Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Pain, Postoperative

Urinary Bladder Neoplasms

Pain

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Postoperative Complications

Neurologic Manifestations

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Outpatient flexible cystoscopy and inpatient rigid cystoscopy

Cystoscopy

Abdelwahab R. Hashem, Msc

Mohammed H. Zahran, MD

Hassan Abol-Enein, MD

Ahmed Mosbah, MD

Mohamed Abdelbaset, Msc

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.

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

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

Outcome measures by histopathological results of bladder biopsy

Outcome measures by visual analog scale (VAS) pain score

Outcome measures by Freiburg Index of Patient Satisfaction (FIPS) questionnaire

Outcome measures by Number of patients surviving for two year without tumor recurrence will be counted and compared

Mansoura University

Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Infections

Musculoskeletal Diseases

Recurrence

Communicable Diseases

Urinary Tract Infections

Hematuria

Urination Disorders

Muscle Rigidity

Hemorrhage

Flexible Cystoscopy

Rigid Cystoscopy

Stephen Nakada, MD

The study will help define the best tolerated approach to cystoscopy in women by randomly comparing flexible to rigid cystoscopy. Previous randomized studies evaluated rigid cystoscopy under general anesthesia versus flexible cystoscopy under local anesthesia. As a result of these studies, flexible cystoscopy is performed in the clinic setting generally in males. However, many women have rigid cystoscopy performed in the clinic while the men have flexible cystoscopy. No studies to date have evaluated whether flexible cystoscopy is better tolerated in women compared to rigid cystoscopy in women in the clinic setting.

Rigid Versus Flexible Cystoscopy in Women

Rigid Versus Flexible Cystoscopy in Women in Outpatient Clinic

The Visual Analog Scale for pain ranges from 1 to 5, with higher scores indicating higher pain. Results report the average of two measures, taken during procedure and 1 week post-procedure.

University of Wisconsin, Madison

Use of Flexible Cystoscope during clinically indicated cystoscopy

Use of Rigid Cystoscope during clinically indicated cystoscopy

Total

Minors, <18 yrs

Adults, >=18 yrs

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Dr. Stephen Nakada

Rigid

Flexible

Visual Analog Scale for Pain

Overall Study

Rare Diseases

Carcinoma, Transitional Cell

Transitional Cell Carcinoma

Urinary cytology will be collected using a Ch.14 bladder catheter after the removal of the cystoscope. Catheter will be placed at the bladder neck level.

Urinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present).

Flexible cystoscopy

Urinary cytology will be collected through a Ch14 urinary catheter after the cystoscopy

Urinary catheter

Ilaria Lucca, MD

François Crettenand, MD

Urine cytology can be collected with spontaneous urine or by washing the bladder. It is commonly accepted among urologist that instrumental bladder washing is the method of choice. There are, however, no solid recommendations regarding the method to collect the urine for bladder wash cytology during cystoscopy. There are mainly two possibilities: 1) the use of an intermittent bladder catheter after the removal of the cystoscope or 2) bladder lavage through working channel of the flexible cystoscope itself. The first choice may increase the number of collected cells because of the larger caliber of the catheter compared to the working channel and thus the better efficacy of bladder wash. However, this method is certainly more invasive and possibly more expensive. To the best of our knowledge and according to available literature, none of both collection method can be defined as gold standard. The aim of the study is to show that use of flexible cystoscope brings the same results in terms of quality of the urine collection for analysis as the use of intermittent bladder catheter and is less unpleasant for the patient. If our study confirms the non-inferiority of "direct" collection through the cystoscope, this will allow the establishment of recommendations in this sense in order to simplify the procedure and reduce as much as possible the manipulations within the urogenital tract.

The aim of the study is to show that use of flexible cystoscope brings the same results in terms of quality of the urine collection for analysis as the use of intermittent bladder catheter and is less unpleasant for the patient.

Group A: Urinary cytology will be collected using a Ch.14 bladder catheter after the removal of the cystoscope. Catheter will be placed at the bladder neck level.

Group B: Urinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present).

Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better?

Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better? A Prospective Randomized Study

Number of urothelial cells, number of inflammatory cells, presence of necrosis or blood will be used to assess this outcome measure

Sensitivity ans specificity percentage will be calculated based on the results of both urinary cytology and cystoscopy

The Faces Pain Scale will be used for each patient after the cytology to assess his satisfaction/pain (0= no pain and 10=the worst pain possible)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident	NCT03148158	Bladder Cancer Flexible Cystos... Non-muscle Inva... Pain, Postopera...	Cystoscopy	18 Years -	Mansoura University
Rigid Versus Flexible Cystoscopy in Women	NCT00214045	Hematuria Urination Disor... Voiding Dysfunc... Recurrent Urina...	Flexible Cystos... Rigid Cystoscop...	18 Years -	University of Wisconsin, Madison
Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident	NCT03148158	Bladder Cancer Flexible Cystos... Non-muscle Inva... Pain, Postopera...	Cystoscopy	18 Years -	Mansoura University
Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better?	NCT05643807	Bladder Cancer	Flexible cystos... Urinary cathete...	18 Years -	Centre Hospitalier Universitaire Vaudois

Spots Global Cancer Trial Database for flexible cystoscopy