Reduced-dose Botox for Urgency Incontinence Among Elder Females

Inclusion Criteria:

1. Adult female at least 70 years old at date of enrollment

2. Urgency urinary incontinence (urge incontinence > stress incontinence per screeningcriteria)

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

4. Refractory urinary urgency incontinence, defined as

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

6. Persistent symptoms despite the use of anticholinergic and/or beta-3 agonistmedication; or inability to tolerate medication due to side effects, or has acontraindication to taking medication, or is unable to afford the cost of themedication.

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

8. Willing and able to complete all study-related items, with assistance ofcaregiver(s) if needed.

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

10. Grossly neurologically normal on exam and no gross systemic neurologic conditionsbelieved to affect urinary function. Patients with a diagnosis of Parkinson'sdisease or diabetes may be eligible provided they have a grossly normal neurologicexam and otherwise fulfill the inclusion/exclusion criteria.

Exclusion Criteria:

1. Lack of capacity to provide consent. Will be assessed if needed per judgment of thesite PI and study staff, with use of optional questionnaire.

2. Baseline persistently elevated post-void residual [PVR] (>150mL on 2 occasions inthe 6 weeks prior to enrollment). If the PVR was obtained via bladder scanner withmeasurements differing by more than 100mL, or if there is concern about the accuracyof the scanner, it will be confirmed via catheterization which will be consideredthe gold standard.

3. Need for BTX injection to take place in the Operating Room or under sedation. (Ofnote, for repeat injection under the protocol, patients may have OR injection ifindicated due to pain with initial BTX injection.)

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

5. Untreated symptomatic urinary tract infection (UTI). Eligible once UTI treatmentcomplete and symptoms resolved.

6. Known bladder abnormality, including current or prior bladder malignancy, carcinomain situ or untreatable cystitis (e.g. eosinophilic cystitis); prior major bladdersurgery that would alter the detrusor muscle, such as augmentation cystoplasty; orhematuria that has not been evaluated.

7. Neurogenic detrusor overactivity or neurologic disease that may impact bladderfunction, including stroke, multiple sclerosis, peripheral neuropathy, spinal cordinjury. Conditions such as Parkinson's disease and diabetes are acceptable providednormal bladder emptying and grossly normal neurologic function.

8. Concurrent BTX use for other indication, participants cannot exceed 300 units BTX ina 3 month period. Participants who may have conflict between study BTXadministration and administration for other purposes may be excluded fromparticipation if there is concern that study drug administration will becompromised. Concurrent use of BTX for another indication that would not exceed 300units in a 3 month period, or that can have time of administration of the other BTXadjusted to avoid excessive dose, is acceptable; for instance, for migraines.

9. Greater than stage 2 pelvic floor prolapse, uncorrected or persistent despitepessary use (leading edge of prolapse not greater than 1cm beyond the hymen).Ongoing pessary use is permissible. Patients may have had a prior repair for pelvicorgan prolapse. (see chart review of recent exam or perform brief exam whilecollecting post-void residual)

10. Planned prolapse or stress incontinence surgery; would defer enrollment to >3 monthspost-operative.

11. Allergy or intolerance to lidocaine or BTX.

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