A Randomized, Double-Blind, Placebo-Controlled, Multi-centre Study to Evaluate the Pharmacodynamic Effects of Teverelix DP, a GnRH Antagonist, on Prostate Volume and Urinary Function in Men following a First Episode of Acute Urinary Retention (AUR)

Condition studied

Acute Urinary Retention

Investigational medicinal product(s)

Eligibility

Primary endpoint

The percent change in total prostate volume from baseline to week 12.

Endpoint detail

Percent change in total prostate volume from baseline to week 52, The proportion of patients who have improved functional parameters of bladder emptying and urinary flow as measured by post-void residual volume (PVR) and Maximum urinary flow rate (Qmax) assessed serially from BL through week 28, The relationship between prostate volume changes (TPV) and improvement in Qmax/PVR, The proportion of patients meeting one of the following 3 criteria during the 28-week treatment period: • Relapse of AUR; and • Need/indication for surgery (including (T)MISTs); and • Instance of an absolute PVR (Post Voiding Residual volume) (PVR >300 mL) coupled with a reduced maximum urinary flow rate (Qmax < 10 mL/sec)., Proportion of patients with a recurrent episode of AUR during the initial 28-week treatment period, Proportion of patients with need/indication for surgery during the initial 28-week treatment period, Proportion of patients with PVR >300 mL coupled with Qmax <10 mL/sec during the initial 28-week treatment period, Proportion of patients with PVR >60% of total bladder volume during the initial 28week treatment period, Proportion of patients meeting the following 3 criteria during the 52-week observation period: o No relapse of AUR; and o No need/indication for surgery (including (T)MISTs); and o No instance of an absolute PVR (Post Voiding Residual volume) (PVR >300 mL) coupled with a reduced maximum urinary flow rate (Qmax < 10 mL/sec)., Proportion of patients with a recurrent episode of AUR during the 52-week observation period, Proportion of patients with need/indication for surgery during the 52-week observation period, Proportion of patients with PVR 300 mL coupled with Qmax <10 mL/sec during the 52-week observation period, Proportion of patients with PVR >60% of total bladder volume during the 52week observation period, Proportion of patients meeting the following 3 criteria during the 52-week observation period: o No relapse of AUR; and o No need/indication for surgery (including (T)MISTs); and o No instance of an absolute PVR >60% of total bladder volume, Time to treatment failure (i.e. recurrent episode of AUR or need/indication for surgery or PVR >300 mL coupled with Qmax <10 mL/sec at any study visit), Time to treatment failure (i.e. recurrent episode of AUR or need/indication for surgery or PVR >60% of total bladder volume, Time to recurrent episode of AUR, Time to prostate surgery, Time to PVR >300 mL coupled with Qmax <10 mL/sec, Time to PVR >60% of total bladder volume, Healthcare consumption (EQ-5D-5L questionnaire), Local and systemic safety, Change in uroflow (Qmax), Change in IPSS (inc. proportion of patients with clinically relevant reduction (i.e. > 3-point reduction) in IPSS), Change in IIEF score, Change in MSHQ-EjD-SF score, Proportion of patients with BPH-related minimally invasive procedures and BPH-related surgery, Change in post-void residual (PVR) volume, Change in hormones (T, DHT), Change in PSA, Generation of anti-drug antibodies