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Urinary Urge IncontinenceNCT01226706

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

A study testing Botulinum Toxins, Type A in people with Urinary Urge Incontinence, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 17 to 80 years, women only
Conditions the study is for
Urinary Urge Incontinence
What is being tested?
Botulinum Toxins, Type A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteCanada
Study dates
Jun 2008to Oct 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 80 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Regina General Hospital

    Regina, Saskatchewan, S4P 0W5

Other trials in Canada

About this study

Official title: Efficacy of Botulinum Toxin A Intradetrusor Injections for the Treatment of Non-neurogenic Urinary Urge Incontinence- A Randomized Double-Blind Control Trial

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.

Read the detailed description

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:

  1. Four to Six Weeks Post-Procedure: The primary and secondary measures will be assessed.
  2. Three Months post-procedure: The same procedures will be repeated as at the four-to-six week assessment.
  3. Six Months post-procedure: The four-to-six week assessment will be performed, and symptoms of retention or residual since the last visit will be discussed. A cystoscopy will be performed to study culture/urinalysis, measure desire and capacity, and show incontinence. Study allocation will be revealed at six months, and BTA injection will be offered to subjects that had received the placebo.
  4. Nine Months: The four-to-six week procedures are repeated.
  5. Twelve Months: The four-to-six week procedures are repeated.

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.

Being tested
Botulinum Toxins, Type A, Placebos
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
Medical subject headings
Urinary Incontinence, Urge, Urinary Bladder, Overactive, Female Urogenital Diseases and Pregnancy Complications, Female Urogenital Diseases, Urologic Diseases, Urination Disorders, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum Toxins, Type ADrug

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

  • PlacebosDrug

    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.

Study groups in NCT01226706
Study groupRoleWhat they receive
PlacebosPlacebo comparatorPlacebo injected into the detrusor at Day 1,
Receives: Drug: Placebos
Botulinum Toxins, Type AExperimentalBotulinum Toxins, Type A 100U injected into the detrusor at Day 1
Receives: Drug: Botulinum Toxins, Type A

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 6 months

Secondary outcomes (38)

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

    Incontinence- involuntary leakage of urine

    Measured: Baseline to 6 weeks

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

    Incontinence- involuntary leakage of urine

    Measured: Baseline to 3 month

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

    Incontinence- involuntary leakage of urine

    Measured: Baseline to 6 month

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

    Incontinence- involuntary leakage of urine

    Measured: Baseline to 9 months

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

    Incontinence- involuntary leakage of urine

    Measured: Baseline and 12 months

  6. Change in Incontinence Episodes Between Baseline and 24 Months Follow-up

    Incontinence- involuntary leakage of urine

    Measured: Baseline and 24 months

  7. Change in Number of Daytime Voids Between Baseline and 6 Week Follow-up

    Frequency of daily urination

    Measured: Baseline to 6 weeks

  8. Change in Number of Daytime Voids Between Baseline and 3 Month Follow-up

    Frequency of daily urination

    Measured: Baseline to 3 month

  9. Change in Number of Daytime Voids Between Baseline and 6 Month Follow-up

    Frequency of daily urination

    Measured: Baseline to 6 months

  10. Change in Number of Daytime Voids Between Baseline and 9 Month Follow-up

    Frequency of daily urination

    Measured: Baseline to 9 months

  11. Change in Number of Daytime Voids Between Baseline and 12 Month Follow-up

    Frequency of daily urination

    Measured: Baseline to 12 months

  12. Change in Number of Daytime Voids Between Baseline and 24 Month Follow-up

    Frequency of daily urination

    Measured: Baseline to 24 months

  13. Change in Number of Night Voids Between Baseline and 6 Week Follow-up

    Frequency of night voiding

    Measured: Baseline to 6 weeks

  14. Change in Number of Night Voids Between Baseline and 3 Month Follow-up

    Frequency of night voiding

    Measured: Baseline to 3 months

  15. Change in Number of Night Voids Between Baseline and 6 Month Follow-up

    Frequency of night voiding

    Measured: Baseline to 6 months

  16. Change in Number of Night Voids Between Baseline and 9 Month Follow-up

    Frequency of night voiding

    Measured: Baseline and 9 months

  17. Change in Number of Night Voids Between Baseline and 12 Month Follow-up

    Frequency of night voiding

    Measured: Baseline to 12 months

  18. Change in Number of Night Voids Between Baseline and 24 Months Follow-up

    Frequency of night voiding

    Measured: Baseline and 24 months

  19. 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:

    1. dry (complete response),
    2. improvement (> 50% reduction in incontinence),
    3. partial response (≤ 50% reduction in incontinence),
    4. no response to treatment.

    Measured: Baseline to 6 weeks

  20. 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:

    1. dry (complete response),
    2. improvement (> 50% reduction in incontinence),
    3. partial response (≤ 50% reduction in incontinence),
    4. no response to treatment.

    Measured: Baseline to 3 months

  21. 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:

    1. dry (complete response),
    2. improvement (> 50% reduction in incontinence),
    3. partial response (≤ 50% reduction in incontinence),
    4. no response to treatment.

    Measured: Baseline to 6 months

  22. 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.

    Measured: Baseline to 6 weeks

  23. 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.

    Measured: Baseline to 3 months

  24. 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.

    Measured: Baseline to 6 months

  25. 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.

    Measured: Baseline to 6 weeks

  26. 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.

    Measured: Baseline to 3 months

  27. 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.

    Measured: Baseline to 6 months

  28. 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.

    Measured: Baseline to 6 weeks

  29. 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.

    Measured: Baseline to 3 months

  30. 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.

    Measured: Baseline to 6 months

  31. 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.

    Measured: Baseline to 6 weeks

  32. 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.

    Measured: Baseline to 3 months

  33. 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.

    Measured: Baseline to 6 months

  34. 24 Hour Pad Weight (gm) at 3 Months

    weight of pad (in gm) worn for 24 hours to detect urine loss

    Measured: 3 months

  35. 24 Hour Pad Weight (gm) at 9 Months

    weight of pad (in gm) worn for 24 hours to detect urine loss

    Measured: 9 months

  36. Frequency of Urinary Tract Infections From Baseline to 6 Months

    Frequency of urinary tract infections from baseline to 6 month-follow-up

    Measured: Baseline to 6 months

  37. 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.

    Measured: Baseline to 6 months

  38. 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

    Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2010 (estimated)
  2. Study startJun 2008
  3. Primary completionSep 2010
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01226706
Sponsor's protocol ID
REB-08-04
Other IDs
120486
Status last verified
Apr 2017
First submitted
18 Oct 2010
Last updated
3 Jul 2017
Data monitoring committee
No
Individual data sharing
No

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

    PubMed 12811491

  • 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.

    PubMed 16426735

  • 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.

    PubMed 17509328

  • 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.

    PubMed 16536751

  • 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.

    PubMed 16153215

  • 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.

    PubMed 15947626

  • 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.

    PubMed 17547312

  • 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.

    PubMed 16831148

  • 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.

    PubMed 15667859

  • 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.

    PubMed 16460875

  • 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.

    PubMed 7780440

  • 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.

    PubMed 16006914

Questions about this trial

What is this clinical trial studying?

A study testing Botulinum Toxins, Type A in people with Urinary Urge Incontinence, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01226706, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2017.

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