NCT01450566

Brief Summary

Ureteroscopy (URS) is minimally invasive procedure for management of renal stones. URS is often involves concomitant of an indwelling ureteral stents. Placements of these stents include pain, bladder irritability, infection, migration, encrustation and stones. Pain is one of most significant problem of ureteral stents. There are no satisfactory measures to deal with this problem. A novel approach to manage the pain is to load a drug onto ureteral stent and deliver the drug into the urinary tract at controlled release rate. Lidocaine has been proven to be effective for management of the pain associated with interstitial cystitis. This agent has the potential for management of post-URS pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 6, 2013

Status Verified

November 1, 2013

Enrollment Period

2.3 years

First QC Date

September 20, 2011

Last Update Submit

November 5, 2013

Conditions

Ureteral CalculiRenal Calculi

Keywords

ureteroscopy (URS)ureteral stent placementUreteral CalculiRenal Calculi

Outcome Measures

Primary Outcomes (1)

  • Pain as measured by the mean VAS pain score over the study period.

    Pain as measured by the mean VAS pain score over the study period. VAS pain, urinary frequency, pain mediation diary and ureteral stent symptoms assessed at different time points during the study. Efficacy will be determined by a 2 or more point mean difference in pain scores between the active treatment group and placebo group.

    7 days

Secondary Outcomes (1)

  • Establishment of safety of intraureteral administration of the alkalinized lidocaine solution

    7 days

Study Arms (2)

Lidocaine

EXPERIMENTAL

Use of lidocaine

Drug: Lidocaine

No lidocaine

PLACEBO COMPARATOR

No lidocaine/standard of care

Drug: Saline

Interventions

LidocaineDRUG

Use of lidocaine

Lidocaine
SalineDRUG

Saline

No lidocaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing URS for treatment of a urinary calculus who requires placement of ureteral stent on a string
  • Able to undergo a general anaesthetic
  • At least 18 years old
  • Willing and able to complete patient symptom questionnaires

You may not qualify if:

  • Solitary Kidney
  • Renal failure
  • Anatomic bladder or ureteral abnormality
  • Uncorrected coagulopathy
  • Previous cystectomy or urinary diversion
  • Neurogenic bladder
  • Interstitial cystitis
  • Transplanted kidney
  • Pregnancy
  • Requires an indwelling catheter
  • Recurrent urinary tract infections
  • Requires an indwelling stent
  • Pelvic kidney
  • Requires bilateral treatment/stents
  • Previous bladder or ureteral reconstructive surgery
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Applied Urological Research/Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

MeSH Terms

Conditions

Ureteral CalculiKidney Calculi

Interventions

LidocaineSodium Chloride

Condition Hierarchy (Ancestors)

UreterolithiasisUreteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNephrolithiasisKidney Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Darren Beiko, MD FRCSC

    Queen's University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvia Robb, RN, CCRP

CONTACT

(613) 548 7800robbs@kgh.kari.net

Joseph A Downey, MSc, CCRP

CONTACT

(613) 548-7832downeyj@queensu.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and Associate Professor

Study Record Dates

First Submitted

September 20, 2011

First Posted

October 12, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 6, 2013

Record last verified: 2013-11

Locations

CA(1)