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

Primary Purpose

Urinary Incontinence, Urinary Incontinence,Stress

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Adjustable Continence Therapy for Women (ACT)

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary Incontinence, Urination Disorders, Urination Involuntary, Urologic Diseases, Lower Urinary Tract Symptoms

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant or lactating
Life expectancy of less than 5 years
Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucose over 130 mg/dL
Has auto-immune disease
Undergoing radiation therapy
Active urinary tract infection
Detrusor instability refractory to medication
Reduced bladder compliance as defined by a cystometrogram
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
Has, had, or is suspected of having bladder cancer
History of bladder stones
Urethral stricture evidenced during cystourethroscopy
Has a neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
Has a diathesis, hemophilia, or a bleeding disorder
Has a rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse of grade 3 or higher
Had prior pelvic radiotherapy
Had a prior artificial urinary sphincter implanted
Has a neurogenic condition known to affect bladder/sphincter function

Sites / Locations

University of ColoradoRecruiting
Ochsner HealthRecruiting
CHI Health Research CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adjustable Continence Therapy for Women

Arm Description

Implantation of the Adjustable Continence Therapy for the treatment of female SUI.

Outcomes

Primary Outcome Measures

Provocative pad weight

Change in provocative pad weight from baseline

Secondary Outcome Measures

Urogenital Distress Inventory (UDI)

Six item questionnaire. Scores range from 0-100. 0 being not distressed, 100 being very distressed.

Incontinence Quality of Life Questionnaire (I-QOL)

Twenty-two item questionnaire. Scores range from 0-100. 0 being lowest quality of life, 100 being highest quality of life.

Full Information

NCT ID

NCT04248283

First Posted

January 27, 2020

Last Updated

May 19, 2023

Sponsor

Uromedica

1. Study Identification

Unique Protocol Identification Number

NCT04248283

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2021 (Actual)

Primary Completion Date

September 30, 2025 (Anticipated)

Study Completion Date

December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Uromedica

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence, Urinary Incontinence,Stress

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

A prospective, single arm, non-randomized, multicenter, prospective case-series trial.

Masking

None (Open Label)

Allocation

N/A

Enrollment

167 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adjustable Continence Therapy for Women

Arm Type

Experimental

Arm Description

Implantation of the Adjustable Continence Therapy for the treatment of female SUI.

Intervention Type

Device

Intervention Name(s)

Adjustable Continence Therapy for Women (ACT)

Intervention Description

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 Measure Information:

Title

Provocative pad weight

Description

Change in provocative pad weight from baseline

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Urogenital Distress Inventory (UDI)

Description

Six item questionnaire. Scores range from 0-100. 0 being not distressed, 100 being very distressed.

Time Frame

12 months

Title

Incontinence Quality of Life Questionnaire (I-QOL)

Description

Twenty-two item questionnaire. Scores range from 0-100. 0 being lowest quality of life, 100 being highest quality of life.

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Complete adverse event profile

Description

Collection of patient safety information

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female at least 22 years old Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency Provocative pad weight of greater than 11.0 grams Candidate for surgical intervention Negative urinalysis Normal cystourethroscopy 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) Willing and able to sign informed consent and comply with trial follow-up requirements Exclusion Criteria: Pregnant or lactating Life expectancy of less than 5 years Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucose over 130 mg/dL Has auto-immune disease Undergoing radiation therapy Active urinary tract infection Detrusor instability refractory to medication Reduced bladder compliance as defined by a cystometrogram 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 Has, had, or is suspected of having bladder cancer History of bladder stones Urethral stricture evidenced during cystourethroscopy Has a neurogenic bladder that is atonic or has detrusor sphincter dyssynergia Has a diathesis, hemophilia, or a bleeding disorder Has a rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse of grade 3 or higher Had prior pelvic radiotherapy Had a prior artificial urinary sphincter implanted Has a neurogenic condition known to affect bladder/sphincter function

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick Gora

Phone

763-694-9880

pgora@uromedica-inc.com

First Name & Middle Initial & Last Name or Official Title & Degree

Timothy C Cook, PhD

Phone

763-694-9880

regulatory@uromedica-inc.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy C Cook, PhD

Organizational Affiliation

Uromedica, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

University of Colorado

City

Denver

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea Pina

andrea.pinalimones@cuanschutz.edu

First Name & Middle Initial & Last Name & Degree

Brian Flynn, MD

First Name & Middle Initial & Last Name & Degree

Nate Coddington, MD

Facility Name

Ochsner Health

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neeti Galwankar

Phone

504-842-9971

neeti.galwankar@ochsner.org

First Name & Middle Initial & Last Name & Degree

Colin Goudelocke, MD

First Name & Middle Initial & Last Name & Degree

Joanna Togami, MD

Facility Name

CHI Health Research Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68124

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jodi Salvatori, RN, BSN

Phone

402-343-8511

jodi.salvatori@commonspirit.org

First Name & Middle Initial & Last Name & Degree

Michael Feloney, MD

12. IPD Sharing Statement

Learn more about this trial

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

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