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Cystoscopic Surgical ProceduresNCT06944314

Physicians' Perception About Patient Pain in Flexible Cystoscopy With Local Anesthesia

A study testing Diagnostic procedures and Flexible Cystoscopy in people with Cystoscopic Surgical Procedures and Pain, run by Marmara University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Cystoscopy with local anesthesia is commonly performed for the follow-up of bladder cancer, evaluation of hematuria, assessment of urethral strictures, and examination of the lower urinary tract. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Cystoscopic Surgical Procedures, Pain
What is being tested?
Diagnostic procedures and Flexible Cystoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2025to 15 Sep 2025
Phase
Interventional
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male patients
  • Over 18 years of age
  • Patients for whom diagnostic cystoscopy is indicated for a urologic reason

Who cannot join

  • Female patients
  • Patients younger than 18 years of age
  • Patients with known urethral stricture
  • Patients with urethral stricture detected during cystoscopy
  • Patients who cannot tolerate flexible cystoscopy with local anesthesia

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
  • Marmara University, School of Medicie, Department of Urology, Istanbul, Türkiye

    Istanbul, Istanbul, 34662

Other trials in Turkey (Türkiye)

About this study

Cystoscopy with local anesthesia is commonly performed for the follow-up of bladder cancer, evaluation of hematuria, assessment of urethral strictures, and examination of the lower urinary tract. While some patients tolerate the procedure comfortably, others may exhibit heightened sensitivity and difficulty tolerating it. In certain cases, even when the procedure is completed, the level of pain experienced and the resistance demonstrated by the patient may render cystoscopy a challenging experience for both the patient and the physician. The physician's perception of the patient's pain may differ from the pain reported by the patient. Currently, there is no available data in the literature regarding the relationship between pre-procedural anxiety and depression levels and the pain experienced during cystoscopy, nor regarding the physician's perception of that pain. The primary objective of the study is to compare the patient-reported pain score with the physician's perception of the pain experienced by the patient. A secondary objective is to evaluate the pre-procedure anxiety and depression scores, along with intra-procedural pain scores, in patients undergoing flexible cystoscopy under local anesthesia.

Read the detailed description

Cystoscopy is one of the most frequently performed procedures in the field of urology. Its widespread application, the impracticality of administering general anesthesia to all patients, and advancements in medical technology have led to the development of devices that enable cystoscopy to be performed with local or intraurethral anesthesia. As a result, cystoscopy under local anesthesia is commonly utilized for the follow-up of bladder cancer, evaluation of hematuria, assessment of urethral strictures, and examination of the lower urinary tract. Both rigid and flexible cystoscopes can be used for this purpose, with flexible instruments generally offering greater comfort for procedures involving local anesthesia.

In patients undergoing cystoscopy with local anesthesia, the standard approach includes the intraurethral administration of a local anesthetic or lubricant prior to the procedure to enhance patient comfort. While some patients tolerate the procedure well, others may exhibit heightened sensitivity and limited tolerance. Even in cases where the procedure is completed, the pain experienced and the resistance demonstrated by the patient may pose challenges for both the patient and the physician. Occasionally, a mismatch is observed between the patient's reported pain and the resistance displayed. The physician's perception of the patient's pain may also differ from the pain reported by the patient.

Previous studies have explored factors that can influence and reduce the perception of pain during cystoscopy performed under local anesthesia. However, data are lacking regarding the relationship between patients' pre-procedural anxiety and depression levels and the pain experienced during the procedure, as well as the physician's perception of that pain. The primary aim of the study is to compare the pain score reported by the patient with the pain level perceived by the physician. A secondary objective is to evaluate patients' pre-procedure anxiety and depression scores, along with their pain scores during the procedure, in the context of flexible cystoscopy performed under local anesthesia.

The study will include male patients aged 18 years and older who are undergoing cystoscopy due to urological complaints. Exclusion criteria include patients with known urethral strictures or those diagnosed with strictures during cystoscopy, individuals with allergies to the local anesthetic used, and patients with cardiopulmonary conditions that preclude the procedure.

Participants will be asked to complete the Hospital Anxiety and Depression Scale (HADS) for the assessment of general anxiety and depression, as well as the Visual Analog Scale (VAS) for pain and anxiety, at the time of admission. All patients will receive standard intraurethral local anesthesia 15 minutes prior to the procedure. Following cystoscopy, participants will complete the VAS for anxiety and pain again, 15 minutes after the procedure, to evaluate their intra-procedural experience. In addition, the physician performing the procedure will complete the VAS for anxiety and pain based on their perception of the patient's experience.

Patients will be randomized into four groups based on the experience level of the physician performing the procedure: a physician with more than five years of experience, a physician with less than five years of experience, a second-year resident under supervision, and a fourth-year resident. A total of 30 patients will be included in each group. The physician will remain blinded to the forms completed by the patient before and after the procedure and will independently assess the patient's condition.

Being tested
Diagnostic procedures, Flexible Cystoscopy
Keywords
Pain, Anxiety, bladder cancer, Hematuria
Medical subject headings
Pain, Anxiety Disorders, Urinary Bladder Neoplasms, Hematuria

What participants receive

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

  • Diagnostic proceduresProcedure or surgery

    Also called Flexible Cystoscopy

    Diagnostic Flexible Cystoscopy

  • Flexible CystoscopyProcedure or surgery

    Also called Cystoscopy

    Diagnostic Flexible Cystoscopy

Study groups in NCT06944314
Study groupRoleWhat they receive
Assistant Urology Doctor (2 years)ExperimentalIntervention: Diagnostic Flexible Cystoscopy Other Names: Flexible Cystoscopy, Cystoscopy Arm Description: The procedure will be performed by an Assistant Urology Doctor with 2 years of experience. The goal is to evaluate the patient's pain perception during diagnostic flexible cystoscopy.
Receives: Procedure: Diagnostic procedures; Procedure: Flexible Cystoscopy
Assistant Urology Doctor (4 years)ExperimentalIntervention: Diagnostic Flexible Cystoscopy Other Names: Flexible Cystoscopy, Cystoscopy Arm Description: The procedure will be performed by an Assistant Urology Doctor with 4 years of experience. The goal is to evaluate the patient's pain perception during diagnostic flexible cystoscopy.
Receives: Procedure: Diagnostic procedures; Procedure: Flexible Cystoscopy
Specialist Urology Physician (<5 years experience)ExperimentalExperimental: Specialist Urology Physician (<5 years experience) Intervention: Diagnostic Flexible Cystoscopy Other Names: Flexible Cystoscopy, Cystoscopy Arm Description: The procedure will be performed by a Specialist Urology Physician with less than 5 years of experience. The goal is to evaluate the patient's pain perception during diagnostic flexible cystoscopy.
Receives: Procedure: Diagnostic procedures; Procedure: Flexible Cystoscopy
Specialist Urology Physician (>5 years experience)ExperimentalExperimental: Specialist Urology Physician (>5 years experience) Intervention: Diagnostic Flexible Cystoscopy Other Names: Flexible Cystoscopy, Cystoscopy Arm Description: The procedure will be performed by a Specialist Urology Physician with more than 5 years of experience. The goal is to evaluate the patient's pain perception during diagnostic flexible cystoscopy.
Receives: Procedure: Diagnostic procedures; Procedure: Flexible Cystoscopy

What is being measured

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

  1. Physicians' Perception about Patient Pain in Flexible Cystoscopy with Local Anesthesia

    The study will examine the differences in the perception of pain scores in patients according to the years of experience of physicians.

    Scale Used: Visual Analog Scale (VAS) for Pain Minimum Value: 0 (No pain) Maximum Value: 10 (Worst possible pain) Interpretation: Higher scores indicate worse pain perception.

    Measured: Immediately after the procedure, upon completion of the diagnostic flexible cystoscopy (15 minutes post-procedure).

Secondary outcomes (1)
  1. Association between patients' pre-procedure HAD score and pain

    Depression and anxiety levels in the pre-procedure HAD scores and VAS pain scores during the procedure will be compared.

    Measured: Pre-procedure (baseline), immediately after the procedure (15 minutes post-procedure).

Timeline

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

  1. First posted25 Apr 2025
  2. Study start1 Mar 2025
  3. Primary completion15 Aug 2025 (estimated)
  4. Study completion15 Sep 2025 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06944314
Sponsor's protocol ID
MAR.UAD.0021
Status last verified
Apr 2025
First submitted
8 Mar 2025
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Demographic data, Hospital Anxiety and Depression Scale (HADS) scores, and Visual Analog Scale (VAS) pain scores collected during the study will be shared with researchers upon request. The data will be anonymized to ensure participant privacy and confidentiality. The sharing will occur in compliance with ethical guidelines and institutional policies.

Publications

  • Yeo JK, Cho DY, Oh MM, Park SS, Park MG. Listening to music during cystoscopy decreases anxiety, pain, and dissatisfaction in patients: a pilot randomized controlled trial. J Endourol. 2013 Apr;27(4):459-62. doi: 10.1089/end.2012.0222. Epub 2012 Dec 5.

    PubMed 23009573
  • Gezginci E, Bedir S, Ozcan C, Iyigun E. Does Watching a Relaxing Video During Cystoscopy Affect Pain and Anxiety Levels of Female Patients? A Randomized Controlled Trial. Pain Manag Nurs. 2021 Apr;22(2):214-219. doi: 10.1016/j.pmn.2020.08.005. Epub 2020 Sep 29.

    PubMed 33008780
  • Luczak M, Nowak L, Chorbinska J, Galik K, Kielb P, Laszkiewicz J, Tukiendorf A, Koscielska-Kasprzak K, Malkiewicz B, Zdrojowy R, Szydelko T, Krajewski W. Influence of Virtual Reality Devices on Pain and Anxiety in Patients Undergoing Cystoscopy Performed under Local Anaesthesia. J Pers Med. 2021 Nov 16;11(11):1214. doi: 10.3390/jpm11111214.

    PubMed 34834565

Questions about this trial

What is this clinical trial studying?

A study testing Diagnostic procedures and Flexible Cystoscopy in people with Cystoscopic Surgical Procedures and Pain, run by Marmara University 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 5 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: enrolling by invitation, as of the sponsor's last update on 27 Apr 2025. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physicians' Perception about Patient Pain in Flexible Cystoscopy with Local Anesthesia (time frame: Immediately after the procedure, upon completion of the diagnostic flexible cystoscopy (15 minutes post-procedure).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06944314, which also lists 3 linked publications.

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 27 Apr 2025.

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