BridgeMD
New treatment option for Pelvic Organ Prolapse (POP)
Official title Evaluation of a Personalizable Pessary for Pelvic Organ Prolapse
ClinicalTrials.gov ID: NCT06954701
What this study is testing
- What it's testing
- Pelvic organ prolapse (POP) is a common health issue. It will impact about half of Canadian women over their lifetime.
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
- Patients assigned female at birth
- At least 18 years old at time of screening
- Patients with symptomatic POP using a pessary for ≥ 3 months
- Capable of giving informed consent
- Fluency in English
You likely can't join if
- Pregnancy
- Short vaginal length (total vaginal length \<5 cm) or subjective vaginal narrowing
- Vaginal erosion due to current pessary
- Presence of vesicovaginal fistula
- Presence of rectovaginal fistula
- Current treatment for vaginal, rectal, or bladder tumor
See the full eligibility criteria
- Patients assigned female at birth
- At least 18 years old at time of screening
- Patients with symptomatic POP using a pessary for ≥ 3 months
- Capable of giving informed consent
- Fluency in English
- Pregnancy
- Short vaginal length (total vaginal length \<5 cm) or subjective vaginal narrowing
- Vaginal erosion due to current pessary
- Presence of vesicovaginal fistula
- Presence of rectovaginal fistula
- Current treatment for vaginal, rectal, or bladder tumor
- Presence of open wound or tear near vagina or anus by exam prior to removal of current pessary
- Presence of pelvic, vaginal, or urinary infection requiring treatment
- Ongoing treatment of recurrent urinary tract or vaginal infections
- Inflammatory bowel disease
- Chronic pain syndromes of pelvic or anorectal origin
- Previous pelvic floor surgery in last 12 months
- Congenital malformation of bladder, rectum, or vagina
- Significant medical condition interfering with study participation (psychologic, neurologic, active drug/alcohol abuse, ambulatory restrictions, etc.)
- Planning pregnancy in next 6 months
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
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 Edmonton, Alberta, Canada. 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.