UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040682
Receipt number R000046433
Scientific Title Change of lower urinary tract symptom related quality of life in patients with adrenal tumor after unilateral adrenalectomy
Date of disclosure of the study information 2020/06/08
Last modified on 2020/06/08 09:08:26

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Basic information

Public title

Change of lower urinary tract symptom related quality of life in patients with adrenal tumor after unilateral adrenalectomy

Acronym

lower urinary tract symptom related quality of life after unilateral adrenalectomy

Scientific Title

Change of lower urinary tract symptom related quality of life in patients with adrenal tumor after unilateral adrenalectomy

Scientific Title:Acronym

lower urinary tract symptom related quality of life after unilateral adrenalectomy

Region

Japan


Condition

Condition

adrenal tumor

Classification by specialty

Endocrinology and Metabolism Endocrine surgery Urology
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the lower urinary tract symptom related quality of life in patients with secreting or non-secreting adrenal tumor and to evaluate the changes due to surgical intervention.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

lower urinary tract symptom related quality of life after unilateral adrenalectomy

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing unilateral adrenalectomy due to diagnosis of secreting or non-secreting adrenal tumor

Key exclusion criteria

1)Patients with active urinary tract infection, urolithiasis, or interstitial cystitis
2)Patients with bladder tumor to be treated or previously treated
3)Patients with a history of prostatectomy or radiotherapy
4)Patients treated with medicine for lower urinary tract symptoms
5)Patients with serious complications such as cardiovascular disease, diabetes mellitus in poor control, liver disease, renal disease, immune system disease, lung disease or malignant tumor
6)Women in pregnancy or nursing, or women who wish to be pregnant during study participation
7)Patients judged to be inappropriate for this study by investigators

Target sample size

170


Research contact person

Name of lead principal investigator

1st name Yasuyuki
Middle name
Last name Miyauchi

Organization

Kagawa University Hospital

Division name

Department of Urology

Zip code

7610793

Address

1750-1 Ikenobe, Miki-cho. Kita-gun, Kagawa

TEL

087-891-2202

Email

miyauchi@med.kagawa-u.ac.jp


Public contact

Name of contact person

1st name Yasuyuki
Middle name
Last name Miyauchi

Organization

Kagawa University Hospital

Division name

Department of Urology

Zip code

7610793

Address

1750-1 Ikenobe, Miki-cho. Kita-gun, Kagawa

TEL

087-891-2202

Homepage URL


Email

miyauchi@med.kagawa-u.ac.jp


Sponsor or person

Institute

Kagawa University Hospital

Institute

Department

Personal name



Funding Source

Organization

Kagawa University Hospital

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

Clinical Research Support Center

Address

1750-1 Ikenobe, Miki-cho. Kita-gun, Kagawa

Tel

087-898-5111

Email

chiken@med.kagawa-u.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

香川大学医学部附属病院(香川県)


Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 08 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

106

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

Completed

Date of protocol fixation

2019 Year 09 Month 17 Day

Date of IRB

2019 Year 10 Month 08 Day

Anticipated trial start date

2019 Year 10 Month 10 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2020 Year 05 Month 31 Day


Other

Other related information

We prospectively recruited the patients who was diagnosed secreting or non-secreting adrenal tumors by an endocrine physician and who underwent unilateral adrenalectomy at a single university-affiliated hospital (Kagawa University Hospital, in Kagawa, Japan) between January 2001 and December 2019. All patients were screened at the first consultation using clinical interviews that obtained information regarding medical history, current medication use and LUTS related QOL evaluated using the following two questionnaires: the International Prostate Symptom Score-QOL (IPSS-QOL) questionnaire and OAB Symptom Score (OABSS) questionnaire. Between October 2019 and March 2020, the patients received the same questionnaires by postal mail and sent back questionnaires and further information of current medication about not only antihypertensive agent or diuretics but also urination-related agent for LUTS.


Management information

Registered date

2020 Year 06 Month 08 Day

Last modified on

2020 Year 06 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046433


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name