Clinical trial NCT02533687: Comparison of Different Energy Sources During TUR-P
Official title: Comparison of Two Different Bipolar and A Monopolar Energy Sources During Transurethral Resection of Prostate
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Benign Prostatic Hypertrophy
Keywords: prostate
transurethral resection
bipolar
monopolar
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 90
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Uroflowmetry test
timeFrame: Within the first 30 days after surgery.
Secondary outcomes:
measure: Overall complication rates
timeFrame: Within the first 30 days after surgery.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University, School of Medicine, Department of Urology
Study officials:
affiliation: Selcuk University, School of Medicine, Department of Urology
name: Murat Akand, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.