Over Active Bladder Instillation Study - Botox
Condition: Overactive Bladder; Urinary Urge Incontinence; Urinary Incontinence; Detrusor Hyperreflexia; Urge Incontinence
MeSH terms: Reflex, Abnormal; Urinary Incontinence; Enuresis; Urinary Bladder, Overactive; Urinary Incontinence, Urge
Intervention: Botox Instillation; DMSO Instillation
Intervention description: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.; DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
Intervention MeSH terms: Botulinum Toxins, Type A; Dimethyl Sulfoxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: OAB; Over Active Bladder; overactive bladder; Urinary Urge Incontinence; Urinary Incontinence; Botox; DMSO; bladder instillation; instillation; detrusor hyperreflexia; urge incontinence

Summary:

      The purpose of this study is to determine whether women with overactive bladder (OAB) who
      receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl
      Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms
      when compared to a similar group of women with OAB who receive instillation of DMSO only.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patient aged 18 years or older

          -  No evidence of stress urinary incontinence on physical examination or urodynamics

          -  Patients who have failed prior drug therapy for overactive bladder or detrusor
             hyperreflexia

          -  Patients with symptoms and signs of OAB, detrusor hyperreflexia, urinary urgency,
             urinary urge incontinence.

          -  Patient who is mentally competent with the ability to understand and comply with the
             requirements of the study

          -  Patient who agrees to be available for the follow-up evaluations as required by the
             protocol

          -  Patient who has given signed informed consent

        Exclusion Criteria:

          -  Patient with Post-Void Residual Urine (PVRU) greater than 100 ml on repeated measures.
             (Patient with a single PVRU of >100 ml and followed by two consecutive PVRU
             measurements of <100 ml may be included in the study)

          -  Patient with greater than vesicoureteral reflux grade 1, 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 (>+1), at straining

          -  Patient with un-investigated hematuria

          -  Patient with lower tract genitourinary malignancies

          -  Patient on current medication for stress urinary incontinence, such as
             alpha-adrenergic agonists or duloxetine, within three weeks prior to completing the
             baseline Bladder Diary (estrogen therapy on a stable dose for at least two months
             prior to study start is allowed)

          -  Patient with ongoing complications of prior anti-incontinence surgery

          -  Patient who is pregnant, lactating, or planning to become pregnant within the study
             period

          -  Patient who has received pelvic radiation

          -  Patient with any condition, which could lead to significant postoperative
             complications, including current infection and uncontrolled diabetes.

          -  Patient who is morbidly obese (defined as BMI > 40 Kg/m2)

          -  Patient who is bedridden, institutionalized or in such physical condition that she
             cannot move to the closest bathroom without assistance from another person

          -  Patient with current or acute urinary tract infection, including cystitis or
             urethritis. (Patient with such infections should be treated with antibiotics, with
             subsequent urinalysis tests confirming the absence of such infection before study
             inclusion)

          -  Patient with any condition that would preclude treatment due to contraindications
             and/or warnings in the study product's labeling

          -  Patient on immunomodulatory therapy (suppressive or stimulatory)

          -  Patient with known lidocaine hypersensitivity or hypersensitivity to any anesthetics
             to be used during the treatment session/surgical procedure

          -  Patient with a concurrent use of another study product within two weeks prior to study
             start, or who concurrently participate in any other clinical study

          -  Any disease that in the opinion of the Investigator would make the patient unsuitable
             for the study

          -  Patient with a life expectancy of less than 12 months