We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    act | Recruiting Studies | Urinary Incontinence | Studies with Female Participants
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04248283
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : December 5, 2022
Sponsor:
Information provided by (Responsible Party):
Uromedica

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Urinary Incontinence,Stress Device: Adjustable Continence Therapy for Women (ACT) Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 167 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A prospective, single arm, non-randomized, multicenter, prospective case-series trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
Actual Study Start Date : January 26, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Adjustable Continence Therapy for Women
Implantation of the Adjustable Continence Therapy for the treatment of female SUI.
 Device: Adjustable Continence Therapy for Women (ACT)
Two ACT devices are implanted in each patient. The devices are intended for implantation in the paraurethral space, with the balloons located on each side of the urethra near the bladder neck. The ports are placed subcutaneously in the labia majora. The balloons are filled after implantation with an isotonic solution via needle injection into the port. The ACT implant can be placed using local, spinal or general anesthesia with the surgical instruments (provided separately).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Provocative pad weight [ Time Frame: 12 months ]
    Change in provocative pad weight from baseline


Secondary Outcome Measures :
  1. Urogenital Distress Inventory (UDI) [ Time Frame: 12 months ]
    Six item questionnaire. Scores range from 0-100. 0 being not distressed, 100 being very distressed.

  2. Incontinence Quality of Life Questionnaire (I-QOL) [ Time Frame: 12 months ]
    Twenty-two item questionnaire. Scores range from 0-100. 0 being lowest quality of life, 100 being highest quality of life.


Other Outcome Measures:
  1. Complete adverse event profile [ Time Frame: 12 months ]
    Collection of patient safety information


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female at least 22 years old
  2. Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency
  3. Provocative pad weight of greater than 11.0 grams
  4. Candidate for surgical intervention
  5. Negative urinalysis
  6. Normal cystourethroscopy
  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. Willing and able to sign informed consent and comply with trial follow-up requirements

Exclusion Criteria:

  1. Pregnant or lactating
  2. Life expectancy of less than 5 years
  3. Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucose over 130 mg/dL
  4. Has auto-immune disease
  5. Undergoing radiation therapy
  6. Active urinary tract infection
  7. Detrusor instability refractory to medication
  8. Reduced bladder compliance as defined by a cystometrogram
  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. Has, had, or is suspected of having bladder cancer
  11. History of bladder stones
  12. Urethral stricture evidenced during cystourethroscopy
  13. Has a neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
  14. Has a diathesis, hemophilia, or a bleeding disorder
  15. Has a rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse of grade 3 or higher
  16. Had prior pelvic radiotherapy
  17. Had a prior artificial urinary sphincter implanted
  18. Has a neurogenic condition known to affect bladder/sphincter function
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04248283


Contacts
Layout table for location contacts
Contact: Ricardo De Medeiros 763-694-9880 rmedeiros@uromedica-inc.com

Locations
Layout table for location information
United States, Louisiana
Ochsner Health Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Neeti Galwankar    504-842-9971    neeti.galwankar@ochsner.org   
Principal Investigator: Colin Goudelocke, MD         
Sub-Investigator: Joanna Togami, MD         
United States, Nebraska
CHI Health Research Center Recruiting
Omaha, Nebraska, United States, 68124
Contact: Corrina Cramer    402-343-8544    corrina.cramer@commonspirit.org   
Principal Investigator: Michael Feloney, MD         
United States, New Jersey
Virtua Health, Inc. Recruiting
Moorestown, New Jersey, United States, 08057
Contact: Katharine Ference    856-761-3903    kference@virtua.org   
Principal Investigator: Joseph Maccarone, MD         
Sub-Investigator: C. Sage Claydon, MD         
United States, Pennsylvania
The Institute for Female Pelvic Medicine and Reconstructive Surgery Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Eileen Taff    610-730-2502    Eileen.Taff@axiawh.com   
Principal Investigator: Vincent Lucente, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jessica Jenkins    843-876-0630    jenkijn@musc.edu   
Principal Investigator: Eric Rovner, MD         
Sponsors and Collaborators
Uromedica
Investigators
Layout table for investigator information
Study Director: Timothy C Cook, PhD Uromedica, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Uromedica
ClinicalTrials.gov Identifier: NCT04248283    
Other Study ID Numbers: UM08
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: December 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Uromedica:
Urinary Incontinence
Urination Disorders
Urination Involuntary
Urologic Diseases
Lower Urinary Tract Symptoms
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders