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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03148158
• Other study ID #: F-Cystoscopy NMIBC
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2017
• Last updated: January 6, 2018
• Start date: January 15, 2018
• Est. completion date: June 15, 2019

Study information

• Verified date: May 2017
• Source: Mansoura University
• Contact: Abdelwahab R. Hashem, Msc
• Phone: 01069678979
• Email: abdelwahab_hashem[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 15, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Flexible Cystoscopy
• Non-muscle Invasive Bladder Cancer (NMIBC)
• Pain, Postoperative
• Urinary Bladder Neoplasms

Intervention

Device:
• Cystoscopy
Outpatient flexible cystoscopy and inpatient rigid cystoscopy

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura	Aldakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of clinical grade and stage of bladder lesions diagnosed by flexible cystoscopy done by urology residents	Outcome measures by histopathological results of bladder biopsy	1 year
Secondary	Evaluation of pain perception in patient undergoing flexible or rigid diagnostic cystoscopy	Outcome measures by visual analog scale (VAS) pain score	1 year
Secondary	Assessment of the patient reported outcomes after both flexible and rigid cystoscopy	Outcome measures by Freiburg Index of Patient Satisfaction (FIPS) questionnaire	1 year
Secondary	Assessment of the prognostic value of gross morphology with recurrence, progression	Outcome measures by Number of patients surviving for two year without tumor recurrence will be counted and compared	2 year