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Recruiting NCT04248283

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

No phase Interventional Urinary Incontinence Urinary Incontinence,Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adjustable Continence Therapy for Women (ACT).
Who it may be relevant to
Registry conditions: Urinary Incontinence, Urinary Incontinence,Stress. Basic parameters: from 22 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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).

Primary outcome measures

  • Provocative pad weight [Time frame: 12 months]
Secondary outcome measures (2)
  • Urogenital Distress Inventory (UDI) [Time frame: 12 months]
  • Incontinence Quality of Life Questionnaire (I-QOL) [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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
  • Negative urinalysis
  • Normal cystourethroscopy
  • 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)
  • Willing and able to sign informed consent and comply with trial follow-up requirements

Exclusion criteria

  • 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
  • Undergoing radiation therapy
  • Active urinary tract infection
  • Detrusor instability refractory to medication
  • Reduced bladder compliance as defined by a cystometrogram
  • 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
  • Has, had, or is suspected of having bladder cancer
  • History of bladder stones
  • Urethral stricture evidenced during cystourethroscopy
  • Has a neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
  • Has a diathesis, hemophilia, or a bleeding disorder
  • Has a rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse of grade 3 or higher
  • Had prior pelvic radiotherapy
  • Had a prior artificial urinary sphincter implanted
  • Has a neurogenic condition known to affect bladder/sphincter function

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 3 centers
  • Hôpital de la Conception - Marseille — Marseille
  • CHU de Nantes — Nantes
  • Pitié Salpêtrière University Hospital Paris — Paris
United States · 2 centers
  • University of Colorado — Denver
  • CHI Health Research Center — Omaha

Identifiers

NCT: NCT04248283 · UM08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗