Daniel Rukstalis1, Prem Rashid2, William K Bogache3, Ronald F Tutrone4, Jack Barkin5, Peter T Chin6, Henry H Woo7, Anthony L Cantwell8, Barrett E Cowan9, Damien M Bolton10. 1. Wake Forest Baptist Health, Winston Salem, NC, USA. 2. Urology Centre, Port Macquarie, NSW, Australia. 3. Carolina Urologic Research Center, Myrtle Beach, SC, USA. 4. Chesapeake Urology Research Associates, Baltimore, MD, USA. 5. Toronto Urology Clinical Study Group, Toronto, ON, Canada. 6. Illawarra Urology, Figtree, NSW, Australia. 7. Sydney Adventist Hospital Clinical School, Wahroonga, NSW, Australia. 8. Advanced Urology Institute, Daytona Beach, FL, USA. 9. Urology Associates of Denver, Englewood, CO, USA. 10. Austin Health, Heidelberg, Vic., Australia. damienmbolton@gmail.com.
Abstract
OBJECTIVE: To evaluate the 24-month effectiveness of the prostatic urethral lift (PUL) procedure in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) assessed through a crossover study. PATIENTS AND METHODS: In all, 53 patients underwent a sham procedure as part of the blinded, randomised L.I.F.T. (Luminal Improvement Following prostatic Tissue approximation for the treatment of LUTS secondary to BPH) study at 19 centres and elected to enrol in this crossover study. The crossover procedure involved placement of permanent implants (UroLift® system) into the prostatic lateral lobes. Patients were followed for 3 months after the sham procedure and then for 24 months after crossover to PUL, with assessments of urinary symptom relief, quality of life (QoL), urinary flow rate, sexual function, and adverse events. RESULTS: At 24 months after crossover to PUL, the International Prostate Symptom Score (IPSS), QoL, BPH Impact Index, and maximum urinary flow rate improved 36%, 40%, 54%, and 77% from baseline, respectively. Each IPSS parameter on average improved significantly from baseline (P < 0.005) and remained stable throughout follow-up. Symptom response after the sham procedure indicated initial improvement at 1 month with significant decay by 3 months. Adverse events were typically mild to moderate and patients returned rapidly to normal activity. Four patients (8%) required intervention with transurethral resection of the prostate and one patient required additional PUL implants within the 24-month period. There were no reported instances of de novo sustained erectile or ejaculatory dysfunction. CONCLUSIONS: The PUL procedure is associated with rapid symptom relief, increased urinary flow rate and QoL improvement that remain stable over 24 months. Morbidity is low and sexual function is preserved.
RCT Entities:
OBJECTIVE: To evaluate the 24-month effectiveness of the prostatic urethral lift (PUL) procedure in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) assessed through a crossover study. PATIENTS AND METHODS: In all, 53 patients underwent a sham procedure as part of the blinded, randomised L.I.F.T. (Luminal Improvement Following prostatic Tissue approximation for the treatment of LUTS secondary to BPH) study at 19 centres and elected to enrol in this crossover study. The crossover procedure involved placement of permanent implants (UroLift® system) into the prostatic lateral lobes. Patients were followed for 3 months after the sham procedure and then for 24 months after crossover to PUL, with assessments of urinary symptom relief, quality of life (QoL), urinary flow rate, sexual function, and adverse events. RESULTS: At 24 months after crossover to PUL, the International Prostate Symptom Score (IPSS), QoL, BPH Impact Index, and maximum urinary flow rate improved 36%, 40%, 54%, and 77% from baseline, respectively. Each IPSS parameter on average improved significantly from baseline (P < 0.005) and remained stable throughout follow-up. Symptom response after the sham procedure indicated initial improvement at 1 month with significant decay by 3 months. Adverse events were typically mild to moderate and patients returned rapidly to normal activity. Four patients (8%) required intervention with transurethral resection of the prostate and one patient required additional PUL implants within the 24-month period. There were no reported instances of de novo sustained erectile or ejaculatory dysfunction. CONCLUSIONS: The PUL procedure is associated with rapid symptom relief, increased urinary flow rate and QoL improvement that remain stable over 24 months. Morbidity is low and sexual function is preserved.
Authors: Karthik Tanneru; Shiva Gautam; Daniel Norez; Jatinder Kumar; Muhammad Umar Alam; Shahriar Koocheckpour; K C Balaji; Costa Joseph Journal: Int Urol Nephrol Date: 2020-02-17 Impact factor: 2.370
Authors: Kapil Sethi; Michael Bozin; Tebogo Jabane; Richard McMullin; David Cook; Rob Forsyth; Lachlan Dodds; Lydia Johns Putra Journal: Investig Clin Urol Date: 2017-10-23
Authors: Gregg Eure; Steven Gange; Peter Walter; Ansar Khan; Charles Chabert; Thomas Mueller; Paul Cozzi; Manish Patel; Sheldon Freedman; Peter Chin; Steven Ochs; Andrew Hirsh; Michael Trotter; Douglas Grier Journal: J Endourol Date: 2019-06-25 Impact factor: 2.942