Treatment of LUTS Secondary to BPH While Preserving Sexual Function: Randomized Controlled Study of Prostatic Urethral Lift
Version of Record online: 30 SEP 2013
© 2013 International Society for Sexual Medicine
The Journal of Sexual Medicine
Volume 11, Issue 1, pages 279–287, January 2014
How to Cite
McVary, K. T., Gange, S. N., Shore, N. D., Bolton, D. M., Cowan, B. E., Brown, B. T., Te, A. E., Chin, P. T., Rukstalis, D. B., Roehrborn, C. G. and L.I.F.T. Study Investigators (2014), Treatment of LUTS Secondary to BPH While Preserving Sexual Function: Randomized Controlled Study of Prostatic Urethral Lift. Journal of Sexual Medicine, 11: 279–287. doi: 10.1111/jsm.12333
- Issue online: 16 JAN 2014
- Version of Record online: 30 SEP 2013
- NeoTract, Inc.
- Benign Prostatic Hyperplasia;
- Sexual Function;
- Erectile Dysfunction;
- Ejaculatory Dysfunction;
- Retrograde Ejaculation
We analyzed data obtained from a randomized controlled blinded study of the prostatic urethral lift (PUL) to evaluate the sexual side effects of this novel treatment.
We sought to determine whether PUL, when conducted in a randomized study, significantly improved lower urinary tract symptoms (LUTS) and urinary flow rate while preserving sexual function.
Men ≥50 years with prostates 30–80 cc, International Prostate Symptom Score (IPSS) >12, and peak urinary flow rate (Qmax) ≤12 ml/s were randomized 2:1 between PUL and sham. Sexual activity was not an inclusion criterion. In PUL, permanent transprostatic implants are placed to retract encroaching lateral lobes and open the prostatic fossa. Sham entailed rigid cystoscopy with sounds to mimic PUL and a blinding screen.
Main Outcome Measures
Blinded groups were compared at 3 months and active arm then followed to 12 months for LUTS with IPSS and for sexual function with sexual health inventory for men (SHIM) and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). Subjects were censored from primary sexual function analysis if they had baseline SHIM < 5 at enrollment. Secondary stratified analysis by erectile dysfunction (ED) severity was conducted.
There was no evidence of degradation in erectile or ejaculatory function after PUL. SHIM and MSHQ-EjD scores were not different from control at 3 months but were modestly improved and statistically different from baseline at 1 year. Ejaculatory bother score was most improved with a 40% improvement over baseline. Twelve-month SHIM was significantly improved from baseline for men entering the study with severe ED, P = 0.016. IPSS and Qmax were significantly superior to both control at 3 months and baseline at 1 year. There was no instance of de novo sustained anejaculation or ED over the course of the study.
The PUL improves LUTS and urinary flow while preserving erectile and ejaculatory function. McVary KT, Gange SN, Shore ND, Bolton DM, Cowan BE, Brown BT, Te AE, Chin PT, Rukstalis DB, and Roehrborn CG on behalf of the L.I.F.T. Study Investigators. Treatment of LUTS secondary to BPH while preserving sexual function: Randomized controlled study of Prostatic Urethral Lift. J Sex Med 2014;11:279–287.