Diclofenac Suppository to Control Pain During Flexible Cystoscopy

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Pain, Hematuria, Lower Urinary Tract Symptoms

Intervention / Treatment
-----------------
* Drug: Diclofenac


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Gel only<br>This group will be given only intraurethral gel during flexible cystoscopy. | |
| Experimental: Diclofenac and Gel<br>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<br> <br> * 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Flexible Cystoscopy, Pain control, Diclofenac, Non steroidal anti inflammatory drug