Riyadh benign prostatic hyperplasia (BPH) protocol
| ISRCTN | ISRCTN74130527 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74130527 |
| Secondary identifying numbers | N/A |
- 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
Scientific
P.O.Box 5439
Riyadh
11422
Saudi Arabia
Study information
| Study design | Prospective randomised placebo-controlled double-blinded crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2008 |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 260 patients |
| 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
11422
Saudi Arabia
Sponsor information
The Continuous Medical Research Centre at King Khaled University Hospital (Saudi Arabia)
Hospital/treatment centre
Hospital/treatment centre
College of Medicine
University Hospital
P.O. Box 245
Riyadh
11411
Saudi Arabia
"ROR" |
https://ror.org/046gga527 |
|---|
Funders
Funder type
Hospital/treatment centre
The Continuous Medical Research Centre at King Khaled University Hospital (Saudi Arabia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
