UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060902 |
|---|---|
| Receipt number | R000069695 |
| Scientific Title | Impact of photoselective vaporization of the prostate (PVP-XPS) on work productivity in working-age men with benign prostatic hyperplasia requiring surgical treatment |
| Date of disclosure of the study information | 2026/03/12 |
| Last modified on | 2026/03/11 23:40:20 |
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Basic information
Public title
Impact of photoselective vaporization of the prostate (PVP-XPS) on work productivity in working-age men with benign prostatic hyperplasia requiring surgical treatment
Acronym
Impact of photoselective vaporization of the prostate (PVP-XPS) on work productivity
Scientific Title
Impact of photoselective vaporization of the prostate (PVP-XPS) on work productivity in working-age men with benign prostatic hyperplasia requiring surgical treatment
Scientific Title:Acronym
Impact of photoselective vaporization of the prostate (PVP-XPS) on work productivity
Region
| Japan |
Condition
Condition
Benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate whether photoselective vaporization of the prostate (PVP-XPS) improves work productivity in working-age men with benign prostatic hyperplasia requiring surgical treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in overall work impairment (%) assessed by the Work Productivity and Activity Impairment (WPAI) questionnaire at 1, 3, and 6 months after PVP
Key secondary outcomes
Change from baseline in absenteeism, presenteeism, overall activity impairment, and productivity loss cost assessed by the Work Productivity and Activity Impairment (WPAI) questionnaire at 1, 3, and 6 months after PVP
Change from baseline in the International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS) and the simple frailty index at 1, 3, and 6 months after PVP
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 with benign prostatic hyperplasia undergoing photoselective vaporization of the prostate.
2.Male patients aged 40 years or more.
3.Patients with an estimated prostate volume of 30 to 80 g.
4.Patients who provide written informed consent for participation in the study.
Key exclusion criteria
1.Patients who are unable to speak Japanese.
2.Patients with anatomical abnormalities of the urinary tract.
3.Patients with a history of surgical intervention for benign prostatic hyperplasia.
4.Patients deemed unsuitable for the study by the attending physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Wanifuchi |
Organization
Japanese Red Cross Kushiro Hospital
Division name
Department of Urology
Zip code
0850032
Address
21-14, Shinei-Cho, Kushiro, Hokkaido, Japan
TEL
+81-154-22-7171
a-wanifuchi@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Wanifuchi |
Organization
Japanese Red Cross Kushiro Hospital
Division name
Department of Urology
Zip code
0850032
Address
21-14, Shinei-Cho, Kushiro, Hokkaido, Japan
TEL
+81-154-22-7171
Homepage URL
a-wanifuchi@sapmed.ac.jp
Sponsor or person
Institute
Japanese Red Cross Kushiro Hospital
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
Japanese Red Cross Kushiro Hosipital
Address
21-14, Shinei-Cho, Kushiro, Hokkaido, Japan
Tel
+81-154-22-7171
a-wanifuchi@sapmed.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
釧路赤十字病院（北海道）、札幌医科大学付属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preoperative Assessments
1.Patient characteristics: age, height, weight, laboratory data, prostate volume, educational background, occupation, marital status, current medications, medical history, and presence of an indwelling catheter.
2.Lower urinary tract symptoms(LUTS): International Prostate Symptom Score (IPSS) and Overactive Bladder Symptom Score (OABSS).
3.Productivity indicators: Work Productivity and Activity Impairment questionnaire (WPAI).
4.Frailty indicator: Simple frailty index.
5.Voiding parameters: postvoid residual urine volume and uroflowmetry.
6.PVP-related surgical factors: operative time, laser time, total energy delivered (J), complications, and American Society of Anesthesiologists physical status (ASA-PS).
Postoperative Assessments
At 1 month postoperatively: IPSS, OABSS and WPAI.
At 3 months postoperatively: IPSS, OABSS and WPAI.
At 6 months postoperatively: IPSS, OABSS and WPAI. Frailty will be assessed using the simple frailty index.
Management information
Registered date
| 2026 | Year | 03 | Month | 11 | Day |
Last modified on
| 2026 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069695
