Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Launched by WOMEN AND INFANTS HOSPITAL OF RHODE ISLAND · Mar 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to compare two different treatments for women who experience urgency urinary incontinence (UUI), which is a condition where you feel a sudden, strong urge to urinate and may have trouble controlling it. One treatment being tested is an oral medication called a beta agonist, and the other is a series of injections using a substance called onabotulinumtoxinA. Women who join this study will be randomly assigned to receive one of these treatments, and researchers will assess how well each treatment works over a period of 12 months, focusing especially on how satisfied participants are with their treatment and how severe their urinary symptoms are.

To participate in this trial, women must be at least 18 years old and have been bothered by their urinary issues. They should not be pregnant and must have tried other treatments without success or be unable to tolerate those treatments. Participants will need to stop taking certain medications before starting the study. Throughout the trial, women can expect regular follow-ups to monitor their progress and experiences with the treatments. Overall, this research aims to find out which treatment option might be more effective and satisfying for women dealing with UUI.

Gender

FEMALE

Eligibility 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 therapeutic trial 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
• • 9. anticipating pelvic surgery within primary outcome follow up period (3 months)