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

Evaluation of Complex (Physical Therapy and Diet) Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse

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

Study Overview

• Status: Recruiting
• Conditions: Functional Constipation; Pelvic Floor Prolapse; Rectocele
• Intervention / Treatment: Procedure: Biofeedback therapy; Procedure: Tibial neuromodulation; Behavioral: Pelvic floor muscles training; Behavioral: Diet modification

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Oksana Fomenko, MD, PhD; Phone Number: +79164817323; Email: oksana671@yandex.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115446
    • Recruiting
    • Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
    • Contact: Marina Biryukova, MD; Phone Number: +74997943572; Email: bibi24@yandex.ru
    • Sub-Investigator: Marina Biryukova, MD
  • Moscow, Russian Federation
    • Recruiting
    • Federal Research Center of Coloproctology
    • Contact: Oksana Fomenko, MD, PhD; Phone Number: +79164817327; Email: oksana671@yandex.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: biofeedback and tibial neuromodulation (BFB+TNM)	Procedure: Biofeedback therapy; 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; Other Names: BFB; Procedure: Tibial neuromodulation; 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.; Other Names: TNM
Experimental: BFB+TNM + pelvic floor muscles training (PFMT)	Procedure: Biofeedback therapy; 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; Other Names: BFB; Procedure: Tibial neuromodulation; 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.; Other Names: TNM; Behavioral: Pelvic floor muscles training; 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.; Other Names: PFMT
Experimental: BFB+TNM+PFMT+diet modification	Procedure: Biofeedback therapy; 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; Other Names: BFB; Procedure: Tibial neuromodulation; 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.; Other Names: TNM; Behavioral: Pelvic floor muscles training; 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.; Other Names: PFMT; Behavioral: Diet modification; 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.; Other Names: DM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): March 3, 2024

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: pelvic floor prolapse; conservative treatment; rectocele; functional disorders of defecation; diet modification; biofeedback therapy; tibial neuromodulation
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Hernia; Prolapse; Pelvic Organ Prolapse; Constipation; Rectocele
• Other Study ID Numbers: DGH-SSCC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: within 2 years after study completion
• IPD Sharing Access Criteria: per request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No