory disorders in patients with mild to moderate grade of pelvic organ prolapse

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-14
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
biofeedback and tibial neuromodulation (BFB+TNM)	Biofeedback therapy	-
BFB+TNM + pelvic floor muscles training (PFMT)	Biofeedback therapy	-
BFB+TNM+PFMT+diet modification	Biofeedback therapy	-
BFB+TNM+PFMT+diet modification	Tibial neuromodulation	-
BFB+TNM + pelvic floor muscles training (PFMT)	Tibial neuromodulation	-
BFB+TNM + pelvic floor muscles training (PFMT)	Pelvic floor muscles training	-
biofeedback and tibial neuromodulation (BFB+TNM)	Tibial neuromodulation	-
BFB+TNM+PFMT+diet modification	Pelvic floor muscles training	-
BFB+TNM+PFMT+diet modification	Diet modification	-

Primary Outcome Measures

Name	Time	Method
Mean stool frequency	A week	clinical outcome
Mean stool form value	A week	clinical outcome, assessed with the use of the Bristol stool scale (BSS)
Mean defecation with difficult bowel emptying	a week	patient-reported outcome, clinical
Change of KESS scale points	at the end-point, 6 months after enrolment	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.
Change in Scale of bowel evacuatory function assessment	at the end-point, 6 months after enrolment	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
Average anal resting pressure	at the end-point, 6 months after enrolment	Values obtained during HR anorectal manometry
Maximum absolute anal squeeze pressure	at the end-point, 6 months after enrolment	Values obtained during HR anorectal manometry
Average absolute anal squeeze pressure	at the end-point, 6 months after enrolment	Values obtained during HR anorectal manometry
Average incremental anal squeeze pressure	at the end-point, 6 months after enrolmentat the end-point, 6 months after enrolment	Values obtained during HR anorectal manometry
Residual push pressure	at the end-point, 6 months after enrolment	Values obtained during HR anorectal manometry
Push relaxation percentage	at the end-point, 6 months after enrolment	Values obtained during HR anorectal manometry

Trial Locations

Locations (2)

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology; 🇷🇺 Moscow, Russian Federation

Federal Research Center of Coloproctology; 🇷🇺 Moscow, Russian Federation