BridgeMD
Tests treatment safety and results for Obstetric Fistula
Official title Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
ClinicalTrials.gov ID: NCT05444504
What this study is testing
- What it's testing
- The investigators propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Two intervention models will be compared among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity.
- 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 15 and older, women only
You may be able to join if
- VVF confirmed by dye test and clinical exam at least 3cm from the external urethral orifice (regardless of size), adequate vaginal capacity to...
- Willing to insert and remove cup/cup+
- Clear understanding of the study procedures
- Willing to participate fully, not yet been repaired or previously failed surgical repair, at least 6mo post-surgery
- If previous fistula repair, ≥3mo post-delivery
You likely can't join if
- Any rectovaginal fistula
- Urinary leakage \<6ml over 6 hours
- Women who are candidates for catheterization who could be healed without surgery will be excluded as they are \<3mo post-delivery.
See the full eligibility criteria
- VVF confirmed by dye test and clinical exam at least 3cm from the external urethral orifice (regardless of size), adequate vaginal capacity to accommodate the cup (per physician)
- Willing to insert and remove cup/cup+
- Clear understanding of the study procedures
- Willing to participate fully, not yet been repaired or previously failed surgical repair, at least 6mo post-surgery
- If previous fistula repair, ≥3mo post-delivery
- If recent birth, age 18+ or emancipated minor
- Speak English or local language
- Any rectovaginal fistula
- Urinary leakage \<6ml over 6 hours
- Women who are candidates for catheterization who could be healed without surgery will be excluded as they are \<3mo post-delivery.
The study team makes the final eligibility decision.
Where it's taking place
- Mankessim, Ghana
- Tamale, Ghana
- Eldoret, Kenya
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, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mankessim, Ghana; Tamale, Ghana; Eldoret, Kenya. 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.