Comparison of Different Energy Sources During TUR-P

Benign Prostatic Hypertrophy Clinical Trial

Official title:

Comparison of Two Different Bipolar and A Monopolar Energy Sources During Transurethral Resection of Prostate

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02533687
• Other study ID #: SU-TURP-BM-01
• Status: Suspended
• Phase: N/A
• Start date: July 2020
• Est. completion date: October 2020

Study information

• Verified date: November 2019
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Following data will be collected and evaluated prospectively for the three groups of patients who will undergo TUR-P due to benign prostate hyperplasia (BPH) with one of the resectoscopes using different energy sources:

1. Preoperative data: age, height, weight, body-mass index, concomitant morbidities, use of any drug, history of operation, duration of lower urinary tract symptoms, history of any previous treatment taken for BPH, serum level of prostate specific antigen, prostate volume, maximum and average urine flow rate, postmicturation residual urine volume, hemoglobin level

2. Operative data: duration of operation, volume of resected tissue, observation of obturator reflex (if any), kind and size of the urethral catheter used

3. Postoperative data: time to removal of urethral catheter, hospitalization duration, change in hemoglobin, rate of blood transfusion, any other complications

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy
• Hypertrophy
• Prostatic Hyperplasia

Intervention

Procedure:
• Bipolar TURP-1
Bipolar transurethral resection of prostate (TURP)
• Bipolar TURP-2
Bipolar TURP
• Monopolar TURP
Monopolar TURP

Locations

Country	Name	City	State
Turkey	Selcuk University, School of Medicine, Department of Urology	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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

Outcome

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.