Idiopathic overactive bladder MedDRA version: 9.1 Level: LLT Classification code 10020853 Term: Hypertonic bladder
Conditions
Interventions
Trade Name: Dysport
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Clostridium botulinum type A toxin - haemagglutinin complex
Concentration unit: U unit(s)
Concentration
Sponsors
Ipsen Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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. Incontinence is defined as “the complaint of any involuntary leakage of urine”. The subject has =3 urgency episodes over the course of the 3 days immediately preceding the Baseline visit. Urgency is defined as “a compelling desire to pass urine that is difficult to defer” (ICS definition) 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The subject has bladder outlet obstruction (on urodynamic assessment). 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 nocturia due to kidney diseases and/or cardiac insufficiency. The subject has pollakiuria due to urinary tract infection or bladder tumour. The subject has active or history of interstitial cystitis, malignancy of the bladder or urothelial tract, a carcinoma in situ 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. The subject is suffering from haemostatic disorders. The subject is receiving treatment with anti-coagulation therapy at the time of injection. The subject has been diagnosed with a neuromuscular transmission disorder The subject is receiving systemic medications that might interfere with neuromuscular transmission. The subject has a history of hypersensitivity to the investigational drug or its excipients or drugs with a similar chemical structure. The subject has previously been treated with botulinum toxin (any serotype) injections into the bladder whenever injected. The subject has been treated with botulinum toxin within 6 months before screening The subject has been treated with any investigational drug within the last 30 days before screening. The subject has overactive bladder due to spinal cord injury, multiple sclerosis or other neurogenic cause. The subject has any conditions that interfere with mental function, such as dementia due to Alzheimer's disease, or psychosis, rendering the subject unable to understand the nature, scope and possible consequences of the study. The Subject is taking medication / substances influencing bladder function for which the dose is not anticipated to remain stable for the duration of the study. The subject has a history of pelvic radiation therapy. Subject with a history of drug or alcohol abuse. The subject has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of treatment with three doses of botulinum toxin type-A (Dysport®) versus placebo on the number of episodes of urgency and frequency of micturition experienced in continent female subjects with idiopathic overactive bladder (iOAB) at Week 12 in comparison to Baseline.;Secondary Objective: To assess the effect of 3 doses of Dysport® vs placebo on the number of episodes of urgency, frequency of micturition, and frequency of nocturia at all assessment timepoints To assess the severity of urgency using the OAB-Q SF at all timepoints To assess the effect of 3 doses of Dysport® vs placebo on maximum flow rate and PMRV at Day 4 and week 6 To assess the effect of three doses of Dysport® vs placebo on standard ICS urodynamic parameters at Week 12 To assess the effect of 3 doses of Dysport® vs placebo on QoL Extension study objectives: To assess the duration of effect as determined by the persistence of a positive response To assess the effect of treatment on the number of episodes of urgency, frequency of micturition, and frequency of nocturia at all assessment timepoints To assess the effect of treatment on the severity of urgency using the OAB-Q SF To assess the effect of treatment on QoL using EQ-5D at all assessment timepoints;Primary end point(s): Percent change in the cumulative number of episodes of urgency recorded during the three day period immediately prior to the Week 12 or early termination princeps study visit compared to the three day period prior to the Baseline visit. Percent change in the cumulative number of episodes of frequency recorded during the three day period immediately prior to the Week 12 or early termination princeps study visit compared to the three day period prior to the Baseline visit. | — |
Countries
Belgium, Czech Republic, France, Germany, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed