Trial Search Results

Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

The primary purpose of this study is to demonstrate the safety and effectiveness of Bulkamid® in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Contura

Collaborator: Regulatory and Clinical Research Institute (RCRI)

Stanford Investigator(s):

Intervention(s):

  • Device: Bulkamid
  • Device: Contigen

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Be female 18 or more years of age.

   - Females of childbearing potential or <2 years post-menopausal must be using 2 forms of
   contraception.

   - Suffer from SUI for at least 6 months.

   - Have failed 2 previous non-invasive therapies for 3 months each.

   - Have at least 3 incontinence episodes measured over 3 days.

   - Have a baseline 24h pad test weight greater than or equal to 5 gm.

   - Have VLPP ≤ 100 cm H2O.

   - Have maximum cystometric capacity equal or higher than (≥) 250 mL.

   - Have PVR urine ≤ 100 mL.

   - Have a life expectancy of more than 2 years.

Exclusion Criteria:

   - Has urethral hypermobility >30 deg.

   - Has predominant urge incontinence.

   - Has detrusor overactivity.

   - Regularly or intermittently users of urethral catheter.

   - Has had previous radiation treatment in the pelvic floor.

   - Has had previous urethral surgery (i.e. fistula, diverticula)or urethral bulking.
   Failed sling or colposuspension procedure for at least 6 months may be included.

   - Suffers from known polyuria.

   - Has had three (3) or more culture-proven bacterial UTIs in the last 12 months.

   - Has a current infection (urethritis, cystitis or vaginitis).

   - Has unevaluated hematuria.

   - Has a Prolapse Stage greater than II.

   - Has a BMI>35 kg/m2.

   - Is taking pharmacological treatment for stress urinary incontinence, 4 weeks prior to
   screening.

   - Is allergic to bovine collagen.

   - Is known to suffer from severe allergies or anaphylaxis.

   - Suffers from autoimmune diseases (e.e. connective tissue diseases) that could confound
   the treatment.

   - Is currently taking or has taken systemic corticosteroids within the past 3 months.

   - Currently has cancer or has a history of any cancer within the past 5 years (skin
   cancer with no evidence of skin malignancy, for at least 2 years, can be included).

   - Currently suffering from unstable cardiovascular disease, cancer or uncontrolled
   diabetes.

   - Has active herpes genitalis.

   - Is currently participating in any other clinical trial or has participated in another
   clinical trial within 3 months of screening/baseline visit.

   - Is pregnant, lactating or intending to become pregnant.

   - Is not physically able to perform study procedure.

   - Has a neurogenic bladder

   - Had a vaginal delivery within 3 months prior to screening.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Tine Bjornlund
6507247826
Recruiting