UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035446
Receipt number R000040385
Scientific Title Standardization for reliable uroflowmetry testing
Date of disclosure of the study information 2019/01/21
Last modified on 2019/07/08 03:37:39

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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 or person

Institute

Erman Ceyhan, M.D.
Idil State Hospital

Institute

Department

Personal name



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

Value
https://center6.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