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A prospective, randomized, double-blinded study to compare bipolar Trans Urethral Resection of the Prostate (bipolar TURP) versus monopolar Trans Urethral Resection of the Prostate (monopolar TURP) in terms of safety and efficacy.


- candidate number2127
- NTR NumberNTR703
- ISRCTNISRCTN16583435
- Date ISRCTN created21-jul-2006
- date ISRCTN requested19-jul-2006
- Date Registered NTR13-jun-2006
- Secondary IDsN/A 
- Public TitleA prospective, randomized, double-blinded study to compare bipolar Trans Urethral Resection of the Prostate (bipolar TURP) versus monopolar Trans Urethral Resection of the Prostate (monopolar TURP) in terms of safety and efficacy.
- Scientific TitleA prospective, randomized, double-blinded study to compare bipolar Trans Urethral Resection of the Prostate (bipolar TURP) versus monopolar Trans Urethral Resection of the Prostate (monopolar TURP) in terms of safety and efficacy.
- ACRONYMMonopolar-bipolar TURP
- hypothesisBipolar devices will minimize the disadvantages of the monopolar device; risk of electrolyte disturbances by using saline irrigation, bleeding and the risk of nervous stimulation
- Healt Condition(s) or Problem(s) studiedBenign prostatic hyperplasia (BPH), Benign prostate obstruction, Trans urethral resection of the prostate (TURP)
- Inclusion criteria1. Candidates foor TURP; 2. Qmax < 16 ml/sec; 3. IPSS score >14; 4. Voided volume > 125; 5. Patients in retention with an indwelling catheter or intermittent catheterisation; 6. Given informed consent.
- Exclusion criteria1. Suspected from prostate cancer; 2. Prior prostate surgery, including minimal invasive therapies; 3. Active urinary tract infection; 4. Known or suspected neurogenic decompensated bladder (PVR>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 3 months before baseline; 8. Alpha-blockers within the last 6 weeks before baseline; 9. Specific severe heart disease in whom anti-coagulant therapy might jeopardize treatment outcome.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jul-2006
- planned closingdate31-dec-2010
- Target number of participants94
- InterventionsPatients will be randomized in either: Group A: Who will undergo a bipolar TURP or in Group B: who will undergo a monopolar TURP.
- Primary outcomeSafety bipolar TURP compared with monoploar TURP by means of TUR syndrome, blood loss, number and severity of adverse events.
- Secondary outcomeEfficacy bipolar TURP compared with monopolar TURP by means of IPSS/QoL-scores, IIEF-score, Qmax, cutting rate, length of catherisation, lenght of hospital stay, length of operation, impact on PSA level, number of strictures.
- Timepoints
- Trial web sitehttp://www.turp.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S.A. Zaaijer
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.J.M.C.H. Rosette, de la
- Sponsor/Initiator Academic Medical Center (AMC), Department of Urology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Urology, Karl Storz
- PublicationsN/A
- Brief summaryPatients who are eligible for an operative treatment with benign prostate obstruction will be randomized in either the bipolar TURP or in the monopolar TURP. The two arms will be compared in terms of safety and efficacy with a follow up of 36 months.
- Main changes (audit trail)
- RECORD13-jun-2006 - 24-jul-2006


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