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
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