Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/09/2014
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 Richard Batstone

ORCID ID

Contact details

Box No 43
Department of Urology
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 216070

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544074138

Study information

Scientific title

Acronym

Study hypothesis

Alpha blockers and Voltarol in treating chronic prostatitis

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Urological and Genital Diseases: Prostatitis

Intervention

The study is a randomised controlled trial using four arms in the treatment of chronic pelvic pain syndrome in men:

1. Placebo only
2. Tamsulosin
3. Voltarol
4. Tamsulosin and Voltarol

The study will require the usual investigations for chronic prostatitis, and then a 6-week randomisation period in one of the four arms of treatment, taking a total of four tablets a day. The main outcome measure will be a reduction in the National Institute of Health Chronic Prostatitis Symptom Index (NIHCPSI), which is a newly produced and validated symptom score for assessing men with this condition.

Intervention type

Drug

Phase

Not Applicable

Drug names

Tamsulosin, Voltarol

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

04/05/2000

Overall trial end date

03/11/2003

Reason abandoned

Eligibility

Participant inclusion criteria

60 patients aged between 30 and 50

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

04/05/2000

Recruitment end date

03/11/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box No 43
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Cambridge Consortium - Addenbrooke's (UK)

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