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.

Phase 2

Completed

• Conditions: idiopathic overactive bladder; 10004994

• Registration Number: NL-OMON31902
• Lead Sponsor: Ipsen Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

• The subject has given written informed consent to participate in the 2 phases of the study.
• The subject is female and aged between 18 and 75 years.
• 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.
• The subject has failed to respond sufficiently to oral anticholinergics, or is unable to tolerate anticholinergics, as determined by the treating physician.
• If the subject is taking anticholinergics she must be willing to discontinue their use at screening (2 weeks before the first urodynamic investigation) and refrain from taking them for the duration of the study.
• The subject is able and willing to complete questionnaires and maintain accurate records on the eDiary.
• The subject is willing and physically able to perform ISC should it be necessary following treatment with the investigational medicinal product.

Exclusion Criteria

• Subject with a PMRV > 150 ml (ultrasound assessment).
• The subject has evidence of a urinary tract infection at Screening or Baseline in the study (detection by midstream urine dipstick analysis).
• The subject has 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, or a history of any of the above.
• The subject is at risk of pregnancy or lactation during the study. Females of childbearing potential must provide a negative pregnancy test at baseline (visit 2) prior to administration of study medication and must be using oral, double barrier (e.g., diaphragm with spermicide; or male condom and diaphragm) or injectable contraception. Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study.
• The subject has overactive bladder due to spinal cord injury, multiple sclerosis or other neurogenic cause (e.g. Parkinson*s disease).

Study & Design

• Study Type: Interventional
• Study Design: Not specified