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

NCT04248283 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2024-07-23

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Uromedica

    lead INDUSTRY

Principal Investigators

  • Timothy C Cook, PhD · Uromedica, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-26
Primary Completion
2025-09-30
Completion
2025-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04248283 on ClinicalTrials.gov