Tamsulosin Assisted Ureteral Access Sheath Insertion
Sponsor
Sengkang General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05197088
Collaborator
(none)
110
2
18.7
Study Details
Study Description
Brief Summary
Aim is to study if 1 week of pre operative tamsulosin would enable easier insertion of ureteral access sheath in primary retrograde intrarenal surgery for renal stone disease
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
110 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Medication Facilitated Ureteral Access Sheath Deployment During Ureteroscopy: the Impact of One Week of Pre-operative Tamsulosin
Anticipated Study Start Date
:
Jan 9, 2022
Anticipated Primary Completion Date
:
Mar 31, 2023
Anticipated Study Completion Date
:
Jul 31, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 week of tamsulosin 1 week of tamsulosin tablet 400mcg once a night |
Drug: Tamsulosin
1 week of tamsulosin
|
| No Intervention: no additional medication
|
Outcome Measures
Primary Outcome Measures
- successful insertion of ureteral access sheath to the upper ureter (above the level of SI joint on fluoroscopy) [during operation]
Secondary Outcome Measures
- grade of ureteric injury after ureteral access sheath removal [during operation]
- post operative complications [3 months]
- stone free rate [3 months]
- need for additional procedures [3 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- renal stone undergoing retrograde intrarenal surgery
Exclusion Criteria:
-
not on tamsulosin or other alpha blockers regularly
-
ureteral stricture
-
concurrent ureteric stone
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sengkang General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sundaram Palaniappan,
Dr,
Sengkang General Hospital
ClinicalTrials.gov Identifier:
NCT05197088
Other Study ID Numbers:
- 2019/2156
First Posted:
Jan 19, 2022
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: