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

Purpose

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.

Condition	Intervention
Urinary Urge Incontinence Non-neurogenic	Drug: botulinum toxin Type A Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Efficacy of Botulinum Toxin A Intradetrusor Injections for the Treatment of Non-neurogenic Urinary Urge Incontinence- A Randomized Double-Blind Control Trial

Resource links provided by NLM:

MedlinePlus related topics: Botox Urinary Incontinence Urine and Urination

Drug Information available for: OnabotulinumtoxinA

U.S. FDA Resources

Further study details as provided by Regina Qu'Appelle Health Region:

Primary Outcome Measures:

Maximum capacity at cystoscopy (MCC) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Cystoscopy is a test performed with a cystoscope, a narrow tube with a tiny camera at its tip, inserted into the urethra and bladder to see the inside of the bladder and urethra.

Maximum bladder capacity--the amount of liquid or gas the bladder can hold under anesthesia. Without anesthesia, capacity is limited by either pain or a severe urge to urinate.

Secondary Outcome Measures:

Incontinence Episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Incontinence- involuntary leakage of urine
Number of daytime and night time voids [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Frequency of daily and nightly urination
Patient Perception of Bladder Condition [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder
Incontinence Impact Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.
Urogenital Distress Inventory [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.
Indevus Urgency Severity Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder
Subjective benefit assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Self assessed description of how well they believed the Botulinum Toxin type A was working, ranging from no change to dry/complete response
Adverse effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Documented adverse effects to Botulinum Toxin type A
Urinary Tract Infections [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Documented urinary track infections
Need for self-catheterization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
24-hour pad test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
measures a pad before and after wear to get an indication of urine lost

Enrollment:	20
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo injected into the detrusor at Day 1,	Drug: Placebo Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.
Experimental: Botulinum toxin Type A Botulinum toxin Type A 100U injected into the detrusor at Day 1	Drug: botulinum toxin Type A Botulinum toxin Type A 100U injected into the detrusor at Day 1

Show Detailed Description

Eligibility

Ages Eligible for Study:	17 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226706

Locations

Canada, Saskatchewan
Regina General Hospital
Regina, Saskatchewan, Canada, S4P 0W5

Sponsors and Collaborators

Regina Qu'Appelle Health Region

Investigators

Principal Investigator:

Corrine Jabs, MD

Regina Qu'Appelle Health Region

More Information

Publications:

Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. Epub 2002 Nov 15.

Kalsi V, Apostolidis A, Popat R, Gonzales G, Fowler CJ, Dasgupta P. Quality of life changes in patients with neurogenic versus idiopathic detrusor overactivity after intradetrusor injections of botulinum neurotoxin type A and correlations with lower urinary tract symptoms and urodynamic changes. Eur Urol. 2006 Mar;49(3):528-35. Epub 2006 Jan 6.

Sahai A, Khan MS, Dasgupta P. Efficacy of botulinum toxin-A for treating idiopathic detrusor overactivity: results from a single center, randomized, double-blind, placebo controlled trial. J Urol. 2007 Jun;177(6):2231-6.

Sahai A, Kalsi V, Khan MS, Fowler CJ. Techniques for the intradetrusor administration of botulinum toxin. BJU Int. 2006 Apr;97(4):675-8. No abstract available.

Rajkumar GN, Small DR, Mustafa AW, Conn G. A prospective study to evaluate the safety, tolerability, efficacy and durability of response of intravesical injection of botulinum toxin type A into detrusor muscle in patients with refractory idiopathic detrusor overactivity. BJU Int. 2005 Oct;96(6):848-52.

Schurch B, de Seze M, Denys P, Chartier-Kastler E, Haab F, Everaert K, Plante P, Perrouin-Verbe B, Kumar C, Fraczek S, Brin MF; Botox Detrusor Hyperreflexia Study Team. Botulinum toxin type a is a safe and effective treatment for neurogenic urinary incontinence: results of a single treatment, randomized, placebo controlled 6-month study. J Urol. 2005 Jul;174(1):196-200.

Vo AH, Satori R, Jabbari B, Green J, Killgore WD, Labutta R, Campbell WW. Botulinum toxin type-a in the prevention of migraine: a double-blind controlled trial. Aviat Space Environ Med. 2007 May;78(5 Suppl):B113-8.

Patki PS, Hamid R, Arumugam K, Shah PJ, Craggs M. Botulinum toxin-type A in the treatment of drug-resistant neurogenic detrusor overactivity secondary to traumatic spinal cord injury. BJU Int. 2006 Jul;98(1):77-82.

Smith CP, Nishiguchi J, O'Leary M, Yoshimura N, Chancellor MB. Single-institution experience in 110 patients with botulinum toxin A injection into bladder or urethra. Urology. 2005 Jan;65(1):37-41.

Coyne KS, Matza LS, Kopp Z, Abrams P. The validation of the patient perception of bladder condition (PPBC): a single-item global measure for patients with overactive bladder. Eur Urol. 2006 Jun;49(6):1079-86. Epub 2006 Jan 24.

Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9.

Nixon A, Colman S, Sabounjian L, Sandage B, Schwiderski UE, Staskin DR, Zinner N. A validated patient reported measure of urinary urgency severity in overactive bladder for use in clinical trials. J Urol. 2005 Aug;174(2):604-7.

Responsible Party:	Dr. Corrine Jabs, Regina Qu'Appelle Health Region
ClinicalTrials.gov Identifier:	NCT01226706 History of Changes
Other Study ID Numbers:	REB-08-04, 120486
Study First Received:	October 18, 2010
Last Updated:	October 20, 2010
Health Authority:	Canada: Health Canada Canada: Ethics Review Committee

Keywords provided by Regina Qu'Appelle Health Region:

Urinary incontinence, urge
detrusor hyperreflexia
detrusor instability
non-neurogenic
Female Urogenital Diseases and Pregnancy Complications

Female Urogenital Diseases
Urologic Diseases
Urination Disorders
Urinary Incontinence

Additional relevant MeSH terms:

Urinary Incontinence, Urge
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins

Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013