Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
Anti-cholinergics might improve symptomatic benign prostatic hyperplasia (BPH).
Ethics approval
This study was approved by the Ethical Committee of the Continuous Medical Research Centre at King Khaled University Hospital in late 2007.
Study design
Prospective randomised placebo-controlled double-blinded crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Alpha blocker (tamsulosin), anti-cholinergic (tolterodine)
Primary outcome measure
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 outcome measures
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).
Overall trial start date
01/04/2008
Overall trial end date
01/06/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
260 patients
Participant 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)
Recruitment start date
01/04/2008
Recruitment end date
01/06/2009
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
P.O.Box 5439
Riyadh
11422
Saudi Arabia
Funders
Funder type
Hospital/treatment centre
Funder name
The Continuous Medical Research Centre at King Khaled University Hospital (Saudi Arabia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list