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Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo With Long Term Follow Up after successful Trial Without Catheter In Acute Urinary Retention

Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo With Long Term Follow Up after successful Trial Without Catheter In Acute Urinary Retention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000719
Enrollment
Unknown
Registered
2008-04-10
Start date
2006-10-07
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Benign prostatic hyperplasia (BPH), Acute urine Retention (AUR)

Interventions

Two groups:Alfuzosin GITS 10 mg vs placebo for two years

Sponsors

Division of Urology, Department of Surgery, the Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged 50 or above; 2. Presented with first episode of AUR due to BPH with residual urine of 500 - 1500ml; 3. Successful TWOC after use of Alfuzosin GITS.

Exclusion criteria

Exclusion criteria: 1. Previous history of TURP or other form of invasive therapy for benign prostate hyperplasia; 2. Patient suspected or confirmed to have carcinoma of prostate; 3. Use of alpha blockers within recent 6 months; 4. Use of phytotherapy or 5-alpha reductase inhibitors within recent 6 months; 5. Clot retention secondary to haematuria of any cause; 6. Patients with depressive illness on medication, extra-pyramidal disorders, neurological disease; 7. Patients with unstable angina, myocardial infarction, transient ischaemic attacks, cerebrovascular accident or congestive cardiac failure during the previous 6 months; 8. Patients contraindicated for alfuzosin: (1) Known hypersensitivity to alfuzosin; (2) Orthostatic hypotension; (3) Hepatic insufficiency. 9. Poor premorbid state

Design outcomes

Primary

MeasureTime frame
The primary objective of the study is to compare alfuzosin GITS 10 mg daily with placebo, in delaying or avoiding invasive therapy for BPH on long term follow up of Hong Kong Chinese males patients achieving a successful TWOC after AUR secondary to BPH.;

Secondary

MeasureTime frame
The secondary objective is to investigate the safety of alfuzosin GITS and also predicting factors for recurrent AUR.;

Countries

China

Contacts

Public ContactNg Chi Fai
ngcf@surgery.cuhk.edu.hk+852 26322625

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026