Benign Prostatic Hypertrophy Clinical Trial
Official title:
Comparison of Two Different Bipolar and A Monopolar Energy Sources During Transurethral Resection of Prostate
NCT number | NCT02533687 |
Other study ID # | SU-TURP-BM-01 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2020 |
Est. completion date | October 2020 |
Verified date | November 2019 |
Source | Selcuk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
With this study, it is aimed to compare the operative results and complication rates in transurethral resection of the prostate (TUR-P) performed by resectoscopes with two different bipolar and a monopolar energy sources.
Status | Suspended |
Enrollment | 90 |
Est. completion date | October 2020 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Having an indication due to BPH - Aged between 40 and 80 years old Exclusion Criteria: - Kidney failure due to BPH - Any kind of coagulopathy or use of anticoagulants in the preoperative period - History of any previous open or endoscopic prostate surgery |
Country | Name | City | State |
---|---|---|---|
Turkey | Selcuk University, School of Medicine, Department of Urology | Konya |
Lead Sponsor | Collaborator |
---|---|
Selcuk University |
Turkey,
Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25. Review. — View Citation
Komura K, Inamoto T, Takai T, Uchimoto T, Saito K, Tanda N, Minami K, Uehara H, Takahara K, Hirano H, Nomi H, Kiyama S, Watsuji T, Azuma H. Could transurethral resection of the prostate using the TURis system take over conventional monopolar transurethral resection of the prostate? A randomized controlled trial and midterm results. Urology. 2014 Aug;84(2):405-11. doi: 10.1016/j.urology.2014.04.025. Epub 2014 Jun 21. — View Citation
Nakamura A, Osonoi T, Terauchi Y. Relationship between urinary sodium excretion and pioglitazone-induced edema. J Diabetes Investig. 2010 Oct 19;1(5):208-11. doi: 10.1111/j.2040-1124.2010.00046.x. — View Citation
Tang Y, Li J, Pu C, Bai Y, Yuan H, Wei Q, Han P. Bipolar transurethral resection versus monopolar transurethral resection for benign prostatic hypertrophy: a systematic review and meta-analysis. J Endourol. 2014 Sep;28(9):1107-14. doi: 10.1089/end.2014.0188. Epub 2014 Jun 5. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Uroflowmetry test | Determining the improvement in maximal urine flow (mL/s) and average urine flow (mL/s). | Within the first 30 days after surgery. | |
Secondary | Overall complication rates | Number of patients with any complications related with TURP (including hemorrhage, blood transfusion, urinary tract infections, urethral strictures) classified according to modified Clavien-Dindo classification. | Within the first 30 days after surgery. |
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