Longterm F/U study of BOTOX® in Idiopathic Overactive Bladder patients
Research type
Research Study
Full title
A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Idiopathic Overactive Bladder with Urinary Incontinence
IRAS ID
26384
Contact name
Vikram Khullar
Contact email
Sponsor organisation
Urology, EU R&D, Allergan Ltd
Eudract number
2009-013089-26
Clinicaltrials.gov Identifier
Research summary
After successful completion of the preceding study (for EU this is study 191622-520, however an identical study is also occurring involving only North American sites, study 191622-095) patients can directly roll over into study 191622-096. This study is a multicentre, multinational study to evaluate whether BOTOX® is safe and effective for the long term treatment of patients with idiopathic overactive bladder (OAB). Idiopathic overactive bladder is a chronic condition where a patient has urgency (a sudden and urgent need to urinate) and commonly they urinate frequently, have urinary incontinence (accidental loss of urine) and nocturia (waking up at night to urinate). Long term treatment is therefore expected to be required.
It is believed that in idiopathic OAB there are inappropriate signals coming from and going to the bladder so that the bladder is unable to store urine properly, but the underlying reason for this is not known. BOTOX® may provide an appropriate treatment in patients where the standard treatment for this condition (anticholinergic medication) has failed. Idiopathic OAB symptoms are expected to be experienced for a long time if not treated, and since the BOTOX® effect decreases after several months, repeat treatment is expected to be required when the patient symptoms return.
Therefore, after patients successfully complete the preceding study (191622-520), they have the opportunity to enter this long term study where BOTOX® treatment over a further 2 years is assessed. During this time patients have the opportunity to receive multiple active treatments, if certain criteria are fulfilled and the design is similar to that anticipated in clinical practice, whilst maintaining sufficient rigour of a clinical trial. In this study patients may also have the opportunity to slightly increase the dose they receive, however this is only after the patient has been treated with the lower BOTOX® dose and if certain criteria are fulfilled. This ensures it is appropriate from both an efficacy and safety perspective.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
09/H0505/100
Date of REC Opinion
16 Sep 2009
REC opinion
Further Information Favourable Opinion