Bladder Cancer, Flexible Cystoscopy, Non-muscle Invasive Bladder Cancer (NMIBC), Pain, Postoperative
Conditions
Keywords
Bladder Cancer, Flexible cystoscopy, Diagnosis
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.
Interventions
DEVICECystoscopy
Outpatient flexible cystoscopy and inpatient rigid cystoscopy
Sponsors
Mansoura University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary ContactAbdelwahab R. Hashem, Msc
Backup ContactMohammed H. Zahran, MD
Outcome results
None listed