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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00578097
• Date of registration: 18/12/2007
• Prospective Registration: Yes
• Primary sponsor: Ipsen
• Public title: Efficacy and Safety Study of Botulinum Toxin Type-A (Dysport®) in Continent Female Subjects Suffering From Idiopathic Overactive Bladder
• Scientific 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.
• Date of first enrolment: February 2008
• Target sample size: 81
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00578097
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Belgium, Czech Republic, Czechia, France, Germany, Italy, Netherlands, Spain, United Kingdom

Contacts

• Name: Ipsen Medical Director
• Affiliation: Ipsen

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Overactive Bladder

Intervention(s)

Biological: Botulinum toxin type A

Drug: Placebo

Primary Outcome(s)

Number of episodes of urgency and frequency of micturition. [Time Frame: Week 12]

Secondary Outcome(s)

Extension study - Severity of urgency. [Time Frame: All timepoints]

Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia. [Time Frame: All timepoints]

Severity of urgency. [Time Frame: All timepoints]

The number of episodes of urgency, frequency of micturition, and frequency of nocturia. [Time Frame: All timepoints]

Extension study - Duration of effect as determined by the persistence of a positive response. [Time Frame: All timepoints]

Quality of Life (QoL). [Time Frame: All timepoints]

Extension study Quality of Life (QoL) [Time Frame: All timepoints]

Safety [Time Frame: All timepoints]

Maximum flow rate and post-micturition residual volume (PMRV). [Time Frame: Day 4 and Week 6]

Extension study safety. [Time Frame: All timepoints]

Standard International Continence Society (ICS) urodynamic parameters. [Time Frame: Week 12]

Secondary ID(s)

2007-002999-34

Y-79-52120-126

Source(s) of Monetary Support

Please refer to primary and secondary sponsors