Clinical trial NCT03148158: Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident
Official title: Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Flexible Cystoscopy
Non-muscle Invasive Bladder Cancer (NMIBC)
Pain, Postoperative
Keywords: Bladder Cancer
Flexible cystoscopy
Diagnosis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients diagnosed with suspected denovo, recurrent bladder mass or hematuria needing assessment by flexible cystoscopy will be asked to participate in this study at Urology and Nephrology Center Outpatient Clinics and will be provided with an informed consent form in line with Good Clinical Practise and the Declaration of Helsinki.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of clinical grade and stage of bladder lesions diagnosed by flexible cystoscopy done by urology residents
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of pain perception in patient undergoing flexible or rigid diagnostic cystoscopy
timeFrame: 1 year
measure: Assessment of the patient reported outcomes after both flexible and rigid cystoscopy
timeFrame: 1 year
measure: Assessment of the prognostic value of gross morphology with recurrence, progression
timeFrame: 2 year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: Aldakahlia
Study officials:
affiliation: Urology and Nephrology center
name: Hassan Abol-Enein, MD
role: STUDY_CHAIR
affiliation: Urology and Nephrology center
name: Ahmed Mosbah, MD
role: STUDY_DIRECTOR
affiliation: Urology and Nephrology Center
name: Mohamed Abdelbaset, Msc
role: PRINCIPAL_INVESTIGATOR
References: