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.
- Conditions
- Benign Prostate Obstruction/Hyperplasia who are eligible for an TURP
- Registration Number
- NL-OMON19882
- Lead Sponsor
- Academic Medical Center, Department of Urology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 94
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety bipolar TURP compared with monoploar TURP by means of TUR syndrome, blood loss, number and severity of adverse events.
- Secondary Outcome Measures
Name Time Method 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.