BridgeMD
Compares treatment options for Urinary Incontinence
Official title Biofeedback Versus Vaginal Palpation to Teach a Voluntary Pelvic Floor Muscle Contraction
ClinicalTrials.gov ID: NCT05194137
What this study is testing
- What it's testing
- Pelvic floor muscle training (PFMT) is the first line treatment of urinary incontinence (UI), anal incontinence (AI) and mild/moderate pelvic organ prolapse (POP) in women. However, 25 to 40% of women with pelvic floor dysfunction symptoms are unable to voluntarily contract their pelvic floor muscle (PFM) and PFM proprioception of this population is specially reduced.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women aged 18 or over;
- Women referred to the physiotherapeutic treatment of the Lucy Montoro Rehabilitation Center (Ribeirão Preto Medical School) or the Women's Health...
- Women unable to perform a PFM contraction (i.e. PFM function classified as 0 or 1 according to the modified oxford scale);
- Women with urinary incontinence (i.e ICIQ-UI-SF score ≥ 3)
- Agree to participate in the research by signing the informed consent form It will not be included in this study:
You likely can't join if
- Women who become pregnant while conducting the study
- Women with intolerance or pain that prevents the conduct of research protocols.
See the full eligibility criteria
- Women aged 18 or over;
- Women referred to the physiotherapeutic treatment of the Lucy Montoro Rehabilitation Center (Ribeirão Preto Medical School) or the Women's Health Reference Center (MATER) for any pelvic floor dysfunction;
- Women unable to perform a PFM contraction (i.e. PFM function classified as 0 or 1 according to the modified oxford scale);
- Women with urinary incontinence (i.e ICIQ-UI-SF score ≥ 3)
- Agree to participate in the research by signing the informed consent form It will not be included in this study:
- Women whose pelvic floor dysfunction has an associated neuropathy;
- Women with vaginal or urological symptoms of possible infections;
- Women with pelvic organs prolapse that makes it impossible to evaluate or conduct treatment (stage \> 2 according to Baden-Walker Scale);
- Pregnant women;
- Women with cognitive impairment.
- Women who become pregnant while conducting the study
- Women with intolerance or pain that prevents the conduct of research protocols.
The study team makes the final eligibility decision.
Where it's taking place
- Ribeirão Preto, São Paulo, Brazil
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ribeirão Preto, São Paulo, Brazil. 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.