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

NCT02179099 | Terminated Phase 1

• 1 other identifier: TC-OAB-02
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder

Keywords

overactive bladder; OAB; urgency; botulinum toxin; BTX; botox; intravesical; TheraCoat; TCGel; TC-3 Gel

Outcome Measures

Primary Outcomes (2)

• 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.

  16 weeks

• 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).

  16 weeks

Secondary Outcomes (1)

• exploratory efficacy

  16 weeks

Study Arms (1)

BTX mixed with TC-3 Gel

EXPERIMENTAL

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

Device: BTX mixed with TC-3 Gel

Interventions

BTX mixed with TC-3 Gel DEVICE

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

Also known as: TCGel, TheraCoat hydrogel, Botox, botulinum toxin A, BTX

BTX mixed with TC-3 Gel

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• UroGen Pharma Ltd.: lead

Study Sites (1)

Urology Department, Edith Wolfson Medical Center

Holon, Israel

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ami Sidi, Prof MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2014
• First Posted: July 1, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

IL (1)