NCT04248283

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 167 (estimated)
• Sponsor: Uromedica · Industry
• Sex: Female
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence
• Urinary Incontinence,Stress

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-01-26
• Primary completion: 2025-09-30
• Completion: 2025-12-30
• First posted: 2020-01-30
• Last updated: 2024-07-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study