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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038125
Receipt No. R000043452
Scientific Title Efficacy of Tamsulosin plus Tadalafil versus Tamsulosin as medical expulsive therapy for lower ureteric stones: A randomized controlled trial
Date of disclosure of the study information 2019/10/01
Last modified on 2019/09/26

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Basic information
Public title Efficacy of Tamsulosin plus Tadalafil versus Tamsulosin as medical expulsive therapy for lower ureteric stones: A randomized controlled trial
Acronym Tamsulosin plus Tadalafil study
Scientific Title Efficacy of Tamsulosin plus Tadalafil versus Tamsulosin as medical expulsive therapy for lower ureteric stones: A randomized controlled trial
Scientific Title:Acronym Tamsulosin plus Tadalafil vs Tamsulosin as Medical expulsive Therapy
Region
Asia(except Japan)

Condition
Condition Study Completed
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of Tamsulosin and Tadalafil with Tamsulosin in patients with distal ureteric calculi
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Stone Passed or not
Key secondary outcomes stone passage duration,
analgesics requirement
number of colics and emergency room visits

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tamsulosin o.4mg at bed time plus Tadalafil 10 mg once daily up to 3 weeks of duration
Interventions/Control_2 Tamsulosin 0.4 mg at bed time once daily up to 3 weeks of duration
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
16 years-old <
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria All patients visiting TUTH with distal ureteric stones less than 1cm

Key exclusion criteria Presence of multiple ureteric stones,
Radiolucent stones,
Urinary tract infection,
Pregnancy,
Pediatric population,
Patients with a history of ureteral surgery or previous endoscopic procedures and
Patient requiring emergency intervention
Target sample size 176

Research contact person
Name of lead principal investigator
1st name Diwas
Middle name
Last name Gnyawali
Organization Institute of Medicine, Tribhuvan University Teaching Hospital,
Division name Department of Urology and Kidney Transplant Surgery
Zip code 44608
Address Maharajgung, Kathmandu
TEL +9779851159214
Email diwasgnyawali@gmail.com

Public contact
Name of contact person
1st name Diwas
Middle name
Last name Gnyawali
Organization Tribhuvan University Teaching Hospital
Division name Department of Urology and Kidney Transplant Surgery
Zip code N/A
Address Maharajgung
TEL +9779851159214
Homepage URL
Email diwasgnyawali@gmail.com

Sponsor
Institute Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital
Institute
Department

Funding Source
Organization Self Funding
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 Institute of Medicine
Address Maharajgung, Kathmandu
Tel 0097714413187
Email irc@iom.edu.np

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

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 01 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 176
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 02 Month 08 Day
Date of IRB
2019 Year 02 Month 24 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2019 Year 09 Month 14 Day
Date of closure to data entry
2019 Year 09 Month 20 Day
Date trial data considered complete
2019 Year 09 Month 20 Day
Date analysis concluded
2019 Year 09 Month 24 Day

Other
Other related information

Management information
Registered date
2019 Year 09 Month 26 Day
Last modified on
2019 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043452

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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