To study whether anaesthetizing the deep urine passage in men decreases pain during cystoscopy and stent removal
Phase 3
- Conditions
- Health Condition 1: N209- Urinary calculus, unspecified
- Registration Number
- CTRI/2021/03/031761
- Lead Sponsor
- CMC Fluid research funding
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Adult males between 18-75 years where cystoscopic stent removal is indicated.
Exclusion Criteria
1.Age less than 18 years or more than 75 years.
2.Oral/injectable analgesic usage in last 24 hours.
3.Known or diagnosed urethral stricture.
4.Meatal or submeatal stenosis requiring dilation.
•Need for additional procedure like stent removal, fulguration or biopsy.
5.Known allergy/intolerance to lignocaine jelly.
6.Patient who cannot be positioned into lithotomy due to musculoskeletal diseases.
7.Neurological disease.
8.Patient on indwelling foley catheter.
9.Patient on bilateral DJ stents
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain score (patient reported) by Visual analog scale (0-10)Timepoint: 1.Following the application of the penile clamp, <br/ ><br>2.At the end of cystoscopy, and <br/ ><br>3.At 2 hours after cystoscopy (after voiding). <br/ ><br>
- Secondary Outcome Measures
Name Time Method Duration of procedure (in minutes) <br/ ><br>Timepoint: After cystoscopy procedure;Surgeonâ??s assessment of patient comfort/compliance during the cystoscopy. (0-10) <br/ ><br>Timepoint: After cystoscopy procedure