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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000040682 |
Receipt No. | 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 |
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 |
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Condition | |||||
Condition | adrenal tumor | ||||
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Target sample size | 170 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
miyauchi@med.kagawa-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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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 |
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Last modified on |
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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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