RECRUITING

Adjustable Continence Therapy (ACT) for the Treatment of Female SUI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant improvement in stress urinary incontinence.

Official Title

A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency

Quick Facts

Study Start:2021-01-26
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04248283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Female at least 22 years old
  2. 2. Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency
  3. 3. Provocative pad weight of greater than 11.0 grams
  4. 4. Candidate for surgical intervention
  5. 5. Negative urinalysis
  6. 6. Normal cystourethroscopy
  7. 7. Failed at least 6 months of previous treatment(s) for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc). Note: patients may have failed prior anti-incontinence procedures for SUI (e.g., suspension, sling, or urethral bulking agent)
  8. 8. Willing and able to sign informed consent and comply with trial follow-up requirements
  1. 1. Pregnant or lactating
  2. 2. Life expectancy of less than 5 years
  3. 3. Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucose over 130 mg/dL
  4. 4. Has auto-immune disease
  5. 5. Undergoing radiation therapy
  6. 6. Active urinary tract infection
  7. 7. Detrusor instability refractory to medication
  8. 8. Reduced bladder compliance as defined by a cystometrogram
  9. 9. Significant residual volume (greater than 100 ml) after voiding in which detrusor contraction is weak, when the bladder volume is greater than or equal to 250 ml
  10. 10. Has, had, or is suspected of having bladder cancer
  11. 11. History of bladder stones
  12. 12. Urethral stricture evidenced during cystourethroscopy
  13. 13. Has a neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
  14. 14. Has a diathesis, hemophilia, or a bleeding disorder
  15. 15. Has a rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse of grade 3 or higher
  16. 16. Had prior pelvic radiotherapy
  17. 17. Had a prior artificial urinary sphincter implanted
  18. 18. Has a neurogenic condition known to affect bladder/sphincter function

Contacts and Locations

Study Contact

Patrick Gora
CONTACT
763-694-9880
pgora@uromedica-inc.com
Timothy C Cook, PhD
CONTACT
763-694-9880
regulatory@uromedica-inc.com

Principal Investigator

Timothy C Cook, PhD
STUDY_DIRECTOR
Uromedica, Inc.

Study Locations (Sites)

University of Colorado
Denver, Colorado, 80045
United States
CHI Health Research Center
Omaha, Nebraska, 68124
United States

Collaborators and Investigators

Sponsor: Uromedica

  • Timothy C Cook, PhD, STUDY_DIRECTOR, Uromedica, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-26
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2021-01-26
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • Urinary Incontinence
  • Urination Disorders
  • Urination Involuntary
  • Urologic Diseases
  • Lower Urinary Tract Symptoms

Additional Relevant MeSH Terms

  • Urinary Incontinence
  • Urinary Incontinence,Stress