UroLift System post-marketing surveillance

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2032220377

Enrollment

200

Registered

2022-10-14

Start date

2022-10-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria: -

Design outcomes

Primary

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Contacts

Public ContactYoshihiko Kadono

Teleflex Medical Japan,Ltd.

yoshihiko.kadono@teleflex.com+81-366323600

Outcome results