Anticholinergic vs. Botox Comparison Study (ABC)
Urge Urinary Incontinence, Overactive Bladder
About this trial
This is an interventional treatment trial for Urge Urinary Incontinence focused on measuring incontinence, overactive bladder, botox, anticholinergic
Eligibility Criteria
Inclusion Criteria:
- Subject has signed informed consent.
- Females at least 21 years of age
- Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing self-characterization of incontinence type.
- Urge predominant (urge >50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary.
- Demonstrated ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization in the event that this would be required.
- Request for treatment for urge urinary incontinence. The patient may have tried other non-pharmacologic treatments for urge incontinence, such as supervised behavioral therapy, supervised physical therapy, unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation.
- Subject has undergone 3-week washout period if subject were on anticholinergic therapy prior to enrollment.
- Subject is able to complete all study related items and interviews.
Exclusion Criteria:
- Any previous therapy with trospium chloride, solifenacin, or darifenacin
- Failed three or more anticholinergic drugs.
- Contraindication to anticholinergic therapy, specifically with solifenacin or trospium.
- Current symptomatic urinary tract infection that has not resolved prior to randomization.
- Uncontrolled narrow-angle glaucoma
- Gastric retention
- Baseline need for intermittent self catheterization
- PVR >150ml on 2 occasions with void(s) of greater than 150ml
- Surgical treatment for stress incontinence (sling, Burch or urethral injection) or pelvic organ prolapse recommended or planned at enrollment by study investigator(s).
- Any prior intra-detrusor botulinum toxin A injections
- Previous or currently implanted neuromodulation (sacral or tibial).
- Surgically altered detrusor muscle, such as augmentation cystoplasty.
- Known allergy to botulinum toxin A.
- Women with known neurologic disease believed to potentially affect urinary function (Multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease).
- Known allergy to lidocaine.
- Currently pregnant or lactating patients or patients planning pregnancy within the next year.
- Sexually active premenopausal women with a uterus who have either not had a tubal ligation or are not on a medically approved form of contraception for at least 3 months prior to and throughout the duration of the study.
- Cystoscopic findings that preclude injection, in the opinion of the investigator.
- Current or prior bladder malignancy.
- In the opinion of the investigator, inability to understand diary instructions and complete 3-day voiding diary.
- Subjects who are on anticoagulant therapy,excluding aspirin
- Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome.
- Subjects with hematuria who have not undergone a clinically appropriate evaluation.
- Subjects taking aminoglycosides at the time of injection.
- Serum creatinine level greater than twice the upper limit of normal within the previous year.
- Two or more hospitalizations for medical conditions in the previous year.
- Plans to move out of area in the next 6 months.
Sites / Locations
- The University of Alabama at Birmingham
- USCD Medical Center
- Kaiser Permanente
- Loyola University Medical Center
- Oakwood Hospital
- Beaumont Hospital
- Duke University
- Cleveland Clinic
- Magee-Women's Hospital
- University of Texas Southwestern Medical Center
- University of Utah
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Botox A
Standardized Anticholinergic Regimen
A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets
A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium chloride XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.