Desmopressin: PRN Treatment in OAB

1. Desmopressin: PRN Treatment in OAB • Prospective, randomised, multi-centre, multinational, double-blind, placebo controlled observational study • 60 women with severe daytime urinary incontinence • PRN desmopressin 40µg spray vs placebo • Primary Endpoint: 4hr dry period following dosing • Secondary Endpoints: time to first void / incontinence episode Voided volumes Dry periods • Patients taking desmopressin; Higher frequency of dry days Lower voided volume Longer time to first void/incontinence episode Robinson et al, 2004

2. PRN Desmopressin: Efficacy in First 4 Hours Robinson et al, 2004

3. Desmopressin: PRN Treatment in OAB • 37% of patients had no leakage on virtually all treatment days for 4 hours after administration • 4-8 hours: 67.8% incidence of dry periods on desmopressin Vs 62.7% on placebo • 8-24 hours: incidence of dry periods was similar • No serious adverse effects; 11% failed to complete • Desmopressinis safe and effective, allowing women to choose when they need treatment • Self-motivation allows choice; thus improving compliance Robinson et al, 2004

4. Desmopressin: PRN Treatment in OAB • 2 week, multi-national, multi-centre, proof of concept, phase IIB, double blind, placebo controlled, prospective randomised cross over study • Men and women with OAB • Inclusion: • ≥4 voids in the first 8 hrs after rising • Oral Desmopressin 0.2mg Vs Placebo • Primary endpoint; Effectiveness of desmopressin in increasing the time to first OAB symptom episodes during 8 hrs post dose Hashim et al, 2009

5. Desmopressin: PRN Treatment in OAB • Time to 1st void 8 min later on desmopressin (p=0.27) • Desmopressin; One less void per 8hrs (3.2 vs 4.2) (p<0.001) Increase in time to first urgency episode (p<0.003) Decrease in urgency episodes (p<0.003) • Subjective improvement in frequency and urgency • Improvement in QoL using ICIQ-OAB • Adverse events reported as mild, no hyponatremia • Novel, feasible and safe short term treatment for OAB Hashim et al, 2009