Condition category
Urological and Genital Diseases
Date applied
21/07/2006
Date assigned
21/07/2006
Last edited
19/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.turp.nl

Contact information

Type

Scientific

Primary contact

Dr S.A. Lagerveld-Zaaijer

ORCID ID

Contact details

Academic Medical Center (AMC)
Department of Urology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5666030
S.A.Zaaijer@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

TURP

Study hypothesis

Bipolar devices will minimise the disadvantages of the monopolar device such as the risk of electrolyte disturbances by using saline irrigation, bleeding and the risk of nervous stimulation.

Ethics approval

Not provided at time of registration.

Study design

A prospective, randomised, double-blinded study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Benign Prostatic Hyperplasia (BPH)

Intervention

Patients will be randomised into either:
Group A: who will undergo a bipolar TURP
Group B: who will undergo a monopolar TURP

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Safety bipolar TURP compared with monoploar TURP by means of transurethral resection (TUR) syndrome
2. Blood loss
3. Number and severity of adverse events

Secondary outcome measures

1. Efficacy of bipolar TURP compared with monopolar TURP by means of IPSS or quality of life (QoL) scores
2. International index of erectile function (IIEF) score
3. Qmax
4. Cutting rate
5. Length of catherisation
6. Length of hospital stay
7. Length of operation
8. Impact on prostate specific antigen (PSA) level
9. Number of strictures

Overall trial start date

01/07/2006

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Candidates for transurethral resection of the prostate (TURP)
2. Qmax less than 16 ml/sec
3. International Prostate Symptom Score (IPSS) score greater than 14
4. Voided volume greater than 125
5. Patients in retention with an indwelling catheter or intermittent catheterisation
6. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

94

Participant exclusion criteria

1. If patient is suspected to be suffering from prostate cancer
2. Prior prostate surgery, including minimal invasive therapies
3. Active urinary tract infection
4. Known or suspected neurogenic decompensated bladder (postvoid residual urine volume [PVR] greater than 400ml/sec) or compensated detrusor function
5. Immunosuppression; using prednisone
6. Known or suspected malignant disease affecting the bladder or lower urinary tract
7. 5-alpha-reductase inhibitor within the last three months before baseline
8. Alpha-blockers within the last six weeks before baseline
9. Specific severe heart disease in whom anti-coagulant therapy might jeopardize treatment outcome

Recruitment start date

01/07/2006

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC), Department of Urology (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Karl Storz (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Academic Medical Center (AMC) (The Netherlands) - Department of Urology

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