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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Pelvic Floor Prolapse, Functional Constipation, Rectocele

Intervention / Treatment
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* Procedure: Biofeedback therapy
* Procedure: Tibial neuromodulation
* Behavioral: Pelvic floor muscles training
* Behavioral: Diet modification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random assignment to one of the groups depending on the treatment options: biofeedback and tibial neuromodulation biofeedback and tibial neuromodulation + pelvic floor muscles training biofeedback and tibial neuromodulation + pelvic floor muscles training + diet modification
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conservative treatment, pelvic floor prolapse, functional disorders of defecation, rectocele, diet modification, biofeedback therapy, tibial neuromodulation