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OpenTrials
Completed

NCT Number: NCT03130907

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

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.

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Key information

Conditions

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BAMC

San Antonio, Texas, 78234, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placement of ureteral stent

Device

will randomize groups to either receive a postoperative ureteral stent or not.

Primary outcomes

  1. Postoperative complications

    Time frame: 30 days

    ED returns, Unplanned OR returns, admissions, UTIs

Secondary outcomes

  1. Subjective patient symptom scores

    Time frame: 6 weeks

    symptom questionnaires

Sponsors and collaborators

Lead sponsor

San Antonio Uniformed Services Health Education Consortium

Fed

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 27, 2017
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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