NCT03503721

Brief Summary

The aim of this study is to compare two different surgical methods for treating benign prostatic obstruction (BPO). The investigators are going to compare the risks and benefits of bipolar transurethral resection of the prostate (TURP) and bipolar transurethral enucleation of the prostate (BipolEP). Furthermore, the investigators are going to compare the amount of tissue resected per minute, in order to assess the efficiency of each surgical method. It is a prospective, interventional, multi-centre (2 centres total), randomized trial. Approximately 84 patients will be included

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

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

January 17, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2021

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

3 years

First QC Date

January 17, 2018

Last Update Submit

April 19, 2018

Conditions

Benign Prostatic HyperplasiaBladder Outlet Obstruction

Keywords

BipolEPTURP

Outcome Measures

Primary Outcomes (1)

  • Long-term outcome - Change in IPSS (Difference in IPSS before and 12 months after surgery)

    The long-term outcome will be measured by comparing the change in IPSS (International Prostate Symptom Score) before and 12 months after surgery. The IPSS is based on the answers to seven questions concerning urinary symptoms (Incomplete emptying, Frequency, Intermittency, Urgency, Weak Stream, Straining, Nocturia) and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic) Question eight refers to the patient's perceived quality of life.

    Start: before the surgery End: 356 days after surgery

Secondary Outcomes (1)

  • Efficiency of surgical intervention (tissue resected intraoperatively per minute)

    Intraoperative

Other Outcomes (1)

  • Safety of surgical intervention (comparison of adverse events using the Clavien Dindo-Classification)

    Start: start of the surgery End: 356 days after surgery

Study Arms (2)

BipolEP

EXPERIMENTAL

includes all patients undergoing BipolEP surgery

Procedure: BipolEP

TURP

ACTIVE COMPARATOR

includes all patients undergoing TURP surgery

Procedure: bipolarTURP

Interventions

BipolEPPROCEDURE

the prostate will be transurethrally enucleated using a bipolar current

BipolEP
bipolarTURPPROCEDURE

the prostate will transurethrally resected using a bipolar current

TURP

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Refractory LUTS (lower urinary tract symptoms) secondary to BPH benign prostate hyperplasia)
  • I-PSS greater than 15
  • QOL score 3 or greater
  • Qmax less than 15 ml per second or patients with acute urinary retention secondary to BPH in whom trial of voiding failed
  • Prostate size on preoperative TRUS of 40 to 150 ml

You may not qualify if:

  • Patients with neurological disorder
  • Active urinary tract infection, active bladder or prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinik für Urologie und Andrologie, Salzburger Landeskliniken

Salzburg, 5020, Austria

RECRUITING

Urologische Klinik Spital Thurgau, Kantonsspital Frauenfeld

Frauenfeld, Thurgau, 8500, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic HyperplasiaUrinary Bladder Neck Obstruction

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrinary Bladder Diseases

Study Officials

  • Thomas Kunit, MD

    Vice Chairman

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maximilian Pallauf, MD

CONTACT

+435725557212m.pallauf@salk.at

Thomas Kunit, MD

CONTACT

+435725557439t.kunit@salk.at

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
Vice Chairman, Department of Urology and Andrology

Study Record Dates

First Submitted

January 17, 2018

First Posted

April 20, 2018

Study Start

January 18, 2018

Primary Completion

January 18, 2021

Study Completion

June 18, 2021

Last Updated

April 20, 2018

Record last verified: 2018-04

Locations

CH(1)AU(1)