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

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ClinicalTrials.gov Identifier: NCT04248283
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
Uromedica

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

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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, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


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).




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



Information from the National Library of Medicine

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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

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
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Contact: Clinical Project Manager 763-999-7048 tplouffe@uromedica-inc.com

Locations
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United States, Missouri
Kansas City Urology Care Recruiting
Overland, Missouri, United States, 66211
Contact: Judy Searcy         
Principal Investigator: Samuel Kuykendall, MD         
United States, Nebraska
CHI Health Research Center Recruiting
Omaha, Nebraska, United States, 68124
Contact: Crystal Granados       crystal.granados@alegent.org   
Principal Investigator: Michael Feloney, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Reba Blissell    206-616-8723    blissr@uw.edu   
Principal Investigator: Suzette Sutherland, MD         
Sponsors and Collaborators
Uromedica
Investigators
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Study Director: Timothy C Cook, PhD Uromedica, Inc.
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Responsible Party: Uromedica
ClinicalTrials.gov Identifier: NCT04248283    
Other Study ID Numbers: UM08
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021

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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:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders