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Diclofenac Suppository to Control Pain During Flexible Cystoscopy (DUF)

Primary Purpose

Pain, Hematuria, Lower Urinary Tract Symptoms

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Diclofenac
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Flexible Cystoscopy, Pain control, Diclofenac, Non steroidal anti inflammatory drug

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts 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.

Sites / Locations

  • Aga Khan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Gel only

Diclofenac and Gel

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 14, 2013
Last Updated
December 14, 2013
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT01812928
Brief Title
Diclofenac Suppository to Control Pain During Flexible Cystoscopy
Acronym
DUF
Official Title
Phase 2 Study of Diclofenac Suppository to Control Pain During Flexible Cystoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Hematuria, Lower Urinary Tract Symptoms
Keywords
Flexible Cystoscopy, Pain control, Diclofenac, Non steroidal anti inflammatory drug

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gel only
Arm Type
No Intervention
Arm Description
This group will be given only intraurethral gel during flexible cystoscopy.
Arm Title
Diclofenac and Gel
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Other Intervention Name(s)
Non steroidal anti-inflammatory drug
Primary Outcome Measure Information:
Title
difference in pain score between two groups
Description
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
Secondary Outcome Measure Information:
Title
Need of additional analgesia after the procedure
Description
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
Other Pre-specified Outcome Measures:
Title
adverse effect of diclofenac suppository
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mehwash nadeem, M.B.,B,S
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
15253827
Citation
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.
Results Reference
background
PubMed Identifier
8976223
Citation
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.
Results Reference
background
PubMed Identifier
11788018
Citation
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.
Results Reference
background
PubMed Identifier
19397430
Citation
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.
Results Reference
background
PubMed Identifier
19239453
Citation
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.
Results Reference
background
PubMed Identifier
18206920
Citation
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.
Results Reference
background
PubMed Identifier
19780869
Citation
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.
Results Reference
background
PubMed Identifier
9570000
Citation
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.
Results Reference
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Diclofenac Suppository to Control Pain During Flexible Cystoscopy

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