NCT06069453

Hyaluronic Acid Sodium Salt and Hydeal-D in the Management of LUTS After TURBT for NMIBC.

Intravesical Hyaluronic Acid Sodium Salt and Hydeal-D for Relief of Storage Lower Urinary Tract Symptoms (LUTS) After Trans-urethral Resection of Bladder Tumor (TURBT) for Non-muscle Invasive Bladder Cancer (NMIBC). Monocentric, Randomized, Controlled Investigation.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be an open-label, prospective, single-centre, randomised, controlled, parallel-group medical device investigation. The investigational plan will include four visits in total at the investigational site. One visit (Visit 2) will consist in the hospitalisation period and will last 3/4 days. Patients will be admitted to hospital in the day preceding the TURBT (Day -1; in case the TURBT is programmed in the morning) or in the day of the TURBT (Day 0; in case the TURBT is programmed in the afternoon) and will stay in the hospital for 3/4 days after the intervention (performed on Day 0). Patients will then be discharged, if considered as appropriate based on Investigator's judgment, following the removal of the catheter and the first clear urination. Patients will be asked to remain in the same geographic area of the investigational site up to the end of study visit.

Detailed description

The following visits/activities will be performed: * Visit 1: the screening visit will be performed between 60 and 14 days before the TURBT (Day -60/-14); * Visit 2 (hospitalisation): patients will be admitted to hospital in the day preceding the TURBT or in the day of the TURBT and will be randomised to the assigned treatment group. TURBT will be performed on Day 0. The first treatment with the investigational device will be performed within 6 hours from the end of TURBT. The catheter will be removed at Day 2 ± 1 if considered as appropriate based on Investigator's judgment, following the first clear urination). The second treatment with the investigational device will be performed just before the removal of the catheter and the discharge from hospital. * Visit 3: a follow-up visit will be performed at Day 5 ± 1 (i.e. 3 days after catheter removal); * Visit 4: the end of study visit will be performed at Day 25 ± 4.

Conditions

• Non-muscle Invasive Bladder Cancer (NMIBC)

Interventions

Type	Name	Description
DEVICE	Hyaluronic Acid (HA) sodium salt and Hydeal-D	intravesical solution containing Hyaluronic Acid (HA) sodium salt and Hydeal-D

Timeline

• Start date: 2020-08-19
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2023-10-05
• Last updated: 2023-10-05

Locations

1 site across 1 country: Italy