Anticholinergic vs. Botox Comparison Study

Status:	Completed
Conditions:	Overactive Bladder, Urology
Therapuetic Areas:	Gastroenterology, Nephrology / Urology
Healthy:	No
Age Range:	21 - Any
Updated:	5/4/2018
Start Date:	March 2010
End Date:	May 2012

Efficacy and Impact of Botulinum Toxin A Versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence

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 frequency with urge urinary incontinence (OAB-wet) and without urge incontinence
(OAB-dry). Conservative first line treatments for urge incontinence combined with other OAB
symptoms (OAB-wet) include behavioral therapy, pelvic floor training +/- biofeedback, or the
use of anticholinergic medications. These treatment modalities may not result in total
continence and often drug therapy is discontinued because of lack of efficacy, side effects
and cost or because of not wanting to take a pill. Behavioral therapy and pelvic muscle
exercises require consistent, active intervention by the patient which is often not
sustained. Thus, the objective of the Anticholinergic vs Botox Comparison Study (ABC) is to
determine whether a single intra-detrusor injection of botulinum toxin A (Botox A®) is more
effective than a standardized regimen of oral anticholinergics in reducing urge urinary
incontinence. The null hypothesis is that there is no difference in the change from baseline
in average number of urge urinary incontinence episodes over 6 months between groups.

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. Subjects will be followed up to an additional six months off study drug to
determine duration of treatment effect.

The primary aim is to compare the change in urge incontinence episodes over 6 months between
women receiving a single intra-detrusor injection of 100 unit of botulinum toxin A (Botox A®)
plus daily oral placebo tablets versus women receiving a single intra-detrusor injection of
saline plus daily anticholinergic therapy.

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.

We found this trial at

sites

Beaumont Hospital

Royal Oak, Michigan 48073

from

Royal Oak, MI