UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057856 |
|---|---|
| Receipt number | R000066133 |
| Scientific Title | A Study on Postoperative Urogenital Infections in Patients Without Preoperative Antibiotic Prophylaxis Undergoing Transurethral Water Vapor Energy Therapy (WAVE) |
| Date of disclosure of the study information | 2025/05/26 |
| Last modified on | 2025/05/13 18:32:43 |
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Basic information
Public title
A Study on Postoperative Urogenital Infections in Patients Without Preoperative Antibiotic Prophylaxis Undergoing Transurethral Water Vapor Energy Therapy (WAVE)
Acronym
Infections Following WAVE Without Preoperative Antibiotic Prophylaxis
Scientific Title
A Study on Postoperative Urogenital Infections in Patients Without Preoperative Antibiotic Prophylaxis Undergoing Transurethral Water Vapor Energy Therapy (WAVE)
Scientific Title:Acronym
Infections Following WAVE Without Preoperative Antibiotic Prophylaxis
Region
| Japan |
Condition
Condition
Benign prostatic hypertrophy
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence and characteristics of genitourinary infections following WAVE in patients without prophylactic antibiotic administration
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of genitourinary infections following WAVE
Key secondary outcomes
Association between infection, surgical procedures and patient characteristics
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. Patients undergoing WAVE for benign prostatic hyperplasia
2. Individuals who do not meet any of the exclusion criteria listed below and have consented to forgo preoperative antibiotic administration for WAVE
3. Individuals who have provided informed consent to participate in the study
Key exclusion criteria
1. Patients with an indwelling urinary catheter
2. Patients with a clinically evident urinary tract infection prior to surgery
3. Patients with pyuria (5- WBCs per high-power field) or bacteriuria on urinalysis conducted the day before or on the day of surgery
4. Patients undergoing treatment with steroids or immunosuppressive agents
5. Patients with poorly controlled diabetes mellitus. "Poorly controlled diabetes" is defined as having an HbA1c higher than 8.5% within the past 3 months, or fasting blood glucose higher than 180 mg/dL / random blood glucose higher than 250 mg/dL confirmed on at least two occasions, or as determined by the physician to have poor glycemic control
6. Any other individuals deemed inappropriate for study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naohiro |
| Middle name | |
| Last name | Fujimoto |
Organization
Local Incorporated Administrative Agency Kurate Hospital
Division name
Department of Urology
Zip code
807-1311
Address
2226-2 Komaki Kurate, Fukuoka, Japan
TEL
0949-42-1231
n-fuji@kurate-hp.com
Public contact
Name of contact person
| 1st name | Naohiro |
| Middle name | |
| Last name | Fujimoto |
Organization
Local Incorporated Administrative Agency Kurate Hospital
Division name
Department of Urology
Zip code
807-1311
Address
2226-2 Komaki Kurate, Fukuoka, Japan
TEL
9049-42-1231
Homepage URL
n-fuji@kurate-hp.com
Sponsor or person
Institute
Local Incorporated Administrative Agency Kurate Hospital
Institute
Department
Personal name
Funding Source
Organization
Local Incorporated Administrative Agency Kurate Hospital
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
Ethics Committee of Kurate Hospital, Local Incorporated Administrative Agency
Address
2226-2 Komaki Kurate, Fukuoka, Japan
Tel
0949-42-1231
keieikikaku@kurate-hp.com
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
| 2025 | Year | 05 | Month | 26 | 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 | 05 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The occurrence of infections will be monitored for a minimum of three months following WAVE therapy using medical interviews, physical examinations, laboratory tests (blood and urine), and imaging studies
Management information
Registered date
| 2025 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066133
