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Active Clinical Trials

VESICAL

Pending NCT:
03082118
West Penn Hospital
West Penn Hospital

Sponsor: 
Solace Therapeutics, Inc.
Contact: 

For more information, please contact Erin Baldauf at 412-578-4517 or Erin.Baldauf@ahn.org

Vesair Continued Access Trial: Use of the Vesair® Bladder Control System in the Treatment of Post-Menopausal Female Subjects With Stress Urinary Incontinence

Purpose: 

Single arm study of the Vesair Balloon in postmenopausal women.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Post-menopausal women with SUI or stress predominant mixed incontinence
  • Maximum score on IQOL of 60
  • Positive cough test for leakage
  • Willing to undergo procedures
  • Free from infection
  • Have previously tried (and failed) noninvasive treatment for SUI

Exclusion Criteria:

  • SUI due to SUI
  • Urge-predominant mixed incontinence
  • Incontinence of neurogenic etiology
  • 2 or more UTIs in past year and 1 in past 3 months
  • Surgery for SUI in the past 6 months
  • taking medication that can be used to treat SUI
  • taking medication that affects urinary symptoms for less than 3 months
  • undergoing biofeedback
  • Grade 3 or worse cystocele
  • last menstrual period within 12 months
  • oral progesterone or estrogen in the past 12 months
  • BMI > 40
  • involuntary detrusor contractions or discomfort during bladder filling
  • previous stage III or worse cancer
  • previous cancer of the urinary tract
  • previous symptoms for early stage cancer in the past 2 years
  • anticoagulation therapy other than aspirin
  • history of prosthetic heart valve
  • neurological or connective tissue condition or disease affecting bladder function
  • known allergy to device components