search
Back to results

Comparison of Different Energy Sources During TUR-P

Primary Purpose

Benign Prostatic Hypertrophy

Status
Suspended
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bipolar TURP-1
Bipolar TURP-2
Monopolar TURP
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hypertrophy focused on measuring prostate, transurethral resection, bipolar, monopolar

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Selcuk University, School of Medicine, Department of Urology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Bipolar TURP-1

Bipolar TURP-2

Monopolar TURP

Arm Description

Transurethral resection of prostate (TURP) with bipolar resectoscope (Gyrus brand)

TURP with bipolar resectoscope (Olympus brand)

TURP with monopolar resectoscope (Karl Storz brand)

Outcomes

Primary Outcome Measures

Uroflowmetry test
Determining the improvement in maximal urine flow (mL/s) and average urine flow (mL/s).

Secondary Outcome Measures

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.

Full Information

First Posted
August 23, 2015
Last Updated
November 15, 2019
Sponsor
Selcuk University
search

1. Study Identification

Unique Protocol Identification Number
NCT02533687
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Suspended
Why Stopped
Due to unwillingness of surgeons to use monopolar energy & technical problems
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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 Operative data: duration of operation, volume of resected tissue, observation of obturator reflex (if any), kind and size of the urethral catheter used Postoperative data: time to removal of urethral catheter, hospitalization duration, change in hemoglobin, rate of blood transfusion, any other complications

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hypertrophy
Keywords
prostate, transurethral resection, bipolar, monopolar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bipolar TURP-1
Arm Type
Active Comparator
Arm Description
Transurethral resection of prostate (TURP) with bipolar resectoscope (Gyrus brand)
Arm Title
Bipolar TURP-2
Arm Type
Active Comparator
Arm Description
TURP with bipolar resectoscope (Olympus brand)
Arm Title
Monopolar TURP
Arm Type
Active Comparator
Arm Description
TURP with monopolar resectoscope (Karl Storz brand)
Intervention Type
Procedure
Intervention Name(s)
Bipolar TURP-1
Intervention Description
Bipolar transurethral resection of prostate (TURP)
Intervention Type
Procedure
Intervention Name(s)
Bipolar TURP-2
Intervention Description
Bipolar TURP
Intervention Type
Procedure
Intervention Name(s)
Monopolar TURP
Intervention Description
Monopolar TURP
Primary Outcome Measure Information:
Title
Uroflowmetry test
Description
Determining the improvement in maximal urine flow (mL/s) and average urine flow (mL/s).
Time Frame
Within the first 30 days after surgery.
Secondary Outcome Measure Information:
Title
Overall complication rates
Description
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.
Time Frame
Within the first 30 days after surgery.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat Akand, MD
Organizational Affiliation
Selcuk University, School of Medicine, Department of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University, School of Medicine, Department of Urology
City
Konya
ZIP/Postal Code
42075
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24972732
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.
Results Reference
background
PubMed Identifier
24958486
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.
Results Reference
background
PubMed Identifier
24843434
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.
Results Reference
background
PubMed Identifier
24754254
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.
Results Reference
background

Learn more about this trial

Comparison of Different Energy Sources During TUR-P

We'll reach out to this number within 24 hrs