Refractory Urge Incontinence and Botox Injections

United States Department of Health and Human Services (HHS)

Status and phase: Terminated; Phase 3

Conditions: Urinary Urgency; Detrusor Overactivity; Urge Urinary Incontinence; Urinary Incontinence

Treatments: Drug: Vehicle saline as placebo; Drug: Botulinum Toxin A, bladder detrusor muscle injection

Study type: Interventional

Funder types: NIH

Identifiers

NCT00373789

PFDN 12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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87 participants in 2 patient groups, including a placebo group

Botox A

Experimental group

Description:

up to two injections of 200 Units of intra-detrusor Botulinum Toxin A , which must be separated by at least eight weeks and no more than 52 weeks

Treatment:

Drug: Botulinum Toxin A, bladder detrusor muscle injection

Placebo

Placebo Comparator group

Description:

up to two injections of inactive injection (carrier saline), which must be separated by at least eight weeks and no more than 52 weeks

Treatment:

Drug: Vehicle saline as placebo