Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms

Pfizer27 enrolled

Overview

This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Prostatic Hyperplasia

Interventions

UK-369,003DRUG

100 mg MR tablet once daily for 2 weeks

UK-369,003DRUG

UK-369,003-100 mg MR formulation for 2 weeks

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13. * Clinical diagnosis of BPH * Qmax 5 to 15 ml/sec with a voided volume of ≥150 ml * Urodynamically defined bladder outlet obstruction Exclusion Criteria: * prostate cancer * Post-void residual urine volume \>200 ml * Documented UTI * History of relevant urological surgery

Locations (11)

Pfizer Investigational Site

Brno, Czechia

Pfizer Investigational Site

Hradec Králové, Czechia

Pfizer Investigational Site

Olomouc, Czechia

Outcomes

Primary Outcomes

There is no specific primary endpoint for this study as it is not powered for that. It is mainly to generate hypotheses on the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.

Time frame: Duration of study

Secondary Outcomes

Maximum flow rate (Qmax)

Time frame: Duration of study

Cystometric capacity

Time frame: Duration of study

Post void residual volume (PVR)

Time frame: Duration of study

Average flow rate (Qave)

Time frame: Duration of study

Volume at first unstable contraction

Time frame: Duration of study

Average detrusor pressure during micturition

Time frame: Duration of study

Detrusor pressure at maximum flow rate (PdetQmax)

Time frame: Duration of study

Bladder outlet obstruction index (BOOI)

Time frame: Duration of study

Bladder contractility index (BCI)

Time frame: Duration of study

Bladder voiding efficiency (BE)

Time frame: Duration of study

Frequency of unstable contractions

Data from ClinicalTrials.gov

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