Overview

Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Status:
Not yet recruiting
Trial end date:
2027-07-15
Target enrollment:
0
Participant gender:
Female
Summary
The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI). Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months. Based on patient expert input, there are 2 primary outcomes: Treatment satisfaction and urinary symptom severity.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Collaborators:
Brown University
Howard University
Patient-Centered Outcomes Research Institute
University of Alabama at Birmingham
University of California, San Diego
University of New Mexico
Treatments:
abobotulinumtoxinA
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-3 Receptor Agonists
Botulinum Toxins, Type A
Criteria
Inclusion criteria*:

1. 18 years or older

2. report at least "quite a bit bothered" or worse by their UUI defined by response to
OAB-q-SS item #8 "How bothered are you by urine loss associated with a strong desire
to urinate?"

3. are not and do not plan to become pregnant

4. have persistent UUI defined as previous unsuccessful results after conservative and
anticholinergic treatment, or are unable to tolerate or have contraindications to
anticholinergics

5. are currently not taking anticholinergics or are willing to stop medication for 3
weeks prior to enrollment.

6. for participants reporting mixed urinary incontinence symptoms, participant must (a)
have less bother from SUI than from UUI, defined as a response of "Not at all
bothered" or only "a little bit bothered" by SUI on the Urogenital Distress Inventory
item "Do you experience urine leakage related to physical activity? (walking, running,
laughing, sneezing, coughing), and (b) SUI symptoms be stable (> 3 months), and
(c)participant does not desire additional treatment for SUI in the upcoming 3 months.

7. Participants after unsuccessful neuromodulation trial can be eligible after a 4-week
washout period.

Exclusion criteria:

1. clinical contraindication to beta-3 agonist or onabotulinumtoxinA

2. prior use of either study treatment

3. unevaluated hematuria, current or prior bladder malignancy

4. surgically altered detrusor muscle

5. prior pelvic radiation

6. post-void residual >150 mL in past 3 months

7. neurogenic bladder

8. pelvic floor surgery within the past 3 months