Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?

NCT03713411 | Completed

• 1 other identifier: MAR.UAD.004
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

After semirigid or flexible ureteroscopy operations where a DJ stent was placed, there is diversity in practice of placing a urethral catheter. The presence of vesico-ureteral reflux due to DJ stents has been proven to exist and can cause flank pain and UTI due to retrograde urine flow. The main purpose to place a urethral catheter is to keep a low-pressure bladder in order to prevent reflux alongside the DJ stent. However, this practice doesn't have an evidence-based support on the literature and some surgeons also advice patients to void frequently in the early postoperative period to avoid these aforementioned complications. The purpose of this study is to compare the 2 different approaches after ureteroscopy and DJ stent placement by evaluating the patient-reported outcomes along with laboratory tests.

Conditions

Complications; Urethral Catheter; Ureteral Catheterization; Ureteroscopy; Lower Urinary Tract Symptoms; Flank Pain

Outcome Measures

Primary Outcomes (1)

• ureteric stent symptom questionnaire (USSQ) score

  evaluation of flank pain

  at the 24th hour of the operation

Secondary Outcomes (2)

• white blood cell count on complete blood count

  at the 24th hour of the operation

• c-reactive protein (CRP) levels

  at the 24th hour of the operation

Study Arms (2)

No-catheter

NO INTERVENTION

after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones, patients in whom a urethral catheter wasn't placed

Catheter

ACTIVE COMPARATOR

urethral catheter placement after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones

Procedure: urethral catheter placement

Interventions

urethral catheter placement PROCEDURE

urethral catheter placement to provide low-pressure urinary bladder by providing active drainage of the bladder

Catheter

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients
• Patients with indications for semirigid or flexible ureteroscopy and DJ stent placement for unilateral ureteral and/or kidney stones according to European Association of Urology Urolithiasis Guidelines

You may not qualify if:

• none

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Hospital

Istanbul, 34890, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Flank Pain

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Tarik Emre Sener, MD

  Marmara University Hospital, Department of Urology

  PRINCIPAL INVESTIGATOR

• Yiloren Tanidir

  Marmara University Hospital, Department of Urology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 19, 2018
• Study Start: April 1, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: January 29, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)