No registrations found.
ID
Source
Brief title
Health condition
Benign Prostate Obstruction/Hyperplasia who are eligible for an TURP
Sponsors and support
Technical Support: Karl Storz
Intervention
Outcome measures
Primary outcome
Safety bipolar TURP compared with monoploar TURP by means of TUR syndrome, blood loss, number and severity of adverse events.
Secondary outcome
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.
Background summary
Patients 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.
Study objective
Bipolar devices will minimize the disadvantages of the monopolar device; risk of electrolyte disturbances by using saline irrigation, bleeding and the risk of nervous stimulation
Intervention
Patients will be randomized in either:
Group A: Who will undergo a bipolar TURP or in
Group B: who will undergo a monopolar TURP.
P.O. Box 22660
S.A. Zaaijer
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5666030
S.A.Zaaijer@amc.uva.nl
P.O. Box 22660
S.A. Zaaijer
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5666030
S.A.Zaaijer@amc.uva.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL643 |
| NTR-old | NTR703 |
| Other | : N/A |
| ISRCTN | ISRCTN16583435 |