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

NCT06069453 | Terminated

• 1 other identifier: UQP6-19-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-muscle Invasive Bladder Cancer (NMIBC)

Outcome Measures

Primary Outcomes (1)

• Evaluation of severity rate of storage symptoms (frequency, urgency, nocturia) compared to control group

  Severity of storage symptoms will be evaluated through a patient's bladder diary

  3 days after catheter removal

Secondary Outcomes (8)

• Evaluation of severity rate of storage symptoms (frequency, urgency, nocturia) compared to control group

  25 days

• Evaluation of changes from baseline in severity of urinary symptoms compared to control group

  25 days

• Evaluation of changes from baseline in severity rate of urinary symptoms compared to control group

  25 days

• Evaluation of changes from baseline in severity of pelvic pain compared to control group

  25 days

• Duration of catheter implant as time of permanence of cathether implanted compared to control group

  49 hours

Study Arms (2)

Group A

EXPERIMENTAL

Solution containing Hyaluronic Acid (HA) sodium salt and Hydeal-D

Device: Hyaluronic Acid (HA) sodium salt and Hydeal-D

Group B

NO INTERVENTION

standard management according to institutional protocol

Interventions

Hyaluronic Acid (HA) sodium salt and Hydeal-D DEVICE

intravesical solution containing Hyaluronic Acid (HA) sodium salt and Hydeal-D

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females patients aged ≥ 18 years old;
• Patients with suspected clinical diagnosis of primary or secondary single or multiple, any size, NMIBC scheduled for TURBT;
• 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.
• Patients available to remain in the same geographical area of the investigational site from the hospitalisation to the end of the investigation;
• Patients able to understand and comply with the requirements of the study and voluntarily provide written informed consent.

You may not qualify if:

• Patients with Schistosoma haematobium infestation or neurologenic bladder;
• 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;
• Patients with indication for early instillation due to new treatment guideline;
• Patients with any potential interfering factors for LUTS evaluation, such as obstruction, nocturnal polyuria strictures, neurogenic bladder, detrusor over/under capacity;
• Patients with clinically relevant comorbidities that could potentially interfere with study evaluations, such as diabetes, renal disease and cardiac failure;
• 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;
• 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;
• Patients with known or suspected allergy, hypersensitivity or intolerance to hyaluronic acid and/or any other component of the investigational device;
• Patients with hypersensitivity to local anaesthetics or other drugs used for the procedure;
• Women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception;
• Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the investigation;
• Patients who have used any investigational drug or device in an investigational protocol in the past 3 months;
• Patients who have been previously enrolled in this investigation.

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Mi, 20089, Italy

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Nicola Giordan

  Fidia Farmaceutici s.p.a.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Monocentric, randomized, controlled investigation

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: October 5, 2023
• Study Start: August 19, 2020
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)