None listed
Conditions
Brief summary
This study will investigate the safety and efficacy of Tadalafil when given to women with an overactive bladder. We aim to investigate if women who receive this therapy have a decrease in urinary incontinence both during the day and night. All participants will receive six weeks of Tadalafil and six week of placebo in random order.
Interventions
All participant will be given either Tadalafil or placebo and then have a one week washout and crossover to receive other treatment. This is a phase 2A study. Dose will be 10mg Tadalafil (oral capsule) for 6 weeks.
Arm 1 will receive Tadalafil 10mg daily for 6 weeks - then a 1 week washout then 6 weeks placebo
Arm 2 will recieve placebo for 6 weeks, then a one week washout and then Tadalafil for six weeks
Participants will be asked to complete a diary daily including symptoms and indicate the
All participant will be given either Tadalafil or placebo and then have a one week washout and crossover to receive other treatment. This is a phase 2A study. Dose will be 10mg Tadalafil (oral capsule) for 6 weeks. Arm 1 will receive Tadalafil 10mg daily for 6 weeks - then a 1 week washout then 6 weeks placebo Arm 2 will recieve placebo for 6 weeks, then a one week washout and then Tadalafil for six weeks Participants will be asked to complete a diary daily including symptoms and indicate they have taken medication. All medications unused should be returned to clinic so accountability can be conducted
Sponsors
Western Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Eligible patients are those with urodynamically proven idiopathic detrusor overactivity who have failed to respond significantly to all other medical treatments (including botulinum toxin injections) for their overactive bladder symptoms. Patients who had some benefit but intolerable side-effects from any of these treatments can also be enrolled.
Exclusion criteria
• Age > 85 years • Pregnancy, lactation • Undiagnosed bleeding in patients with a uterus (use of PDE5 inhibitors in assisted reproduction can cause endometrial thickening) • Unstable angina, uncontrolled hypotension <90/50 • Moderately severe cardiac failure or uncontrolled arrhythmias • Myocardial or cerebral infarction within six months • Concomitant use of nitrates • Previous NAION – non-arteritic anterior ischaemic optic neuropathy • Severe hepatic impairment • End-stage renal disease • Some medication and juices
Outcome results
None listed