UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055956 |
|---|---|
| Receipt number | R000063945 |
| Scientific Title | Exploratory Research to evaluate the efficacy of pelvic floor muscle training for urinary incontinence symptoms in patients with hip osteoarthritis |
| Date of disclosure of the study information | 2024/10/27 |
| Last modified on | 2024/10/27 12:10:51 |
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Basic information
Public title
Research on the effectiveness of training to improve urinary leakage related to hip osteoarthritis
Acronym
Research on the effectiveness of training to improve urinary leakage related to hip osteoarthritis
Scientific Title
Exploratory Research to evaluate the efficacy of pelvic floor muscle training for urinary incontinence symptoms in patients with hip osteoarthritis
Scientific Title:Acronym
Exploratory Research to evaluate the efficacy of pelvic floor muscle training for urinary incontinence symptoms in patients with hip osteoarthritis
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of adding an approach to the pelvic floor muscles to physical therapy after total hip arthroplasty for urinary incontinence symptoms associated with female patients with hip osteoarthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of disappearance of urinary incontinence symptoms 12 weeks after the start of intervention
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
Pelvic floor muscle training
Endurance training: Pelvic floor muscle contraction for 10 seconds at approximately 50% of maximum contraction and relaxation for 10 seconds
Strengthening training: pelvic floor muscle contraction with maximum effort for 5 seconds and relaxation for 5 seconds
One set is 10 repetitions, and each set is performed 3 times a day.
The above contractions are started in the supine position, and can also be performed in the sitting or standing position if contraction is possible.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
A woman who underwent total hip arthroplasty for osteoarthritis of the hip.
Have had urinary incontinence symptoms within 30 days before surgery (ICIQ-SF score of 1 or more).
ICIQ-SF score of 1 or more on the 7th postoperative day
Must be 18 years of age or older at the time of consent.
Written consent was obtained from the individual to participate in the study.
Key exclusion criteria
If you have other diseases that can cause urinary incontinence (dementia, stroke, pelvic organ prolapse, spinal cord disease, neurological disorders after rectal or uterine surgery, etc.).
If you are already receiving or have received treatment for urinary incontinence (exercise therapy, drug therapy, surgical therapy).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Fukutani |
Organization
Shimane University
Division name
Devision of rehabilitation, Shimane university hospital
Zip code
6938501
Address
89-1, Ennya-cho, Izumo, Shimane
TEL
0853-20-2242
fuku.s@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Kadowaki |
Organization
Shimane University
Division name
Department of Orthopaedic surgery
Zip code
6938501
Address
89-1, Ennya-cho, Izumo, Shimane
TEL
0853202242
Homepage URL
masaru11@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
none
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
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1, Ennya-cho, Izumo, Shimane
Tel
0853-20-2515
kenkyu@med.shimane-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 27 | Day |
Last modified on
| 2024 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063945
