Unique ID issued by UMIN | UMIN000011536 |
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Receipt number | R000013494 |
Scientific Title | Clinical study of trans-obturator tape operation for male patients with severe stress incontinence |
Date of disclosure of the study information | 2013/09/01 |
Last modified on | 2016/08/22 09:49:55 |
Clinical study of trans-obturator tape operation for male patients with severe stress incontinence
TOT study for male incontinence
Clinical study of trans-obturator tape operation for male patients with severe stress incontinence
TOT study for male incontinence
Japan |
stress urinary incontinence
Urology |
Others
NO
To assess the utility and safety of trans-obturator tape operation for iatrogenic male stress urinary incontinence
Safety,Efficacy
Exploratory
Phase II
Degree of improvement the scores of the IPSS, ICIQSF, and SF36 at 1 and 3 months after operation, compared with those at baseline
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Operation of insertion of a tape via obturator foramen
50 | years-old | <= |
Not applicable |
Male
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
1)Severe infectious disease, or other uncontrollable diseases
2)Active urothelial or prostate cancer
3)Past history of irradiation to bulbous urethra
30
1st name | |
Middle name | |
Last name | Osamu Ogawa |
Kyoto University, graduate school of medicine
Urology
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
075-751-3337
ogawao@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Koji Yoshimura |
Kyoto University, graduate school of medicine
Urology
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
075-751-3337
ky7527@kuhp.kyoto-u.ac.jp
Kyoto University, Graduate School of Medicine, Department of Urology
none
Other
NO
2013 | Year | 09 | Month | 01 | Day |
Partially published
Open public recruiting
2009 | Year | 01 | Month | 28 | Day |
2009 | Year | 01 | Month | 28 | Day |
2013 | Year | 08 | Month | 20 | Day |
2016 | Year | 08 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013494
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