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Overactive BladderPhase 1/2NCT02179099

Safety and Efficacy of Intravesical Botulinum Toxin in TC-3 Gel in OAB Patients

A Phase 1/2 study testing BTX mixed with TC-3 Gel in people with Overactive Bladder, run by UroGen Pharma Ltd. at 1 site in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a single arm pilot study evaluating the feasibility and preliminary safety of a single intravesical instillation of TC-3 gel mixed with botulinum toxin (BTX) for symptomatic improvement in overactive bladder patients. Read more about this study

Who is it for?
Ages 18 to 85 years, women only
Conditions the study is for
Overactive Bladder
What is being tested?
BTX mixed with TC-3 Gel
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteIsrael
Study dates
Jul 2014to Feb 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 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female 18 to 85 years old with symptoms of idiopathic OAB for ≥ 3 months prior to screening.
  • Patient has signed Informed Consent Form and is willing and able to comply with all requirements of the protocol, including proper completion of the voiding diaries and self-administered questionnaires.
  • Patient is non-responder to anticholinergic or beta-agonist drug therapy or is not compliant to the treatment due has intolerable side effects.
  • Patient has urination frequency of at least 8 micturitions per 24 hours.
  • Patients has at least 3 urinary urgency incontinence (UUI) episodes per 3-day bladder diary, with no more than 1 incontinence-free day.
  • 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).
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  • If patient is a female of childbearing potential, she has a negative urine pregnancy test at screening visit and practice a reliable method of contraception throughout the study, until 6 months post treatment.
  • Patient is mentally competent with the ability to understand and comply with the requirements of the study.
  • Patient does not have active urinary tract infection as confirmed by urine culture. In case of UTI proven by urine culture, the patient will be treated with full course of antibiotics, and the instillation will be postponed for 1 week following negative urine culture demonstration.

Who cannot join

  • Pregnant (positive urine pregnancy test), planning to become pregnant during the study period, breast-feeding, or of childbearing potential and not practicing reliable contraception**.
  • Patient has a clinically significant Bladder Outlet Obstruction (BOO).
  • Patient has neurogenic bladder.
  • Patient currently uses Clean Intermittent Catheterization (CIC).
  • Patient has documented unstable diabetes with or without diabetic neuropathy.
  • Patient who is currently undergoing biofeedback, pelvic muscle rehabilitation, pelvic floor physical therapy, or electrical-stimulation.
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  • Patient with 24-hour total urine volume voided greater than 3,000 ml as measured at screening period.
  • Patient with vesico-ureteral reflux, interstitial cystitis, genitourinary fistulae
  • Patient with pelvic organ prolapse stage III or IV, (i.e. the most distal part of the prolapse protruding more than 1 cm beyond the hymen at straining)
  • Patient with lower tract genitourinary malignancies
  • Patient with prior anti-incontinence surgery and interventions including mid-urethral slings, Burch bladder suspension, sacral neuromodulation, or tibial nerve stimulation.
  • Patient with prior Botox anti-incontinence therapy.
  • Patient with previous pelvic radiation therapy
  • Patient who is morbidly obese (BMI > 40 Kg/m2).
  • Patient had been treated for 2 or more UTIs within last 6 months.
  • Patient on immunomodulatory therapy (suppressive or stimulatory)
  • Patient participated in prior clinical trials with BTX+TC-3 gel
  • Patient has current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc).
  • Subject has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study.
  • Patient with a life expectancy of less than 12 months.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Urology Department, Edith Wolfson Medical Center

    Holon

Other trials in Israel

About this study

Official title: Pilot Study Evaluating Safety and Efficacy of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in OAB Patients

This is a single arm pilot study evaluating the feasibility and preliminary safety of a single intravesical instillation of TC-3 gel mixed with botulinum toxin (BTX) for symptomatic improvement in overactive bladder patients.

Read the detailed description

BTX is considered as therapeutic option for overactive bladder (OAB). Randomized placebo-controlled studies have shown that BTX administered by intramural injection into the bladder wall in patients with OAB leads to significant improvement in urodynamic parameters and quality of life. (Schurch 2008). On the other hand, the animal study suggests that intravesically applied BTX acts to decrease frequency of bladder contraction by inhibiting sensory mechanism in the urothelium rather than directly through inhibition of the smooth muscle contraction. (Khera 2005). The efficacy of intravesical BTX instillation was only tested in a few open label trials for overactive bladder patients whereby the clinical improvement observed was short-lasting with a mean duration of 6.8 weeks (Petrou 2009, Krhut 2011). The short exposure duration of the urothelium to BTX could be one of the factors responsible for the lack of a sustained effect. TC-3 is a hydrogel with reverse thermal gelation properties that when mixed with BTX and instilled intravesically serves as the drug reservoir allowing for gradual release of BTX and thereby for its extended contact with bladder urothelium.

Being tested
BTX mixed with TC-3 Gel
Keywords
overactive bladder, OAB, urgency, botulinum toxin, BTX, botox, intravesical, TheraCoat, TCGel, TC-3 Gel
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.

  • BTX mixed with TC-3 GelDevice

    Also called TCGel, TheraCoat hydrogel, Botox, botulinum toxin A

    Patients will be treated with a single intravesical instillation of 40 ml TC-3 gel mixed with 300U BTX

Study groups in NCT02179099
Study groupRoleWhat they receive
BTX mixed with TC-3 GelExperimentalPatients will be treated with a single intravesical instillation of 40 ml TC-3 gel mixed with 300U BTX
Receives: Device: BTX mixed with TC-3 Gel

What is being measured

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

  1. Safety

    1. Adverse events measured during entire study period. Adverse events will be graded according to the Common Toxicity Criteria on a scale of 0 to 5.
    2. Presence of the urinary retention defined as a PVR >200 ml.

    Measured: 16 weeks

  2. Efficacy

    1. Number of urinary urge episodes in 24-hour period per 3-day voiding diary (primary endpoint - week 12 post instillation)
    2. Proportion of patients who had positive treatment response per Treatment Benefit Scale (TBS) (primary endpoint - week 12 post instillation).

    Measured: 16 weeks

Secondary outcomes (1)

  1. exploratory efficacy

    1. Number of voids in 24-hour period per 3-day voiding diary (primary endpoint - week 12 post instillation)
    2. Number of urge incontinence episodes in 24-hour period per 3-day voiding diary (primary endpoint - week 12 post instillation)
    3. Number of nocturnal voids per night per 3-day voiding diary (primary endpoint - week 12 post instillation).
    4. Post Void Residual Volume (PVR) as measured by bladder ultrasonography (primary endpoint - week 12 post instillation)
    5. KHQ score (Kings Health Questionnaire) (primary endpoint - week 12 post instillation).
    6. I-QOL score (Incontinence Quality of Life questionnaire) (primary endpoint - week 12 post instillation).

    Measured: 16 weeks

Timeline

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

  1. First posted1 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionNov 2015
  4. Study completionFeb 2016

Why it stopped: Decision to open a randomized controlled trial with two groups receiving different Botulinum Toxin in comparison to placebo group.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02179099
Sponsor's protocol ID
TC-OAB-02
Status last verified
Feb 2016
First submitted
29 Jun 2014
Last updated
1 Mar 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BTX mixed with TC-3 Gel in people with Overactive Bladder, run by UroGen Pharma Ltd. at 1 site in Israel.

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 9 inclusion and 20 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 1 Mar 2016. 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 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. 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 stopped early (reason given: Decision to open a randomized controlled trial with two groups receiving different Botulinum Toxin in comparison to placebo group.). 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?

Safety (time frame: 16 weeks). The study lists 2 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 NCT02179099.

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 1 Mar 2016.

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