Clinical study of trans-obturator tape operation for male patients with severe stress incontinence

Clinical study of trans-obturator tape operation for male patients with severe stress incontinence - TOT study for male incontinence

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011536

Enrollment

Registered

2013-09-01

Start date

2009-01-28

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

stress urinary incontinence

Interventions

Operation of insertion of a tape via obturator foramen

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1)Stress urinary incontinence, assessed by ICIQSF 2)PS 2 or less 3)6 months or more after operation, causing stress incontinence 4)Lack of urethral stricture, assessed by urethro-cystoscopy 5)ALPP 65cmH2O or less 6)Obtainment of written informed consent

Exclusion criteria

Exclusion criteria: 1)Severe infectious disease, or other uncontrollable diseases 2)Active urothelial or prostate cancer 3)Past history of irradiation to bulbous urethra

Design outcomes

Primary

Measure	Time frame
Degree of improvement the scores of the IPSS, ICIQSF, and SF36 at 1 and 3 months after operation, compared with those at baseline	—

Countries

Japan

Contacts

Public ContactKoji Yoshimura

Kyoto University, graduate school of medicine Urology

ky7527@kuhp.kyoto-u.ac.jp075-751-3337

Outcome results

None listed

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