UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060937 |
|---|---|
| Receipt number | R000069734 |
| Scientific Title | Retrospective observational study on success factors and prognosis of re-trial without catheter in patients with persistent urinary retention |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/14 15:32:28 |
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Basic information
Public title
Retrospective observational study on success factors and prognosis of re-trial without catheter in patients with persistent urinary retention
Acronym
Retrospective observational study on success factors and prognosis of re-trial without catheter in patients with persistent urinary retention
Scientific Title
Retrospective observational study on success factors and prognosis of re-trial without catheter in patients with persistent urinary retention
Scientific Title:Acronym
Retrospective observational study on success factors and prognosis of re-trial without catheter in patients with persistent urinary retention
Region
| Japan |
Condition
Condition
Persistent urinary retention
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In older adults, indwelling urethral catheterization for urinary retention is associated with an increased risk of urinary tract infections and a decline in quality of life; therefore, catheter removal to restore spontaneous voiding is strongly recommended. However, in patients with persistent urinary retention who require re-catheterization following an initial failed trial without catheter (TWOC), the optimal endpoint for repeated TWOC attempts and the specific predictors for successful complete spontaneous voiding remain poorly defined. Utilizing retrospective data from patients enrolled in our urinary independence support program, this study investigates the physical and clinical risk factors predicting complete spontaneous voiding. Furthermore, we will evaluate the overall survival of patients with unresolved urinary retention and the clinical safety of repeated TWOC procedures. Ultimately, this study seeks to establish evidence-based criteria for TWOC decision-making, thereby contributing to safer and more effective urinary management strategies for elderly patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Establishment of Spontaneous Voiding
Key secondary outcomes
Overall survival (OS) depending on the resolution of urinary retention (spontaneous voiding vs. non-spontaneous voiding)
Incidence rate of febrile urinary tract infection during the catheter removal trials
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria:
1. Entered into the Urinary Independence Support program at our institution.
2. Underwent an initial trial without catheter (TWOC) at a previous hospital or our institution, but required re-catheterization due to increased residual urine or urinary retention.
2. Planned for a second or subsequent TWOC.
Key exclusion criteria
Refusal to participate (opt-out).
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Okinami |
Organization
Akashi Ninjyu Hospital
Division name
Department of Urology
Zip code
6740051
Address
1871-3 Shimizu, Uozumi-cho, Akashi, Hyogo, Japan
TEL
0789421921
t.okinami@kojinkai.hyogo.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Okinami |
Organization
Akashi Ninjyu Hospital
Division name
Department of Urology
Zip code
6740051
Address
1871-3 Shimizu, Uozumi-cho, Akashi, Hyogo, Japan
TEL
0789421921
Homepage URL
t.okinami@kojinkai.hyogo.jp
Sponsor or person
Institute
Akashi Ninjyu Hospital
Institute
Department
Personal name
Takeshi Okinami
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akashi Ninjyu Hospital
Address
1871-3 Shimizu, Uozumi-cho, Akashi, Hyogo, Japan
Tel
0789421921
t.okinami@kojinkai.hyogo.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
兵庫県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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
| 2026 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation Items (Data Collection Variables)
A. Baseline characteristics at the time of initial catheterization:
Age, sex, past medical history (diabetes mellitus, stroke, neurological diseases), reason for urethral catheterization, estimated prostate volume, current medications, etc.
B. Clinical parameters at the time of evaluation (re-catheterization and final TWOC):
Physical status including BMI, Functional Independence Measure (FIM) scores (motor and cognitive), primary route of nutrition, current medications, presence of febrile UTI, etc.
C. Clinical outcomes:
Complete spontaneous voiding (SV), clean intermittent self-catheterization (CISC), assisted clean intermittent catheterization (ACIC), continuation of indwelling urethral catheterization (IUC), and death including cause of death.
Management information
Registered date
| 2026 | Year | 03 | Month | 14 | Day |
Last modified on
| 2026 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069734
