Uterine ProlapseNCT02921451
Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
A study testing Restorelle Smartmesh in people with Uterine Prolapse, run by Michigan Institution of Women's Health PC at 1 site in United States.
Trial summary
The purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Uterine Prolapse
- What is being tested?
- Restorelle Smartmesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Aug 2020
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is female.
- Subject is at least 18 years of age.
- Subjects who have already made the decision to proceed with uterine prolapse surgery using Restorelle Mesh.
- Subject has uterine prolapse defined by Prolapse Quantification System Assessment (POPQ) score of C -2 or greater.
- Subject reports a bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 2 or higher (i.e. response of "somewhat", "moderately" or "quite a bit").
- Subject is willing to provide written informed consent.
- Subject is willing and able to comply with follow-up regimen.
Who cannot join
- Subject is pregnant or intends to become pregnant in the future.
- Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical).
- Subject has undergone any previous repair for pelvic organ prolapse.
- Subject has undergone a hysterectomy.
- Subject lacks competency of the English language.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Urogynecology of Michigan, P.C.
Dearborn, Michigan, 48125
About this study
The purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse.
Read the detailed description
This study is being done to evaluate the performance of the Restorelle system, which uses Smartmesh - an ultra-lightweight mesh for uterine prolapse management. Most patients undergo a hysterectomy i.e. removal of the uterus when they have a prolapse. However, this has often been found to be an unnecessary operation. The investigators are studying the use of the Restorelle mesh system to preserve the uterus when there is a uterine prolapse.
- Conditions
- Uterine Prolapse
- Being tested
- Restorelle Smartmesh
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restorelle SmartmeshDevice
Patients will have surgery using the device, Restorelle Smartmesh, for treatment of uterine prolapse.
| Study group | Role | What they receive |
|---|---|---|
| Restorelle Smartmesh | Other | Surgical procedure for treatment of uterine prolapse will use the device, Restorelle Smartmesh. Receives: Device: Restorelle Smartmesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who present with recurrence of uterine prolapse following surgery as assessed by failing to meet success criteria
Success criteria will be defined through the examination of patient's Prolapse Quantification System Assessment (POPQ) score of C -1 or less and patient's report of bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 0 or 1 (i.e. response of "not at all"). Failure to meet this criteria will be considered recurrence of uterine prolapse.
Measured: Within first two years after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine ProlapseStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan Institution of Women's Health PC
- Sponsor type
- University, hospital or other
- Collaborators
- Coloplast A/S
- Responsible party
- Principal investigator, Salil Khandwala, Michigan Institution of Women's Health PC
- Investigators
- Salil Khandwala, Principal investigator, Advanced Urogynecology of Michigan, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921451
- Sponsor's protocol ID
- IISP 16-05
- Status last verified
- Aug 2019
- First submitted
- 23 Sep 2016
- Last updated
- 14 Aug 2019
- 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 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
- ClinicalTrials.gov ID
- NCT02921451
- Acronym / sponsor ID
- IISP 16-05
- Conditions
- Uterine Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Michigan Institution of Women's Health PCUniversity, hospital or other
- Collaborators
- Coloplast A/S
- Study start
- Aug 2016
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 3 Oct 2016 (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 purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse.
Detailed description
This study is being done to evaluate the performance of the Restorelle system, which uses Smartmesh - an ultra-lightweight mesh for uterine prolapse management. Most patients undergo a hysterectomy i.e. removal of the uterus when they have a prolapse. However, this has often been found to be an unnecessary operation. The investigators are studying the use of the Restorelle mesh system to preserve the uterus when there is a uterine prolapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restorelle Smartmesh | Other | Device: Restorelle SmartmeshSurgical procedure for treatment of uterine prolapse will use the device, Restorelle Smartmesh. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is female.
- Subject is at least 18 years of age.
- Subjects who have already made the decision to proceed with uterine prolapse surgery using Restorelle Mesh.
- Subject has uterine prolapse defined by Prolapse Quantification System Assessment (POPQ) score of C -2 or greater.
- Subject reports a bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 2 or higher (i.e. response of "somewhat", "moderately" or "quite a bit").
Key exclusion criteria (5 listed)
- Subject is pregnant or intends to become pregnant in the future.
- Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical).
- Subject has undergone any previous repair for pelvic organ prolapse.
- Subject has undergone a hysterectomy.
- Subject lacks competency of the English language.
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 |
|---|---|---|
| Restorelle SmartmeshPatients will have surgery using the device, Restorelle Smartmesh, for treatment of uterine prolapse. | Device | Restorelle Smartmesh |
Primary outcome
Number of patients who present with recurrence of uterine prolapse following surgery as assessed by failing to meet success criteria
Time frame: Within first two years after surgical procedure
Success criteria will be defined through the examination of patient's Prolapse Quantification System Assessment (POPQ) score of C -1 or less and patient's report of bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 0 or 1 (i.e. response of "not at all"). Failure to meet this criteria will be considered recurrence of uterine prolapse.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Salil Khandwala principal investigator
Advanced Urogynecology of Michigan, P.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restorelle Smartmesh in people with Uterine Prolapse, run by Michigan Institution of Women's Health PC at 1 site 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 7 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of patients who present with recurrence of uterine prolapse following surgery as assessed by failing to meet success criteria (time frame: Within first two years after surgical procedure). 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 14 Aug 2019.