UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011536 |
|---|---|
| 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 |
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Basic information
Public title
Clinical study of trans-obturator tape operation for male patients with severe stress incontinence
Acronym
TOT study for male incontinence
Scientific Title
Clinical study of trans-obturator tape operation for male patients with severe stress incontinence
Scientific Title:Acronym
TOT study for male incontinence
Region
| Japan |
Condition
Condition
stress urinary incontinence
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the utility and safety of trans-obturator tape operation for iatrogenic male stress urinary incontinence
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Degree of improvement the scores of the IPSS, ICIQSF, and SF36 at 1 and 3 months after operation, compared with those at baseline
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Operation of insertion of a tape via obturator foramen
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key 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
Key exclusion criteria
1)Severe infectious disease, or other uncontrollable diseases
2)Active urothelial or prostate cancer
3)Past history of irradiation to bulbous urethra
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Ogawa |
Organization
Kyoto University, graduate school of medicine
Division name
Urology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3337
ogawao@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Yoshimura |
Organization
Kyoto University, graduate school of medicine
Division name
Urology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3337
Homepage URL
ky7527@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University, Graduate School of Medicine, Department of Urology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2009 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 20 | Day |
Last modified on
| 2016 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013494
