Evaluation of Complex (Physical Therapy and Diet) Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Who is this study for? Females with pelvic organ prolapse
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Behavioral
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Russian Federation
Federal Research Center of Coloproctology
RECRUITING
Moscow
Federal State Budgetary Scientific Institution Federal Research Centre of Nutrition, Biotechnology
RECRUITING
Moscow
Contact Information
Primary
Sergey Morozov, MD, PhD
morosoffsv@mail.ru
+79104681801
Backup
Oksana Fomenko, MD, PhD
oksana671@yandex.ru
+79164817323
Time Frame
Start Date: 2020-07-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 100
Treatments
Experimental: biofeedback and tibial neuromodulation (BFB+TNM)
Experimental: BFB+TNM + pelvic floor muscles training (PFMT)
Experimental: BFB+TNM+PFMT+diet modification
Related Therapeutic Areas
Sponsors
Collaborators: Ministry of Health, Russian Federation, State Scientific Centre of Coloproctology, Russian Federation, Ministry of Science and Higher Education, Russian Federation
Leads: Federal State Budgetary Scientific Institution Federal Research Centre of Nutrition, Biotechnology