Evaluation of Complex (Physical Therapy and Diet) Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change of KESS scale points
Study Overview
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
Study Design
- Study Type
- Interventional
- 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
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
biofeedback and tibial neuromodulation (BFB+TNM)
Intervention: Biofeedback therapy (Procedure)
biofeedback and tibial neuromodulation (BFB+TNM)
Intervention: Tibial neuromodulation (Procedure)
BFB+TNM + pelvic floor muscles training (PFMT)
Intervention: Pelvic floor muscles training (Behavioral)
BFB+TNM + pelvic floor muscles training (PFMT)
Intervention: Biofeedback therapy (Procedure)
BFB+TNM + pelvic floor muscles training (PFMT)
Intervention: Tibial neuromodulation (Procedure)
BFB+TNM+PFMT+diet modification
Intervention: Biofeedback therapy (Procedure)
BFB+TNM+PFMT+diet modification
Intervention: Tibial neuromodulation (Procedure)
BFB+TNM+PFMT+diet modification
Intervention: Pelvic floor muscles training (Behavioral)
BFB+TNM+PFMT+diet modification
Intervention: Diet modification (Behavioral)
Outcomes
Primary Outcomes
Change of KESS scale points
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.
Change in Scale of bowel evacuatory function assessment
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
Mean stool frequency
Time Frame: A week
clinical outcome
Mean stool form value
Time Frame: A week
clinical outcome, assessed with the use of the Bristol stool scale (BSS)
Mean defecation with difficult bowel emptying
Time Frame: a week
patient-reported outcome, clinical
Average anal resting pressure
Time Frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Maximum absolute anal squeeze pressure
Time Frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Average absolute anal squeeze pressure
Time Frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Average incremental anal squeeze pressure
Time Frame: at the end-point, 6 months after enrolmentat the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Residual push pressure
Time Frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Push relaxation percentage
Time Frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Secondary Outcomes
No secondary outcomes reported
Investigators
Sergey Morozov
MD, PhD
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology