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comparing the effectiveness between 2 ureteral stents- 5Fr vs 6Fr

A prospective randomized controlled trial on comparison of 5 Fr and 6 Fr ureteral stents on stent-related symptoms following ureterorenoscopy - NIL

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/11/059605
Enrollment
106
Registered
2023-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N201- Calculus of ureter

Interventions

Intervention1: 5 FRENCH URETERIC STENT: URS or RIRS is to be performed under spinal or general anesthesia by using a semi-rigid or flexible ureteroscope. After lithotripsy, the same type of 5F or 6F u

Sponsors

Dr Nisanth Puliyath
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age >18 years 2. Patients undergoing unilateral semi-rigid URS or retrograde intrarenal surgery (RIRS) with planned ureteral stent insertion for urinary tract stones

Exclusion criteria

Exclusion criteria: Age 2. Pregnant patients 3. Breastfeeding 4. Involvement in bilateral procedures 5. concomitant use of confounding medications 6. acive urinary tract infection 7. comorbid urologic malignancy 8. comorbid urologic anatomical abnormalities and conditions, such as ureteral stricture

Design outcomes

Primary

MeasureTime frame
•To assess the stent-related symptoms as different domain scores, as recorded by the USSQs in patients undergoing ureteric stenting. •To compare the USSQ scores between the stent sizes 5 Fr and 6 Fr in different domains like general health, work performance, sexual function, and global quality of life scores recorded by the USSQs. Timepoint: Different domain scores, as recorded by the USSQs in patients undergoing ureteric stenting at TWO TIME POPINTS: After 1 week of stenting (with stent in-situ) and 2 weeks after stent removal

Secondary

MeasureTime frame
To analyze hydronephrosis, analgesics usage & post operative complications in stented patients. To compare the stone-free rates between 5 Fr & 6 Fr stent sizes. • To propose the ideal stent diameter to be used in patients after ureterorenoscopy Timepoint: 4 WEEKS

Countries

India

Contacts

Public ContactNisanth PULIYATH

GOVERNMENT MEDICAL COLLEGE, KOZHIKODE

whitestethescope@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026