Jens Sønksen1, Neil J Barber2, Mark J Speakman3, Richard Berges4, Ulrich Wetterauer5, Damien Greene6, Karl-Dietrich Sievert7, Christopher R Chapple8, Francesco Montorsi9, Jacob M Patterson8, Lasse Fahrenkrug1, Martin Schoenthaler5, Christian Gratzke10. 1. Department of Urology, Herlev Hospital, Herlev, Denmark. 2. Frimley Park Hospital NHS Foundation Trust, Surrey, UK. 3. Department of Urology, Taunton and Somerset NHS Trust, Taunton, UK. 4. PAN Klinik Köln, Köln, Germany. 5. Department of Urology, University Hospital Freiburg, Freiburg, Germany. 6. City Hospitals Sunderland, Sunderland, UK. 7. University Clinic of Lübeck, Lübeck, Germany. 8. Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK. 9. Urology Division, Instituto San Rafaele, Milan, Italy. 10. Department of Urology, Ludwig-Maximilians University, Munich, Germany. Electronic address: christian.gratzke@med.uni-muenchen.de.
Abstract
BACKGROUND:Transurethral resection of the prostate (TURP) is considered the gold standard for male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). However, TURP may lead to sexual dysfunction and incontinence, and has a long recovery period. Prostatic urethral lift (PUL) is a treatment option that may overcome these limitations. OBJECTIVE: To compare PUL to TURP with regard to LUTS improvement, recovery, worsening of erectile and ejaculatory function, continence and safety (BPH6). DESIGN, SETTING, AND PARTICIPANTS: Prospective, randomized, controlled trial at 10 European centers involving 80 men with BPH LUTS. INTERVENTION: PUL or TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The BPH6 responder endpoint assesses symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation, and safety. Noninferiority was evaluated using a one-sided lower 95% confidence limit for the difference between PUL and TURP performance. RESULTS AND LIMITATIONS: Preservation of ejaculation and quality of recovery were superior with PUL (p<0.01). Significant symptom relief was achieved in both treatment arms. The study demonstrated not only noninferiority but also superiority of PUL over TURP on the BPH6 endpoint. Study limitations were the small sample size and the inability to blind participants to enrollment arm. CONCLUSIONS: Assessment of individual BPH6 elements revealed that PUL was superior to TURP with respect to quality of recovery and preservation of ejaculatory function. PUL was superior to TURP according to the novel BPH6 responder endpoint, which needs to be validated in future studies. PATIENT SUMMARY: In this study, participants who underwentprostatic urethral lift responded significantly better than those who underwent transurethral resection of the prostate as therapy for benign prostatic hyperplasia with regard to important aspects of quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT01533038.
RCT Entities:
BACKGROUND: Transurethral resection of the prostate (TURP) is considered the gold standard for male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). However, TURP may lead to sexual dysfunction and incontinence, and has a long recovery period. Prostatic urethral lift (PUL) is a treatment option that may overcome these limitations. OBJECTIVE: To compare PUL to TURP with regard to LUTS improvement, recovery, worsening of erectile and ejaculatory function, continence and safety (BPH6). DESIGN, SETTING, AND PARTICIPANTS: Prospective, randomized, controlled trial at 10 European centers involving 80 men with BPH LUTS. INTERVENTION: PUL or TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The BPH6 responder endpoint assesses symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation, and safety. Noninferiority was evaluated using a one-sided lower 95% confidence limit for the difference between PUL and TURP performance. RESULTS AND LIMITATIONS: Preservation of ejaculation and quality of recovery were superior with PUL (p<0.01). Significant symptom relief was achieved in both treatment arms. The study demonstrated not only noninferiority but also superiority of PUL over TURP on the BPH6 endpoint. Study limitations were the small sample size and the inability to blind participants to enrollment arm. CONCLUSIONS: Assessment of individual BPH6 elements revealed that PUL was superior to TURP with respect to quality of recovery and preservation of ejaculatory function. PUL was superior to TURP according to the novel BPH6 responder endpoint, which needs to be validated in future studies. PATIENT SUMMARY: In this study, participants who underwent prostatic urethral lift responded significantly better than those who underwent transurethral resection of the prostate as therapy for benign prostatic hyperplasia with regard to important aspects of quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT01533038.
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