UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015468 |
|---|---|
| Receipt number | R000017584 |
| Scientific Title | Long-term outcomes of patients with benign prostatic hyperplasia undergoing transurethral resection of prostate, prospective observational study in single center |
| Date of disclosure of the study information | 2014/10/18 |
| Last modified on | 2025/10/26 09:07:50 |
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Basic information
Public title
Long-term outcomes of patients with benign prostatic hyperplasia undergoing transurethral resection of prostate, prospective observational study in single center
Acronym
Long-term outcomes of patients undergoing transurethral resection of prostate
Scientific Title
Long-term outcomes of patients with benign prostatic hyperplasia undergoing transurethral resection of prostate, prospective observational study in single center
Scientific Title:Acronym
Long-term outcomes of patients undergoing transurethral resection of prostate
Region
| Japan |
Condition
Condition
Benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the lower urinary tract function in patients with undergoing transurethral resection of prostate in this long-term prospective study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective and objective assessment of lower urinary tract function in 5 years after transurethral resection of prostate
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
Transurethral resection of prostate
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
A patient who are diagnosed as benign prostatic hyperplasia and undergoing transurethral resection of prostate
Key exclusion criteria
(1)A patient with urological malignancy
(2)A patient with neurogenic bladder or urinary tract infection
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Masumori |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
060-8543
Address
S-1, W-16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
masumori@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Nakane |
Organization
Sapporo Medical University School of Medicine
Division name
Department of clinical reseach
Zip code
060-8543
Address
S-1, W-16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
Homepage URL
k.nakane@sapmed.ac.jp
Sponsor or person
Institute
Department of Urology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Sapporo Medical University School of Medicine
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
Sapporo Medical University School of Medicine
Address
S-1, W-16, Chuo-ku, Sapporo, Japan
Tel
011-611-2111
ji-rskk@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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 18 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
60
Results
Of the 60 patients, 39 completed the protocol. Regardless of age, the bladder outlet obstruction indices at 6, 24, and 60 months after surgery were significantly lower than before surgery (all, p<0.01). Although the BCI did not significantly change during 60 months for the entire group of 39 patients, it was significantly decreased at 60 months (85.6) after surgery compared to before surgery (102) in the elderly group (p=0.02). We prospectively evaluated detrusor contractility up to 5 years after TURP.
Results date posted
| 2024 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The total IPSS and total OABSS were significantly higher in the elderly group (n=40) than in the younger group (n=20). There were no significant differences in other variables, including the BCI between the two groups.
Participant flow
Of the 60 patients, 39 completed our protocol for 60 months.
Adverse events
Three patients (7.7%) received urological medications during follow-up. No patients were clinically diagnosed with urethral stricture, BNC or BPH recurrence requiring surgery.
Outcome measures
The BCI, as the primary endpoint, showed no significant change from preoperative values up to 60 months after surgery in the 39 patients as a whole. However, in the elderly group, the BCI was significantly decreased at 60 months (85.6) after surgery compared to before surgery (102, p=0.02), but no decreases were observed in the younger group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 09 | 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
| 2014 | Year | 10 | Month | 18 | Day |
Last modified on
| 2025 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017584
