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

May 19, 2023 updated by: Uromedica

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Contact:
        • Principal Investigator:
          • Brian Flynn, MD
        • Sub-Investigator:
          • Nate Coddington, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Health
        • Principal Investigator:
          • Colin Goudelocke, MD
        • Sub-Investigator:
          • Joanna Togami, MD
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Recruiting
        • CHI Health Research Center
        • Principal Investigator:
          • Michael Feloney, MD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provocative pad weight
Time Frame: 12 months
Change in provocative pad weight from baseline
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urogenital Distress Inventory (UDI)
Time Frame: 12 months
Six item questionnaire. Scores range from 0-100. 0 being not distressed, 100 being very distressed.
12 months
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.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete adverse event profile
Time Frame: 12 months
Collection of patient safety information
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uromedica

Investigators

  • Study Director: Timothy C Cook, PhD, 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 Major Dates

Study Start (Actual)

January 26, 2021

Primary Completion (Anticipated)

September 30, 2025

Study Completion (Anticipated)

December 30, 2025

Study Registration Dates

First Submitted

January 27, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UM08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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