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

Uromedica

Status: Enrolling

Conditions: Urinary Incontinence,Stress; Urinary Incontinence

Treatments: Device: Adjustable Continence Therapy for Women (ACT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04248283

UM08

Details and patient eligibility

About

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.

Enrollment: 167 estimated patients

Sex: Female

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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167 participants in 1 patient group

Adjustable Continence Therapy for Women

Experimental group

Description:

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

Treatment:

Device: Adjustable Continence Therapy for Women (ACT)