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

Functional Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04547816
• Other study ID #: DGH-SSCC1
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2020
• Est. completion date: March 3, 2024

Study information

• Verified date: April 2023
• Source: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
• Contact: Sergey Morozov, MD, PhD
• Phone: +79104681801
• Email: morosoffsv[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 3, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Functional Constipation
• Pelvic Floor Prolapse
• Pelvic Organ Prolapse
• Prolapse
• Rectocele

Intervention

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
• 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.

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Federal Research Center of Coloproctology	Moscow
Russian Federation	Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology	Moscow

Sponsors (4)

Lead Sponsor	Collaborator
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology	Ministry of Health, Russian Federation, Ministry of Science and Higher Education, Russian Federation, State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean stool frequency	clinical outcome	A week
Primary	Mean stool form value	clinical outcome, assessed with the use of the Bristol stool scale (BSS)	A week
Primary	Mean defecation with difficult bowel emptying	patient-reported outcome, clinical	a week
Primary	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
Primary	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
Primary	Average anal resting pressure	Values obtained during HR anorectal manometry	at the end-point, 6 months after enrolment
Primary	Maximum absolute anal squeeze pressure	Values obtained during HR anorectal manometry	at the end-point, 6 months after enrolment
Primary	Average absolute anal squeeze pressure	Values obtained during HR anorectal manometry	at the end-point, 6 months after enrolment
Primary	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
Primary	Residual push pressure	Values obtained during HR anorectal manometry	at the end-point, 6 months after enrolment
Primary	Push relaxation percentage	Values obtained during HR anorectal manometry	at the end-point, 6 months after enrolment