Artificial Urinary Sphincter vs. Adjustable Male Sling for Treating male stress urinary INcontinence

Artificial Urinary Sphincter vs. Adjustable Male Sling for Treating male stress urinary INcontinence - AUSTIN

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015253

Enrollment

270

Registered

2019-08-28

Start date

2019-11-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

N39.3

Interventions

Group 1: Artificial urinary sphincter AMS 800 Group 2: Adjustable male Sling (Argus or ATOMS)

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: > age min. 18 years > moderate-severe urinary incontinence > cause of incontiennce: radical prostatectomy > signed inform consent

Exclusion criteria

Exclusion criteria: > neurological disease > medical or operative therapy or urge incontiennce > prior surgery for stress urinary incontiennce > cause for incontinence: salvage prostatectomy or any other cause than primary radical prostatectomy > impaired cognitive or manual skills for usage of an artificial urinary sphincter > missing informed consent

Design outcomes

Primary

Measure	Time frame
Cure of urinary incontinence. Definition: Usage of 0 or 1 Pad	—

Secondary

Measure	Time frame
• complications rates • revision and explantation free survival • Quality of life according standardized and validated questionaires (ICIQ-SF, IQoL, PGI-I) und 24h Pad-Test • Timeperiod for urinary continence (Periode from cure until recurrence of urinary incontinence	—

Countries

Austria, Germany

Contacts

Public ContactTanja Hüsch

Universitätsmedizin Mainz

tanjahuesch@gmail.com00496131170

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026