Urinary IncontinenceProACTNCT00277095
ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males
A study testing ProACT (Adjustable Continence Therapy) in people with Urinary Incontinence, run by Uromedica at 10 sites in 3 countries.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for… Read more about this study
- Who is it for?
- Ages 45 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- ProACT (Adjustable Continence Therapy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Aug 2005to Dec 2017
- 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 45 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergone either a radical prostatectomy, transurethral resection of the prostate or other prostate surgery at least 12 months prior without radiation therapy
- Demonstrate primary stress urinary incontinence
- Male subjects at least 45 years of age
- Willing and able to undergo surgical implantation of the ProACT devices
- Willing and able to comply with the follow-up requirements
- Willing and able to forego any other surgical urinary incontinence treatments while participating in the study
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- Willing and able to sign the informed consent
- Positive 24 hour pad weight tests (greater than or equal to 8 gram pad weight increase demonstrated in two 24-hour pad weight tests)
- Experiences at least 3 incontinence episodes per day during two baseline voiding diaries.
- Negative Urine culture
- No recurrent stricture at the anastamosis
- No known urogenital malignancy other than previously treated prostate cancer
- Physician determines subject to be suitable surgical candidate
Who cannot join
- Primarily Urge incontinence
- Detrusor instability or over-activity
- Residual volume greater that 100 ml or greater than 25% of the total bladder capacity after voiding.
- Subject has/had or is suspected of having bladder cancer
- History of recurrent bladder stones
- Neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
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- Known hemophilia or a bleeding disorder
- Abnormal PSA (Prostate Specific Antigen), according to sites laboratory standards, unless further investigation confirms no underlying prostate malignancy.
- Known sever contrast solution allergy
- Has a genitourinary mechanical prosthesis other than previous sling procedure (e.g., Artificial Urinary sphincter, implantable penile prosthesis)
- Has a urethral stricture that prevents passage of an 18 F cystoscope or has had more than one urethrotomy
- Undergone bulking procedure within 6 months of the baseline assessment
- Subject is currently enrolled or plans to enroll in another device or drug clinical trial.
- Subject is currently using an indwelling catheter or condom catheter for treatment of incontinence and is not willing to discontinue use at least 4 weeks prior to baseline assessment.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States7 sites
Urological Surgeons
Kankakee, Illinois, 60901
Kansas City Urology Care
Kansas City, Missouri, 64123
Kaiser Permanente-Los Angeles
Los Angeles, California, 90027
The Pelvic Clinic
Pembroke Pines, Florida, 33028
Metro Urology
Saint Paul, Minnesota, 55102
University of Arizona
Tucson, Arizona, 85724
Indian River Urology
Vero Beach, Florida, 32960
Canada2 sites
CHUS-Fleurimont
Fleurimont, Quebec, J1H5N4
Can-Med Clinical Research Inc.
Victoria, British Columbia, V8T5G1
New Zealand1 site
Urology Bay of Plenty (formerly Promed Urology)
Tauranga
About this study
Official title: Clinical Investigation of the ProACT Adjustable Continence Therapy for Treatment of Post-Prostatectomy Stress Urinary Incontinence
The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for benign prostatic hyperplasia. 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 patients demonstrate at least a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at baseline.
Read the detailed description
The study is a prospective, non-randomized multi-center investigation. Multiple measurements using 24 hour pad weight and pad count, validated questionnaires, voiding diaries will be used to evaluate the achievement of the study objectives. Subjects will be followed for a minimum of 18 months following implantation. Subjects will be requested to continue annual follow-ups through the FDA approval.
The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for benign prostatic hyperplasia. 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 patients demonstrate at least a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at baseline.
- Conditions
- Urinary Incontinence
- Being tested
- ProACT (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.
ProACT (Adjustable Continence Therapy)Device
Also called ProACT,Adjustable Incontinence therapy for Males
Implantable device to reduce urinary stress incontinence
| Study group | Role | What they receive |
|---|---|---|
| ProACT (Adjustable Continence Therapy) | Experimental | Implantation with ProACT (Adjustable Continence Therapy), Single Arm Receives: Device: ProACT (Adjustable Continence Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy: Demonstrate the Efficacy of the ProACT Device in Reducing Incontinence as Measured by the 24-hour Pad Weight at 18 Months Compared to Baseline. A Subject is a Success if he Demonstrates a 50% Reduction.
The percentage of participants with 50% reduction in pad weight.
Measured: 18 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startAug 2005
- Primary completionFeb 2009
- Study completionDec 2017
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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uromedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Cook, Ph.D, Study director, Uromedica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277095
- Sponsor's protocol ID
- UM02
- Acronym
- ProACT
- Status last verified
- Apr 2018
- First submitted
- 11 Jan 2006
- Last updated
- 31 May 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 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the ProACT Adjustable Continence Therapy for Treatment of Post-Prostatectomy Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00277095
- Acronym / sponsor ID
- ProACT / UM02
- Conditions
- Urinary Incontinence
- Keywords
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- UromedicaIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Jan 2006 (estimated)
- Results
- Posted 3 Feb 2016
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 the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for benign prostatic hyperplasia. 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 patients demonstrate at least a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at baseline.
Detailed description
The study is a prospective, non-randomized multi-center investigation. Multiple measurements using 24 hour pad weight and pad count, validated questionnaires, voiding diaries will be used to evaluate the achievement of the study objectives. Subjects will be followed for a minimum of 18 months following implantation. Subjects will be requested to continue annual follow-ups through the FDA approval.
The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for benign prostatic hyperplasia. 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 patients demonstrate at least a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ProACT (Adjustable Continence Therapy) | Experimental | Device: ProACT (Adjustable Continence Therapy)Implantation with ProACT (Adjustable Continence Therapy), Single Arm |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Undergone either a radical prostatectomy, transurethral resection of the prostate or other prostate surgery at least 12 months prior without radiation therapy
- Demonstrate primary stress urinary incontinence
- Male subjects at least 45 years of age
- Willing and able to undergo surgical implantation of the ProACT devices
- Willing and able to comply with the follow-up requirements
Key exclusion criteria (14 listed)
- Primarily Urge incontinence
- Detrusor instability or over-activity
- Residual volume greater that 100 ml or greater than 25% of the total bladder capacity after voiding.
- Subject has/had or is suspected of having bladder cancer
- History of recurrent bladder stones
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 |
|---|---|---|
| ProACT (Adjustable Continence Therapy)Also: ProACT,Adjustable Incontinence therapy for MalesImplantable device to reduce urinary stress incontinence | Device | ProACT (Adjustable Continence Therapy) |
Primary outcome
Primary Efficacy: Demonstrate the Efficacy of the ProACT Device in Reducing Incontinence as Measured by the 24-hour Pad Weight at 18 Months Compared to Baseline. A Subject is a Success if he Demonstrates a 50% Reduction.
Time frame: 18 month follow-up
The percentage of participants with 50% reduction in pad weight.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- ProACT Adjustable Continence for Men Premarket Approval (PMA) 11/24/2015Link provided by the sponsor.
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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, Ph.D study director
Uromedica, Inc.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProACT (Adjustable Continence Therapy) in people with Urinary Incontinence, run by Uromedica at 10 sites in 3 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 13 inclusion and 14 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 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, New Zealand. 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 3 Feb 2016). 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?
Primary Efficacy: Demonstrate the Efficacy of the ProACT Device in Reducing Incontinence as Measured by the 24-hour Pad Weight at 18 Months Compared to Baseline. A Subject is a Success if he Demonstrates a 50% Reduction. (time frame: 18 month follow-up). 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 31 May 2018.