Skip to content

Riyadh benign prostatic hyperplasia (BPH) protocol

Prospective randomised placebo-controlled double-blind crossover trial in using anti-cholinergics with alpha blockers for the treatment of benign prostatic hyperplasia (BPH) in newly diagnosed patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74130527
Enrollment
260
Registered
2008-07-16
Start date
2008-04-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Benign prostatic hyperplasia Urological and Genital Diseases Prostatic hyperplasia

Interventions

All patients will have the following investigations at the recruitment visit: prostate specific antigen (PSA), peak urinary flow rate, post-voiding urine volume, ultrasound for the prostate, kidneys a

Sponsors

The Continuous Medical Research Centre at King Khaled University Hospital (Saudi Arabia)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Male patients; no specific age group but for the condition most patients will be aged 50 years and older 2. Naive patients with BPH 3. Have an International Prostate Symptom Score (IPSS) more than seven 4. Must be living in Riyadh city; patients from the peripheries will be excluded 5. Patients who are already on alpha blockers can be included after a washout period of two weeks

Exclusion criteria

Exclusion criteria: 1. Patients with renal failure 2. Acute angle glaucoma 3. Arrythmias (will be excluded by the past medical history and the current cardiac medication)

Design outcomes

Primary

MeasureTime frame
Symptoms measured by: 1. The International Prostatic Symptoms Score (IPSS) 2. Peak urinary flow rate (Q max) All outcomes will be assessed at visit one (zero time), visit two (eight weeks), visit three (one week from the last visit for wash out) and visit four (final visit at sixteen weeks).

Secondary

MeasureTime frame
1. Post voiding urine volume (PVR) 2. Ultrasound (optional) All outcomes will be assessed at visit one (zero time), visit two (eight weeks), visit three (one week from the last visit for wash out) and visit four (final visit at sixteen weeks).

Countries

Saudi Arabia

Outcome results

None listed

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