UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037287 |
|---|---|
| Receipt number | R000042513 |
| Scientific Title | Evaluation of the effect of rehabilitation intervention in biofeedback training using Femiscan for female stress urinary incontinence |
| Date of disclosure of the study information | 2019/07/10 |
| Last modified on | 2024/07/08 16:47:34 |
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Basic information
Public title
Evaluation of the effect of rehabilitation intervention in biofeedback training using Femiscan for female stress urinary incontinence
Acronym
Rehabilitation for stress urinary incontinence
Scientific Title
Evaluation of the effect of rehabilitation intervention in biofeedback training using Femiscan for female stress urinary incontinence
Scientific Title:Acronym
Rehabilitation for stress urinary incontinence
Region
| Japan |
Condition
Condition
stress urinary incontinence/Female
Classification by specialty
| Urology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of rehabilitation interventions on female patients with stress urinary incontinence, we examine changes in pelvic floor muscle contraction measured with Femiscan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EMG output
Key secondary outcomes
OABSS
ICIQ-SF
Urination diary
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
| Other |
Interventions/Control_1
Pelvic floor muscle training
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Female patient with stress urinary incontinence
Patients who can go outpatient continuously for rehabilitation
Key exclusion criteria
Urinary incontinence patients other than stress urinary incontinence
Patients with cognitive decline
Patients during pregnancy and postpartum
Patients with hypersensitivity to devices and drugs used in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Mizushima |
Organization
Dokkyo Medical University
Division name
Department of Rehabilitation Medicine
Zip code
3210293
Address
880, Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL
0282-87-2215
mizushima@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Minowa |
Organization
Dokkyo Medical University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
3210293
Address
880, Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL
0282-87-2215
Homepage URL
noriko-a@dokkyomed.ac.jp
Sponsor or person
Institute
Dokko Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokko 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
IRB of Dokkyo Medical University
Address
880, Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
Tel
0282-87-2275
r-kenkyu@dokkyomed.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
獨協医科大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
https://doi.org/10.2490/jjrmc.60.S1388
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.2490/jjrmc.60.S1388
Number of participants that the trial has enrolled
45
Results
Number of cases 45. Mean age 70.6 years.
Duration of intervention, mean 67.7 days Number of interventions, mean 3.6.
ICIQ-SF results improved in 30 cases, remained unchanged in 9 cases and worsened in 6 cases.
ICIQ-SF change between two and three or more interventions averaged 1.09 points for two interventions.
3 or more times averaged 3.15 points and there was a significant difference in the Mann-Whitney U test
Results date posted
| 2024 | Year | 07 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Female outpatients with abdominal pressure urinary incontinence
Participant flow
Physiotherapy included palpation of the pelvic floor muscles from over clothing as part of pelvic floor muscle training, and one-second contractions to strengthen instantaneous force,
5-second contractions to strengthen endurance.
In terms of lifestyle guidance, the participants were instructed on appropriate BMI, the amount of water they should drink and how to maintain light physical activity such as walking.
The content of independent training at home was taught using pamphlets.
Adverse events
None
Outcome measures
Age, duration of intervention, number of interventions, International Congress on Urinary Incontinence Quality of Life Questionnaire, ICIQ-SF
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042513
