UMIN-CTR Clinical Trial

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