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Tests treatment safety and results for Pelvic Floor Prolapse
Official title Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
ClinicalTrials.gov ID: NCT04547816
What this study is testing
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- 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...
You likely can't join if
- 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...
- start of any new concomitant medication with mechanisms of action that influence rectal motility, sensory function, muscle tone and/or contractility
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.