Health TrialsbyHealthPanel

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

ConditionsUrinary IncontinenceUrinary Incontinence,Stress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22+
SponsorUromedica

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female at least 22 years old

Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency

Provocative pad weight of greater than 11.0 grams

Candidate for surgical intervention

Disqualifiers

Pregnant or lactating

Life expectancy of less than 5 years

Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucose over 130 mg/dL

Has auto-immune disease

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

167 Participants
are divided into 1 treatment group
Group A: Adjustable Continence Therapy for WomenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Provocative pad weight

Change in provocative pad weight from baseline

Time frame
12 months

Secondary outcomes

1

Urogenital Distress Inventory (UDI)

Six item questionnaire. Scores range from 0-100. 0 being not distressed, 100 being very distressed.

Time frame
12 months
2

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.

Time frame
12 months

Other outcomes

1

Complete adverse event profile

Collection of patient safety information

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uromedica

Lead sponsor

Source ClinicalTrials.gov
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