UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030684 |
|---|---|
| Receipt number | R000034943 |
| Scientific Title | The utility of penile compression device for the quality of life in Male urinary incOntinence after pRostatEctomy: A randomized prospective study |
| Date of disclosure of the study information | 2018/03/15 |
| Last modified on | 2023/11/07 13:23:13 |
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Basic information
Public title
The utility of penile compression device for the quality of life in Male urinary incOntinence after pRostatEctomy: A randomized prospective study
Acronym
The MORE study
Scientific Title
The utility of penile compression device for the quality of life in Male urinary incOntinence after pRostatEctomy: A randomized prospective study
Scientific Title:Acronym
The MORE study
Region
| Japan |
Condition
Condition
Male urinary incOntinence after prostatectomy
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the utility of penile compression device for the quality of life in male urinary incontinence after prostatectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of King's Health Questionnaire scores
Key secondary outcomes
Changes in the number of urine pads used per day
Changes in the weight of urine pads per day
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of the penile compression device for 28 days except at bedtime
Interventions/Control_2
No use of the penile compression device
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients who suffer from stress urinary incontinence after prostatectomy
Key exclusion criteria
- Less than a month after prostatectomy
- Severe disease of penile skin
- After the implantation of artificial urinary sphincter
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazumasa |
| Middle name | |
| Last name | Torimoto |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
torimoto@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Torimoto |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
http://www.naramed-u.ac.jp/~urol/
torimoto@naramed-u.ac.jp
Sponsor or person
Institute
Department of Urology,
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
840 Shijo-cho, Kashihara, Nara
Tel
0744-22-3051
f-okumura@naramed-u.ac.jp
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
奈良県立医科大学附属病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1186/s13104-023-06564-z
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1186/s13104-023-06564-z
Number of participants that the trial has enrolled
40
Results
The average daily use of urinary care pads was significantly reduced in the clamp group than in the non-clamp group (-0.83+/-1.51 vs -0.16+/-0.69, P = 0.0071). King's Health Questionnaire scores did not change significantly in either group. Wearing the CLAMPMED reduced the amount of urinary incontinence but did not improve the quality of life.
Results date posted
| 2023 | Year | 11 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 10 | Month | 18 | Day |
Baseline Characteristics
Clamp group Age 71.2+/-4.8 Period after RP 26.2+/-39.0 months Pads used per day 5.7+/-2.8
Non-clamp group Age 68.3+/-7.1 Period after RP 28.9+/-44.0 months Pads used per day 5.0+/-3.4
Participant flow
Although 40 patients were enrolled, only 19 and 18 patients in the non-clamp and clamp groups, respectively, were analyzed because of a lack of data.
Adverse events
None
Outcome measures
We checked the average daily usage for two weeks, and evaluated each participant using the King's Health Questionnaire (KHQ). After 4 weeks, the average daily usage of urinary care pads was monitored, and the KHQ evaluation was performed again.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 09 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 10 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 05 | Day |
Last modified on
| 2023 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034943
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