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

Recruiting
18 - 70 years of age
Female
Phase 3

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Overview

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

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

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

Study details

Pelvic Floor Prolapse, Functional Constipation, Rectocele

NCT04547816

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

26 January 2024

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