Riyadh benign prostatic hyperplasia (BPH) protocol

ISRCTN	ISRCTN74130527
DOI	https://doi.org/10.1186/ISRCTN74130527
Protocol serial number	N/A
Sponsor	The Continuous Medical Research Centre at King Khaled University Hospital (Saudi Arabia)
Funder	The Continuous Medical Research Centre at King Khaled University Hospital (Saudi Arabia)

Submission date: 23/03/2008
Registration date: 16/07/2008
Last edited: 16/07/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Abdulaziz Al Thunayan
Scientific

P.O.Box 5439
Riyadh
11422
Saudi Arabia

Study information

Primary study design	Interventional
Study design	Prospective randomised placebo-controlled double-blinded crossover trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study objectives	Anti-cholinergics might improve symptomatic benign prostatic hyperplasia (BPH).
Ethics approval(s)	This study was approved by the Ethical Committee of the Continuous Medical Research Centre at King Khaled University Hospital in late 2007.
Health condition(s) or problem(s) studied	Benign prostatic hyperplasia
Intervention	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 and the bladder with the ditrusal wall thickness, urine analysis, digital rectal exam, the symptoms are more voiding or imitative in nature creatinine level and International Prostatic Symptoms Score (IPSS). 1. Anti-cholinergic group: the patients in this group should receive alpha-blockers (tamsulosin) 0.4 mg orally (PO) once daily (OD) and anti-cholinergic (tolterodine) 2 mg PO twice daily (BID) for eight weeks 2. Control group: the patients in this group should receive alpha-blockers (tamsulosin) 0.4 mg PO OD and placebo tablet PO BID for eight weeks. The patients will then be crossed over for another four weeks. All of them will be followed up throughout the study.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Alpha blocker (tamsulosin), anti-cholinergic (tolterodine)
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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).
Completion date	01/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	260
Key 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
Key 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)
Date of first enrolment	01/04/2008
Date of final enrolment	01/06/2009

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

P.O.Box 5439

Riyadh
11422
Saudi Arabia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes