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

January 6, 2018 updated by: Abdelwahab Hashem, Mansoura University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Aldakahlia
      • Mansoura, Aldakahlia, Egypt, 35516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of clinical grade and stage of bladder lesions diagnosed by flexible cystoscopy done by urology residents
Time Frame: 1 year
Outcome measures by histopathological results of bladder biopsy
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Director: Ahmed Mosbah, MD, Urology and nephrology center
  • Study Chair: Hassan Abol-Enein, MD, Urology and nephrology center
  • Principal Investigator: Mohamed Abdelbaset, Msc, Urology and nephrology center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2018

Primary Completion (Anticipated)

June 15, 2019

Study Completion (Anticipated)

June 15, 2019

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

May 9, 2017

First Posted (Actual)

May 10, 2017

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 6, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-Cystoscopy NMIBC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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