Comparing body positions and ureteral sheaths for treating kidney stones
The Effect of Different Body Positions and Channel Sheaths on Retrograde Intrarenal Stone Surgery(RIRS) Treatment of Lower Pole Renal Stones: a Randomized Controlled Trial
This study is testing whether different body positions and types of ureteral sheaths can help adults with kidney stones get rid of them more effectively during a specific procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Guangzhou Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06438497 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of different body positions and ureteral access sheaths during retrograde flexible ureteroscopy (RIRS) for treating lower pole renal stones. The study aims to compare the stone-free rates achieved using a flexible negative pressure suction ureteral sheath versus a traditional ureteral access sheath, while also evaluating the impact of patient positioning (lateral vs. lithotomy). By conducting a prospective randomized controlled trial, the researchers hope to provide insights into optimizing treatment for patients with lower pole stones. The trial will include adult patients with specific inclusion criteria related to stone size and health status.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with lower pole renal stones measuring 10-20 mm in diameter and classified as ASA score I, II, or III.
Not a fit: Patients with ureteric strictures, urethral deformities, renal malformations, pregnancy, or multiple stones in different calyces may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the stone-free rates for patients undergoing treatment for lower pole renal stones.
How similar studies have performed: While there is a lack of relevant prospective randomized controlled studies specifically addressing this approach, the concept of optimizing body position and sheath type in RIRS is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * LPS with a diameter of 10-20 mm * American Society of Anesthesiologists(ASA) score Ⅰ,Ⅱ and Ⅲ * Adult patients Exclusion Criteria: * Ureteric stricture * Urethral deformity * Renal malformation, including horseshoe kidney, ectopic kidney and transplanted kidney * Pregnancy * Multiple stones in diferent calyces, including upper pole and middle pole
Where this trial is running
Guangzhou, Guangdong
- Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Guohua Zeng, Ph.D and M.D
- Email: gzgyzgh@vip.tom.com
- Phone: +8613802916676
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.