The Effect of Ureteric Stent Tethers on Patient Symptoms and Urinary Infection

NCT01812772 | Terminated

• 1 other identifier: 10-370
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

RESEARCH QUESTION Do ureteric stents with tethers, left in-situ for 1-2 weeks, increase the rate of stent bacterial colonization, urinary bacterial colonization and stent related lower urinary tract symptoms compared to stents without tethers? HYPOTHESIS We hypothesize that ureteral double-J stents with tethers increase the rate of stent bacterial colonization, but do not increase the rate of urinary bacterial colonization or stent related lower urinary tract symptoms compared to stents without tethers when left in-situ for 1-2 weeks.

Conditions

Kidney Stone

Keywords

urinary stents; ureteroscopy

Outcome Measures

Primary Outcomes (1)

• The difference in stent related lower urinary tract symptoms based on mean scores from the Ureteral Stent Symptoms questionnaires

  The Ureteral Stent Symptoms Questionnaires will be completed before the procedure, 1 week after the procedure and 1 month after the stent was removed (5 weeks post procedure)

Secondary Outcomes (1)

• the rate of stent bacterial colonization

  1 week post procedure

Study Arms (2)

Double J-stent with a long tether

EXPERIMENTAL

Following ureteroscopy patients will have placed a double J-stent with a long tether.

Device: Double J-stent with a long tether

Double J-stent without a long tether

ACTIVE COMPARATOR

Following ureteroscopy patients will have a double J-stent placed without a long tether

Device: Double J-stent without a long tether

Interventions

Double J-stent with a long tether DEVICE

Patients will receive a double-J stent placement with a long tether following ureteroscopy.

Double J-stent with a long tether

Double J-stent without a long tether DEVICE

Patients will receive a double-J stent placement without a long tether following ureteroscopy.

Double J-stent without a long tether

Eligibility Criteria

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

You may qualify if:

• Age over 18 years
• First presentation for ureteroscopy for this particular stone
• Planned insertion of a double J-stent
• Follow-up conducted at St. Michael's Hospital

You may not qualify if:

• Age \<18years
• Preexisting stent in place
• Bilateral ureteric stents to be inserted
• Patients with congenital kidney anomalies (horseshoe kidney, ectopic kidney, etc.)
• Patients with an indwelling foley catheter
• Patients with neurogenic bladder, chronic prostatitis, painful bladder syndrome or interstitial cystitis
• Patients with a urinary diversion (ileal conduit, ileal neobladder)
• Patient currently taking an α-blocker (alfuzosin, terazosin,tamsulosin, prazosin)
• Active urinary tract infection or positive screening urine culture at preadmission
• Pregnancy
• Patients who will not be returning to St. Michael's Hospital for follow-up

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• R. John D Honey, MD FRCSC

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Kenneth T Pace, MD FRCSC

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

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: March 14, 2013
• First Posted: March 18, 2013
• Study Start: March 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 21, 2015

Record last verified: 2014-02

Locations

CA (1)