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Ejaculatory function and bother after the ProVee prostatic urethral stent for benign prostatic hyperplasia: Results from the ProVIDE Study
Muhieddine Labban, MD1, Lori Lerner, MD2.
1Brigham and Women's Hospital, BOSTON, MA, USA, 2VA Boston Healthcare, BOSTON, MA, USA.
BACKGROUND: ProVee is a new permanent prostatic urethral stent delivered cystoscopically to improve BPH-related lower urinary tract symptoms (LUTS). The stent sits between the bladder neck and external sphincter, around the verumontanum; designed to preserve ejaculatory function. However, those outcomes have not yet been reported. We examined ejaculatory function and bother scores among men in the ProVIDE study who received ProVee.
METHODS: ProVIDE is a prospective, multicenter, randomized, double-blind sham-controlled trial demonstrating effectiveness of ProVee in improving LUTS. Our cohort included all ProVee subjects (randomization, n=146 plus unblinded crossovers, n=61). Outcomes included results from the Male Sexual Health Questionnaire (ability, strength, and volume of ejaculate, where high scores indicate better outcomes) and bother scores at baseline, 3, 6, and 12 months (where low scores indicate better outcomes). Paired two-sample t-test was used to compare scores to baseline. Sensitivity analysis was done among the ProVee and cross-over arms.
RESULTS: ProVee did not affect the ability to ejaculate in all 207 men (Figure 1A). At 12-months, there was slight improvement in the strength (0.30; 95%CI [0.09-0.51], p=0.01), volume of ejaculate (0.24; 95%CI [0.01-0.46], p=0.04) (Figure 1B and 1C); and slightly improved bother scores (-0.41; 95%CI [-0.19 - -0.63); p<0.01) (Figure 1D). Sensitivity analysis demonstrated similar trends in ProVee and cross-over arms.
CONCLUSIONS: ProVee may offer modest improvements in ejaculatory strength and volume up to one-year post-procedure, with a slight improvement in ejaculatory bother. ProVee is an appealing addition to the armamentarium of BPH surgery, particularly for men prioritizing preservation of ejaculatory function.
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