Sling vs Botox for Mixed Incontinence (MUSA) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about the best way to treat women who have Mixed Urinary Incontinence (MUI).

Because MUI includes both types of incontinence (stress and urgency), it is difficult to treat. This study will compare the 2 different procedures for the treatment of MUI.

What is the Condition Being Studied?

Women who have Mixed Urinary Incontinence (MUI)

Who Can Participate in the Study?

Adult women who have:
-Felt urinary leakage when sneezing, coughing, etc.
-Felt a sudden, strong desire to pass urine that leads to leakage before getting to the toilet

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
-Be randomized (like a flip of a coin) to Group1 or Group 2
--Group 1 will get BOTOX injections to relax your bladder muscles
--Group 2 will have a surgery called mid-urethral sling surgery

After you have you procedure, you will:
-Complete 3 follow-up visits within 6 months (each are about an hour long)
-Keep a diary about how you feel

Study Details

Full Title
Treatment for Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A (MUSA)
Principal Investigator
Urogynecologist
Protocol Number
IRB: PRO00104991
NCT: NCT04171531
Phase
Phase IV
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698