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3-year outcomes of sexual function after water vapor thermal therapy (REZŪM®) and medical therapy for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH): Rigorous assessment of sexual function questionnaires with ITE

  • Joseph Mahon,
  • Nikhil Gupta,
  • Tyson Rogers,
  • Bradley Holland,
  • Kevin McVary





Introduction

Medical therapy for lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH) has a negative impact on sexual function. Three year data from the randomized controlled trial (RCT) of water vapor thermal therapy (Rezum) shows durable, effective relief of LUTS while preserving sexual function. This report compares effects on sexual function (SF) domains over 3 years after a one-time Rezum procedure and continuous daily drug therapy in the Medical Therapy of Prostatic Symptoms (MTOPS) trial.

Methods

Longitudinal sexual function data from the Rezum RCT was compared to results of MTOPS trial arms; monotherapy with doxazosin or finasteride, or combination drugs in subjects determined to be sexually active at baseline. Sexual function was evaluated using the International Index of Erectile Function (Rezum) and Brief Male Sexual Function Inventory (MTOPS); domains common to both questionnaires – sexual desire (SD), erectile function (EF), ejaculatory function (EjD) and overall sexual satisfaction were assessed at 1, 2, and 3-years. Item Response Theory (IRT) modeling further assessed these two questionnaires using a graded response model to determine whether both instruments were appropriately measuring the intended and similar aspects across all items within each sexual function domain.

Results

Subjects treated: Rezum (N=86), doxazosin (N=301), finasteride (N=319), and combination of both drugs (N=310). The IRT model analysis confirmed significant discrimination between the SF domains to validly assess longitudinal changes in outcomes in both trials. With continued daily drug use men experienced significant worsening of SD, EF and EjD with finasteride and combination drug therapy, and reduced SD and EF with doxazosin (p≤0.004). Thermal therapy was not associated with significant mean negative changes in SF throughout 3 years after treatment.

Conclusions

The single water vapor thermal therapy procedure had no deleterious effect on four sexual function domains compared with appreciable worsening of SF after long-term mono- or combination drug use. This minimally invasive treatment may be a superior option for patients with moderate-to-severe LUTS unwilling to compromise sexual function.

Source of Funding

Boston Scientific