Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Status and phase: Enrolling; Phase 3

Conditions: Functional Constipation; Pelvic Floor Prolapse; Rectocele

Treatments: Procedure: Tibial neuromodulation; Behavioral: Diet modification; Procedure: Biofeedback therapy; Behavioral: Pelvic floor muscles training

Study type: Interventional

Funder types: Other

Identifiers

NCT04547816

DGH-SSCC1

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups

biofeedback and tibial neuromodulation (BFB+TNM)

Experimental group

Treatment:

Procedure: Biofeedback therapy

Procedure: Tibial neuromodulation

BFB+TNM + pelvic floor muscles training (PFMT)

Experimental group

Treatment:

Behavioral: Pelvic floor muscles training

Procedure: Biofeedback therapy

Procedure: Tibial neuromodulation

BFB+TNM+PFMT+diet modification

Experimental group

Treatment:

Behavioral: Pelvic floor muscles training

Procedure: Biofeedback therapy

Behavioral: Diet modification

Procedure: Tibial neuromodulation