Urinary IncontinenceNCT04248283
Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
A study testing Adjustable Continence Therapy for Women (ACT) in people with Urinary Incontinence and Urinary Incontinence,Stress, run by Uromedica at 8 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Incontinence,Stress
- What is being tested?
- Adjustable Continence Therapy for Women (ACT)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 26 Jan 2021to 31 May 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States5 sites, 4 recruiting
- Recruiting
University of Colorado
Denver, Colorado, 80045
Andrea Pina, andrea.pinalimones@cuanschutz.edu
Brian Flynn, MD
- Recruiting
Penn State University
Hershey, Pennsylvania, 17033
Jocelyn Chavla, jchavla@pennstatehealth.psu.edu
Arturo Garcia Mora, MD
- Active, not recruiting
Saint Lukes Health System
Independence, Missouri, 64055
- Recruiting
Idaho Urologic Institute, PA
Meridian, Idaho, 83642
Karrie Fox, karried@idurolog.com
Brian Mihm, bmihm@idurology.com
- Recruiting
CHI Health Research Center
Omaha, Nebraska, 68124
Jodi Salvatori, RN, BSN, 402-343-8511, jodi.salvatori@commonspirit.org
Michael Feloney, MD
France3 sites, 3 recruiting
- Recruiting
Hôpital de la Conception - Marseille
Marseille, 13005
Nassima Rabah, +33 (0)4 91 38 11 34, nassima.rabah@ap-hm.fr
Gilles Karsenty, MD
- Recruiting
CHU de Nantes
Nantes, 44000
Amanda Simon, +33 2 40 08 39 10, amanda.simon@chu-nantes.fr
Marie-Aimee Perrouin-Verbe, MD
- Recruiting
Pitié Salpêtrière University Hospital Paris
Paris, 75013
Kamilia Zedek, +33 (01) 84 82 83 23, kamilia.zedek@aphp.fr
Emmanuel Chartier-Kastler, MD
About this study
Official title: A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
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.
- Conditions
- Urinary Incontinence, Urinary Incontinence,Stress
- Being tested
- Adjustable Continence Therapy for Women (ACT)
- Keywords
- Urinary Incontinence, Urination Disorders, Urination Involuntary, Urologic Diseases, Lower Urinary Tract Symptoms
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress, Urination Disorders, Nocturnal Enuresis, Urologic Diseases, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Adjustable Continence Therapy for Women | Experimental | Implantation of the Adjustable Continence Therapy for the treatment of female SUI. Receives: Device: Adjustable Continence Therapy for Women (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provocative pad weight
Change in provocative pad weight from baseline
Measured: 12 months
Secondary outcomes (2)
Urogenital Distress Inventory (UDI)
Six item questionnaire. Scores range from 0-100. 0 being not distressed, 100 being very distressed.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start26 Jan 2021
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- A prospective, single arm, non-randomized, multicenter, prospective case-series trial.
- Masking
- None (open label)
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uromedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Johnson, PhD, Study director, Uromedica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248283
- Sponsor's protocol ID
- UM08
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2020
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
- ClinicalTrials.gov ID
- NCT04248283
- Acronym / sponsor ID
- UM08
- Conditions
- Urinary Incontinence, Urinary Incontinence,Stress
- Keywords
- Urinary Incontinence, Urination Disorders, Urination Involuntary, Urologic Diseases, Lower Urinary Tract Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- UromedicaIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2032 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, single arm, non-randomized, multicenter, prospective case-series trial.
| Arm | Type | Receives |
|---|---|---|
| Adjustable Continence Therapy for Women | Experimental | Device: Adjustable Continence Therapy for Women (ACT)Implantation of the Adjustable Continence Therapy for the treatment of female SUI. |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| 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). | Device | Adjustable Continence Therapy for Women |
Primary outcome
Provocative pad weight
Time frame: 12 months
Change in provocative pad weight from baseline
2 secondary outcomes
Urogenital Distress Inventory (UDI)
Time frame: 12 months
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Philip Johnson, PhD study director
Uromedica, Inc.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustable Continence Therapy for Women (ACT) in people with Urinary Incontinence and Urinary Incontinence,Stress, run by Uromedica at 8 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 8 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Draper (612-834-7494, USLDR@COLOPLAST.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provocative pad weight (time frame: 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 6 Oct 2026.