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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04248283
• Other study ID #: UM08
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2023
• Source: Uromedica
• Contact: Patrick Gora
• Phone: 763-694-9880
• Email: pgora[@]uromedica-inc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 167
• Est. completion date: December 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

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).

Locations

Country	Name	City	State
United States	University of Colorado	Denver	Colorado
United States	Ochsner Health	New Orleans	Louisiana
United States	CHI Health Research Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Uromedica

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complete adverse event profile	Collection of patient safety information	12 months
Primary	Provocative pad weight	Change in provocative pad weight from baseline	12 months
Secondary	Urogenital Distress Inventory (UDI)	Six item questionnaire. Scores range from 0-100. 0 being not distressed, 100 being very distressed.	12 months
Secondary	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.	12 months