UMIN-CTR Clinical Trial

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
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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
Institute	Kagawa University Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046433

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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