A study of treatment with Tadalifil in women with overactive bladder

Category Primary study
Registry of TrialsANZCTR
Year 2022
CONDITION: Overactive bladder; ; Overactive bladder Renal and Urogenital ‐ Other renal and urogenital disorders INTERVENTION: 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 si Xweeks 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 PRIMARY OUTCOME: 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] 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] SECONDARY OUTCOME: Quality of life of the participants assessed by the I‐QOL ( Incontinence Quality of Life) questionnaire[Si Xweeks of active treatment compared to si Xweeks of placebo] 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.
Epistemonikos ID: 8ecfaea7a8e827a8fa3b7df49a4d2aff2abeab33
First added on: Aug 26, 2024