UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060408 |
|---|---|
| Receipt number | R000069108 |
| Scientific Title | A Prospective Single-Arm Study on the Anatomical Success Rate of Heineke-Mikulicz Urethroplasty |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/01/20 13:24:58 |
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Basic information
Public title
Prospective Single-Arm Study of Anatomical Success after Heineke-Mikulicz Urethroplasty
Acronym
HM Urethroplasty Study
Scientific Title
A Prospective Single-Arm Study on the Anatomical Success Rate of Heineke-Mikulicz Urethroplasty
Scientific Title:Acronym
HM-AS Study
Region
| Japan |
Condition
Condition
urethral stricture
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to prospectively evaluate the anatomical success rate and safety of Heineke-Mikulicz urethroplasty for proximal bulbar or membranous urethral strictures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The anatomical success rate at 6 months postoperatively, defined as successful passage of a 17-Fr flexible cystoscope through the reconstructed urethra without resistance and without the need for additional dilation.
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
Heineke-Mikulicz urethroplasty
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
Male
Key inclusion criteria
1. Non-traumatic proximal bulbar or membranous urethral stricture
2. Age >= 18 years at the time of informed consent
3. A single stricture located in the proximal bulbar or membranous urethra on preoperative retrograde urethrography
4. Intraoperative measurement confirming a stricture length of =< 10 mm
5. Provision of written informed consent to participate in this study
Key exclusion criteria
1. Urethral stricture associated with lichen sclerosus
2. Traumatic urethral stricture
3. History of prior urethroplasty, including childhood hypospadias repair
4. Complete obliteration of the urethral lumen
5. Multiple urethral strictures
6. Withdrawal of informed consent
Target sample size
79
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Tabei |
Organization
Fujisawa Shonandai hospital
Division name
Urology
Zip code
252-0802
Address
2345 Takakura Fujisawa Kanagawa
TEL
0466-44-1451
tadashiokclub@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Tabei |
Organization
Fujisawa Shonandai Hospital
Division name
Urology
Zip code
252-0802
Address
2345 Takakura Fujisawa Kanagawa
TEL
0466-44-1451
Homepage URL
tadashiokclub@yahoo.co.jp
Sponsor or person
Institute
Fujisawa Shonandai hospital
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
Fujisawa Shonandai Hospital Institutional Review Board
Address
2345 Takakura Fujisawa Kanagawa
Tel
0466-44-1451
k_sato_17166@fj-shounandai.or.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
| 2026 | Year | 02 | 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
| 2025 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 20 | Day |
Last modified on
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069108
