roLift System post-marketing surveillance

Not Applicable

Conditions: 110200
Benign prostatic hyperplasia with lower urinary tract symptoms (LUTS)
BPH, LUTS

Registration Number: JPRN-jRCT2032220377

Lead Sponsor: Kadono Yoshihiko

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 200

Inclusion 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures