Stress Urinary IncontinenceROSENCT01115465
Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
A study testing Macroplastique in people with Stress Urinary Incontinence, run by Uroplasty, Inc at 19 sites in United States.
Trial summary
The ROSE Registry will determine the long-term safety and effectiveness of Macroplastique in the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Macroplastique
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 19 sitesUnited States
- Study dates
- Jan 2008to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has signed written informed consent
- Subject is a female at least 18 years of age
- Subject has been diagnosed with SUI primarily due to intrinsic sphincter deficiency (ISD)
- Subject understands all study requirements including five year follow-up schedule
- Subject is psychologically stable and suitable for intervention as determined by the Investigator
Who cannot join
- Subject has an acute urogenital tract inflammation or infection
- Subject is pregnant or intends to become pregnant within one year
- Subject has had a sling placement within 12 weeks
- Subject has had a bulking agent treatment within 12 weeks
- Subject has a bladder neck or urethral stricture, gross utero-vaginal prolapse, untreated detrusor instability or hyperreflexia, neuropathic bladder, or overflow incontinence
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
The University of Michigan Health Center
Ann Arbor, Michigan, 48109
Western Carolina Women's Specialty Center
Asheville, North Carolina, 28806
Western New York Urology
Cheektowaga, New York, 14225
Northwestern University Prentice Women's Hospital
Chicago, Illinois, 60611
Southern Urogynecology
Columbia, South Carolina, 29169
Urology Associates, PC
Englewood, Colorado, 80113
Carolina Urology Partners
Gastonia, North Carolina, 28054
Kaiser Permanente Southern California-Irvine Medical Center
Irvine, California, 92618
Athena Urology
Issaquah, Washington, 98027
Mercy Heatlh Partners at the Lakes
Muskegon, Michigan, 49444
Specialists in Urology
Naples, Florida, 34102
The Florida Bladder Institute
Naples, Florida, 34109
Deaconess Clinic
Newburgh, Indiana, 47630
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Univeristy of California- Irvine
Orange, California, 92868
Oregon Health & Science University
Portland, Oregon, 97239
The University of California- of San Diego
San Diego, California, 92121
Urological Associates of Southern Arizona
Tucson, Arizona, 85715
Urology of Virginia
Virginia Beach, Virginia, 23462
About this study
Official title: Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
The ROSE Registry will determine the long-term safety and effectiveness of Macroplastique in the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).
Read the detailed description
The Rose Registry is a five-year post-market study of the safety and effectiveness of Macroplastique in the treatment of female stress urinary incontinence due to intrinsic sphincter deficiency.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Macroplastique
- Keywords
- Stress Urinary Incontinence, silicone elastomer
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacroplastiqueDevice
Also called polydimethylsiloxane, PDMS
Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD).
| Study group | Role | What they receive |
|---|---|---|
| Macroplastique | Other | Macroplastique will be used for the treatment in an open-label, five year, post-market study Receives: Device: Macroplastique |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the incidence of additional or alternative treatment for stress urinary incontinence due to ISD following up to two Macroplastique treatments over a 5 year period.
To describe the incidence of additional or alternative treatments
Measured: 5-years
Secondary outcomes (1)
To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure.
To describe the incidence of genitourinary and treatment related adverse events
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startJan 2008
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress 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
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uroplasty, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115465
- Sponsor's protocol ID
- MPQ092006
- Acronym
- ROSE
- Status last verified
- Mar 2020
- First submitted
- 30 Apr 2010
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01115465
- Acronym / sponsor ID
- ROSE / MPQ092006
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress Urinary Incontinence, silicone elastomer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Uroplasty, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2008 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 4 May 2010 (estimated)
- 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.
The ROSE Registry will determine the long-term safety and effectiveness of Macroplastique in the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).
Detailed description
The Rose Registry is a five-year post-market study of the safety and effectiveness of Macroplastique in the treatment of female stress urinary incontinence due to intrinsic sphincter deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Macroplastique | Other | Device: MacroplastiqueMacroplastique will be used for the treatment in an open-label, five year, post-market study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has signed written informed consent
- Subject is a female at least 18 years of age
- Subject has been diagnosed with SUI primarily due to intrinsic sphincter deficiency (ISD)
- Subject understands all study requirements including five year follow-up schedule
- Subject is psychologically stable and suitable for intervention as determined by the Investigator
Key exclusion criteria (5 listed)
- Subject has an acute urogenital tract inflammation or infection
- Subject is pregnant or intends to become pregnant within one year
- Subject has had a sling placement within 12 weeks
- Subject has had a bulking agent treatment within 12 weeks
- Subject has a bladder neck or urethral stricture, gross utero-vaginal prolapse, untreated detrusor instability or hyperreflexia, neuropathic bladder, or overflow incontinence
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 |
|---|---|---|
| MacroplastiqueAlso: polydimethylsiloxane, PDMSMacroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD). | Device | Macroplastique |
Primary outcome
To describe the incidence of additional or alternative treatment for stress urinary incontinence due to ISD following up to two Macroplastique treatments over a 5 year period.
Time frame: 5-years
To describe the incidence of additional or alternative treatments
1 secondary outcome
To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure.
Time frame: 5-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Stress Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macroplastique in people with Stress Urinary Incontinence, run by Uroplasty, Inc at 19 sites in United States.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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?
Results are not available in the source record.
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?
To describe the incidence of additional or alternative treatment for stress urinary incontinence due to ISD following up to two Macroplastique treatments over a 5 year period. (time frame: 5-years). 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 11 Mar 2020.