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| ID | Type | Description | Link |
|---|---|---|---|
| 120486 | Registry Identifier | Health Canada |
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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.
Introduction:
Non-neurogenic urinary urge incontinence (UUI) is a common quality of life disorder that becomes more prevalent with age. It is described as a condition that causes people to feel an "urgent" need to urinate due to muscle spasms in the bladder. Factors such as infection, inflammation, strokes, and dementia can stimulate the bladder to create spasms and cause urine loss. Overactive bladder refers to the symptom complex of urinary frequency, urgency and or nocturia with or without incontinence. Overactive bladder is a disorder of the storage phase of the bladder affecting approximately 16.9% of the US women, increasing to 31% after age 75. Standard treatment for UUI includes behavior modification, pelvic floor exercises, anticholinergic medication, and less commonly, sacral neuromodulation. Unfortunately anticholinergic therapy is only moderately effective and causes bothersome side effects, particularly at higher doses. Sacral neuromodulation therapy is currently unavailable in Saskatchewan with the closest treatment centre being located in Calgary.
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, migraines following spinal cord injuries, and a variety of lower urinary tract disorders. This product has been approved by FDA for treatments of the following conditions: two eye muscle disorders (blepharospasm and strabismus in December 1989), severe underarm sweating (primary axillary hyperhydrosis), brow furrow and frown lines (April 2002) and other cosmetic purposes (July 2004). For the treatment of UUI, BTA is injected into the detrusor muscle of the bladder which is the muscle of the bladder that squeezes urine towards the outlet. BTA has been used in other studies to improve the symptoms in urinary incontinence and a variety of lower urinary tract disorders, however, the treatment for non-neurogenic urinary urge incontinence has not been examined in a well-controlled study.
Research Purpose and Objectives:
The primary purpose of this study is to determine the efficacy of BTA in the treatment of non-neurogenic 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.
Research Methods:
This study employs a 12 month, double-blinded, randomized, partial cross-over design. The first 6 months of the study, subjects will be randomized to receive either detrusor injection of BTA or a placebo injection. In the remaining six months, subjects in the control group will be offered the detrusor injection of BTA. All 36 subjects will be followed for the remaining 6 months.
Study Procedures and Protocol
Pre-injection Assessment:
The pre-injection and assessment stage includes an evaluation of the medical history and physical exam. Previous therapy and medication will be disclosed to the physician. The investigator will ensure the subject meets the inclusion criteria, has had urinalysis and a pregnancy test if under 50 years old.
Day of the Procedure:
On the day of the surgery, the study pharmacist will randomize subjects using a random numbers table. The study doctor, nurses, and subjects will be blinded to treatment allocation. Ancef 1gm, or in the case of penicillin allergy, cipro 400 mg, will be given by intravenous.
A local anaesthetic will be instilled at the end of the cystoscopy (40 ml 1% lidocaine) and sedation will be provided as required. Fifteen minutes will lapse before beginning the procedure.
Using a 30 degree rigid scope and minimally invasive cystoscopic technique, 10 injections at 10 U/ml per injection (altogether 100 U of BTA) will be injected into the bladder wall, sparing the trigone.3,4 Subjects assigned to the placebo condition will receive injections of a saline at a similar frequency as the BTA injections.
Subjects will be observed for 60 minutes post procedure and then discharged home. This is the standard protocol for other BTA procedures performed on an outpatient basis in the RQHR. Catheter supplies will be provided upon discharge.
Follow-up Schedule:
Potential Significance:
Current anticholinergic therapy for non neurogenic UUI has limitations. In addition to significant systemic side effects, studies have shown that only 50% of patients improve with anticholinergic therapy, and that improvement does not always involve continence. Thus, detrusor injection of BTA may be a safe and efficacious therapy for patients who have failed standard therapy with anticholinergic medication and allow for an improved quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebos | Placebo Comparator | Placebo injected into the detrusor at Day 1, |
|
| Botulinum Toxins, Type A | Experimental | Botulinum Toxins, Type A 100U injected into the detrusor at Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxins, Type A | Drug | Botulinum Toxins, Type A 100U injected into the detrusor at Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Incontinence Episodes Between Baseline and 6 Week Follow-up | Incontinence- involuntary leakage of urine | Baseline to 6 weeks |
| Change in Incontinence Episodes Between Baseline and 3 Month Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corrine Jabs, MD | Saskatchewan Health Authority - Regina Area | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regina General Hospital | Regina | Saskatchewan | S4P 0W5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12811491 | Background | 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. | |
| 16426735 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy |
| FG001 | Botulinum Toxin Type A | Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo injected into the detrusor at Day 1, 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. |
| BG001 | Botulinum Toxin Type A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mL | Baseline to 6 months |
|
Adverse events were monitored from baseline up to 12 months after intervention (at 4-6 weeks, 3 months, 6 months, 9 months and 12 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perioperative Cardiac Event (Takotsubo syndrome) | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematuria | Infections and infestations | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Corrine Jabs | Gynecology, Regina Qu'Appelle Health Region | (306) 586-3120 | corrinejabs@hotmail.com |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| D053201 | Urinary Bladder, Overactive |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D052776 | Female Urogenital Diseases |
| D014570 | Urologic Diseases |
| D014555 | Urination Disorders |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| 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. |
|
Incontinence- involuntary leakage of urine
| Baseline to 3 month |
| Change in Incontinence Episodes Between Baseline and 6 Month Follow-up | Incontinence- involuntary leakage of urine | Baseline to 6 month |
| Change in Incontinence Episodes Between Baseline and 9 Month Follow-up | Incontinence- involuntary leakage of urine | Baseline to 9 months |
| Change in Incontinence Episodes Between Baseline and 12 Month Follow-up | Incontinence- involuntary leakage of urine | Baseline and 12 months |
| Change in Incontinence Episodes Between Baseline and 24 Months Follow-up | Incontinence- involuntary leakage of urine | Baseline and 24 months |
| Change in Number of Daytime Voids Between Baseline and 6 Week Follow-up | Frequency of daily urination | Baseline to 6 weeks |
| Change in Number of Daytime Voids Between Baseline and 3 Month Follow-up | Frequency of daily urination | Baseline to 3 month |
| Change in Number of Daytime Voids Between Baseline and 6 Month Follow-up | Frequency of daily urination | Baseline to 6 months |
| Change in Number of Daytime Voids Between Baseline and 9 Month Follow-up | Frequency of daily urination | Baseline to 9 months |
| Change in Number of Daytime Voids Between Baseline and 12 Month Follow-up | Frequency of daily urination | Baseline to 12 months |
| Change in Number of Daytime Voids Between Baseline and 24 Month Follow-up | Frequency of daily urination | Baseline to 24 months |
| Change in Number of Night Voids Between Baseline and 6 Week Follow-up | Frequency of night voiding | Baseline to 6 weeks |
| Change in Number of Night Voids Between Baseline and 3 Month Follow-up | Frequency of night voiding | Baseline to 3 months |
| Change in Number of Night Voids Between Baseline and 6 Month Follow-up | Frequency of night voiding | Baseline to 6 months |
| Change in Number of Night Voids Between Baseline and 9 Month Follow-up | Frequency of night voiding | Baseline and 9 months |
| Change in Number of Night Voids Between Baseline and 12 Month Follow-up | Frequency of night voiding | Baseline to 12 months |
| Change in Number of Night Voids Between Baseline and 24 Months Follow-up | Frequency of night voiding | Baseline and 24 months |
| Subjective Benefit Assessment at 6 Weeks | Self assessed description of how well they believed the Botulinum Toxin type A was working. The patients' subjective assessment of the treatment's efficacy was obtained verbally using a four-point rating scale. Rating options were:
| Baseline to 6 weeks |
| Subjective Benefit Assessment at 3 Months | Self assessed description of how well they believed the Botulinum Toxin type A was working. The patients' subjective assessment of the treatment's efficacy was obtained verbally using a four-point rating scale. Rating options were:
| Baseline to 3 months |
| Subjective Benefit Assessment at 6 Months | Self assessed description of how well they believed the Botulinum Toxin type A was working.The patients' subjective assessment of the treatment's efficacy was obtained verbally using a four-point rating scale. Rating options were:
| Baseline to 6 months |
| Change in Incontinence Impact Questionnaire From Baseline to 6 Weeks Follow-up | Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence. Incontinences Impact Questionnaire - 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients' life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. | Baseline to 6 weeks |
| Change in Incontinence Impact Questionnaire From Baseline to 3 Months Follow-up | Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence. Incontinences Impact Questionnaire - 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients' life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. | Baseline to 3 months |
| Change in Incontinence Impact Questionnaire From Baseline to 6 Months Follow-up | Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence. Incontinences Impact Questionnaire - 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients' life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. | Baseline to 6 months |
| Change in Urogenital Distress Inventory From Baseline to 6 Week Follow-up | Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence. Urogenital Distress Inventory - 6 (UDI-6) The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. | Baseline to 6 weeks |
| Change in Urogenital Distress Inventory From Baseline to 3 Months Follow-up | Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence. The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. | Baseline to 3 months |
| Change in Urogenital Distress Inventory From Baseline to 6 Months Follow-up | Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence. The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. | Baseline to 6 months |
| Change in Patient Perception of Bladder Condition From Baseline to 6 Weeks | Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder. Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 "no problems at all", 2 "some very minor problems". 3 "some minor problems", 4"(some) moderate problems", 5 "severe problems", and 6 "many severe problems". A higher score indicates a more negative impression of current bladder problems. | Baseline to 6 weeks |
| Change in Patient Perception of Bladder Condition From Baseline to 3 Months | Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder. Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 "no problems at all", 2 "some very minor problems". 3 "some minor problems", 4"(some) moderate problems", 5 "severe problems", and 6 "many severe problems". A higher score indicates a more negative impression of current bladder problems. | Baseline to 3 months |
| Change in Patient Perception of Bladder Condition From Baseline to 6 Months | Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder. Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 "no problems at all", 2 "some very minor problems". 3 "some minor problems", 4"(some) moderate problems", 5 "severe problems", and 6 "many severe problems". A higher score indicates a more negative impression of current bladder problems. | Baseline to 6 months |
| Change in Indevus Urgency Severity Scale From Baseline to 6 Weeks | A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder. Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient's urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges. | Baseline to 6 weeks |
| Change in Indevus Urgency Severity Scale From Baseline to 3 Months | A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder. Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient's urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges. | Baseline to 3 months |
| Change in Indevus Urgency Severity Scale From Baseline to 6 Months | A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder. Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient's urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges. | Baseline to 6 months |
| 24 Hour Pad Weight (gm) at 3 Months | weight of pad (in gm) worn for 24 hours to detect urine loss | 3 months |
| 24 Hour Pad Weight (gm) at 9 Months | weight of pad (in gm) worn for 24 hours to detect urine loss | 9 months |
| Frequency of Urinary Tract Infections From Baseline to 6 Months | Frequency of urinary tract infections from baseline to 6 month-follow-up | Baseline to 6 months |
| Frequency of Participants Needing Self-catheterization From Baseline to 6 Month Follow-up | Frequency of participants needing self-catheterization from baseline to 6 month follow-up. | Baseline to 6 months |
| Frequency of Participants With Urinary Tract Infections From Baseline to 6 Months | Frequency of particiapnts with urinary tract infections from baseline to 6 month-follow-up | Baseline to 6 months |
| 17509328 | 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. |
| 16536751 | 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. |
| 16153215 | 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. |
| 15947626 | 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. |
| 17547312 | 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. |
| 16831148 | 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. |
| 15667859 | 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. |
| 16460875 | 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. |
| 7780440 | 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. |
| 16006914 | 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. |
Botulinum toxin Type A 100U injected into the detrusor at Day 1 botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Change in Incontinence Episodes Between Baseline and 6 Week Follow-up | Incontinence- involuntary leakage of urine | Posted | Mean | Standard Deviation | number of episodes | Baseline to 6 weeks |
|
|
|
|
| Secondary | Change in Incontinence Episodes Between Baseline and 3 Month Follow-up | Incontinence- involuntary leakage of urine | Posted | Mean | Standard Deviation | number of occurences | Baseline to 3 month |
|
|
|
|
| Secondary | Change in Incontinence Episodes Between Baseline and 6 Month Follow-up | Incontinence- involuntary leakage of urine | Posted | Mean | Standard Deviation | number of episodes | Baseline to 6 month |
|
|
|
|
| Secondary | Change in Incontinence Episodes Between Baseline and 9 Month Follow-up | Incontinence- involuntary leakage of urine | Posted | Mean | Standard Deviation | number of occurences | Baseline to 9 months |
|
|
|
| Secondary | Change in Incontinence Episodes Between Baseline and 12 Month Follow-up | Incontinence- involuntary leakage of urine | Posted | Mean | Standard Deviation | number of occurences | Baseline and 12 months |
|
|
|
| Secondary | Change in Incontinence Episodes Between Baseline and 24 Months Follow-up | Incontinence- involuntary leakage of urine | Posted | Mean | Standard Deviation | number of occurences | Baseline and 24 months |
|
|
|
| Secondary | Change in Number of Daytime Voids Between Baseline and 6 Week Follow-up | Frequency of daily urination | Posted | Mean | Standard Deviation | number of voids | Baseline to 6 weeks |
|
|
|
|
| Secondary | Change in Number of Daytime Voids Between Baseline and 3 Month Follow-up | Frequency of daily urination | Posted | Mean | Standard Deviation | number of voids | Baseline to 3 month |
|
|
|
|
| Secondary | Change in Number of Daytime Voids Between Baseline and 6 Month Follow-up | Frequency of daily urination | Posted | Mean | Standard Deviation | number of voids | Baseline to 6 months |
|
|
|
|
| Secondary | Change in Number of Daytime Voids Between Baseline and 9 Month Follow-up | Frequency of daily urination | Posted | Mean | Standard Deviation | number of voids | Baseline to 9 months |
|
|
|
| Secondary | Change in Number of Daytime Voids Between Baseline and 12 Month Follow-up | Frequency of daily urination | Posted | Mean | Standard Deviation | number of voids | Baseline to 12 months |
|
|
|
| Secondary | Change in Number of Daytime Voids Between Baseline and 24 Month Follow-up | Frequency of daily urination | Posted | Mean | Standard Deviation | number of voids | Baseline to 24 months |
|
|
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| Secondary | Change in Number of Night Voids Between Baseline and 6 Week Follow-up | Frequency of night voiding | Posted | Mean | Standard Deviation | number of voids | Baseline to 6 weeks |
|
|
|
|
| Secondary | Change in Number of Night Voids Between Baseline and 3 Month Follow-up | Frequency of night voiding | Posted | Mean | Standard Deviation | Number of voids | Baseline to 3 months |
|
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| Secondary | Change in Number of Night Voids Between Baseline and 6 Month Follow-up | Frequency of night voiding | Posted | Mean | Standard Deviation | number of voids | Baseline to 6 months |
|
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|
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| Secondary | Change in Number of Night Voids Between Baseline and 9 Month Follow-up | Frequency of night voiding | Posted | Mean | Standard Deviation | Number of voids | Baseline and 9 months |
|
|
|
| Secondary | Change in Number of Night Voids Between Baseline and 12 Month Follow-up | Frequency of night voiding | Posted | Mean | Standard Deviation | number of voids | Baseline to 12 months |
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| Secondary | Change in Number of Night Voids Between Baseline and 24 Months Follow-up | Frequency of night voiding | Posted | Mean | Standard Deviation | number of voids | Baseline and 24 months |
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| Secondary | Subjective Benefit Assessment at 6 Weeks | Self assessed description of how well they believed the Botulinum Toxin type A was working. The patients' subjective assessment of the treatment's efficacy was obtained verbally using a four-point rating scale. Rating options were:
| Posted | Mean | Standard Deviation | score on a 4-point rating scale | Baseline to 6 weeks |
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| Secondary | Subjective Benefit Assessment at 3 Months | Self assessed description of how well they believed the Botulinum Toxin type A was working. The patients' subjective assessment of the treatment's efficacy was obtained verbally using a four-point rating scale. Rating options were:
| Posted | Mean | Standard Deviation | score on a 4-point rating scale | Baseline to 3 months |
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| Secondary | Subjective Benefit Assessment at 6 Months | Self assessed description of how well they believed the Botulinum Toxin type A was working.The patients' subjective assessment of the treatment's efficacy was obtained verbally using a four-point rating scale. Rating options were:
| Posted | Mean | Standard Deviation | score on a 4-point rating scale | Baseline to 6 months |
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| Secondary | Change in Incontinence Impact Questionnaire From Baseline to 6 Weeks Follow-up | Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence. Incontinences Impact Questionnaire - 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients' life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to 6 weeks |
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| Secondary | Change in Incontinence Impact Questionnaire From Baseline to 3 Months Follow-up | Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence. Incontinences Impact Questionnaire - 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients' life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. | Posted | Mean | Standard Deviation | summary score | Baseline to 3 months |
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| Secondary | Change in Incontinence Impact Questionnaire From Baseline to 6 Months Follow-up | Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence. Incontinences Impact Questionnaire - 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients' life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. | Posted | Mean | Standard Deviation | summary score | Baseline to 6 months |
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| Secondary | Change in Urogenital Distress Inventory From Baseline to 6 Week Follow-up | Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence. Urogenital Distress Inventory - 6 (UDI-6) The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. | Posted | Mean | Standard Deviation | summary score | Baseline to 6 weeks |
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| Secondary | Change in Urogenital Distress Inventory From Baseline to 3 Months Follow-up | Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence. The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. | Posted | Mean | Standard Deviation | summary score | Baseline to 3 months |
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| Secondary | Change in Urogenital Distress Inventory From Baseline to 6 Months Follow-up | Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence. The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. | Posted | Mean | Standard Deviation | summary score | Baseline to 6 months |
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| Secondary | Change in Patient Perception of Bladder Condition From Baseline to 6 Weeks | Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder. Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 "no problems at all", 2 "some very minor problems". 3 "some minor problems", 4"(some) moderate problems", 5 "severe problems", and 6 "many severe problems". A higher score indicates a more negative impression of current bladder problems. | Posted | Mean | Standard Deviation | summary score | Baseline to 6 weeks |
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| Secondary | Change in Patient Perception of Bladder Condition From Baseline to 3 Months | Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder. Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 "no problems at all", 2 "some very minor problems". 3 "some minor problems", 4"(some) moderate problems", 5 "severe problems", and 6 "many severe problems". A higher score indicates a more negative impression of current bladder problems. | Posted | Mean | Standard Deviation | summary score | Baseline to 3 months |
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| Secondary | Change in Patient Perception of Bladder Condition From Baseline to 6 Months | Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder. Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 "no problems at all", 2 "some very minor problems". 3 "some minor problems", 4"(some) moderate problems", 5 "severe problems", and 6 "many severe problems". A higher score indicates a more negative impression of current bladder problems. | Posted | Mean | Standard Deviation | summary score | Baseline to 6 months |
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| Secondary | Change in Indevus Urgency Severity Scale From Baseline to 6 Weeks | A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder. Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient's urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges. | Posted | Mean | Standard Deviation | summary score | Baseline to 6 weeks |
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| Secondary | Change in Indevus Urgency Severity Scale From Baseline to 3 Months | A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder. Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient's urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges. | Posted | Mean | Standard Deviation | summary score | Baseline to 3 months |
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| Secondary | Change in Indevus Urgency Severity Scale From Baseline to 6 Months | A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder. Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient's urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges. | Posted | Mean | Standard Deviation | summary score | Baseline to 6 months |
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| Secondary | 24 Hour Pad Weight (gm) at 3 Months | weight of pad (in gm) worn for 24 hours to detect urine loss | Posted | Mean | Standard Deviation | gm | 3 months |
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| Secondary | 24 Hour Pad Weight (gm) at 9 Months | weight of pad (in gm) worn for 24 hours to detect urine loss | Posted | Mean | Standard Deviation | gm | 9 months |
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| Secondary | Frequency of Urinary Tract Infections From Baseline to 6 Months | Frequency of urinary tract infections from baseline to 6 month-follow-up | Posted | Number | number of occurences | Baseline to 6 months |
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| Secondary | Frequency of Participants Needing Self-catheterization From Baseline to 6 Month Follow-up | Frequency of participants needing self-catheterization from baseline to 6 month follow-up. | Posted | Number | Participants | Baseline to 6 months |
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| Secondary | Frequency of Participants With Urinary Tract Infections From Baseline to 6 Months | Frequency of particiapnts with urinary tract infections from baseline to 6 month-follow-up | Posted | Count of Participants | Participants | Baseline to 6 months |
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| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | Botulinum Toxin Type A | Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy | 1 | 11 | 5 | 11 |
| Pain/Discomfort | General disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |