Effect of Double J Stent on Outcomes of Extracorporeal Shock Wave Lithotripsy

NCT03636516 | Completed

• 1 other identifier: 123456789
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Many studies showed that stone-free rates (SFRs) after extracorporeal shock wave lithotripsy (SWL) might be related to both the patient (body mass index; BMI, skin-to-stone distance; SSD), and stone related factors (location, stone size, and stone density). However, the possible effect of pre-stenting on success as well as complication rates after SWL has not been evaluated in detail to date. Taking this fact into account, the effect of pre-stenting on the outcomes of SWL treatment in renal stones must be evaluated in the absence of possible effects induced by the patient and stone-related factors. Aim: To evaluate the effect of double J (JJ) stents on SWL treatment of moderate sized (15-25-mm) renal pelvic stones. Study design: Randomized prospective study Methods: Between January 2016 and December 2017, a total of 152 adult patients who were planned to undergo SWL for a single radiopaque renal pelvic stone were included in the study. Patients with solitary kidney, congenital abnormality, skeletal tract abnormalities, previous urinary system surgery, hydronephrosis (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded. The remaining 114 patients were randomly divided into two groups; nonstented and stented. Twenty-two patients whose stone could not be fragmented despite 3 consecutive sessions were also excluded from the study. A total of 92 patients (54 non-stented and 38 stented) were included in the final analysis.

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (1)

• Number of patients, who have JJ stent or not, with successful SWL treatment.

  Number of patients, who have JJ stent or not, with successful SWL treatment which assessed after 3 months following the last SWL session.

  15 weeks

Study Arms (2)

jj stent yes

ACTIVE COMPARATOR

Device: SWL

jj stent no

ACTIVE COMPARATOR

Device: SWL

Interventions

SWL DEVICE

extracorporeal shockwave lithotripsy apply

jj stent no; jj stent yes

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with solitary kidneys, congenital abnormalities, skeletal system abnormalities, previous urinary system surgery, HN (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded from the study.

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 17, 2018
• Study Start: January 1, 2016
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share