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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.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON19882
Enrollment
94
Registered
2006-06-13
Start date
2006-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostate Obstruction/Hyperplasia who are eligible for an TURP

Interventions

Patients will be randomized in either: Group A: Who will undergo a bipolar TURP or in Group B: who will undergo a monopolar TURP.

Sponsors

Academic Medical Center, Department of Urology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Candidates foor TURP; 2. Qmax 14; 4. Voided volume > 125; 5. Patients in retention with an indwelling catheter or intermittent catheterisation; 6. Given informed consent.

Exclusion criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
Safety bipolar TURP compared with monoploar TURP by means of TUR syndrome, blood loss, number and severity of adverse events.

Secondary

MeasureTime frame
Efficacy 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.

Contacts

Public ContactS.A. Zaaijer

Academic medical Center (AMC) Department of Urology P.O. Box 22660

S.A.Zaaijer@amc.uva.nl+31 (0)20 5666030

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)