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
ID
Bron
Verkorte titel
Aandoening
Benign Prostate Obstruction/Hyperplasia who are eligible for an TURP
Ondersteuning
Technical Support: Karl Storz
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Safety bipolar TURP compared with monoploar TURP by means of TUR syndrome, blood loss, number and severity of adverse events.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksproduct en/of interventie
Patients will be randomized in either:
Group A: Who will undergo a bipolar TURP or in
Group B: who will undergo a monopolar TURP.
Publiek
P.O. Box 22660
S.A. Zaaijer
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5666030
S.A.Zaaijer@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
S.A. Zaaijer
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5666030
S.A.Zaaijer@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL643 |
| NTR-old | NTR703 |
| Ander register | : N/A |
| ISRCTN | ISRCTN16583435 |