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

NCT02674269 | Withdrawn Phase 1

• 1 other identifier: TC-OAB-03-P
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Overactive Bladder

Keywords

Overactive bladder; Botox; TC-3 Gel; Intravesical; UroGen Pharma; Botulinum Toxin; Urgency; OAB; Incontinence; I-QOL; KHQ; TBS; RTG

Outcome Measures

Primary Outcomes (4)

• 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.

  6 weeks

• Urinary tract infection (UTI) events

  Urinary tract infection (UTI) events\* \*Asymptomatic bacteruria will not be considered UTI and will be reported as separate AEs.

  6 weeks

• Post-void residual (PVR)

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

  6 weeks

• Adverse events

  Adverse events during and post instillation procedure.

  6 weeks

Secondary Outcomes (5)

• 3-day voiding Diary

  Week 4 and 6 post-instillation

• Kings Health Questionnaire (KHQ score) comparing to baseline

  Week 4 and 6 post-instillation

• Incontinence Quality of Life Questionnaire (I-QOL)

  Week 4 and 6 post-instillation

• Treatment Benefit Scale (TBS)

  Week 4 and 6 post-instillation

• Comparison of resulted delta scores between the treatment arms and Placebo

  Week 4 and 6 post-instillation

Study Arms (3)

300 IU of BotuGelTM (60ml)

EXPERIMENTAL

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

Drug: 300 IU of BotuGelTM (60ml)

400 IU of BotuGelTM (60ml)

EXPERIMENTAL

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

Drug: 400 IU of BotuGelTM (60ml)

TC-3 Gel

PLACEBO COMPARATOR

One intravesical instillation of 60 ml TC-3 gel

Device: TC-3 Gel

Interventions

300 IU of BotuGelTM (60ml) DRUG

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

Also known as: BotuGelTM 300

300 IU of BotuGelTM (60ml)

400 IU of BotuGelTM (60ml) DRUG

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

Also known as: BotuGelTM 400

400 IU of BotuGelTM (60ml)

TC-3 Gel DEVICE

Intravesical instillation of 60 ml TC-3 gel

TC-3 Gel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• UroGen Pharma Ltd.: lead

Study Sites (2)

Rambam Health Care Campus

Haifa, Israel

Location

Meir Medical Center

Kfar Saba, 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

• Ifat Klein, PhD

  iklein@urogen.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 4, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 16, 2017

Record last verified: 2017-06

Locations

IL (2)