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โ† Trials
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Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse

RecruitingPhase 3Ages 18 Years - 70 YearsFemaleFederal State Budgetary Scientific Institution
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Biofeedback therapy
  • Tibial neuromodulation
  • Pelvic floor muscles training
  • Diet modification
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Where

2 sites
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Moscow, Russia
Federal Research Center of Coloproctology
Moscow, Russia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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