Status:
COMPLETED
Anticholinergic vs. Botox Comparison Study
Lead Sponsor:
NICHD Pelvic Floor Disorders Network
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Urge Urinary Incontinence
Overactive Bladder
Eligibility:
FEMALE
21+ years
Phase:
PHASE3
Brief Summary
Urinary incontinence is a prevalent condition that markedly impacts quality of life and disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms of urgency and freque...
Detailed Description
This study is a 6-month double-blind randomized trial comparing intra-detrusor botulinum toxin A (Botox A®) and anticholinergic therapy in women without neurologic disease with urge incontinence. Subj...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT01166438
Start Date
March 1 2010
End Date
May 1 2012
Last Update
May 2 2018
Active Locations (11)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
USCD Medical Center
La Jolla, California, United States, 92037
3
Kaiser Permanente
San Diego, California, United States, 92037
4
Loyola University Medical Center
Maywood, Illinois, United States, 60153