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AzTrials

Overactive BladderPhase 1/2INTIMO2NCT02674269

Safety and Efficacy Study of Intravesical Instillations of BotuGelTM, Slow Release RTGel Based Botox® Formulations, in Idiopathic OAB Patients With Urinary Incontinence ("INTIMO2")

A Phase 1/2 study testing 300 IU of BotuGelTM (60ml), 400 IU of BotuGelTM (60ml) and TC-3 Gel in people with Overactive Bladder, run by UroGen Pharma Ltd. at 2 sites in Israel.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The study will investigate the safety and efficacy of UroGen's TC-3 Gel for sustained release of Botulinum Toxin A (BTX) in urinary bladder in patients with idiopathic overactive bladder. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Overactive Bladder
What is being tested?
300 IU of BotuGelTM (60ml), 400 IU of BotuGelTM (60ml) and TC-3 Gel
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
2 sitesIsrael
Study dates
Oct 2016to Oct 2016
Phase
Phase 1/2
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  • Female patient 18 to 75 years old diagnosed with idiopathic OAB.
  • Patient has symptoms of OAB for ≥ 3 months prior to screening.
  • Patient is a non-responder to pharmacologic therapy or has intolerable side effects or is not compliant to the treatment.
  • On screening three-day voiding diary- Patient has a frequency of at least 8 micturitions per 24 hours \& Total of ≥3 urgency urinary incontinence (UUI) episodes.
  • Patient is willing and able to initiate self catheterization post-treatment, if required.
  • Patients has PVR ≤100 ml. Patient with a single PVR of >100 ml and followed by two consecutive PVR measurements of <100 ml may be included in the study).

Main Exclusion Criteria:

  • Patient currently uses CIC or indwelling catheter to manage their urinary incontinence
  • Patient who has clinically significant Bladder Outlet Obstruction (BOO).
  • Patient with active urinary tract infection.
  • OAB due to any known neurological reason.
  • Patient with 24-hour total urine volume voided greater than 3,000 ml as measured at screening visit.
  • Predominance of stress incontinence in the opinion of the investigator, determined by patient history.
  • Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening.
  • Patient with prior botulinum toxin therapy of any serotype within 12 weeks for any indication.
  • Patient with prior use of Botulinum toxin therapy of any serotype for any urological condition.
  • Patient with previous pelvic radiation therapy.
  • Patient had been treated for two or more UTIs within last 6 months or use of prophylactic antibiotics to prevent chronic UTIs.
  • ANY condition identified which may cause overactive bladder symptoms

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

  • Rambam Health Care Campus

    Haifa

  • Meir Medical Center

    Kfar Saba

Other trials in Israel

About this study

Official title: A Randomized Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Intravesical Instillations of BotuGelTM, Slow Release RTGel Based Botulinum Toxin (Botox®) Formulations, in Idiopathic OAB Patients With Urinary Incontinence ("INTIMO2")

The study will investigate the safety and efficacy of UroGen's TC-3 Gel for sustained release of Botulinum Toxin A (BTX) in urinary bladder in patients with idiopathic overactive bladder.

Read the detailed description

Overactive bladder (OAB) is a syndrome, defined by the International Continence Society (ICS), as the presence of "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of a urinary tract infection (UTI) or other obvious pathology." This study will evaluate a new of mode of treatment, with intravesical bladder instillation with Botox® mixed with TC-3 that may bypass the drawbacks of the current bladder injection treatment mode in OAB patients. Additionally it will provide preliminary safety and efficacy data that may serve as a basis for a larger study exploring safety and efficacy aspects of this new mode of treatment.

50 patients will be randomized in a horse race fashion in a ~2:2:1 ratio. The patients will be screened for up to 3 weeks prior to treatment.

The patients will be requested to stop their OAB medications 7 days prior to treatment visit. 20 patients will receive one instillation of 300U of BotuGel (60ml), 20 patients will receive one instillation of 400U of BotuGel (60ml) and 10 patients will receive one instillation of 60 ml RTGel-TC-3 Gel (Placebo), all patients will be followed up for safety and efficacy endpoints until 6 weeks post instillation.

Being tested
300 IU of BotuGelTM (60ml), 400 IU of BotuGelTM (60ml), TC-3 Gel
Keywords
Overactive bladder, Botox, TC-3 Gel, Intravesical, UroGen Pharma, Botulinum Toxin, Urgency, OAB, Incontinence, I-QOL, KHQ, TBS, RTG
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 300 IU of BotuGelTM (60ml)Drug

    Also called BotuGelTM 300

    One intravesical instillation of 300 IU of botox in 60 ml of TC-3 gel

  • 400 IU of BotuGelTM (60ml)Drug

    Also called BotuGelTM 400

    One intravesical instillation of 400 IU of botox in 60 ml of TC-3 gel

  • TC-3 GelDevice

    Intravesical instillation of 60 ml TC-3 gel

Study groups in NCT02674269
Study groupRoleWhat they receive
300 IU of BotuGelTM (60ml)ExperimentalOne intravesical instillation of 300 IU of botox in 60 ml of TC-3 gel
Receives: Drug: 300 IU of BotuGelTM (60ml)
400 IU of BotuGelTM (60ml)ExperimentalOne intravesical instillation of 400 IU of botox in 60 ml of TC-3 gel
Receives: Drug: 400 IU of BotuGelTM (60ml)
TC-3 GelPlacebo comparatorOne intravesical instillation of 60 ml TC-3 gel
Receives: Device: TC-3 Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urinary retention

    Urinary retention events defined as a PVR >200 and <350 ml with patient reported symptoms that in the investigator's opinion require initiation of CIC, or PVR≥350 regardless of symptoms.

    Measured: 6 weeks

  2. Urinary tract infection (UTI) events

    Urinary tract infection (UTI) events*

    *Asymptomatic bacteruria will not be considered UTI and will be reported as separate AEs.

    Measured: 6 weeks

  3. Post-void residual (PVR)

    PVR-Change from baseline in PVR as measured by bladder ultrasonography at week 4 post instillation

    Measured: 6 weeks

  4. Adverse events

    Adverse events during and post instillation procedure.

    Measured: 6 weeks

Secondary outcomes (5)

  1. 3-day voiding Diary

    3-day voiding Diary

    • Change from baseline in number of Urgency episodes and Urinary Incontinence episodes/24h
    • Change from baseline in number of voids/24h
    • Change from baseline in number of nocturnal voids per night (Based on individual patient's night and day hours)
    • Change from baseline in Mean volume voided per micturition/24h

    Measured: Week 4 and 6 post-instillation

  2. Kings Health Questionnaire (KHQ score) comparing to baseline

    KHQ score comparing to baseline

    Measured: Week 4 and 6 post-instillation

  3. Incontinence Quality of Life Questionnaire (I-QOL)

    I-QOL score comparing to baseline

    Measured: Week 4 and 6 post-instillation

  4. Treatment Benefit Scale (TBS)

    Proportion of patients who had positive treatment response per Treatment Benefit Scale (TBS)

    Measured: Week 4 and 6 post-instillation

  5. Comparison of resulted delta scores between the treatment arms and Placebo

    Measured: Week 4 and 6 post-instillation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2016 (estimated)
  2. Study startOct 2016 (estimated)
  3. Primary completionOct 2016 (estimated)
  4. Study completionOct 2016 (estimated)

Why it stopped: UroGen's RTGelTM delivery system technology for use with neurotoxins licensed to Allergan plc before the activation of this trial.

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02674269
Sponsor's protocol ID
TC-OAB-03-P
Acronym
INTIMO2
Status last verified
Jun 2017
First submitted
1 Feb 2016
Last updated
16 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 300 IU of BotuGelTM (60ml), 400 IU of BotuGelTM (60ml) and TC-3 Gel in people with Overactive Bladder, run by UroGen Pharma Ltd. at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: withdrawn, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Urinary retention (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02674269.

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 16 Jun 2017.

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