UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057485 |
|---|---|
| Receipt number | R000065584 |
| Scientific Title | Does patient-controlled irrigation reduce pain or anxiety in male outpatients undergoing flexible cystoscopy? |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/04/01 20:02:39 |
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Basic information
Public title
Does patient-controlled irrigation reduce pain or anxiety in male outpatients undergoing flexible cystoscopy?
Acronym
Cystoscopy trial
Scientific Title
Does patient-controlled irrigation reduce pain or anxiety in male outpatients undergoing flexible cystoscopy?
Scientific Title:Acronym
Cystoscopy trial
Region
| Japan |
Condition
Condition
male patients undergoing cystoscopy
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this trial is to assess whether patient-controlled irrigation reduce anxiety and pain in male patients undergoing flexible cystoscopy in an outpatient setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the impact of patient-controlled irrigation on pain measured by Visual Analogue Scale between pre- and post-cystoscopy
Key secondary outcomes
To assess the impact of patient-controlled irrigation on anxiety (State-Trait Anxiety Inventory), satisfaction (Visual Analogue Scale) and vital sign between pre- and post-cystoscopy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention group: The squeezing bag was connected to the cystoscopy.
Interventions/Control_2
Sham group: The squeezing bag was not connected to the cystoscopy. Cystoscopy is performed under drip irrigation.
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
Inclusion criteria
(1) Patients undergoing cystoscopy for diagnostic purposes.
(2) Male patients aged 18 years or older.
(3) Patients who have provided informed consent for participation in the study.
Key exclusion criteria
Exclusion
(1) Patients who do not speak Japanese.
(2) Patients with active, untreated anxiety disorders.
(3) Patients with anatomical urinary tract abnormalities.
(4) Patients with allergy to lidocaine.
(5) Patients with neuromuscular disorders causing muscle weakness.
(6) Any other cases deemed inappropriate 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
Kushiro red cross hospital
Division name
Department of urology
Zip code
085-8512
Address
21-14, Shinei-Cho, Kushiro, Hokkaido 085-8512, Japan
TEL
+81-154-22-7171
a06m100@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Wanifuchi |
Organization
Kushiro red cross hospital
Division name
Department of urology
Zip code
085-8512
Address
21-14, Shinei-Cho, Kushiro, Hokkaido 085-8512, Japan
TEL
+81-154-22-7171
Homepage URL
a06m100@yahoo.co.jp
Sponsor or person
Institute
Kushiro red cross hospital
Institute
Department
Personal name
Atsushi Wanifuchi
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
Kushiro red cross hospital
Address
21-14, Shinei-Cho, Kushiro, Hokkaido 085-8512, Japan
Tel
+81-154-22-7171
nakagoshi@kushiro.jrc.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
| 2025 | 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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065584
