NL-OMON19882
Recruiting
Not Applicable
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.
Academic Medical Center, Department of Urology0 sites94 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Benign Prostate Obstruction/Hyperplasia who are eligible for an TURP
- Sponsor
- Academic Medical Center, Department of Urology
- Enrollment
- 94
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 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 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.
Outcomes
Primary Outcomes
Not specified
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