NCT02533687

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
4.8 years until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

Same day

First QC Date

August 23, 2015

Last Update Submit

November 15, 2019

Conditions

Benign Prostatic Hypertrophy

Keywords

prostatetransurethral resectionbipolarmonopolar

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Overall complication rates

    Within the first 30 days after surgery.

Study Arms (3)

Bipolar TURP-1

ACTIVE COMPARATOR

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

Procedure: Bipolar TURP-1

Bipolar TURP-2

ACTIVE COMPARATOR

TURP with bipolar resectoscope (Olympus brand)

Procedure: Bipolar TURP-2

Monopolar TURP

ACTIVE COMPARATOR

TURP with monopolar resectoscope (Karl Storz brand)

Procedure: Monopolar TURP

Interventions

Bipolar TURP-1PROCEDURE

Bipolar transurethral resection of prostate (TURP)

Bipolar TURP-1
Bipolar TURP-2PROCEDURE

Bipolar TURP

Bipolar TURP-2
Monopolar TURPPROCEDURE

Monopolar TURP

Monopolar TURP

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having an indication due to BPH
  • Aged between 40 and 80 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University, School of Medicine, Department of Urology

Konya, 42075, Turkey (Türkiye)

Location

Related 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.

    PMID: 24972732BACKGROUND

  • 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.

    PMID: 24958486BACKGROUND

  • 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.

    PMID: 24843434BACKGROUND

  • 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.

    PMID: 24754254BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Murat Akand, MD

    Selcuk University, School of Medicine, Department of Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, M.D.

Study Record Dates

First Submitted

August 23, 2015

First Posted

August 27, 2015

Study Start

July 1, 2020

Primary Completion

July 1, 2020

Study Completion

October 1, 2020

Last Updated

November 19, 2019

Record last verified: 2019-11

Locations

TU(1)