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

Urinary Incontinence Clinical Trial

— ACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00113555
• Other study ID #: URM01-01-01
• Status: Completed
• Phase: N/A
• Start date: December 2001
• Est. completion date: November 2010

Study information

• Verified date: July 2018
• Source: Uromedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: November 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• ACT (Adjustable Continence Therapy)
surgically implanted device

Locations

Country	Name	City	State
Canada	CHUS-Fleurimont	Fleurimont	Quebec
Canada	Can-Med Clinical Research Inc.	Victoria	British Columbia
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Lahey Clinic	Burlington	Massachusetts
United States	Kansas City Urology Care	Kansas City	Missouri
United States	Kaiser Permanente	Los Angeles	California
United States	Metro Urology	Plymouth	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Uromedica

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Stamey Grade From 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.	Baseline to 12 months
Secondary	Incontinence Quality of Life (IQoL) Questionnaire	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.	Baseline to 12 months
Secondary	Incontinence Impact Questionnaire (IIQ-7)	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.	Baseline to 12 months
Secondary	Urinary Distress Inventory (UDI-6)	Change on Urinary Distress Inventory (UDI-6) questionnaire from baseline to 12 months. 0 being not distressed, 100 being very distressed.	Baseline to 12 months
Secondary	Number of Incontinence Episodes Per Day (Voiding Diary)	Change in Number of Incontinence Episodes Per Day from baseline to 12 months. 0 being the best.	Baseline to 12 months
Secondary	Number of Pads Changed Per Day (Voiding Diary)	Change in Number of Pads Changed Per Day from baseline to 12 months. 0 pads changed a day being the best.	Baseline to 12 months
Secondary	Provocative Pad Weight	Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best.	Baseline to 12 months