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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01812772
Recruitment Status : Terminated (Low enrollment)
First Posted : March 18, 2013
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Unity Health Toronto

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.


Condition or disease Intervention/treatment Phase
Kidney Stone Device: Double J-stent with a long tether Device: Double J-stent without a long tether Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Ureteric Stent Tethers on Patient Symptoms, Stent Bacterial Colonization and Urinary Tract Infection
Study Start Date : March 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

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Arm Intervention/treatment
Experimental: Double J-stent with a long tether
Following ureteroscopy patients will have placed a double J-stent with a long tether.
Device: Double J-stent with a long tether
Patients will receive a double-J stent placement with a long tether following ureteroscopy.

Active Comparator: Double J-stent without a long tether
Following ureteroscopy patients will have a double J-stent placed without a long tether
Device: Double J-stent without a long tether
Patients will receive a double-J stent placement without a long tether following ureteroscopy.




Primary Outcome Measures :
  1. The difference in stent related lower urinary tract symptoms based on mean scores from the Ureteral Stent Symptoms questionnaires [ Time Frame: 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 Outcome Measures :
  1. the rate of stent bacterial colonization [ Time Frame: 1 week post procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT01812772


Locations
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Canada, Ontario
St. Michael Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
Unity Health Toronto
Investigators
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Principal Investigator: R. John D Honey, MD FRCSC Unity Health Toronto
Principal Investigator: Kenneth T Pace, MD FRCSC Unity Health Toronto
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT01812772    
Other Study ID Numbers: 10-370
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: February 2014
Keywords provided by Unity Health Toronto:
urinary stents
ureteroscopy
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical