NCT04547816 Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
| NCT ID | NCT04547816 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Federal State Budgetary Scientific Institution |
| Condition | Pelvic Floor Prolapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-07-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 100 participants in total. It began in 2020-07-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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-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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04547816 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Pelvic Floor Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04547816 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 100 participants.
Is NCT04547816 currently recruiting?
Yes, NCT04547816 is actively recruiting participants. Contact the research team at morosoffsv@mail.ru for enrollment information.
Where is the NCT04547816 trial being conducted?
This trial is being conducted at Moscow, Russia, Moscow, Russia.
Who is sponsoring the NCT04547816 clinical trial?
NCT04547816 is sponsored by Federal State Budgetary Scientific Institution. The trial plans to enroll 100 participants.