A Phase 2 interventional study of Diclofenac in Pain, Hematuria and Lower Urinary Tract Symptoms, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-17.
Sponsored by Aga Khan University · Phase 2, Interventional, and Treatment
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.
58 studies on the registry are indexed under Hematuria; 18 are open to participants now.
This study's enrollment of 60 is below the median of 86 across 32 interventional studies indexed under Hematuria.
Browse Hematuria studies →Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.
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Exclusion criteria:
This group will be given only intraurethral gel during flexible cystoscopy.
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
Also known as: Non steroidal anti-inflammatory drug
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.
Time frame: five minutes after procedure
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.
Time frame: with in an hour after procedure
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.
Time frame: 1 hour
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Aga Khan University