Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms
- Registration Number
- NCT00408954
- Lead Sponsor
- Pfizer
- Brief Summary
This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 27
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo UK-369,003 - UK-369,003 UK-369,003 -
- Primary Outcome Measures
Name Time Method 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. Duration of study
- Secondary Outcome Measures
Name Time Method Maximum flow rate (Qmax) Duration of study Cystometric capacity Duration of study Post void residual volume (PVR) Duration of study Average flow rate (Qave) Duration of study Volume at first unstable contraction Duration of study Average detrusor pressure during micturition Duration of study Detrusor pressure at maximum flow rate (PdetQmax) Duration of study Bladder outlet obstruction index (BOOI) Duration of study Bladder contractility index (BCI) Duration of study Bladder voiding efficiency (BE) Duration of study Frequency of unstable contractions Duration of study International Prostate Symptom Score (IPSS) Duration of study Mean amplitude of unstable contractions Duration of study Patient Reported Treatment Impact (PRTI) Duration of study
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does UK-369,003 modulate in men with lower urinary tract symptoms from prostatic hyperplasia?
How does UK-369,003 compare to alpha-blockers and 5-alpha reductase inhibitors in managing BPH symptoms?
Are there specific biomarkers that correlate with urodynamic response to UK-369,003 in prostatic hyperplasia patients?
What adverse events were observed in the Phase 2 trial of UK-369,003 for lower urinary tract symptoms?
What are the current research trends in modified release formulations for lower urinary tract symptom management?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇸🇰Trencin, Slovakia
Pfizer Investigational Site🇸🇰Trencin, Slovakia