N/A N=21 Randomized Double-blind Treatment

Efficacy of Botulinum Toxin Type A for the Treatment of Non-neurogenic Urinary Urge Incontinence

Urinary Urge Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT01226706 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

Jul 2017

Primary outcome: Primary: Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up — -97.5; 64.1 mL — p=.016

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Botulinum Toxins, Type A (Drug); Placebos (Drug)
Age: Pediatric, Adult, Older Adult · 17+ yrs
Sex: Female
Sponsor: Saskatchewan Health Authority - Regina Area
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up	-97.5; 64.1	.016 sig
SECONDARY Change in Incontinence Episodes Between Baseline and 6 Week Follow-up	.50; 3.00	0.152
SECONDARY Change in Incontinence Episodes Between Baseline and 3 Month Follow-up	1.28; 5.05	0.095
SECONDARY Change in Incontinence Episodes Between Baseline and 6 Month Follow-up	-.39; 4.09	0.067
SECONDARY Change in Incontinence Episodes Between Baseline and 9 Month Follow-up	-3.38; NA	—
SECONDARY Change in Incontinence Episodes Between Baseline and 12 Month Follow-up	-3.83; -2.17	—
SECONDARY Change in Incontinence Episodes Between Baseline and 24 Months Follow-up	-3.75; -2.78	—
SECONDARY Change in Number of Daytime Voids Between Baseline and 6 Week Follow-up	-0.50; 2.14	0.038 sig
SECONDARY Change in Number of Daytime Voids Between Baseline and 3 Month Follow-up	0.89; 3.32	0.095
SECONDARY Change in Number of Daytime Voids Between Baseline and 6 Month Follow-up	-0.22; 2.73	0.038 sig
SECONDARY Change in Number of Daytime Voids Between Baseline and 9 Month Follow-up	-1.13; NA	—
SECONDARY Change in Number of Daytime Voids Between Baseline and 12 Month Follow-up	-1.61; -1.67	—
SECONDARY Change in Number of Daytime Voids Between Baseline and 24 Month Follow-up	-0.33; -2.61	—
SECONDARY Change in Number of Night Voids Between Baseline and 6 Week Follow-up	0.31; 0.77	0.904
SECONDARY Change in Number of Night Voids Between Baseline and 3 Month Follow-up	0.06; 1.36	0.080
SECONDARY Change in Number of Night Voids Between Baseline and 6 Month Follow-up	0.33; 1.32	0.230
SECONDARY Change in Number of Night Voids Between Baseline and 9 Month Follow-up	-1.13; NA	—
SECONDARY Change in Number of Night Voids Between Baseline and 12 Month Follow-up	-0.94; -1.28	—
SECONDARY Change in Number of Night Voids Between Baseline and 24 Months Follow-up	-0.72; -1.00	—
SECONDARY Subjective Benefit Assessment at 6 Weeks	3.4; 2.4	0.021 sig
SECONDARY Subjective Benefit Assessment at 3 Months	3.2; 1.9	0.007 sig
SECONDARY Subjective Benefit Assessment at 6 Months	2.8; 1.6	0.013 sig
SECONDARY Change in Incontinence Impact Questionnaire From Baseline to 6 Weeks Follow-up	.00; 27.27	0.173
SECONDARY Change in Incontinence Impact Questionnaire From Baseline to 3 Months Follow-up	4.29; 35.35	0.051
SECONDARY Change in Incontinence Impact Questionnaire From Baseline to 6 Months Follow-up	3.81; 34.63	0.051
SECONDARY Change in Urogenital Distress Inventory From Baseline to 6 Week Follow-up	6.11; 17.68	0.557
SECONDARY Change in Urogenital Distress Inventory From Baseline to 3 Months Follow-up	15.33; 32.32	0.029 sig
SECONDARY Change in Urogenital Distress Inventory From Baseline to 6 Months Follow-up	11.11; 28.48	0.132
SECONDARY Change in Patient Perception of Bladder Condition From Baseline to 6 Weeks	.20; 1.45	0.085
SECONDARY Change in Patient Perception of Bladder Condition From Baseline to 3 Months	.50; 1.82	0.099
SECONDARY Change in Patient Perception of Bladder Condition From Baseline to 6 Months	.50; 1.55	0.132
SECONDARY Change in Indevus Urgency Severity Scale From Baseline to 6 Weeks	1.00; 1.09	0.072
SECONDARY Change in Indevus Urgency Severity Scale From Baseline to 3 Months	0.67; 1.36	0.230
SECONDARY Change in Indevus Urgency Severity Scale From Baseline to 6 Months	0.60; 1.09	0.314
SECONDARY 24 Hour Pad Weight (gm) at 3 Months	413.30; 141.18	0.013 sig
SECONDARY 24 Hour Pad Weight (gm) at 9 Months	64.11; 110.63	0.888
SECONDARY Frequency of Urinary Tract Infections From Baseline to 6 Months	4; 6	—
SECONDARY Frequency of Participants Needing Self-catheterization From Baseline to 6 Month Follow-up	0; 1	—
SECONDARY Frequency of Participants With Urinary Tract Infections From Baseline to 6 Months	4; 6	—

Summary

Non-neurogenic urinary urge incontinence (UUI) is a common quality of life disorder that causes people to feel an "urgent" need to urinate. Standard treatment for UUI includes behavior modification, pelvic floor exercises, anticholinergic medication, and less commonly, sacral neuromodulation. Unfortunately anticholinergic therapy is only moderately effective. Botulinum toxin A (BTA or Botox©) may be a useful treatment in patients that do not respond to standard therapy. Botulinum toxin A has been used in other studies to improve symptoms in neurogenic urinary incontinence, and a variety of lower urinary tract disorders. BTA has been used in other studies to improve the symptoms in urinary incontinence, migraines, spinal cord injuries and a variety of lower urinary tract disorders. However, the treatment of non-neurogenic urinary urge incontinence has not been examined in a well-controlled study. The primary purpose of this study is to determine the efficacy of botulinum toxin A (BTA) in the treatment of non-neurogenic urinary urge incontinence (UUI). The secondary objectives are to examine the side effects associated with BTA treatment and the impact this treatment has on patients' quality of life.

Eligibility Criteria

Inclusion Criteria

Female subjects, greater than 17 years of age
Written informed consent has been obtained
Ability to follow study instructions and likely to complete all required visits
Written authorization for Use and Release of Health and Research Study Information has been obtained
Subject meets the following criteria: clinical diagnosis of urinary urge incontinence with resistance to or intolerance of anticholinergic medication
Anticholinergic medications allowed
Willingness and ability to use self-catheterization if necessary

Exclusion Criteria

Uncontrolled clinically significant medical condition other than the condition under evaluation
Known allergy or sensitivity to any of the components in the study medication
Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study
Concurrent participation in another investigational drug or device study
Treatment with botulinum toxin of any serotype for urological condition prior to enrolment in study (if applicable)
Any medical condition that may put the subject at increased risk with exposure to botulinum toxin A including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function
Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study
Symptomatic urinary retention or post-void residual of >200ml
Anticoagulation therapy within 3 days of injection procedure
Familial bleeding disorder
UUI secondary to neurologic disease
Myasthenia gravis
Previous bladder pathology (e.g. transitional cell carcinoma)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01226706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.