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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFederal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

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

Treatment groups

100 Participants
are divided into 3 treatment groups

Sponsors and collaborators

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

Lead sponsor

State Scientific Centre of Coloproctology, Russian Federation

Collaborator

Ministry of Health, Russian Federation

Collaborator

Ministry of Science and Higher Education, Russian Federation

Collaborator