Non-muscle Invasive Bladder Cancer (NMIBC)NCT06069453
Hyaluronic Acid Sodium Salt and Hydeal-D in the Management of LUTS After TURBT for NMIBC.
A study testing Hyaluronic Acid (HA) sodium salt and Hydeal-D in people with Non-muscle Invasive Bladder Cancer (NMIBC), run by Fidia Farmaceutici s.p.a. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer (NMIBC)
- What is being tested?
- Hyaluronic Acid (HA) sodium salt and Hydeal-D
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 19 Aug 2020to 22 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the 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.
- Being tested
- Hyaluronic Acid (HA) sodium salt and Hydeal-D
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid (HA) sodium salt and Hydeal-DDevice
intravesical solution containing Hyaluronic Acid (HA) sodium salt and Hydeal-D
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Solution containing Hyaluronic Acid (HA) sodium salt and Hydeal-D Receives: Device: Hyaluronic Acid (HA) sodium salt and Hydeal-D |
| Group B | No intervention | standard management according to institutional protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days after catheter removal
Secondary outcomes (8)
Evaluation of severity rate of storage symptoms (frequency, urgency, nocturia) compared to control group
Severity of storage symptoms will be evaluated through patient's bladder diary
Measured: 25 days
Evaluation of changes from baseline in severity of urinary symptoms compared to control group
Change from baseline (Day -1) in severity of urinary symptoms will be evaluated by IPSS. Scores obtained in the group of patients treated with Hydeal Cyst® will be compared with scores obtained in the control group. Storage and voiding symptoms will be also estimated in both arms by IPSS-s and IPSS-v subscores.The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic) and the overall intensity of urinary symptoms is categorised in mild (score 1-7), moderate (score 8-19) and severe (score 20-35).
Measured: 25 days
Evaluation of changes from baseline in severity rate of urinary symptoms compared to control group
Change from baseline in severity and frequency of urinary symptoms, as evaluated by ICIQ-MLUTS in males and ICIQ-FLUTS in females. Scores obtained in the group of patients treated with Hydeal Cyst® will be compared with scores obtained in the control group.The ICIQ is a questionnaire for evaluating male lower urinary tract symptoms and impact on quality of life (QoL) .All items are evaluated using a score rated 0-4 for frequency and a score 0-10 for bothering, with higher scores corresponding to higher severity of symptoms.
Measured: 25 days
Evaluation of changes from baseline in severity of pelvic pain compared to control group
Change from baseline in severity of pelvic pain, as evaluated by means of a 0-100 mm visual analogue scale (VAS). Scores in the group of patients treated with Hydeal Cyst® will be compared with scores obtained in the control group.
Measured: 25 days
Duration of catheter implant as time of permanence of cathether implanted compared to control group
The time (hours) of permanence of catheter implanted will be counted for every patient and will be codified in classes (< 47 hours, 48 ± 1 hours, > 49 hours). The frequencies in the group of patients treated with Hydeal Cyst® will be calculated and compared with those of the control group. The analysis of the duration of catheter implant will be performed by means of a Chi-square test or a Fisher's Exact test on the analysis of classes (< 47 hours, 48 ± 1 hours, > 49 hours).
Measured: 49 hours
Rescue medication consumption after surgery compared to control group
The proportion of users and the amount of used rescue medication in the treated-group of patients with Hydeal Cyst® will be compared with those of the control group.
Measured: 25 days
Evaluation of quality of life using the EuroQoL-5D compared to control group
Quality of life will be evaluated using the EQ-5D-5L (QoL), as mean scores of patients treated with Hydeal Cyst® compared with scores of control group.The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: 25 days
Number of participants with treatment-related adverse events compared to the control group
Adverse Events (AEs) encountered will be reported and documented in the AE page of the e-CRF, whether considered to be related to the investigational device or not. If the Adverse Event is serious, the Serious Adverse Event Form must also be completed.
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start19 Aug 2020
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder Cancer (NMIBC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, randomized, controlled investigation
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicola Giordan, Study director, Fidia Farmaceutici s.p.a.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069453
- Sponsor's protocol ID
- UQP6-19-01
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06069453
- Acronym / sponsor ID
- UQP6-19-01
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric, randomized, controlled investigation
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Hyaluronic Acid (HA) sodium salt and Hydeal-DSolution containing Hyaluronic Acid (HA) sodium salt and Hydeal-D |
| Group B | No intervention | –standard management according to institutional protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic Acid (HA) sodium salt and Hydeal-Dintravesical solution containing Hyaluronic Acid (HA) sodium salt and Hydeal-D | Device | Group A |
Primary outcome
Evaluation of severity rate of storage symptoms (frequency, urgency, nocturia) compared to control group
Time frame: 3 days after catheter removal
Severity of storage symptoms will be evaluated through a patient's bladder diary
8 secondary outcomes
Evaluation of severity rate of storage symptoms (frequency, urgency, nocturia) compared to control group
Time frame: 25 days
Evaluation of changes from baseline in severity of urinary symptoms compared to control group
Time frame: 25 days
Evaluation of changes from baseline in severity rate of urinary symptoms compared to control group
Time frame: 25 days
Evaluation of changes from baseline in severity of pelvic pain compared to control group
Time frame: 25 days
Duration of catheter implant as time of permanence of cathether implanted compared to control group
Time frame: 49 hours
Rescue medication consumption after surgery compared to control group
Time frame: 25 days
Evaluation of quality of life using the EuroQoL-5D compared to control group
Time frame: 25 days
Number of participants with treatment-related adverse events compared to the control group
Time frame: 25 days
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Giordan study director
Fidia Farmaceutici s.p.a.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid (HA) sodium salt and Hydeal-D in people with Non-muscle Invasive Bladder Cancer (NMIBC), run by Fidia Farmaceutici s.p.a. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of severity rate of storage symptoms (frequency, urgency, nocturia) compared to control group (time frame: 3 days after catheter removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.