A Study of the Effectiveness of Transvaginal Administration of Botulinum-A Toxin for the Treatment of Women with Over Active Bladder (OAB) Syndrome

Overview

About this study

The purpose of this study is to assess the effectiveness and side effects of Botox solution injected through the vagina for the treatment of patients who have over active bladder (OAB), by assessing changes in an Incontinence Quality of Life Score, after three months.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

 Inclusion Criteria

  • Females
  • 18 years or older
  • No evidence of stress urinary incontinence on physical examination or  previous urodynamics
  • Has failed prior drug therapy for overactive bladder or symptoms or has never taken pharmacologic therapy
  • Symptoms and signs of OAB, characterized by symptoms of urgency, with or without urge incontinence, usually with frequency and nocturia 
  • Is mentally competent with the ability to understand and comply with the requirements of the study
  • Agrees to be available for follow-up evaluations as required by the protocol
  • Has given signed informed consent

Exclusion Criteria

  • Post-Void Residual Urine (PVRU) greater than 100 ml on repeated measures
    • A single PVRU of >100 ml and followed by two consecutive PVRU measurements of <100 ml may be included in the study
  • A history of greater than vesicoureteral reflux grade 1, interstitial cystitis, or genitourinary fistulae
  • 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
  • Uninvestigated hematuria
  • Lower tract genitourinary malignancies
  • On current medication for stress urinary incontinence such as alpha-adrenergic or imipramine prior to initiating study
  • Has ongoing complications of prior anti-incontinence surgery
  • Is pregnant, lactating, or planning to become pregnant within the study period
  • Has received pelvic radiation
  • Any condition, which could lead to significant postoperative complications, including current infection and uncontrolled diabetes
  • Is morbidly obese (defined as BMI >  40 Kg/m2)
  • Is bedridden, institutionalized or in such physical condition that she cannot move to the closest bathroom without assistance from another person
  • Has current or acute urinary tract infection, including cystitis or urethritis (such infections should be treated with antibiotics with subsequent urinalysis tests confirming the absence of infection before study inclusion)
  • Any condition that would preclude treatment due to contraindications and/or warnings in the study product’s labeling
  • On immunomodulatory therapy (suppressive or stimulatory)
  • Known lidocaine hypersensitivity or hypersensitivity to any anesthetics
  • A concurrent use of another study product within two weeks prior to study start, or concurrently participating in any other clinical study
  • Any disease that in the opinion of the Investigator would make the patient unsuitable for the study
  • A life expectancy of less than 12 months
  • Has received Botox for any other diagnosis within 90 days of study initiation
  • Has active neurologic disease   

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Steven Petrou, M.D.

Open for enrollment

Contact information:

Kaitlynn Custer

(904)953-9464

Custer.Kaitlynn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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