N/A N=60 Randomized Diagnostic

The Value of Multiple Urine Flow Rate Measurements in Male Benign Prostatic Hyperplasia (BPH) Subjects

Bladder Outlet Obstruction · Lower Urinary Tract Symptoms

Bottom Line

View on ClinicalTrials.gov: NCT00710749 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2011

Primary outcome: Primary: Mean Urine Flow Rate — 12; 13; 16 ml/s — p=0.44

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Disposable device (Device); Digital device (Device); Clinic flow measurement (Device)
Age: Adult, Older Adult · 45+ yrs
Sex: Male
Sponsor: Wellspect HealthCare
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Urine Flow Rate	12; 13; 16	0.44

Summary

Crossover comparison of different flow meters with a digital home flow meter as a reference. Main hypothesis: Reapeated home flow measurements with a disposable device will provide a better understanding of the patients urinary flow than a single measurement performed in the clinic.

Eligibility Criteria

Inclusion Criteria

Provision of informed consent
Males aged 45-85 years
>60% of the voiding volume is above 100 ml per voiding verified by a urinary diary
Able to read write and understand given instructions

Exclusion Criteria

Patients practicing CIC
Ongoing symptomatic UTI
Known Neurological Disease that is affecting the bladder function
Known past or present alcohol or drug abuse
Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
Previous enrolment or randomisation of treatment in the present study.
Suspected poor compliance based on less than 80 % compliance to voiding diary
Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
On alpha-blocker or 5-alpha reductase inhibitor treatment, treatment started less than 2 months prior to enrolment
Clinic flow below 100 ml

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00710749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.