Diclofenac Suppository to Control Pain During Flexible Cystoscopy (DUF)

Aga Khan University

Status and phase: Completed; Phase 2

Conditions: Lower Urinary Tract Symptoms; Hematuria; Pain

Treatments: Drug: Diclofenac

Study type: Interventional

Funder types: Other

Identifiers

NCT01812928

122010SUR

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Gel only

No Intervention group

Description:

This group will be given only intraurethral gel during flexible cystoscopy.

Diclofenac and Gel

Experimental group

Description:

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.

Treatment:

Drug: Diclofenac