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

A Multi Center Randomized Cross Over Double Blind Third Party Open Placebo Controlled Pilot Study to Assess the Urodynamic Effects of Modified Release UK-369,003 in Men With Lower Urinary Tract Symptoms.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00408954

Enrollment

Registered

2006-12-08

Start date

2007-03-31

Completion date

2008-06-30

Last updated

2010-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia

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.

Interventions

DRUGUK-369,003

100 mg MR tablet once daily for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
Maximum flow rate (Qmax)	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
Bladder outlet obstruction index (BOOI)	Duration of study

Countries

Czechia, Netherlands, Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026