Benign Prostatic Hyperplasia Clinical Trial
Official title:
Bipolar Transurethral Enucleation (BipolEP) vs Bipolar Transurethral Resection of the Prostate: A Prospective Interventional Multi-center Randomized Controlled Trial
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
Status | Recruiting |
Enrollment | 84 |
Est. completion date | June 18, 2021 |
Est. primary completion date | January 18, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Patients with neurological disorder - Active urinary tract infection, active bladder or prostate cancer |
Country | Name | City | State |
---|---|---|---|
Austria | Universitätsklinik für Urologie und Andrologie, Salzburger Landeskliniken | Salzburg | |
Switzerland | Urologische Klinik Spital Thurgau, Kantonsspital Frauenfeld | Frauenfeld | Thurgau |
Lead Sponsor | Collaborator |
---|---|
Salzburger Landeskliniken |
Austria, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety of surgical intervention (comparison of adverse events using the Clavien Dindo-Classification) | All possible adverse events after applying BipolEP or TURP will be assessed using the Clavien-Dindo score. The investigators do want to find out whether the surgery can be performed safer by using BipolEP or TURP. | Start: start of the surgery End: 356 days after surgery | |
Primary | 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 | Efficiency of surgical intervention (tissue resected intraoperatively per minute) | In order to asses the efficiency of the surgical intervention, the amount of prostate tissue (grams) surgically removed per minute will be recorded. The investigators do want to see whether prostate tissue can be resected faster by using any of the two methods. | Intraoperative |
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