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

Official title

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

Overview

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

Interventions

• 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
• 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.
• 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 mu
• 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,

Primary outcome measures

• Mean stool frequency [Time frame: A week]
• Mean stool form value [Time frame: A week]
• Mean defecation with difficult bowel emptying [Time frame: a week]
• Change of KESS scale points [Time frame: at the end-point, 6 months after enrolment]
• Change in Scale of bowel evacuatory function assessment [Time frame: at the end-point, 6 months after enrolment]
• Average anal resting pressure [Time frame: at the end-point, 6 months after enrolment]
• Maximum absolute anal squeeze pressure [Time frame: at the end-point, 6 months after enrolment]
• Average absolute anal squeeze pressure [Time frame: at the end-point, 6 months after enrolment]
• Average incremental anal squeeze pressure [Time frame: at the end-point, 6 months after enrolmentat the end-point, 6 months after enrolment]
• Residual push pressure [Time frame: at the end-point, 6 months after enrolment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Russia · 2 centers

• Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biot — Moscow
• Federal Research Center of Coloproctology — Moscow

Identifiers

NCT: NCT04547816 · DGH-SSCC1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗