Condition category
Urological and Genital Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
24/08/2007
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 Elizabeth Murray

ORCID ID

Contact details

Primary Care and Population Sciences
University College London
Holborn Union Building
Archway Campus
London
N19 3EU
United Kingdom
+44 (0)20 7288 3091
elizabeth.murray@pcps.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSI04-13

Study information

Scientific title

Acronym

Study hypothesis

To determine whether a decision aid on benign prostatic hypertrophy influences decision making, health outcomes, and resource use.

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

Diagnostic

Patient information sheet

Condition

Urological and genital diseases: Other urological and genital disease

Intervention

Patients with clinical diagnosis of benign prostatic hypertrophy were referred into the study by their General Practitioner (GP). The intervention group received an information package consisting of a session with an evidence based interactive video disc plus printout plus booklet; the control group received normal care only. Data were collected at baseline, three months and nine months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Patients' and general practitioners' perceptions of who made the decision, decisional conflict scores, treatment choice and prostatectomy rate, American Urological Association symptom scale, costs, anxiety, utility, and general health status.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1996

Overall trial end date

31/12/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men attending participating general practices with a clinical diagnosis of benign prostatic hypertrophy and sufficient command of English to consult without an interpreter
2. Any clinical suggestion of carcinoma of the prostate
3. Chronic retention of urine
4. Recent urinary tract infection
5. Recent acute urinary retention
6. History of prostate surgery
7. Severe visual or hearing impairment, such that the patient could not use the decision aid
8. Severe learning difficulties or mental illness, such that the patient might not be competent to reach an informed decision

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

112

Participant exclusion criteria

1. Any clinical suggestion of carcinoma of the prostate
2. Chronic retention of urine
3. Recent urinary tract infection
4. Recent acute urinary retention
5. History of prostate surgery
6. Severe visual or hearing impairment, such that the patient could not use the decision aid
7. Severe learning difficulties or mental illness, such that the patient might not be competent to reach an informed decision

Recruitment start date

01/01/1996

Recruitment end date

31/12/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care and Population Sciences
London
N19 3EU
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Primary and Secondary Care Interface National Research and Development Programme (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

Results in:
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=11532845

Publication citations

Additional files

Editorial Notes