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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035446
Receipt No. R000040385
Scientific Title Standardization for reliable uroflowmetry testing
Date of disclosure of the study information 2019/01/21
Last modified on 2019/07/08

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Basic information
Public title Standardization for reliable uroflowmetry testing
Acronym Standardization for reliable uroflowmetry testing
Scientific Title Standardization for reliable uroflowmetry testing
Scientific Title:Acronym Standardization for reliable uroflowmetry testing
Region
Europe

Condition
Condition Prospective
Classification by specialty
Urology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To assess the adequate preparation before good uroflowmetry testing (the sufficient amount of hydration)
2) To expose the proportion of suboptimal uroflowmetry results in daily practice
3) To asses the uroflowmetry results of individuals (reproducibility)
Basic objectives2 Others
Basic objectives -Others To study the proper preparation of a diagnostic test
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To attain a voided volume over 150 ml in a uroflowmetry test after drinking 1500 ml of water in one hour.
Key secondary outcomes -Promoting premedicated uroflowmetry testing as suboptimal test results are likely othervise
-Assessing whether the suboptimal uroflowmetry results is patient related or hydration related

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 4
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Control group's uroflowmetry after drinking 1500 ml water
Interventions/Control_2 Control group's uroflowmetry when the volunteer has full blader
Interventions/Control_3 Benign prostatic hyperplasia patient' group uroflowmetry after drinking 1500 ml water
Interventions/Control_4 Benign prostatic hyperplasia patient' group uroflowmetry when the patient has full blader
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria - Having benign prostatic hyperplasia in patient group
- Healty volunteers whom have no lower urinary tract symptoms
- Participants able to void into uroflowmetry container spontainously
- Participants over 30 years old
Key exclusion criteria - patients suffering neurological disorders
- patients suffering over-active bladder
- patients with urinary incontinence
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Erman
Middle name
Last name Ceyhan
Organization Idil State Hospital
Division name Urology Clinic
Zip code 73300
Address Asagi Mah. Hastane Caddesi Idil Devlet Hastanesi Uroloji Poliklinigi Idil/Sirnak
TEL 00905355873688
Email erman_ceyhan@yahoo.com

Public contact
Name of contact person
1st name Erman
Middle name
Last name Ceyhan
Organization Idil State Hospital
Division name Urology Clinic
Zip code 73300
Address Asagi Mah. Hastane Caddesi Idil Devlet Hastanesi Uroloji Poliklinigi Idil/Sirnak
TEL 00905355873688
Homepage URL https://idildh.saglik.gov.tr/
Email erman_ceyhan@yahoo.com

Sponsor
Institute Erman Ceyhan, M.D.
Idil State Hospital
Institute
Department

Funding Source
Organization Erman Ceyhan, M.D.
Idil State Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Turkish

Other related organizations
Co-sponsor Mehmet Kazim Asutay, M.D.
Name of secondary funder(s) Mehmet Kazim Asutay, M.D.

IRB Contact (For public release)
Organization Harran Univercity Faculty of Medicine Ethical Committee
Address Osmanbey Kampusu Mardin Yolu 20. Km 63300 / Sanliurfa
Tel 00904143182278
Email tip@harran.edu.tr

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 Idil State Hospital (Sirnak, Turkey), Sanliurfa Training and Research Hospital (Sanliurfa, Turkey)

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 21 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 74
Results
Regardless of their groups (BPH or controls), when premedicated with water  subjects have been able to perform more reliable UF tests than tests they performed without the premedication (Table 2). The analysis within each group also revealed favorable result for premedicated tests. In the BPH group the rate of reliable UF tests was higher in premedicated group (p=0.021). Smilarly in the control group, UF test with premedication showed higher rate of reliable results (p<0.001).


Results date posted
2019 Year 07 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Study is conducted in two arms
Participant flow
40 BPH patients

34 healthy volunteers
Adverse events
No adverse events
Outcome measures
Increase in voided volumes
Ratio of reliable test results
Plan to share IPD N/A
IPD sharing Plan description N/A

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 07 Month 25 Day
Date of IRB
2018 Year 09 Month 06 Day
Anticipated trial start date
2019 Year 01 Month 04 Day
Last follow-up date
2019 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 05 Day
Last modified on
2019 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040385

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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