MUSA- Treatment for Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A
Recruiting
21 years - 99 years
All
Phase
N/A
20 participants needed
1 Location
Brief description of study
Mixed urinary incontinence (MUI), defined as the presence of both stress urinary incontinence and urgency
urinary incontinence, is a challenging condition for which clinicians frequently use multiple sequential
treatments that have undergone limited head to head comparison in rigorous clinical trials.
Mid-urethral
Sling vs. Botox A (MUSA) is a randomized 2-arm clinical trial for women who have at least moderate bother
from both stress and urgency incontinence and who have failed one or more conservative treatments.
The
primary objective is to estimate the effect of 100 units of intradetrusor injections of Botulinum toxin A
(Botox A) compared to mid-urethral sling surgery for the treatment of MUI in 110 women. Participants in
the Botox A arm may receive one additional injection of 100 units Botox A between 3 months and 6 months
after the initial injection if they have persistent urgency incontinence symptoms and meet the safety criteria.
The primary outcome for this trial is the change in severity of MUI symptoms which will be measured at 6
months using the Urogenital Distress Inventory.
Secondary objectives include identifying predictors of
treatment failure and cost-effectiveness of treatments. Safety and adverse events data will also be collected.
At the completion of this study, we will better understand whether a surgical treatment that focuses on the
urgency component (Botox A) is superior to a surgical treatment that focuses on the stress component (midurethral sling).
The trial will provide clinically useful information for two treatments that are widely used to
treat MUI but for which evidence-based data are not available.
Participants will be recruited from Penn Medicine practices. Women with MUI will
be offered the full range of treatment options consistent with routine practice including expectant
management, pelvic floor muscle therapy, behavioral therapy, medication, and possibly surgery. Patients
who are considered candidates for either Botox A injection or mid-urethral sling by their physician will be
offered participation in MUSA. Participants will be identified as MUSA candidates by their physician.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: mixed urinary incontinence,botox,urethra,urinary incontinence
-
Age: 21 years - 99 years
-
Gender: All
Updated on
04 Aug 2024.
Study ID: 842657
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