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).
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
- Conditions the study is for
- Urethral Stricture, Bladder (Urothelial, Transitional Cell) Cancer, Benign Prostate Obstruction (BPO)
- 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.
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
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.
- Conditions
- Urethral Stricture, Bladder (Urothelial, Transitional Cell) Cancer, Benign Prostate Obstruction (BPO)
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
Effect of age on pain perception
Association between patient age and post-procedural pain intensity during flexible cystoscopy
Measured: Immediately after the procedure
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.
- First posted29 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdullah Gölbaşi, Kayseri Education and Research Hospital
- Investigators
- Mert Karadağ, Professor, Study chair, Kayseri Education and Research Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07375641
- Acronym / sponsor ID
- PAINCYST / SBU-URO-AG-03
- Conditions
- Urethral Stricture, Bladder (Urothelial, Transitional Cell) Cancer, Benign Prostate Obstruction (BPO)
- Keywords
- flexible cystoscopy, outpatient urology, pain perception
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between expected pain and perceived pain
Time frame: Immediately after completion of the cystoscopy procedure
Correlation between pre-procedural expected pain scores and post-procedural perceived pain scores with using a validated pain scale of Visual Analog Scale [VAS]
4 secondary outcomes
Pre-procedural expected pain level
Time frame: Immediately before flexible cystoscopy
Difference between expected and perceived pain levels
Time frame: From immediately before to immediately after the procedure
Effect of age on pain perception
Time frame: Immediately after the procedure
Effect of sex on pain perception
Time frame: Immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mert Karadağ, Professor study chair
Kayseri Education and Research Hospital
1 site in 1 country: see every site and its status.
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.