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

Primary Purpose

Overactive Bladder

Status

Withdrawn

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

300 IU of BotuGelTM (60ml)

400 IU of BotuGelTM (60ml)

TC-3 Gel

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder, Botox, TC-3 Gel, Intravesical, UroGen Pharma, Botulinum Toxin, Urgency, OAB, Incontinence, I-QOL, KHQ, TBS, RTG

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Rambam Health Care Campus
Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

300 IU of BotuGelTM (60ml)

400 IU of BotuGelTM (60ml)

TC-3 Gel

Arm Description

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

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

One intravesical instillation of 60 ml TC-3 gel

Outcomes

Primary Outcome Measures

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.

Urinary tract infection (UTI) events

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

Post-void residual (PVR)

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

Adverse events

Adverse events during and post instillation procedure.

Secondary Outcome Measures

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

Kings Health Questionnaire (KHQ score) comparing to baseline

KHQ score comparing to baseline

Incontinence Quality of Life Questionnaire (I-QOL)

I-QOL score comparing to baseline

Treatment Benefit Scale (TBS)

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

Comparison of resulted delta scores between the treatment arms and Placebo

Full Information

NCT ID

NCT02674269

First Posted

February 1, 2016

Last Updated

June 15, 2017

Sponsor

UroGen Pharma Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02674269

Brief Title

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

Acronym

INTIMO2

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")

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Withdrawn

Why Stopped

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

Study Start Date

October 2016 (Anticipated)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UroGen Pharma Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

300 IU of BotuGelTM (60ml)

Arm Type

Experimental

Arm Description

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

Arm Title

400 IU of BotuGelTM (60ml)

Arm Type

Experimental

Arm Description

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

Arm Title

TC-3 Gel

Arm Type

Placebo Comparator

Arm Description

One intravesical instillation of 60 ml TC-3 gel

Intervention Type

Drug

Intervention Name(s)

300 IU of BotuGelTM (60ml)

Other Intervention Name(s)

BotuGelTM 300

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

400 IU of BotuGelTM (60ml)

Other Intervention Name(s)

BotuGelTM 400

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

TC-3 Gel

Intervention Description

Intravesical instillation of 60 ml TC-3 gel

Primary Outcome Measure Information:

Title

Urinary retention

Description

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.

Time Frame

6 weeks

Title

Urinary tract infection (UTI) events

Description

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

Time Frame

6 weeks

Title

Post-void residual (PVR)

Description

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

Time Frame

6 weeks

Title

Adverse events

Description

Adverse events during and post instillation procedure.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

3-day voiding Diary

Description

Time Frame