A Phase 3 interventional study of Biofeedback therapy and Tibial neuromodulation in Pelvic Floor Prolapse, Functional Constipation and Rectocele, sponsored by Federal State Budgetary Scientific Institution. Recruiting at 2 sites in Russia. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Federal State Budgetary Scientific Institution · Phase 3, Interventional, and Treatment
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
50 studies on the registry are indexed under Rectocele; 9 are open to participants now.
This study's planned enrollment of 100 is above the median of 62 across 37 interventional studies indexed under Rectocele.
Browse Rectocele studies →Federal State Budgetary Scientific Institution is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Biofeedback therapy · Procedure: Tibial neuromodulation
Procedure: Biofeedback therapy · Procedure: Tibial neuromodulation · Behavioral: Pelvic floor muscles training
Procedure: Biofeedback therapy · Procedure: Tibial neuromodulation · Behavioral: Pelvic floor muscles training · Behavioral: Diet modification
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
Also known as: BFB
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.
Also known as: TNM
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.
Also known as: PFMT
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.
Also known as: DM
Mean stool frequency
clinical outcome
Time frame: A week
Mean stool form value
clinical outcome, assessed with the use of the Bristol stool scale (BSS)
Time frame: A week
Mean defecation with difficult bowel emptying
patient-reported outcome, clinical
Time frame: 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.
Time frame: 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
Time frame: at the end-point, 6 months after enrolment
Average anal resting pressure
Values obtained during HR anorectal manometry
Time frame: at the end-point, 6 months after enrolment
Maximum absolute anal squeeze pressure
Values obtained during HR anorectal manometry
Time frame: at the end-point, 6 months after enrolment
Average absolute anal squeeze pressure
Values obtained during HR anorectal manometry
Time frame: at the end-point, 6 months after enrolment
Average incremental anal squeeze pressure
Values obtained during HR anorectal manometry
Time frame: at the end-point, 6 months after enrolmentat the end-point, 6 months after enrolment
Residual push pressure
Values obtained during HR anorectal manometry
Time frame: at the end-point, 6 months after enrolment
Push relaxation percentage
Values obtained during HR anorectal manometry
Time frame: at the end-point, 6 months after enrolment
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: within 2 years after study completion
Access criteria: per request
Data sharing details ↗ · ion.ru
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Federal State Budgetary Scientific Institution