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| Name | Class |
|---|---|
| State Scientific Centre of Coloproctology, Russian Federation | OTHER_GOV |
| Ministry of Health, Russian Federation | OTHER_GOV |
| Ministry of Science and Higher Education, Russian Federation | UNKNOWN |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| biofeedback and tibial neuromodulation (BFB+TNM) | Experimental |
| |
| BFB+TNM + pelvic floor muscles training (PFMT) | Experimental |
| |
| BFB+TNM+PFMT+diet modification | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofeedback therapy | Procedure | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergey Morozov, MD, PhD | Contact | +79104681801 | morosoffsv@mail.ru | |
| Oksana Fomenko, MD, PhD | Contact | +79164817323 | oksana671@yandex.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology | Recruiting | Moscow | 115446 | Russia |
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within 2 years after study completion
per request
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Random assignment to one of the groups depending on the treatment options:
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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
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| Tibial neuromodulation | Procedure | 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. |
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| Pelvic floor muscles training | Behavioral | 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. |
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| Diet modification | Behavioral | 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. |
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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 |
| Federal Research Center of Coloproctology | Recruiting | Moscow | Russia |
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| ID | Term |
|---|---|
| D020047 | Rectocele |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
| D044623 | Nutrition Therapy |
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