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Trial record 2 of 20 for:    Stents | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

The Role of Ureteral Stenting Following Uncomplicated Ureteroscopy for Ureteral and Renal Stones: A Randomized, Controlled Trial

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ClinicalTrials.gov Identifier: NCT03130907
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Amy Reed, San Antonio Uniformed Services Health Education Consortium

Brief Summary:
It is well established that uncomplicated distal ureteroscopy can be safely performed without leaving a ureteral stent. However, many urologists continue to leave ureteral stents following uncomplicated ureteroscopy, regardless of stone location, due to concerns for post-operative complications, patient symptoms and to reduce unplanned medical visits. There is a paucity of data regarding the utility of stent placement for proximal ureteral or renal stones following ureteroscopy. We have designed a prospective, randomized controlled trial to evaluate the role of ureteral stent placement following ureteroscopy and pyeloscopy in proximal and renal stones.

Condition or disease Intervention/treatment Phase
Ureteroscopy Device: Placement of ureteral stent Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Role of Ureteral Stenting Following Uncomplicated Ureteroscopy for Ureteral and Renal Stones: A Randomized, Controlled Trial
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Active Comparator: Stent Device: Placement of ureteral stent
will randomize groups to either receive a postoperative ureteral stent or not.

Experimental: No stent Device: Placement of ureteral stent
will randomize groups to either receive a postoperative ureteral stent or not.




Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 days ]
    ED returns, Unplanned OR returns, admissions, UTIs


Secondary Outcome Measures :
  1. Subjective patient symptom scores [ Time Frame: 6 weeks ]
    symptom questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients age ranges 18-89 with solitary or multiple proximal ureteral or renal stones 1.5cm or smaller measured in the longest dimension on preoperative imaging (CT or xray). Proximal ureteral stones are those proximal to the pelvic brim in the ureter.

Exclusion Criteria:

  • Stone size greater than 1.5 cm on preoperative imaging
  • Pregnancy
  • Stent placement prior to ureteroscopy ("pre-stented patients")
  • Patients with solitary kidney

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130907


Contacts
Contact: Amy Reed 210-916-4126 amy.m.reed18.mil@mail.mil
Contact: Christopher Allam christopher.l.allam.mil@mail.mil

Locations
United States, Texas
BAMC Recruiting
San Antonio, Texas, United States, 78234
Contact: Christopher L Allam, DO    210-916-0716      
Sponsors and Collaborators
San Antonio Uniformed Services Health Education Consortium

Responsible Party: Amy Reed, Principal Investigator, San Antonio Uniformed Services Health Education Consortium
ClinicalTrials.gov Identifier: NCT03130907     History of Changes
Other Study ID Numbers: C.2017.070
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical