A study of treatment with Tadalifil in women with overactive bladder

Phase 2

• Conditions: Overactive bladder; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12622001251718
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-19
• Last Update Posted: 26 September 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A change in the number of incontinence episodes over the six weeks of active treatment assessed by a diary and counter that all participants will complete daily whilst enrolled on the study. [Six weeks of active treatment compared with six weeks of placebo];A change in daytime frequency of urination assessed by a diary and counter that all participants will complete daily whilst enrolled on the study.[Six weeks of active treatment compared with six weeks of placebo];A change in nightime frequency of urination assessed by a diary and counter that all participants will complete daily whilst enrolled on the study.[Six weeks of active treatment compared with six weeks of placebo]

Secondary Outcome Measures

Name	Time	Method
Quality of life of the participants assessed by the I-QOL ( Incontinence Quality of Life) questionnaire[Six weeks of active treatment compared to six weeks of placebo]