Condition category
Urological and Genital Diseases
Date applied
23/03/2008
Date assigned
16/07/2008
Last edited
16/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Abdulaziz Al Thunayan

ORCID ID

Contact details

P.O.Box 5439
Riyadh
11422
Saudi Arabia

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 measures

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

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

Sponsor information

Organisation

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

Sponsor details

College of Medicine
University Hospital
P.O. Box 245
Riyadh
11411
Saudi Arabia

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes