Diclofenac Suppository to Control Pain During Flexible Cystoscopy (DUF)

Phase 2 Study of Diclofenac Suppository to Control Pain During Flexible Cystoscopy

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.

Study Overview

• Status: Completed
• Conditions: Pain; Lower Urinary Tract Symptoms; Hematuria
• Intervention / Treatment: Drug: Diclofenac

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Aga Khan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Non steroidal anti-inflammatory drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in pain score between two groups	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.	five minutes after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need of additional analgesia after the procedure	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.	with in an hour after procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse effect of diclofenac suppository	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.	1 hour

Collaborators and Investigators

• Sponsor: Aga Khan University
• Investigators: Principal Investigator: mehwash nadeem, M.B.,B,S, Aga Khan University

Publications and helpful links

General Publications

• Goldfischer ER, Cromie WJ, Karrison TG, Naszkiewicz L, Gerber GS. Randomized, prospective, double-blind study of the effects on pain perception of lidocaine jelly versus plain lubricant during outpatient rigid cystoscopy. J Urol. 1997 Jan;157(1):90-4.
• Kobayashi T, Nishizawa K, Mitsumori K, Ogura K. Instillation of anesthetic gel is no longer necessary in the era of flexible cystoscopy: a crossover study. J Endourol. 2004 Jun;18(5):483-6. doi: 10.1089/0892779041271535.
• Herr HW, Schneider M. Immediate versus delayed outpatient flexible cystoscopy: final report of a randomized study. Can J Urol. 2001 Dec;8(6):1406-8.
• Tzortzis V, Gravas S, Melekos MM, de la Rosette JJ. Intraurethral lubricants: a critical literature review and recommendations. J Endourol. 2009 May;23(5):821-6. doi: 10.1089/end.2008.0650.
• Aaronson DS, Walsh TJ, Smith JF, Davies BJ, Hsieh MH, Konety BR. Meta-analysis: does lidocaine gel before flexible cystoscopy provide pain relief? BJU Int. 2009 Aug;104(4):506-9; discussion 509-10. doi: 10.1111/j.1464-410X.2009.08417.x. Epub 2009 Feb 23.
• Patel AR, Jones JS, Babineau D. Lidocaine 2% gel versus plain lubricating gel for pain reduction during flexible cystoscopy: a meta-analysis of prospective, randomized, controlled trials. J Urol. 2008 Mar;179(3):986-90. doi: 10.1016/j.juro.2007.10.065. Epub 2008 Jan 18.
• Komiya A, Endo T, Kobayashi M, Kim W, Araki K, Naya Y, Suzuki H, Tobe T, Ichikawa T, Fuse H. Oral analgesia by non-steroidal anti-inflammatory drug zaltoprofen to manage cystoscopy-related pain: a prospective study. Int J Urol. 2009 Nov;16(11):874-80. doi: 10.1111/j.1442-2042.2009.02384.x. Epub 2009 Sep 24.
• Idkaidek NM, Amidon GL, Smith DE, Najib NM, Hassan MM. Determination of the population pharmacokinetic parameters of sustained-release and enteric-coated oral formulations, and the suppository formulation of diclofenac sodium by simultaneous data fitting using NONMEM. Biopharm Drug Dispos. 1998 Apr;19(3):169-74. doi: 10.1002/(sici)1099-081x(199804)19:33.0.co;2-c.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: March 14, 2013
• First Submitted That Met QC Criteria: March 15, 2013
• First Posted (Estimate): March 18, 2013

Study Record Updates

• Last Update Posted (Estimate): December 17, 2013
• Last Update Submitted That Met QC Criteria: December 14, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Diclofenac; Pain control; Flexible Cystoscopy; Non steroidal anti inflammatory drug
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urological Manifestations; Hemorrhage; Urination Disorders; Lower Urinary Tract Symptoms; Hematuria; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antirheumatic Agents; Cyclooxygenase Inhibitors; Anti-Inflammatory Agents; Diclofenac; Anti-Inflammatory Agents, Non-Steroidal
• Other Study ID Numbers: 122010SUR