Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
07/10/2014
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 Ranjan Thilagarajah

ORCID ID

Contact details

Mid Essex Hospital Services NHS Trust (BH)
Broomfield Hospital
Chelmsford
CM1 7ET
United Kingdom
+44 (0)1245 514021

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0355178146

Study information

Scientific title

Acronym

Study hypothesis

To determine which of the currently used energy delivery systems in laser prostatectomy provides for the most durable clinical outcomes.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Prostatectomy

Intervention

Patients will be invited to participate in the study from the out-patient clinic at the time a decision for surgical intervention has been made. They will have 2-3 weeks to consider whether or not they wish to participate and those electing to join the study will be asked to contact the Clinical Nurse Specialist for formal enrolment and randomization. All patients will be given appropriate information leaflets outlining the aims of the study. Patients electing to join the study will not undergo any further or additional investigations over and above that which is currently regarded as standard or routine practice within the department. The only variable they will submit themselves to is the formal randomization to a particular treatment arm.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Improvements in flow rates and a reduction in IPSS scores

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2005

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

All patients will undergo routine assessment to include uroflowmetry, prostate size assessment, PSA testing and an IPSS score. Those between the ages of 55-75 and have Qmax flow rates of <15 ml/sec and an IPSS score of > 12 (moderate-severe LUTS) and have PSA measurements within the normal range will be eligible for the study. Patients with prostate volumes of between 40-120 cc will be deemed suitable for laser ablation surgery.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

80

Participant exclusion criteria

Patients with prostate volumes of greater than 120 cc may require open surgery and those with prostate volumes of < 40 cc may simply require bladder neck incision and are therefore exclusion criteria. Patients presenting with chronic urinary retention will be excluded from the study. These patients may have atonic bladders and voiding difficulties following the procedure may be more difficult to interpret for the purposes of the study.

Recruitment start date

01/11/2005

Recruitment end date

01/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Mid Essex Hospital Services NHS Trust (BH)
Chelmsford
CM1 7ET
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)

Sponsor details

Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Mid Essex Hospital Services NHS Trust (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