Evaluation of the Optilume BPH Catheter System and the Rezum Water Vapor Therapy in Treating Benign Prostatic Hyperplasia

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Jan 9, 2025

Keywords

ClinConnect Summary

This clinical trial is comparing two new treatments for men with benign prostatic hyperplasia (BPH), a condition where the prostate gland enlarges and can cause urinary problems. The two treatments being studied are the Optilume BPH Catheter System and Rezum Water Vapor Therapy. Both aim to help relieve lower urinary symptoms and improve quality of life for men experiencing these issues.

To participate in the trial, men aged 65 to 74 with symptomatic BPH and a prostate size between 30 and 100 grams can apply. However, those with certain conditions, such as previous prostate surgeries or active urinary infections, may not be eligible. Participants will have the opportunity to experience one of these treatments and provide feedback on their symptoms and overall experience. The study is not yet recruiting, but it promises to offer valuable insights into these innovative therapies for BPH.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male subject with symptomatic BPH.
• • Prostate size 30-100g.
• • Able to complete the study protocol.
• Exclusion Criteria:
• • Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements
• • Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
• • Any prior minimally invasive intervention (e.g., TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
• • Confirmed or suspected malignancy of prostate or bladder
• • Active urinary tract infection (UTI) confirmed by culture
• • History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable
• • Presence of confounding diagnoses impacting lower urinary tract symptoms or bladder function (e.g., urethral strictures, bladder neck contracture, neurogenic bladder, detrusor instability, bladder stones, etc.)
• • History of chronic urinary retention (e.g., PVR ≥300mL on two separate occasions, or catheter dependent drainage)
• • Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
• • Significant obstruction from median lobe (investigator opinion)
• • Disease or other health condition that is not suitable for this study