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Efficacy and Safety Study of Botulinum Toxin Type-A (Dysport®) in Continent Female Subjects Suffering From Idiopathic Overactive Bladder

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ClinicalTrials.gov Identifier: NCT00578097
Recruitment Status : Terminated (The study was terminated early due to poor recruitment.)
First Posted : December 20, 2007
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder.

Condition or disease Intervention/treatment Phase
Overactive Bladder Biological: Botulinum toxin type A Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Princeps Study to Assess the Efficacy and Safety of a One Injection Cycle With Either Botulinum Toxin Type-A (Dysport® 125, 250 or 500 Units) or Placebo Followed by an Optional 6-month Extension Phase in the Symptomatic Treatment of Micturition Urgency and Frequency in Continent Female Subjects Suffering From Idiopathic Overactive Bladder.
Study Start Date : February 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A - 125 units Biological: Botulinum toxin type A
Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
Other Name: AbobotulinumtoxinA (Dysport®)

Experimental: B - 250 units Biological: Botulinum toxin type A
Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
Other Name: AbobotulinumtoxinA (Dysport®)

Experimental: C - 500 units Biological: Botulinum toxin type A
Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
Other Name: AbobotulinumtoxinA (Dysport®)

Placebo Comparator: D Drug: Placebo
Single injection cycle, intradetrusor injection at baseline (visit 2).




Primary Outcome Measures :
  1. Number of episodes of urgency and frequency of micturition. [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. The number of episodes of urgency, frequency of micturition, and frequency of nocturia. [ Time Frame: All timepoints ]
  2. Severity of urgency. [ Time Frame: All timepoints ]
  3. Maximum flow rate and post-micturition residual volume (PMRV). [ Time Frame: Day 4 and Week 6 ]
  4. Standard International Continence Society (ICS) urodynamic parameters. [ Time Frame: Week 12 ]
  5. Quality of Life (QoL). [ Time Frame: All timepoints ]
  6. Safety [ Time Frame: All timepoints ]
  7. Extension study - Duration of effect as determined by the persistence of a positive response. [ Time Frame: All timepoints ]
  8. Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia. [ Time Frame: All timepoints ]
  9. Extension study - Severity of urgency. [ Time Frame: All timepoints ]
  10. Extension study Quality of Life (QoL) [ Time Frame: All timepoints ]
  11. Extension study safety. [ Time Frame: All timepoints ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject has a diagnosis of idiopathic overactive bladder, without incontinence.
  • The subject has ≥ 3 urgency episodes over the course of the 3 days immediately preceding the Baseline visit.
  • The subject has ≥ 24 episodes of micturition over the course of the 3 days immediately preceding the Baseline visit.

Exclusion Criteria:

  • Bladder outlet obstruction (on urodynamic assessment).
  • Post-Micturition Residual Volume > 150 ml (ultrasound assessment).
  • Evidence of a urinary tract infection at Screening or Baseline in the study.
  • Active or history of interstitial cystitis, malignancy of the bladder or urothelial tract, a carcinoma in situ (non malignant melanoma is allowed) bladder and/or kidney stones.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578097


Locations
Show Show 34 study locations
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00578097    
Other Study ID Numbers: Y-79-52120-126
2007-002999-34 ( EudraCT Number )
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents