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

NCT06944314 | Enrolling By Invitation

• 1 other identifier: MAR.UAD.0021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cystoscopic Surgical Procedures; Pain

Keywords

Pain; Anxiety; bladder cancer; Hematuria

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Association between patients' pre-procedure HAD score and pain

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

Study Arms (4)

Assistant Urology Doctor (2 years)

EXPERIMENTAL

Intervention: 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.

Procedure: Diagnostic procedures; Procedure: Flexible Cystoscopy

Assistant Urology Doctor (4 years)

EXPERIMENTAL

Intervention: 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.

Procedure: Diagnostic procedures; Procedure: Flexible Cystoscopy

Specialist Urology Physician (<5 years experience)

EXPERIMENTAL

Experimental: 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.

Procedure: Diagnostic procedures; Procedure: Flexible Cystoscopy

Specialist Urology Physician (>5 years experience)

EXPERIMENTAL

Experimental: 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.

Procedure: Diagnostic procedures; Procedure: Flexible Cystoscopy

Interventions

Diagnostic procedures PROCEDURE

Diagnostic Flexible Cystoscopy

Also known as: Flexible Cystoscopy

Assistant Urology Doctor (2 years); Assistant Urology Doctor (4 years); Specialist Urology Physician (<5 years experience); Specialist Urology Physician (>5 years experience)

Flexible Cystoscopy PROCEDURE

Diagnostic Flexible Cystoscopy

Also known as: Cystoscopy

Assistant Urology Doctor (2 years); Assistant Urology Doctor (4 years); Specialist Urology Physician (<5 years experience); Specialist Urology Physician (>5 years experience)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male patients over 18 years of age who need cystoscopy due to urologic complaints will be included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead
• Marmara University Pendik Training and Research Hospital: collaborator

Study Sites (1)

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

Istanbul, Istanbul, 34662, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 23009573 BACKGROUND

• 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.

  PMID: 33008780 BACKGROUND

• 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.

  PMID: 34834565 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders; Urinary Bladder Neoplasms; Hematuria

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urination Disorders; Hemorrhage; Pathologic Processes

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Haydar Kamil Cam, Professor Doctor

  Marmara University, School of Medicie, Department of Urology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The people who randomize the patient, prepare the patient for cystoscopy, perform the cystoscopy and evaluate the results are different and will be blinded.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: April 25, 2025
• Study Start: March 1, 2025
• Primary Completion: August 15, 2025
• Study Completion: September 15, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD and supporting information will be available starting from the study completion date (September 15, 2025) and will be accessible for a period of 5 years.
• Access Criteria: The IPD and supporting materials will be available to qualified researchers upon request. Researchers will have access to anonymized demographic data, Hospital Anxiety and Depression Scale (HADS) scores, Visual Analog Scale (VAS) pain scores, study protocol, statistical analysis plan, informed consent forms, and the final clinical study report. Access will be granted through a secure, password-protected data-sharing platform hosted by Marmara University, with adherence to ethical guidelines and confidentiality protocols. Requests can be made by contacting the study's central contact person, Dr. Gunal Ozgur (email: gunalozgur91@hotmail.com).

Locations

TU (1)