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Overactive Bladder Syndrome: Incobotulinumtoxin Versus Onabotulinumtoxin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03758235
Recruitment Status : Active, not recruiting
First Posted : November 29, 2018
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Antonella Giannantoni, University Of Perugia

Brief Summary:

The aim of the original study was to compare Incobot/A versus Onabot/A in order to evaluate if the differences in the pharmacologic formulations between the two drugs could affect their efficacy and safety in the treatment of neurogenic overactive bladder (OAB).

In the original study protocol two different dosages for either Incobot/A and Onabot/A (200 U and 100 U) were considered, to treat patients with neurogenic detrusor overactivity incontinence performing intermittent catheterization (IC) with higher dosages and those able to void spontaneously with lower dosage, with the resulting four treatment groups. For such a study, a very large sample of participants should have been treated and followed up, to have adequate power to demonstrate the hypothesis. At the end of last February 2020, we had to temporarily stop all the clinical activities related to the study and patients' recruitment, due to the occurrence of Sars-Cov-2 pandemic in our Country. At that point, a non-inferiority study seemed to be possible and adequate, and we adapted the protocol accordingly. In addition, on the basis of previously published information, we could hypothesize that the new drug (Incobot/A) would have had at least a roughly similar effect to the control drug (Onabot/A). In order to perform a non-inferiority study, the power and sample size analysis have been re-planned.

Thus, we perform a not planned interim analysis to show the preliminary results of an ongoing, non-inferiority trial in which patients' recruitment temporarily stopped due to incontrollable external factors. The present study will be aimed to assess the non-inferiority of Incobot/A compared to Onabot/A on the efficacy and safety parameters, in the treatment of patients with refractory NDOI performing IC, who are randomized to receive 200 U of Incobot/A or Onabot/A intradetrusor injections and who are followed up to 12 wks after treatment


Condition or disease Intervention/treatment Phase
Overactive Bladder Syndrome Drug: IncobotulinumtoxinA 100 UNT Injection [Xeomin] Drug: OnabotulinumtoxinA 100 UNT [Botox] Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to the 4 groups (Incobot/A Group different dosages, or Onabot/A Group different dosages ) in parallel for the duration of the study.
Masking: Double (Participant, Investigator)
Masking Description: Partecipants, investigators and outcomes assessor
Primary Purpose: Treatment
Official Title: Incobotulinumtoxin Versus Onabotulinumtoxin in the Treatment of Patients With Overactive Bladder Syndrome
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Incobot/A 100 U
Incobot/A 100 U diluted in 10 ml of sodium chloride solution 0.9% by endoscopic detrusor injections (20 injections, 0.5 ml of solution for each injection) will be administered in patients able to perform spontaneous micturitions
Drug: IncobotulinumtoxinA 100 UNT Injection [Xeomin]
Incobot/A intradetrusor injections under cystscopic guidance, with local anaethesia in an outpatient basis
Other Name: Incobot/A

Experimental: Incobot/A 200 U
Incobot/A 200 U diluted in 30 ml of sodium chloride solution 0.9% by endoscopic detrusor injections (30 injections, 1 ml of solution for each injection) will be administered in patients performin intermittent catheterization.
Drug: IncobotulinumtoxinA 100 UNT Injection [Xeomin]
Incobot/A intradetrusor injections under cystscopic guidance, with local anaethesia in an outpatient basis
Other Name: Incobot/A

Active Comparator: Onabot/A 100 U
Onabot/A 100 U diluted in 10 ml of sodium chloride solution 0.9% by endoscopic detrusor injections (20 injections, 0.5 ml of solution for each injection) will be administered in patients able to perform spontaneous micturitions
Drug: OnabotulinumtoxinA 100 UNT [Botox]
Onabot/A intradetrusor injections under cystscopic guidance, with local anaethesia in an outpatient basis
Other Name: Onabot/A

Active Comparator: Onabot/A 200 U
Onabot/A 200 U diluted in 30 ml of sodium chloride solution 0.9% by endoscopic detrusor injections (30 injections, 1 ml of solution for each injection) will be administered to patients performing intermittent catheterization
Drug: OnabotulinumtoxinA 100 UNT [Botox]
Onabot/A intradetrusor injections under cystscopic guidance, with local anaethesia in an outpatient basis
Other Name: Onabot/A




Primary Outcome Measures :
  1. Change from baseline in the frequency of urinary incontinence episodes. [ Time Frame: 24 weeks ]
    change from baseline in the daily frequency of urinary incontinence episodes, as assessed by the 3-day voiding diary.

  2. Evaluation of frequency of urinary tract infections in both arms of treatment. [ Time Frame: 2, 12, 24 weeks ]
    Measurement of eventual differencies between the two arms of treatment in the frequency of urinary tract infections at 2, 12 and 24 weeks after treatment


Secondary Outcome Measures :
  1. Change from baseline in urodynamic parameters. [ Time Frame: 24 weeks ]
    Significant improvements in urodynamic parameters (maximum cystometric capacity, maximum detrusor pressure during first involuntary detrusor contraction) at 12 and 24 weeks as compared to baseline.

  2. Change from baseline in Incontinence Quality of Life (I-QoL) questionnaire total score. [ Time Frame: 2, 12, 24 weeks ]
    Significant improvement in I-QoL total score at 2, 12 and 24 weeks as compared to baseline.

  3. Recording of the adverse events. [ Time Frame: 2, 12, 24 weeks ]
    Assessment of possible adverse events-AE (systemic AEs: fatigue, weakness, dyspnoea, gastrointestinal irritation, Flu-like symptoms, dizziness; local AEs: haematuria, dysuria, urinary retention, post-void residual volume > 150 ml) at 2, 12 and 24 weeks after treatment.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients (males and females) with neurogenic urge urinary incontinence (UUI) (with urgency, increase in day- time and night- time urinary frequency) and with urodynamic diagnosis of DO;
  • 18- 80 years;
  • women of childbearing age, who use a reliable method of contraception throughout the study period (a pregnancy test must be performed during enrolment in the study);
  • spinal cord injury at or below T1, diagnosed at least 6 months before the screening in case of a vesico-sphincter dysfunction due to spinal cord injury;
  • EDSS score ≤ 6, in MS patients;
  • patients refractory to anticholinergic therapy (≥ 1 anticholinergic agent)
  • application of intermittent catheterizations to empty the bladder. In the case of spontaneous micturition, the patients should agree for the use of intermittent catheterizations, in case this will be necessary after treatment with the detrusor injection of botulinumtoxin A.

Exclusion Criteria:

  • recurring urinary tract infections (UTIs) (≥ 4 episodes/year);
  • spinal cord injuries above T1;
  • MS patients: EDSS score ≥ 6;
  • patients who won't or can't perform intermittent catheterization;
  • pregnancy or breast- feeding, if female patients;
  • post- void residual volume (PRV) > 150 ml, in the case of spontaneous micturition;
  • hypersensitivity to the active substance or to any of the excipients (listed in section 6.1 of RCP);
  • generalized diseases of muscular activity (e.g. myasthenia gravis, Lambert-Eaton syndrome);
  • presence of infection or inflammation at the injection site;
  • patients with acute urinary retention at the time of treatment, not routinely subjected to catheterization;
  • men with overactive bladder and signs or symptoms of urinary obstruction should not be treated;
  • documented or suspected active malignant neoplasia or previous history, within 2 years prior to screening;
  • patients who must or want to continue taking illegal drugs or drugs that may interfere with the proper conduct of the study;
  • chronic abuse of alcohol or drugs or any condition that in the opinion of the investigator doctor makes an unreliable subject in correctly completing the study procedures;
  • any other clinical condition that would endanger the safety of patients in participating in the study or that could prevent the subjects from adhering to the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758235


Locations
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Italy
Antonella Giannantoni
Siena, SI, Italy, 53100
Sponsors and Collaborators
University Of Perugia
Investigators
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Principal Investigator: Antonella Giannantoni, M.D. University of Siena
Study Chair: Emanuele Rubilotta, MD Universita di Verona
Study Director: Matteo Balzarro, MD Universita di Verona
Publications of Results:

Other Publications:
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Responsible Party: Antonella Giannantoni, PA, University Of Perugia
ClinicalTrials.gov Identifier: NCT03758235    
Other Study ID Numbers: Inco_Ona
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Antonella Giannantoni, University Of Perugia:
overactive bladder syndrome
botulinum toxin type A
onabotulinumtoxin/A
incobotulinumtoxin/A
treatment
neurogenic detrusor overactivity incontinence
urinary incontinence
urinary tract infections
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Syndrome
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Botulinum Toxins, Type A
incobotulinumtoxinA
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents