Pelvic Floor Prolapse, Functional Constipation, Rectocele
Conditions
Keywords
pelvic floor prolapse, conservative treatment, functional disorders of defecation, rectocele, diet modification, biofeedback therapy, tibial neuromodulation
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
Interventions
PROCEDUREBiofeedback 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
PROCEDURETibial 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.
BEHAVIORALPelvic 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.
BEHAVIORALDiet 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.
Sponsors
State Scientific Centre of Coloproctology, Russian Federation
Ministry of Health, Russian Federation
Ministry of Science and Higher Education, Russian Federation
Federal State Budgetary Scientific Institution Federal Research Centre of Nutrition, Biotechnology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
After randomization eligible subjects are to receive one of the treatment option described in the Model Description according to the order placed in a closed envelope which is to be opened by person who perform biofeedback (BFT) and tibial neuromodulation (TNM). The investigator responsible for the study conduction, clinical assessment and high-resolution anorectal manometry measurements is not supposed to get the information about the number of procedures (BFT+TNM; or BFT+TNM + pelvic floor muscles training (PFMT); or BFT+TNM + PFMT + diet modification (DM)) that a certain subject receives
Intervention model description
Random assignment to one of the groups depending on the treatment options: 1. biofeedback and tibial neuromodulation 2. biofeedback and tibial neuromodulation + pelvic floor muscles training 3. biofeedback and tibial neuromodulation + pelvic floor muscles training + diet modification
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Russia
Contacts
Primary ContactSergey Morozov, MD, PhD
Backup ContactOksana Fomenko, MD, PhD
Outcome results
None listed