A Phase 4 interventional study of Axis Dermis biologic mesh repair for pelvic organ prolapse 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 21 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-16.
Sponsored by Michigan Institution of Women's Health PC · Phase 4, Interventional, and Treatment
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 97th largest by enrollment of the 133 interventional ones that give a count, is one of 15 that started in 2021, is one of 25 in phase 4, reaches primary completion later than 3 of the 22 other live ones, and was the 180th 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: 21 Years to 89 Years · 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 50 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.
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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:
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The goal of this study is to assess improvement in subjects who have undergone Axis Dermis, biologic mesh for pelvic organ prolapse repair. [describe participant population/health conditions]. The main question[s] it aims to answer are:
This is a prospective single-arm study of 50 subjects undergoing pelvic organ prolapse repair using the Axis™ Dermis biologic mesh. They will be followed for a period of 3 years. A subgroup analysis is for patients with uterine prolapse and vaginal mesh hysteropexy.
Clinical examination including vaginal wall retraction with or without pelvic ultrasound, POP-Q, and also specific validated questionnaires at baseline, 1 month, 6 month, 12 month, 24 month and 36 month visits will be assessed.
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.
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.
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.
This is a single are which will be composed of subjects with Stage II or greater pelvic organ prolapse who have agreed to undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh. They will undergo the procedure and be followed for a period of 3 years.
Device: Axis Dermis biologic mesh repair for pelvic organ prolapse
Subjects with pelvic organ prolapse will undergo a pelvic organ prolapse repair with the use of Axis Dermis biologic mesh.
Improvement in function
Determine improvement in function based on questionnaire Pelvic Floor Distress Inventory Q#3 "Do you usually have a bulge or something falling out that you can see or fell in the vaginal area?" Answered No, or if Yes: Not at all bothersome.
Time frame: Preoperative to 3 years postoperative.
Improvement in Anatomy
To assess improvement in anatomy with success defined as the leading edge of the prolapse is above the hymen, and no reintervention (surgery or pessary) for pelvic organ prolapse.
Time frame: Preoperative to 3 years postoperative.
Assess complications or untoward side effects.
Assessment of intraoperative complications (such as bleeding and injuries) and post operative complications (such as de novo incontinence, de novo dyspareunia, recurrent urinary tract infections, voiding dysfunction and effect on untreated vaginal wall).
Time frame: intraoperative to 3 years postoperative
Started Nov 2021 (actual). Primary completion is estimated for May 2025, 42 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 Feb 2024. You cannot join it, but the record below documents what was studied.
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Michigan Institution of Women's Health PC