Detrusor Overactivity, Urge Urinary Incontinence, Urinary Incontinence, Urinary Urgency
Conditions
Keywords
Botulinum Toxin A, Urinary Incontinence, Detrusor Overactivity
Brief summary
The purpose of this study is to see whether Botox A (injected into the bladder muscle) can improve symptoms of urge incontinence that has not improved with usual medical treatments.
Detailed description
Women who suffer with urge incontinence may not get relief with usual medical treatment (such as medications or behavioral techniques). We plan to enroll women with refractory urge incontinence in centers across the US. Study participants will undergo cystoscopy (telescope look into the bladder) and injection of either Botox A or placebo. If symptoms are not adequately relieved, subjects participants will receive a second injection that is Botox A. Participants are interviewed monthly by study personnel to determine symptoms and health status.
Interventions
DRUGBotulinum Toxin A, bladder detrusor muscle injection
200 U provided as a total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices.
DRUGVehicle saline as placebo
A total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult women * Detrusor overactivity incontinence confirmed by urodynamic testing * Symptoms refractory to standard first- and second-line treatments * 6 or more urge incontinence episodes on 3-day bladder diary * Normal neurological examination
Exclusion criteria
* Urinary retention * Allergy to Botox (Botulinum Toxin A) * Previous bladder treatment with Botox (Botulinum Toxin A) in the past year * Pregnancy or planning pregnancy within next year * Neurologic disease with impaired neurotransmission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recurrence of detrusor overactivity incontinence symptoms | 6 months | To allow sufficient time for the onset of action of botulinum toxin A, the earliest outcome measurement was 60 days after injection. Failure was defined as a patient global impression of improvement (PGI-I) score of 4 or greater, the commencement of any new treatment at any time after the first injection or increased intensity of previously established treatment for DOI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in incontinence episode frequency by bladder diary | At 12 mos after first injection., but no less than 1 mo after second injection | based on the 3-day bladder diary completed pre-intervention and at 4 weeks post injection. A successful within-subject outcome will be defined as \>75% reduction in the frequency of urge incontinence episodes compared to the baseline frequency. |
| Incontinence-related and health-related quality of life | At 12 mos after first injection, but no less than 1 mo after second injection. | measured by the Urinary Distress Inventory subscale of the PFDI/PFIQ, the PISQ, and SF-36 administered at 4 weeks after the initial injection and either prior to any re-treatment or at the completion of study participation, whichever is earlier. |
| Voiding dysfunction requiring catheterization | throughout 12-month study | — |
Countries
United States
Outcome results
None listed