Reduced-dose Botox for Urgency Incontinence Among Elder Females: A Mixed-methods Randomized Controlled Trial

• Status: Not yet recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to study the treatment of urgency urinary incontinence (UUI), specifically among women 70 years and older, by comparing low-and standard dose of onabotulinumtoxinA (BTX; trade name BOTOX(c)) injection in the bladder.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Dartmouth College; Kaiser Permanente; Oregon Health and Science University; Patient-Centered Outcomes Research Institute; Stanford University; University of Alabama at Birmingham; University of Connecticut; University of Pittsburgh; University of Texas
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

1. Adult female at least 70 years old

2. Urge-predominant mixed urinary incontinence (urge>stress per the Medical, Epidemiological, and Social Aspects of Aging questionnaire) (MESA questionnaire89).

3. On average 2 or more urgency or insensible incontinence episodes per day per patient report

4. Refractory urinary urgency incontinence, defined as

1. Persistent symptoms despite trial of one or more conservative treatments (e.g. behavioral therapy, physical therapy, home Kegel exercises); participants not required to have attempted first line therapies if deemed not feasible or appropriate by provider with input of participant/caregiver.

2. Persistent symptoms despite the use of anticholinergic and/or beta-3 agonist medication; or inability to tolerate medication due to side effects, or has a contraindication to taking medication, or is unable to afford the cost of the medication.

5. Currently not on an anticholinergic or beta-3 agonist medication or is willing to stop medication for 3 weeks prior to completing baseline bladder tally, with plan to remain off medication through duration of the study. Currently not actively using sacral neuromodulation therapy (either has not tried, or unit has been off for 4 weeks prior to baseline bladder diary and will remain turned off for the duration of the study). It is permissible for participants to continue self-led conservative therapies during participation in the study, including Kegel exercises, avoidance of bladder irritants, and urge suppression.

6. Willing and able to complete all study-related items and interviews, with assistance of caregiver(s) if needed.

7. Demonstrates awareness of possible need for catheterization in event of post- injection urinary retention & acknowledges risks of catheterization. Participant does not need to demonstrate ability to perform self-catheterization.

8. Grossly neurologically normal on exam and no gross systemic neurologic conditions believed to affect urinary function.

Exclusion Criteria:

1. Dementia or severe cognitive impairment

2. Baseline persistently elevated post-void residual [PVR] (>150mL on 2 occasions in the 6 weeks prior to enrollment). If the post-void residual (PVR) was obtained via bladder scanner with measurements differing by more than 100mL, it will be confirmed via catheterization which will be considered the gold standard.

3. Previous treatment with intravesical BTX in the last 12 months or use of sacral neuromodulation therapy within the past 4 weeks (unit may remain implanted, but should remain off for duration of the study).

4. Untreated symptomatic urinary tract infection (UTI).

5. Known bladder abnormality, including current or prior bladder malignancy, carcinoma in situ or untreatable cystitis (e.g. eosinophilic cystitis); prior major bladder surgery that would alter the detrusor muscle, such as augmentation cystoplasty; or hematuria that has not been evaluated.

6. Neurogenic detrusor overactivity or neurologic disease that may impact bladder function, including stroke, multiple sclerosis, peripheral neuropathy, spinal cord injury.

7. Concurrent BTX use for other indication, participants cannot exceed 300 units BTX in a 3 month period. Participants who may have conflict between study BTX administration and administration for other purposes may be excluded from participation if there is concern that study drug administration will be compromised.

8. Greater than stage 2 pelvic floor prolapse, uncorrected or persistent despite pessary use. Ongoing pessary use is permissible.

9. Planned prolapse or stress incontinence surgery; would defer enrollment to >3 months post-operative.

10. Allergy or intolerance to lidocaine or BTX.

11. Participation in another research study that could conflict with the RELIEF study, in estimation of the site PI.