NCT Number: NCT04547816
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
Interested in participating?
Request Info18 year–70 year
Female
Interventional
Phase 3
Federal Research Center of Coloproctology, Moscow, Russia
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: 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.
Other names: 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.
Other names: 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.
Other names: DM
Time frame: A week
clinical outcome
Time frame: A week
clinical outcome, assessed with the use of the Bristol stool scale (BSS)
Time frame: a week
patient-reported outcome, clinical
Time frame: 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.
Time frame: 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
Time frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Time frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Time frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Time frame: at the end-point, 6 months after enrolmentat the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Time frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Time frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Contact information is provided by the study sponsor or research team.
Oksana Fomenko, MD, PhD
CONTACT
Sergey Morozov, MD, PhD
CONTACT
Federal State Budgetary Scientific Institution
Other Gov
Evaluation of Complex (Physical Therapy and Diet) Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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