NCT02598102

Brief Summary

Double J (DJ) stents are placed following upper urinary tract surgeries. DJ stents are usually removed under local anesthesia using rigid cystoscope. Patients experience a lot of pain during this procedure and also continue to have discomfort during voiding for few days. The use of lignocaine jelly during this procedure is not very effective. Use of diclofenac suppository during flexible cystoscopy has been proven to be effective. This study was done to assess the effect of oral diclofenac in pain relief in patients undergoing DJ stent removal by rigid cystoscopy when compared to placebo and to assess its safety in these patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

November 4, 2015

Last Update Submit

August 27, 2018

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain during stent removal, first void and 24 hours after procedure

    Intraoperative upto 24 hours postoperative

Secondary Outcomes (1)

  • Adverse reactions

    24 hours

Study Arms (2)

Diclofenac sodium

EXPERIMENTAL

Oral diclofenac 75 mg one hour prior to stent removal

Drug: Diclofenac sodium

Placebo

PLACEBO COMPARATOR

Placebo one hour prior to stent removal

Drug: Placebo

Interventions

Diclofenac sodiumDRUG

Diclofenac for pain relief

Also known as: Voveran
Diclofenac sodium
PlaceboDRUG

Placebo for comparison

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All consecutive consenting male patients aged more than 18 years, undergoing DJ stent removal under local anesthesia (2% Lignocaine jelly) during the study period will be included.

You may not qualify if:

  • Patients unable to understand visual analogue pain score
  • Age \< 18 years
  • Presence of Lower Urinary Tract Symptoms prior to surgery
  • Presence of prostatitis or urethral stricture during cystoscopy
  • Patients with renal failure (Serum creatinine \> 1.3 mg/dl)
  • Patients on concomitant nephrotoxic drugs
  • Patients with history of peptic ulcer or upper gastrointestinal bleed or upper abdominal surgeries
  • Loss to follow up at 24 hours following DJ stent removal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nephro Urology

Bangalore, Karnataka, 560002, India

Location

Related Publications (2)

  • Chen YT, Hsiao PJ, Wong WY, Wang CC, Yang SS, Hsieh CH. Randomized double-blind comparison of lidocaine gel and plain lubricating gel in relieving pain during flexible cystoscopy. J Endourol. 2005 Mar;19(2):163-6. doi: 10.1089/end.2005.19.163.

    PMID: 15798411RESULT

  • Karthikeyan VS, Keshavamurthy R, Mallya A, Chikka Moga Siddaiah M, Kumar S, Chandrashekar CR. Efficacy of preprocedural diclofenac in men undergoing double J stent removal under local anesthesia: A double-blind, randomized control trial. Indian J Urol. 2017 Jan-Mar;33(1):53-57. doi: 10.4103/0970-1591.194783.

    PMID: 28197031DERIVED

MeSH Terms

Conditions

Pain

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • VS Karthikeyan

    Postgraduate in Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MCh Urology Postgraduate in Urology

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 5, 2015

Study Start

April 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations

IN(1)