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Hyaluronic Acid Sodium Salt and Hydeal-D in the Management of LUTS After TURBT for NMIBC. | Clinical Trials | Clareo Health

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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.

NCT06069453•Fidia Farmaceutici s.p.a.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females patients aged ≥ 18 years old;
•2. Patients with suspected clinical diagnosis of primary or secondary single or multiple, any size, NMIBC scheduled for TURBT;
•3. Female patients with child-bearing potential must not be pregnant or lactating, and willing to use adequate contraception for the duration of study. Note: to be considered females of non-child-bearing potential, females must be surgically sterile or postmenopausal as documented in medical history for at least 1 year.
•Highly effective birth control methods include: combined hormonal contraception (containing estrogens and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence.
•4. Patients available to remain in the same geographical area of the investigational site from the hospitalisation to the end of the investigation;
•5. Patients able to understand and comply with the requirements of the study and voluntarily provide written informed consent.

Exclusion Criteria

•1. Patients with Schistosoma haematobium infestation or neurologenic bladder;
•2. Patients having received (in the three months before the screening) previous treatment with neurotoxic drugs (e.g. vanilloids, ovanil, botulinum toxin, etc.) or pelvic irradiation, which could interfere with sensory functions;
•3. Patients with indication for early instillation due to new treatment guideline;
•4. Patients with any potential interfering factors for LUTS evaluation, such as obstruction, nocturnal polyuria strictures, neurogenic bladder, detrusor over/under capacity;
•5. Patients with clinically relevant comorbidities that could potentially interfere with study evaluations, such as diabetes, renal disease and cardiac failure;
•6. Patients with presence of other serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular or neurological disease that could adversely affect the safety of the study treatment or the patient's ability to comply with investigation requirements;
•7. Patients on treatment or having received (in 30 days before screening) the following anticholinergic drugs: oxybutinin, tolterodine, fesoterodine, darifenacin, trospium and beta-3 adrenoreceptor agonist;
•8. Patients with known or suspected allergy, hypersensitivity or intolerance to hyaluronic acid and/or any other component of the investigational device;
•9. Patients with hypersensitivity to local anaesthetics or other drugs used for the procedure;
•10. Women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception;
+3 more criteria

Locations (1)

Humanitas Research Hospital

Rozzano, Mi, Italy

Key Dates

Start Date

August 19, 2020

Primary Completion Date

December 22, 2022

Completion Date

December 22, 2022

Last Updated

October 5, 2023

Enrollment

ACTUAL participants

Conditions

Non-muscle Invasive Bladder Cancer (NMIBC)

Interventions

Hyaluronic Acid (HA) sodium salt and Hydeal-D

DEVICE

A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer

NCT07122414

Non-muscle Invasive Bladder Cancer (NMIBC)

View study

UNKNOWN

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

NCT03148158

Bladder CancerFlexible Cystoscopy+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 5, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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