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

Part of paid clinical trials in Denver, Colorado.

Sponsor
Uromedica
Study ID
NCT04248283
Status
Recruiting
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Conditions

  • Urinary Incontinence
  • Urinary Incontinence,Stress

Eligibility Criteria

Sex
FEMALE
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adjustable Continence Therapy for Women (ACT) — DEVICE
    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).

Study Details

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.

Key Dates

Start date
Jan 26, 2021
Status verified
Jul 2024
Primary completion
Sep 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
167 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adjustable Continence Therapy for Women
    Implantation of the Adjustable Continence Therapy for the treatment of female SUI.

Primary Outcome Measure

Provocative pad weight [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of ColoradoDenverColorado80045
Brian Flynn, MD (PRINCIPAL_INVESTIGATOR)
Nate Coddington, MD (SUB_INVESTIGATOR)
CHI Health Research CenterOmahaNebraska68124
Jodi Salvatori, RN, BSN
[email protected]
402-343-8511
Michael Feloney, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Denver, CO

By research site
University of Colorado· Denver, COCHI Health Research Center· Omaha, NE

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