Skip to main content
OpenTrials
Completed

NCT Number: NCT00113555

Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence

The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 160 implanted female patients in which two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.

The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether the patients demonstrate at least a one-grade (mean) reduction in the Stamey score at 12 months.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Can-Med Clinical Research Inc., Victoria, British Columbia, Canada

Loading trial locations.

About this study

This is a multi-center, prospective, non randomized clinical trial comparing baseline data to the 12 month data. Urodynamic testing, pad weights and a direct visual stress test will be used to determine success along with the Stamey score.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women
  • 18 years or older
  • Diagnosed with stress urinary incontinence with or without urethral hypermobility
  • Willing to sign informed consent
  • Candidates for surgical intervention for stress incontinence
  • Negative urinalysis or urine culture within 2 weeks of implantation
  • Normal cystourethroscopy
  • Failed at least 6 months of previous treatments for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc.)
  • May have failed suspension or sling procedures

Exclusion criteria

  • Pregnant or lactating
  • Life expectancy of less than one year
  • Insulin dependant diabetic
  • Auto-immune disease
  • Undergoing radiation therapy
  • Active urinary tract infection
  • Detrusor instability refractory to meds
  • Reduced bladder compliance
  • Significant bladder residual >100mls
  • Bladder cancer
  • Unsuccessfully treated bladder stones
  • Current urethral stricture preventing the passage of a 24 French endoscope
  • Neurogenic bladder
  • Uncorrected rectocele, cystocele, urethrocele, enterocele or pelvic prolapse of Grade 3 or higher
  • Prior pelvic radiotherapy
  • Artificial urinary sphincter implanted

Treatment and study plan

ACT (Adjustable Continence Therapy)

Device

surgically implanted device

Primary outcomes

  1. Change of Stamey Grade From Baseline to 12 Months.

    Time frame: Baseline to 12 months

    The Stamey grade classifies the severity of stress incontinence in four possible grades from 0-3. Grade 0: no leaking, Grade 1: loss of urine with sudden increases of abdominal pressure: e.g. coughing, sneezing or laughing, Grade 2: loss of urine with lesser degrees of stress: e.g. walking or standing up, and Grade 3: loss of urine without any relation to physical activity or position, e.g. while lying in bed.

    The primary end point at 12 months is a mean change in Stamey Grade from baseline of greater than or equal to -1.

Secondary outcomes

  1. Incontinence Quality of Life (IQoL) Questionnaire

    Time frame: Baseline to 12 months

    Change on Incontinence Quality of Life (IQoL) Questionnaire from baseline to 12 months. 0 being lowest quality of life, 100 being highest quality of life.

  2. Incontinence Impact Questionnaire (IIQ-7)

    Time frame: Baseline to 12 months

    Incontinence Impact Questionnaire (IIQ-7) change from baseline to 12 months. Scores range from 0-100. 0 being impact from incontinence, 100 being most impacted from incontinence.

  3. Urinary Distress Inventory (UDI-6)

    Time frame: Baseline to 12 months

    Change on Urinary Distress Inventory (UDI-6) questionnaire from baseline to 12 months. 0 being not distressed, 100 being very distressed.

  4. Number of Incontinence Episodes Per Day (Voiding Diary)

    Time frame: Baseline to 12 months

    Change in Number of Incontinence Episodes Per Day from baseline to 12 months. 0 being the best.

  5. Number of Pads Changed Per Day (Voiding Diary)

    Time frame: Baseline to 12 months

    Change in Number of Pads Changed Per Day from baseline to 12 months. 0 pads changed a day being the best.

  6. Provocative Pad Weight

    Time frame: Baseline to 12 months

    Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best.

Sponsors and collaborators

Lead sponsor

Uromedica

Industry

Registry information

Official study title

Clinical Investigation of an Adjustable Continence Therapy (ACT) Periurethral Prosthetic System for Treatment of Female Stress Urinary Incontinence With or Without Hypermobility

Acronym: ACT

Important dates

Study start
2001
Primary completion
2008
Study completion
2010
First posted
Jun 9, 2005
Registry last updated
Jul 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.