UroLift System post-marketing surveillance

JRCT ID: jRCT2032220377

Registered date:14/10/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Benign prostatic hyperplasia with lower urinary tract symptoms (LUTS)
• Date of first enrollment: 10/10/2022
• Target sample size: 200
• Study type: Observational

Outcome(s)

Primary Outcome

(1) Percentage of subjects who had a urinary catheter inserted for more than 7 days after the procedure up to 12 months
(2) Percentage of adverse events related to the product or the procedure.
All adverse events/malfunctions should be listed in relation to the procedure or the product, severity, treatment, and outcome.
(3)Surgical re-intervention treatment rate (this product, TURP, PVP, HoLEP, etc.)
All surgical re-intervention procedures will be counted and listed.
(4) Amount of change in urologic symptoms and QOL scores (IPSS, IPSS QOL, etc.)
Change in each QOL score from baseline to the specified follow-up period after the end of treatment and at the time of discontinuation.
(5) Rate of Preservation of sexual function (incidence of new persistent erectile dysfunction and no ejaculation)
Incidence of new persistent erectile dysfunction and no ejaculation from baseline to the specified follow-up period after the end of treatment until discontinuation

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male
• Include criteria: Patients diagnosed with benign prostatic hyperplasia and with lower urinary tract symptoms (LUTS) who used this product according to IFU. Regardless of whether it is lateral or median lobe.
• Exclude criteria: -

Related Information

• Primary Sponsor: Kadono Yoshihiko