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

NCT01226706 | Completed Results

• 2 other identifiers: REB-08-04120486
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Urge Incontinence

Keywords

Urinary incontinence, urge; detrusor hyperreflexia; detrusor instability; non-neurogenic; Female Urogenital Diseases and Pregnancy Complications; Female Urogenital Diseases; Urologic Diseases; Urination Disorders; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up

  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.

  Baseline to 6 months

Secondary Outcomes (38)

• Change in Incontinence Episodes Between Baseline and 6 Week Follow-up

  Baseline to 6 weeks

• Change in Incontinence Episodes Between Baseline and 3 Month Follow-up

  Baseline to 3 month

• Change in Incontinence Episodes Between Baseline and 6 Month Follow-up

  Baseline to 6 month

• Change in Incontinence Episodes Between Baseline and 9 Month Follow-up

  Baseline to 9 months

• Change in Incontinence Episodes Between Baseline and 12 Month Follow-up

  Baseline and 12 months

Study Arms (2)

Placebos

PLACEBO COMPARATOR

Placebo injected into the detrusor at Day 1,

Drug: Placebos

Botulinum Toxins, Type A

EXPERIMENTAL

Botulinum Toxins, Type A 100U injected into the detrusor at Day 1

Drug: Botulinum Toxins, Type A

Interventions

Botulinum Toxins, Type A DRUG

Botulinum Toxins, Type A 100U injected into the detrusor at Day 1

Botulinum Toxins, Type A

Placebos DRUG

Placebos 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.

Placebos

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Saskatchewan Health Authority - Regina Area: lead

Study Sites (1)

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

Location

Related Publications (12)

• 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. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.

  PMID: 12811491 BACKGROUND

• 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. doi: 10.1016/j.eururo.2005.12.012. Epub 2006 Jan 6.

  PMID: 16426735 BACKGROUND

• 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. doi: 10.1016/j.juro.2007.01.130.

  PMID: 17509328 BACKGROUND

• Sahai A, Kalsi V, Khan MS, Fowler CJ. Techniques for the intradetrusor administration of botulinum toxin. BJU Int. 2006 Apr;97(4):675-8. doi: 10.1111/j.1464-410X.2006.06063.x. No abstract available.

  PMID: 16536751 BACKGROUND

• 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. doi: 10.1111/j.1464-410X.2005.05725.x.

  PMID: 16153215 BACKGROUND

• 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. doi: 10.1097/01.ju.0000162035.73977.1c.

  PMID: 15947626 BACKGROUND

• 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.

  PMID: 17547312 BACKGROUND

• 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. doi: 10.1111/j.1464-410X.2006.06192.x.

  PMID: 16831148 BACKGROUND

• 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. doi: 10.1016/j.urology.2004.08.016.

  PMID: 15667859 BACKGROUND

• 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. doi: 10.1016/j.eururo.2006.01.007. Epub 2006 Jan 24.

  PMID: 16460875 BACKGROUND

• 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. doi: 10.1002/nau.1930140206.

  PMID: 7780440 BACKGROUND

• 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. doi: 10.1097/01.ju.0000165461.38088.7b.

  PMID: 16006914 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Bladder, Overactive; Female Urogenital Diseases and Pregnancy Complications; Female Urogenital Diseases; Urologic Diseases; Urination Disorders; Urinary Incontinence

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

Poor recruitment. Recruitment slowed significantly when newer anticholinergic medications became available. Those who were previously eligible for the study had darifenacin and solifenacin to try before considering botulinum toxin treatment.

Results Point of Contact

• Title: Dr. Corrine Jabs
• Organization: Gynecology, Regina Qu'Appelle Health Region

corrinejabs@hotmail.com

(306) 586-3120

Study Officials

• Corrine Jabs, MD

  Saskatchewan Health Authority - Regina Area

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Head Obstetrics & Gynecology

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 22, 2010
• Study Start: June 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2012
• Last Updated: July 3, 2017
• Results First Posted: July 3, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)