The Impact of Age and Sex on Anticipated and Experienced Pain in First-Time Outpatient Flexible Cystoscopy

NCT07375641 | Not Yet Recruiting

• 1 other identifier: SBU-URO-AG-03
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Cystoscopy is a procedure frequently performed in daily urological practice for the diagnosis of various urological conditions, including bladder tumors, benign prostatic hyperplasia, recurrent cystitis, and urethral strictures. Cystoscopy can be performed either in the operating room under sedation, spinal anesthesia, or general anesthesia, or in the outpatient setting under local anesthesia. Performing cystoscopy under outpatient conditions for patients requiring the procedure for follow-up and treatment indications is important in terms of reducing the workload of operating rooms. Although cystoscopy is generally well tolerated under local anesthesia in the outpatient setting, it may cause pain and anxiety in some patients, even when a flexible cystoscope is used. This may lead to adverse outcomes, particularly in patients with bladder tumors, due to loss to follow-up. Despite the use of analgesic methods such as lidocaine-based lubricants to reduce pain and anxiety before cystoscopy, an optimal solution has not yet been achieved. Moreover, some studies have reported that the level of pain experienced during cystoscopy increases with advancing age. In male patients, several studies have demonstrated that the most painful moment during cystoscopy occurs when the tip of the cystoscope passes through the external urinary sphincter. It has been shown that asking patients to take deep breaths or allowing them to watch cystoscopy videos while manually compressing the irrigation fluid bag during the passage of the cystoscope through the bulbar urethra, just distal to the external urinary sphincter, can reduce pain perception. Female patients tend to experience less pain due to the shorter urethral length. Various strategies have been employed to minimize pain and anxiety during the procedure, including listening to music, watching relaxing videos, or allowing patients to view their own cystoscopy recordings during the examination. Given the lack of prior cystoscopy experience, we planned this randomized prospective study to evaluate the effect of age and sex on pain perception during flexible cystoscopy. We believe that the findings of this study may be beneficial in counseling patients during cystoscopic evaluation of urological pathologies

Conditions

Urethral Stricture; Benign Prostate Obstruction (BPO); Bladder (Urothelial, Transitional Cell) Cancer

Keywords

flexible cystoscopy; outpatient urology; pain perception

Outcome Measures

Primary Outcomes (1)

• Correlation between expected pain and perceived pain

  Correlation between pre-procedural expected pain scores and post-procedural perceived pain scores with using a validated pain scale of Visual Analog Scale \[VAS\]

  Immediately after completion of the cystoscopy procedure

Secondary Outcomes (4)

• Pre-procedural expected pain level

  Immediately before flexible cystoscopy

• Difference between expected and perceived pain levels

  From immediately before to immediately after the procedure

• Effect of age on pain perception

  Immediately after the procedure

• Effect of sex on pain perception

  Immediately after the procedure

Study Arms (1)

First-Time Flexible Cystoscopy Under Local Anesthesia Patient Group

Patients who undergo flexible cystoscopy for the first time under local anesthesia in an outpatient clinic and are evaluated for pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) undergoing first-time flexible cystoscopy under local anesthesia in an outpatient setting, with assessment of expected and perceived pain levels

You may qualify if:

• Age ≥18 years
• Patients undergoing flexible cystoscopy for the first time under local anesthesia in an outpatient setting
• Ability to understand the study procedures and provide informed consent

You may not qualify if:

• Use of systemic analgesics, sedatives, or anxiolytics immediately before the procedure
• Presence of active urinary tract infection at the time of cystoscopy
• Presence of an indwelling urethral catheter at the time of cystoscopy

Sponsors & Collaborators

• Kayseri Education and Research Hospital: lead

Study Sites (1)

Kayseri Education and Research Hospital

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urethral Stricture; Neoplasms

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Mert Karadağ, Professor

  Kayseri Education and Research Hospital

  STUDY CHAIR

Central Study Contacts

Abdullah Gölbaşı, Assistant Professor

CONTACT

+90 352 315 77 00; kayserisehir@saglik.gov.tr

Abdullah Gölbaşı, Assistant Proffessor

CONTACT

+90 352 315 77 00; kayserisehir@saglik.gov.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor Abdullah Gölbaşı

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 29, 2026
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)