Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident

• Conditions: Non-muscle Invasive Bladder Cancer (NMIBC); Pain, Postoperative; Bladder Cancer; Flexible Cystoscopy

• Registration Number: NCT03148158
• Lead Sponsor: Mansoura University

Brief Summary

This will be a prospective trial comparing the perspective gross morphological of bladder tumor assessment done by outpatient flexible cystoscopy performed by resident, inpatient rigid cystoscopy done by senior staff and their prediction of the degree of invasion of bladder tumor plus the prediction of the grade compared with the standard pathological result.

Also, assessment of the patient reported outcomes after both flexible and rigid cystoscopy will be done.

In the long run of the study, the prognostic gross morphology with recurrence, progression and cancer specific survival will be assessed.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-10
• Last Update Submitted: 2018-01-06
• Last Update Posted: 2018-01-09
• Study Start: 2018-01-15
• Primary Completion: 2019-06-15
• Study Completion: 2019-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Men and women 18 years or older
• Denovo or recurrent NMIBC
• Bladder mass discovered in hematuria investigation
• Willing to share in study

Exclusion Criteria

• inability to cooperate with flexible cystoscopic evaluations
• cystoscopies for other kind of intervention (e.g., removal of a ureteral stent)
• Untreated infections
• Other causes of storage or voiding symptoms as untreated benign prostatic hyperplasia (BPH) or interstitial cystitis
• Unpassable urethral stricture

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of clinical grade and stage of bladder lesions diagnosed by flexible cystoscopy done by urology residents	1 year	Outcome measures by histopathological results of bladder biopsy

Secondary Outcome Measures

Name	Time	Method
Evaluation of pain perception in patient undergoing flexible or rigid diagnostic cystoscopy	1 year	Outcome measures by visual analog scale (VAS) pain score
Assessment of the patient reported outcomes after both flexible and rigid cystoscopy	1 year	Outcome measures by Freiburg Index of Patient Satisfaction (FIPS) questionnaire
Assessment of the prognostic value of gross morphology with recurrence, progression	2 year	Outcome measures by Number of patients surviving for two year without tumor recurrence will be counted and compared

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Aldakahlia, Egypt