Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Recruiting
Phase 3
Interventional Study
Pelvic Floor Prolapse
Functional Constipation
Rectocele
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Federal State Budgetary Scientific Institution · Government
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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
Trial Locations
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Eligibility Criteria
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-reso…
Contacts