Diclofenac Suppository to Control Pain During Flexible Cystoscopy (DUF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr.Mehwash Nadeem, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01812928
First received: March 14, 2013
Last updated: December 14, 2013
Last verified: December 2013
  Purpose

Flexible cystoscopy has diagnostic as well as therapeutic role in many patients presenting in urology clinic with lower urinary tract symptoms (frequency, nocturia etc) and hematuria (blood in urine).

Pain associated with cystoscopy varies from patient to patient, majority requires local anesthesia or lubricant solution only. During flexible cystoscopy, lubrication, use of topical anesthesia and duration of cystoscopy are recognized as important factors contributing in severity of pain of which use of intraurethral gel left to individual preference. Various studies are available reporting the pain perception with use of various intraurethral gels. Even the highest level of evidence is unable to resolve the query.

With this study the investigators hypothesize that pain perception (recorded in form of pain score) during flexible cystoscopy can be reduced with use of per operative diclofenac(Non Steroidal Anti Inflammatory Drug)suppository in comparison to plain gel alone.

With better control of pain the investigators aim to increase patient comfort and compliance which will increase the patient satisfaction rate and early return to work.


Condition Intervention Phase
Pain
Hematuria
Lower Urinary Tract Symptoms
Drug: Diclofenac
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Diclofenac Suppository to Control Pain During Flexible Cystoscopy

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • difference in pain score between two groups [ Time Frame: five minutes after procedure ] [ Designated as safety issue: No ]
    Patient under goes the procedure and with in the operating room the outcome assessor(who will be blinded to randomization) will record the pain score.


Secondary Outcome Measures:
  • Need of additional analgesia after the procedure [ Time Frame: with in an hour after procedure ] [ Designated as safety issue: No ]
    Patient will be assessed for pain during the stay in recovery that usually last for an hour. If there will be need of additional analgesia (if patient reports pain score of more than 7 on visual analogue scale)the type of analgesia, dose and frequency will be noticed.


Other Outcome Measures:
  • adverse effect of diclofenac suppository [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Diclofenac is safe according to the available literature however minority of patients may have skin itching or difficulty in breathing. Post procedure patient will also be observed for any side effect of diclofenac suppository (if received preoperatively.


Enrollment: 60
Study Start Date: March 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Gel only
This group will be given only intraurethral gel during flexible cystoscopy.
Experimental: Diclofenac and Gel
This group will also receive intraurethral gel during cystoscopy but additionally diclofenac suppository will be given per rectally one hour before procedure as preemptive analgesia.
Drug: Diclofenac
Other Name: Non steroidal anti-inflammatory drug

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All male patients aged 18 and above
  • Visiting for evaluation of Haematuria or
  • Lower urinary tract symptoms (which include poor steam of urine,intermittency, hesitancy, incomplete voiding of urine, increase urgency, increase frequency, nocturia and urge incontinence)
  • For removal of double J ureteral stent will be included in the study.

Exclusion criteria:

  • Patients with clinical evidence of urethral stricture and/or prostatitis,
  • Patients in which biopsy will be taken,
  • those having psychiatric illness,
  • Asthmatics
  • Kidney, liver disease
  • Those allergic to NSAIDs (non-steroidal anti-inflammatory drugs)
  • Those who refuse to participate,
  • Having history of chronic analgesia use or
  • Having language barrier will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812928

Locations
Pakistan
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
Principal Investigator: mehwash nadeem, M.B.,B,S Aga Khan University Hospital
  More Information

Publications:

Responsible Party: Dr.Mehwash Nadeem, Resident, Aga Khan University
ClinicalTrials.gov Identifier: NCT01812928     History of Changes
Other Study ID Numbers: 122010SUR
Study First Received: March 14, 2013
Last Updated: December 14, 2013
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
Flexible Cystoscopy
Pain control
Diclofenac
Non steroidal anti inflammatory drug

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Signs and Symptoms
Urological Manifestations
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Diclofenac
Analgesics
Analgesics, Non-Narcotic
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014