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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN16583435 |
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Date of registration:
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21/07/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A prospective, randomised, double-blinded study to compare bipolar transurethral resection of the prostate (bipolar TURP) versus monopolar transurethral resection of the prostate (monopolar TURP) in terms of safety and efficacy
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Scientific title:
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Date of first enrolment:
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01/07/2006 |
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Target sample size:
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94 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN16583435 |
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Study type:
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Interventional |
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Study design:
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A prospective, randomised, double-blinded study (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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S.A.
Lagerveld-Zaaijer |
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Address:
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Academic Medical Center (AMC)
Department of Urology
P.O. Box 22660
1100 DD
Amsterdam
Netherlands |
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Telephone:
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+31 (0)20 5666030 |
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Email:
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S.A.Zaaijer@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Benign Prostatic Hyperplasia (BPH)
Urological and Genital Diseases
Hyperplasia of prostate
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Intervention(s)
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Patients will be randomised into either:
Group A: who will undergo a bipolar TURP
Group B: who will undergo a monopolar TURP
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Karl Storz (UK), Academic Medical Center (AMC) (The Netherlands) - Department of Urology
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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