A Phase 1/2 interventional study of Restorelle® Flat Mesh in Pelvic Organ Prolapse, sponsored by Michigan Institution of Women's Health PC. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-25.
Sponsored by Michigan Institution of Women's Health PC · Phase 1/2, Interventional, and Device feasibility
Among 195 studies in Pelvic Organ Prolapse with a site in United States — 12 open to participants now, 23 under way, none of them phase 3. Pelvic Organ Prolapse · United States.
Among the 195 studies in Pelvic Organ Prolapse with a site in United States, this one is the 115th largest by enrollment of the 133 interventional ones that give a count, is one of 15 that started in 2021, is one of 2 in phase 1/2, reaches primary completion later than 5 of the 22 other live ones, and was the 160th registered.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
Browse Pelvic Organ Prolapse studies →12 of the 195 studies in Pelvic Organ Prolapse with a site in United States are open now. Recruiting first, the newest first:
Ohio State University · Sites in United States
Ages 18+ · Women only
Cassandra Kisby · Sites in United States
Ages 21+ · Women only
The Cleveland Clinic · Sites in United States
Ages 18+
NICHD Pelvic Floor Disorders Network · Sites in United States
Ages 18–99 · Women only
University of Alabama at Birmingham · Sites in United States
Ages 18+ · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 53 Pelvic Organ Prolapse studies recruiting now, 31 (58%) set no upper age limit and 10 (19%) stop at 75 or younger; 2 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
195 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 9 · Phase 3 9 · Phase 4 25
First in 1996; this study’s year is marked. 15 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Median enrollment 78 across the 133 interventional studies, 103 across the 61 observational. Of the 154 that completed or were terminated, 51 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
28 of 195 have an industry lead sponsor. The 10 most frequent:
Michigan Institution of Women's Health PC is the lead sponsor of 8 studies on the registry; none are open to participants now.
Michigan Institution of Women's Health PC has 3 studies filed under Pelvic Organ Prolapse — fewer than ten, so there is no comparison to draw.
8 of the studies in Pelvic Organ Prolapse with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04179955Mayo ClinicIntraoperative Costs and Patient Perceptions in Sacrocolpopexy for Prolapse | 2026-12 |
| NCT06634459Medstar Health Research InstitutePOMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment | 2027-01 |
| NCT07008898University of Alabama at BirminghamSequence of Midurethral Sling Placement During Robotic Sacrocolpopexy | 2027-05 |
| NCT07692789Ohio State UniversityImproving Uroflowmetry Interpretability: Evaluating the Impact of Patient Reminder Systems | 2027-06 |
| NCT07218016NICHD Pelvic Floor Disorders NetworkAccelerometer Measured Early Recovery After Prolapse Surgery | 2027-06-30 |
Add all 8 to your calendar (.ics) → With an account.
Among the 195 studies in Pelvic Organ Prolapse with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is being done to evaluate the safety and feasibility of using flat polypropylene Restorelle® mesh, an ultra-lightweight mesh, for transvaginal use in surgically correcting certain specific cases of pelvic organ prolapse, such as recurrent (previous failed native tissue repair), large stage III or IV pelvic organ prolapse, and those with symptomatic uterine prolapse desiring uterine-sparing surgery (called hysteropexy).
This study is being done to evaluate the safety and feasibility of using flat polypropylene Restorelle® mesh, an ultra-lightweight mesh, for transvaginal use in surgically correcting certain specific cases of pelvic organ prolapse, such as recurrent (previous failed native tissue repair), large stage III or IV pelvic organ prolapse, and those with symptomatic uterine prolapse desiring uterine-sparing surgery (called hysteropexy).Subjects shall undergo transvaginal mesh surgery per the surgeon's specifications. The surgical procedure may include either a posterior Restorelle or an anterior Restorelle or a combined anterior and posterior Restorelle based upon the findings of the prolapse.
Briefly, a sheet of Restorelle® Flat Mesh-(XL) shall be cut to the dimensions of the former Restorelle® Direct Fix Anterior and Posterior Mesh The posterior Restorelle® procedure involves a posterior vaginal incision with dissection into the pararectal spaces with attachment of the mesh arms to the sacrospinous ligaments bilaterally. A StatTack™ (Medtronic, Dublin, Ireland) device may be used to affix the mesh to the sacrospinous ligament. The apical portions of the mesh will then be attached to the cervix, with at least two, 2-0 Prolene sutures.
The anterior Restorelle® procedure will be performed through an anterior vaginal incision with dissection into the paravaginal spaces with attachment of the arms to the obturator internus or the proximal arms to the sacrospinous ligaments bilaterally. If the patient has occult stress urinary incontinence on preoperative urodynamic testing, a midurethral sling will be placed. Cystourethroscopy will be systematically performed on all subjects undergoing an anterior repair or a sling procedure. A vaginal oval pessary device may be placed at the end of surgery, and this will stay in for the next few weeks as a vaginal support mold while healing occurs. Surgical details such as operative time, estimated blood loss, and complications will be documented accordingly. Adverse events (both immediate and delayed) will be classified according to severity/seriousness using Clavien-Dindo classification for reporting complications. The timing, resolution, and relatedness of these adverse events to the procedure shall be documented as well.
A clinical examination including vaginal wall retraction will be performed along with a POPQ exam and validated questionnaires at 6 months, 12 months, 24 months, and 36 months from the index surgery. Subjects will also complete a PGI-I assessment which asks, "Compared to how you were doing before your recent pelvic floor surgery, would you say that now you are:" with answers being "much better, a little better, about the same, a little worse, or much worse". Subjects will also complete a survey with questions rating satisfaction/regret with making the decision to proceed with treatment. Additionally a pelvic ultrasound to assess the Restorelle mesh will be performed at these visits. Subjects will also be seen at 1 week , 1 month, 3 months, and 18 months after surgery, and an examination and ultrasound will be performed at these visits, but no study questionnaires will be requested. At each follow-up visit, the subject shall be questioned about de novo pelvic pain, dyspareunia, de novo urinary incontinence, recurrent urinary tract infections, repeat operations or treatments, or other adverse events. A vaginal examination shall be completed to determine any mesh exposures with location, mesh erosions, infection, atypical vaginal discharge, tenderness, retraction or shortening of the vaginal walls, vaginal scarring, fistula formation, de novo vaginal bleeding or granulomas, or hematomas. A bladder scan shall assess for voiding function, and a dipstick urinalysis shall be obtained to determine the presence of cystitis. Based upon subjects' symptoms and results on dipstick urinalysis, urine may also be sent for microscopic urinalysis and culture with sensitivities, and antibiotics may be given.
All CRFs will be kept confidential and maintained by the research coordinator in a locked cabinet. The participants will keep the research team aware of any changes in medical history, and if any adverse effects are detected. Data collected onto a Microsoft Excel spreadsheet. Patient reported measures will be collected on paper forms and data entered into the spreadsheet. Analysis will be conducted after the study has been completed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects have failed conservative management for POP and desire a surgical option using transvaginal mesh, and who have a:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects shall undergo transvaginal mesh surgery per the surgeon's specifications. Briefly, a sheet of Restorelle® Flat Mesh-(XL) shall be cut to the dimensions of the former Restorelle® Direct Fix Anterior and Posterior Mesh
Device: Restorelle® Flat Mesh
Pelvic organ prolapse repair using Restorelle® Flat Mesh
Primary Safety outcome
To determine the proportion of subjects with mesh exposures
Time frame: 12 -36 months post operative
Primary efficacy outcome
To determine the proportion of subjects with surgical success
Time frame: up to 36 months post operative
Adverse events
to determine any intraoperative and postoperative adverse events
Time frame: intraoperative to 36 months
Started Sep 2021 (actual). Primary completion is estimated for Dec 2025, 51 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Michigan Institution of Women's Health PC