UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038125 |
|---|---|
| Receipt number | 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 23:37:43 |
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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
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
diwasgnyawali@gmail.com
Sponsor or person
Institute
Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043452
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
