Clinical Research Directory

FILLing Protocols for the Right Bladder Volume at the RIGHT Time (FILLRIGHT)

The goal of this clinical trial is to compare evaluation of oral hydration protocols for the right optimal bladder filling prior to pelvic ultrasound. The main question it aims to answer is which quantity of water should patiente drink before a pelvic ultrasound. Woman participants will drink 4 differents quantity of water over 4 differents days: * Quantity A : 1000 ml in 15 minutes * Quantity B : 750 ml in 10 minutes * Quantity C : 500 ml in 5 minutes * Quantity D : 250 ml in 1 minutes The order of the hydration protocols will be randomized. All procedures are performed in the same way: * Before ingestion of water, the patient should urinate band (the volumen will be measured) an an ultrasound examination will be performed to assess the residual post-void volume * The patiente drinks water and the time was collected * Every 5 minutes during the procedure : * A suprapubic ultrasound examination will be performed to assess the bladder filling and to calculate of bladder volume using the standard formula (length × width × height × 0.52) * The Bladder Sensation Scale (BSS) was collected. * When the score to BBS reaches 3, the procedure should be stopped and the patiente should urinate band (the volumen will be measured). Then a last ultrasound examination will be performed. After each procedure, the patiente answer at this question: "On a scale from 1 (very poor) to 10 (excellent), how would you rate the acceptability of ingesting the required hydration volume?"

A Window of Opportunity Phase I Study of UGN-201 in Patients With Bladder Cancer Undergoing Radical Cystectomy Protocol #: 2021-0630

he primary objective is to characterize the safety profile of UGN-201 in patients with urothelial carcinoma undergoing radical cystectomy. Corresponding primary endpoint: Toxicity of concern (TOX) will be monitored until 30 days after surgery or until the patient meets the surgery prevention or delay TOX definition below, whichever comes first. A patient will be considered to have a TOX if any of the following apply: * Any 30-day grade 3 or higher surgical complication at least possibly related to UGI-201 * Any toxicity at least possibly related to the treatment that prevents surgery or delays it more than 12 weeks from date of cystectomy decision with MDACC Urologist. Missing/delayed surgery due to progression or withdrawal not related to toxicity will not count as a TOX event. Rapid progression is not seen with UGN-201. For such a patient, TOX monitoring will follow for 30 days after the administered dose of UGN-201. * Death between the start of study and the 30-day post-surgical assessment will count if it is toxic death at least possibly related to the UGN-201 or surgery. Deaths clearly unrelated to treatment will not count as an event. Adverse events will be recorded using CTCAE v5 and surgical complications will be recorded using Clavien-Dindo classification. Exploratory objectives are: * To evaluate the efficacy of UGN-201 by pathologic T0 and ≤ pT1 rate (pathologic down-staging) after neoadjuvant treatment with UGN-201, in patients with NMBIC and MIBC undergoing radical cystectomy, respectively. * To assess the immunological/biomarker changes in tumor tissues, peripheral blood, and urine in response to UGN-201 treatment in patients with bladder cancer undergoing radical cystectomy and to explore any potential association between these biomarker measures and antitumor activity. Patients with MIBC will be defined as having a response if their pathologic stage is pT1 stage or less. Patients with NMIBC will be defined as having a response if their pathologic stage is pT0. Immunologic and other biomarker measures will be recorded by laboratory standards for each measure.