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Urethral StricturePAINCYSTNCT07375641

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

An observational study of Urethral Stricture and Bladder (Urothelial, Transitional Cell) Cancer, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
150 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2026to 1 May 2026
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Turkey (Türkiye)1 site
  • Kayseri Education and Research Hospital

    Kayseri, Kocasinan, 38080

    Abdullah Gölbaşı, Assistant Professor, +90 352 315 77 00, kayserisehir@saglik.gov.tr

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Age and Sex on Pre-procedural Anticipated Pain and Post-procedural Experienced Pain in Patients Undergoing Flexible Cystoscopy for the First Time in an Outpatient Setting

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

Read the detailed description

Cystoscopy is one of the most commonly performed diagnostic procedures in daily urological practice and is widely used for the diagnosis and follow-up of various urological conditions, including bladder tumors, benign prostatic hyperplasia, recurrent lower urinary tract infections, evaluation of hematuria, and urethral strictures. Owing to its ability to allow direct visualization of the urothelial surface, cystoscopy provides high diagnostic accuracy and serves as a valuable tool in guiding treatment planning.

Depending on the patient's clinical status, comorbidities, and the indication for the procedure, cystoscopy may be performed in the operating room under sedation, spinal anesthesia, or general anesthesia, or safely conducted in the outpatient setting under local anesthesia. Performing cystoscopy in outpatient conditions, particularly for surveillance and follow-up purposes, is of considerable importance in terms of optimizing healthcare resources. Outpatient cystoscopy reduces operating room workload, eliminates anesthesia-related risks, shortens procedural time, and lowers overall healthcare costs.

Although the development of flexible cystoscopes has significantly improved patient comfort compared with rigid instruments, cystoscopy performed under local anesthesia in the outpatient setting may still cause substantial pain, discomfort, and anxiety in a subset of patients. This issue is of particular clinical relevance in patients with bladder tumors who require regular cystoscopic surveillance, as negative procedural experiences may result in poor compliance and loss to follow-up, potentially leading to delayed diagnosis and adverse oncological outcomes.

Various analgesic and anxiolytic strategies have been employed to alleviate pain and anxiety prior to cystoscopy, most commonly the use of lidocaine-based lubricating gels. In addition, adequate patient information, proper positioning, and gentle instrumentation are routinely applied to improve procedural tolerance. However, current evidence suggests that none of these approaches alone is sufficient to completely eliminate pain and anxiety, and an optimal, universally accepted strategy has yet to be established.

Several studies have reported that pain perception during cystoscopy may be influenced by patient age, with higher pain scores observed in older individuals. This association has been attributed to age-related changes in urethral and bladder neck elasticity, the presence of lower urinary tract symptoms, and increased comorbid conditions in elderly patients.

Sex-related differences also play a significant role in pain perception during cystoscopy. In male patients, previous studies have demonstrated that the most painful phase of the procedure occurs when the tip of the cystoscope passes through the external urinary sphincter. Increased resistance encountered during passage through the bulbar urethra, located immediately distal to the external sphincter, has been associated with heightened pain perception. It has been shown that simple manual compression of the irrigation fluid bag combined with instructing patients to take deep breaths or allowing them to watch cystoscopy videos during this phase can significantly reduce perceived pain.

In contrast, female patients generally report lower pain scores during cystoscopy, which is primarily attributed to the shorter length and more straightforward anatomical course of the female urethra, resulting in shorter procedural duration and less resistance during instrument insertion.

In recent years, increasing attention has been directed toward non-pharmacological interventions aimed at minimizing pain and anxiety during cystoscopy. Techniques such as listening to music, watching relaxing videos, or allowing patients to view their own cystoscopy recordings in real time have been shown to improve patient comfort and reduce pain perception during the procedure.

In light of these findings, we designed this randomized prospective study to evaluate the effect of age and sex on pain perception during flexible cystoscopy in male and female patients aged 18 years and older with no prior history of cystoscopy. We hypothesized that a better understanding of these factors would be beneficial for patient counseling and may improve patient compliance during cystoscopic evaluation of urological pathologies.

Keywords
flexible cystoscopy, outpatient urology, pain perception
Medical subject headings
Urethral Stricture, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07375641
Study groupRoleWhat they receive
First-Time Flexible Cystoscopy Under Local Anesthesia Patient GroupPatients who undergo flexible cystoscopy for the first time under local anesthesia in an outpatient clinic and are evaluated for pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  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]

    Measured: Immediately after completion of the cystoscopy procedure

Secondary outcomes (4)
  1. Pre-procedural expected pain level

    Expected pain level assessed immediately before the procedure using a validated pain scale (e.g., Visual Analog Scale [VAS], 0-10)

    Measured: Immediately before flexible cystoscopy

  2. Difference between expected and perceived pain levels

    Difference between pre-procedural expected pain score and post-procedural perceived pain score

    Measured: From immediately before to immediately after the procedure

  3. Effect of age on pain perception

    Association between patient age and post-procedural pain intensity during flexible cystoscopy

    Measured: Immediately after the procedure

  4. Effect of sex on pain perception

    Comparison of post-procedural pain intensity between male and female patients undergoing first-time flexible cystoscopy

    Measured: Immediately after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07375641
Sponsor's protocol ID
SBU-URO-AG-03
Acronym
PAINCYST
Status last verified
Jan 2026
First submitted
22 Jan 2026
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Urethral Stricture and Bladder (Urothelial, Transitional Cell) Cancer, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abdullah Gölbaşı, Assistant Professor (+90 352 315 77 00, kayserisehir@saglik.gov.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between expected pain and perceived pain (time frame: Immediately after completion of the cystoscopy procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.

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