Prevention of artificial urinary sphincter infection

A multicenter, single-arm clinical study on the effectiveness of device and wound irrigation using plasma fine bubble water to prevent postoperative device-related infections after artificial urinary sphincter implantation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031240059

Enrollment

Registered

2024-05-01

Start date

2024-05-15

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

Male patients with severe urinary incontinence planned for artificial urinary sphincter implantation

Interventions

1)Prior to the start of surgery, spray 100 ml of plasma fine bubble water evenly over the surgical field 5 minutes before disinfecting the surgical field. 2)Clean the surgical field with 5% chlorhexid

Antibiotic Prophylaxis

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1)Male patients scheduled for new implantation, replacement, or reimplantation of an artificial urinary sphincter for severe urinary incontinence. 2)Patients aged 20 years or older at the time of informed consent 3)Patients who have given their written consent to participate in this clinical study

Exclusion criteria

Exclusion criteria: 1)Patients who are judged to be inappropriate for participation in this study by the research principal (sub-research) physician

Design outcomes

Primary

Measure	Time frame
device-related infection rate	—

Secondary

Measure	Time frame
1)device removal rate 2)period from device implantation to occurrence of device-related infection 3)period from device implantation to device removal	—

Contacts

Public ContactYuma Waseda

Institute of Science Tokyo Hospital

waseuro@tmd.ac.jp+81-3-5803-5295

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026