Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004027

Trial Description

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Title

Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type
A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004027
  •   2012/07/11
  •   2006/04/04
  •   no
  •   [---]*
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Secondary IDs

  •   NCT00311376  (ClinicalTrials.gov)
  •   191622-515  (Allergan)
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Health Condition or Problem studied

  •   Overactive Bladder
  •   N32.8 -  Other specified disorders of bladder
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Interventions/Observational Groups

  •   Biological: botulinum toxin Type A (200U)
  •   Biological: botulinum toxin Type A (300U)
  •   Other: Normal Saline (Placebo); botulinum toxin Type A (200U)
  •   Other: Normal Saline (Placebo); botulinum toxin Type A (300U)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo, Other
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Change From Baseline in Number of Weekly Episodes of Urinary Incontinence; time frame: Baseline, Week 6; Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

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Secondary Outcome

- Change From Baseline in Maximum Cystometric Capacity (MCC); time frame: Baseline, Week 6; Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.
- Change From Baseline in Maximum Detrusor Pressure (MDP); time frame: Baseline, Week 6; Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.
- Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire; time frame: Baseline, Week 6; Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). A positive change from baseline represents an improvement

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Belgium
  •   Canada
  •   Czech Republic
  •   France
  •   Germany
  •   New Zealand
  •   Poland
  •   Russian Federation
  •   Slovakia
  •   Ukraine
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2006/08/31
  •   416
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord
injury or multiple sclerosis

- Inadequate response to anticholinergic medication used to treat overactive bladder

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Exclusion Criteria

- History of evidence of pelvic or urologic abnormality

- Previous or current diagnosis of bladder or prostate cancer

- Urinary tract infection at time of enrollment

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Addresses

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    • Allergan
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    • Allergan
    • Medical Director 
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    • Allergan
    • Medical Director 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2010/05/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.