The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy

NCT03831321 | Unknown Phase 4 FDA Drug

• 1 other identifier: MedeniyetUro
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The study was designed as a prospective, randomized double-blind placebo controlled trial. According to power analysis in regards of previous studies in the literature with diclofenac sodium, using a total of 144 patients are needed for Power: 80% and Efficacy: 0.05. diclofenac (20 mg) and placebo drugs to be used in the study will be numbered 1 and 2 individually. Patient randomization was performed using random.org in 144 patients. On the day of cystoscopy, the patient randomized according to inclusion criteria will be given a medication package corresponding to the number given in randomization. It will not be known by the staff and cystoscopy will be performed by the physician who does not know which package is an effective drug. Parameters:

1. 1.Visual Pain Score during cystoscopy
2. 2.Cystoscopy comfort - a questionnaire to be filled by the doctor
3. 3.Excellent
4. 4.Very good
5. 5.Good
6. 6.Bad
7. 7.Too bad
8. 8.Cystoscopy: Is it efficient? Not efficient? - Will be answered by the doctor.
9. 9.1st hour Visual Analog Pain Scale inquiry, dysuria, frequency
10. 10.24th Hour dysuria, Frequency,

Conditions

Bladder Cancer; Benign Prostate Hyperplasia; Hematuria; Pain; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• Assesment for operational pain

  All the patients will be assessed with Visual pain scale during cystoscopy procedure Scale is a well know pain assesment form which is ranged between 0 to 10 points and higher scores mean worse pain.

  1 minute

Secondary Outcomes (2)

• Assesment of doctors comfort for the procedure(cystoscopy)

  1 minute

• Assesment of qualification of cystoscopy

  1 minute

Study Arms (2)

Diclofenac group

ACTIVE COMPARATOR

The group who are 50 mg Diclofenac Sodium and lubricant gel administered one hour before cystoscopy and local

Drug: Diclofenac Sodium; Device: Cystoscopy; Drug: Lubricant Gel

Placebo

PLACEBO COMPARATOR

The group who are not administered 50 mg Diclofenac Sodium before cystoscopy and administered lubricant gel just before local cystoscopy

Device: Cystoscopy; Drug: Lubricant Gel

Interventions

Diclofenac Sodium DRUG

50 mg of diclofenac sodium will be administered to intervention group one hour before cystoscopy and lubricant gel with lidocaine will be administered to all patients just before cystoscopy.

Diclofenac group

Cystoscopy DEVICE

Diagnostic cystoscopy

Diclofenac group; Placebo

Lubricant Gel DRUG

To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort)

Diclofenac group; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accepted to participate
• years old
• Men

You may not qualify if:

• Previous peptic ulcer
• Gastro intestinal bleeding in advance
• Renal failure
• Liver failure
• Patients who underwent cystoscopy for taking or inserting Double J stents 6 - Drug allergies
• Patients under 18 8- Patients receiving antiaggregant and antiplatelet therapy 9- Patients who do not agree to participate in the study

Sponsors & Collaborators

• Taha Uçar: lead

Study Sites (1)

Medeniyet University

Istanbul, Outside U.S./Canada, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Prostatic Hyperplasia; Hematuria; Pain; Lower Urinary Tract Symptoms

Interventions

Diclofenac; Cystoscopy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urination Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Urological Manifestations

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Asıf Yıldırım

  Medeniyet University

  STUDY DIRECTOR

Central Study Contacts

Taha Uçar

CONTACT

05353044736; ucartaha@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double blind placebo controlled
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: February 5, 2019
• Study Start: December 11, 2018
• Primary Completion: April 22, 2019
• Study Completion: May 22, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

TU (1)