Clinical trial NCT04547816: Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Official title: Evaluation of Complex (Physical Therapy and Diet) Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pelvic Floor Prolapse
Functional Constipation
Rectocele
Keywords: pelvic floor prolapse
conservative treatment
functional disorders of defecation
rectocele
diet modification
biofeedback therapy
tibial neuromodulation
Lead sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Sponsor class: OTHER
Collaborators: name: State Scientific Centre of Coloproctology, Russian Federation
name: Ministry of Health, Russian Federation
name: Ministry of Science and Higher Education, Russian Federation
First posted: 2020-09-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Mean stool frequency
timeFrame: A week
measure: Mean stool form value
timeFrame: A week
measure: Mean defecation with difficult bowel emptying
timeFrame: a week
measure: Change of KESS scale points
timeFrame: at the end-point, 6 months after enrolment
measure: Change in Scale of bowel evacuatory function assessment
timeFrame: at the end-point, 6 months after enrolment
measure: Average anal resting pressure
timeFrame: at the end-point, 6 months after enrolment
measure: Maximum absolute anal squeeze pressure
timeFrame: at the end-point, 6 months after enrolment
measure: Average absolute anal squeeze pressure
timeFrame: at the end-point, 6 months after enrolment
measure: Average incremental anal squeeze pressure
timeFrame: at the end-point, 6 months after enrolmentat the end-point, 6 months after enrolment
measure: Residual push pressure
timeFrame: at the end-point, 6 months after enrolment
measure: Push relaxation percentage
timeFrame: at the end-point, 6 months after enrolment
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
city: Moscow
country: Russian Federation
facility: Federal Research Center of Coloproctology
Study officials:
References: