Anticholinergic vs. Botox Comparison Study

• Register: ClinicalTrials.gov
• Last refreshed on: 14 January 2013
• Main ID: NCT01166438
• Date of registration: 19/07/2010
• Primary sponsor: Susan Meikle, MD MSPH
• Public title: Anticholinergic vs. Botox Comparison Study ABC
• Scientific title: Efficacy and Impact of Botulinum Toxin A Versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence
• Date of first enrolment: March 2010
• Target sample size: 242
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01166438
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Anthony Visco, MD
• Affiliation: Duke University

Key inclusion & exclusion 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.



Age minimum: 21 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Overactive Bladder

Urge Urinary Incontinence

Intervention(s)

Drug: Botulinum toxin A (Botox A®)

Drug: Solifenacin 10mg

Drug: Solifenacin 5mg

Drug: Trospium chloride

Primary Outcome(s)

change in urge urinary incontinence episodes [Time Frame: 6 months]

Secondary Outcome(s)

>75% reduction in urge urinary incontinence episodes [Time Frame: 6 months]

change in OABq-SF scores [Time Frame: 6 months]

change in QOL outcomes [Time Frame: 3, 6 months]

Secondary ID(s)

1U10HD054136

1U10HD054214

1U10HD054215

1U10HD054241

2U01HD041249

2U10HD041250

2U10HD041261

2U10HD041267

PFDN 17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Office of Research on Women's Health (ORWH)