Urinary IncontinenceACTNCT00113555
Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence
A study testing ACT (Adjustable Continence Therapy) in people with Urinary Incontinence, run by Uromedica at 7 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- ACT (Adjustable Continence Therapy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2001to Nov 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Pregnant or lactating
- Life expectancy of less than one year
- Insulin dependant diabetic
- Auto-immune disease
- Undergoing radiation therapy
- Active urinary tract infection
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- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Lahey Clinic
Burlington, Massachusetts, 01805
Kansas City Urology Care
Kansas City, Missouri, 64123
Kaiser Permanente
Los Angeles, California, 90027
Metro Urology
Plymouth, Minnesota, 55441
Canada2 sites
CHUS-Fleurimont
Fleurimont, Quebec, J1H5N4
Can-Med Clinical Research Inc.
Victoria, British Columbia, V8T5GI
About this study
Official title: Clinical Investigation of an Adjustable Continence Therapy (ACT) Periurethral Prosthetic System for Treatment of Female Stress Urinary Incontinence With or Without Hypermobility
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.
Read the detailed 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.
- Conditions
- Urinary Incontinence
- Being tested
- ACT (Adjustable Continence Therapy)
- Keywords
- urinary incontinence
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT (Adjustable Continence Therapy)Device
surgically implanted device
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Open Label Study, ACT (Adjustable Continence Therapy) Receives: Device: ACT (Adjustable Continence Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (6)
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.
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
Provocative Pad Weight
Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2005 (estimated)
- Study startDec 2001
- Primary completionJul 2008
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uromedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Cook, Study director, Uromedica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113555
- Sponsor's protocol ID
- URM01-01-01
- Acronym
- ACT
- Status last verified
- Jul 2018
- First submitted
- 8 Jun 2005
- Last updated
- 9 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of an Adjustable Continence Therapy (ACT) Periurethral Prosthetic System for Treatment of Female Stress Urinary Incontinence With or Without Hypermobility
- ClinicalTrials.gov ID
- NCT00113555
- Acronym / sponsor ID
- ACT / URM01-01-01
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- UromedicaIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Primary completion
- Jul 2008 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Jun 2005 (estimated)
- Results
- Posted 4 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: ACT (Adjustable Continence Therapy)Open Label Study, ACT (Adjustable Continence Therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- Pregnant or lactating
- Life expectancy of less than one year
- Insulin dependant diabetic
- Auto-immune disease
- Undergoing radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT (Adjustable Continence Therapy)surgically implanted device | Device | Experimental |
Primary outcome
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.
6 secondary outcomes
Incontinence Quality of Life (IQoL) Questionnaire
Time frame: Baseline to 12 months
Incontinence Impact Questionnaire (IIQ-7)
Time frame: Baseline to 12 months
Urinary Distress Inventory (UDI-6)
Time frame: Baseline to 12 months
Number of Incontinence Episodes Per Day (Voiding Diary)
Time frame: Baseline to 12 months
Number of Pads Changed Per Day (Voiding Diary)
Time frame: Baseline to 12 months
Provocative Pad Weight
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Cook study director
Uromedica, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT (Adjustable Continence Therapy) in people with Urinary Incontinence, run by Uromedica at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Stamey Grade From Baseline to 12 Months. (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.