Biologic Mesh for Pelvic Organ Prolapse

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Michigan Institution of Women's Health PC

Disqualifiers: Language barrier, Consent refusal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a special type of mesh, Axis Dermis (a biologic mesh), can improve symptoms for individuals with pelvic organ prolapse, a condition where pelvic organs descend from their normal position. The study will assess if the prolapse is above the hymen and if participants experience a bulge. It targets those with a bothersome vaginal bulge and Stage II or worse prolapse who are undergoing a repair procedure with Axis Dermis. Participants will undergo the procedure and be monitored for three years to evaluate the results. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective Axis Dermis benefits more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for Axis(TM) Solvent-dehydrate Dermal Allograft?

Research shows that the Axis™ Solvent-dehydrate Dermal Allograft, used to fix pelvic organ prolapse, is generally safe. Studies have found it to be well-tolerated with few side effects. Long-term studies have demonstrated a good safety record for this biologic mesh, indicating no major problems over time.

Earlier research on similar procedures reported a low risk of harm. The safety of this treatment aligns with other common methods for similar repairs, suggesting it is unlikely to cause unusual or severe issues. However, as with any procedure, some risks may still exist. Always consult a healthcare provider for personalized advice. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for pelvic organ prolapse, which often involve synthetic mesh or native tissue repair, Axis(TM) Solvent-dehydrate Dermal Allograft uses a biologic mesh derived from human dermis. This biologic approach aims to integrate more naturally with the body's tissues, potentially reducing complications like erosion or infection that are sometimes associated with synthetic materials. Researchers are excited about this treatment because it could provide a more durable and biocompatible solution, offering long-term support and improved outcomes for patients with Stage II or greater pelvic organ prolapse.

What evidence suggests that Axis Dermis biologic mesh is effective for pelvic organ prolapse?

Research has shown that the Axis Dermis biologic mesh, which participants in this trial will receive, effectively treats pelvic organ prolapse. Studies have found that this mesh is safe and significantly reduces prolapse symptoms. It matches the effectiveness of other repair methods and carries a low risk of complications. Patients using this mesh often experience better outcomes, with fewer noticing a bulge after the procedure. Thus, the Axis Dermis biologic mesh is a reliable choice for relieving prolapse symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Salil Khandwala, MD

Principal Investigator

Michigan Institution of Women's Health PC

Are You a Good Fit for This Trial?

This trial is for individuals experiencing pelvic organ prolapse, where organs like the bladder or uterus drop from their normal position. Participants should notice a bulge or have the leading edge of the prolapse above the hymen. Details on who can't join are not provided.

Inclusion Criteria

I have had surgery involving the skin layer near my spine.

My pelvic organ prolapse is stage II or higher.

I feel a bothersome bulge in my vagina.

Exclusion Criteria

Subjects who are unable to follow-up

Subjects who do not sign an informed consent

Subjects who cannot complete the validated questionnaires

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Axis Dermis pelvic organ prolapse repair procedure using biologic mesh

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with clinical examinations and questionnaires

3 years

Visits at 1 month, 6 months, 12 months, 24 months, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Axis(TM) Solvent-dehydrate Dermal Allograft

Trial Overview The study is testing Axis Dermis, a biologic mesh repair procedure for those with pelvic organ prolapse. It aims to see if this treatment improves conditions by keeping organs in place and reducing symptoms like bulging.

How Is the Trial Designed?

Group I: Subjects undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Michigan Institution of Women's Health PC

Lead Sponsor

Trials

8

Recruited

390+

Coloplast A/S

Industry Sponsor

Trials

155

Recruited

14,800+

Founded

1957

Headquarters

Humlebæk, Denmark

Known For

Intimate Healthcare Solutions

Top Products

Ostomy bags, Continence products, Wound dressings

Kristian Villumsen

Coloplast A/S

Chief Executive Officer since 2018

Master's degree in Political Science from Aarhus University

Preeti Jain

Coloplast A/S

Chief Medical Officer since 2023

MD from University of Copenhagen

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06263985

Axis(TM) Solvent-dehydrate Dermal Allograft in the ... The goal of this study is to assess improvement in subjects who have undergone Axis Dermis, biologic mesh for pelvic organ prolapse repair. [describe ...

2. iu.coloplast.us iu.coloplast.us/products/allografts/

Axis™ Dermis & Suspend® Fascia Lata Tutoplast ... The only allografts used for soft tissue repair in pelvic floor repair procedures that are processed using the trusted Tutoplast Tissue Sterilization Process.

3. withpower.com withpower.com/trial/phase-4-prolapse-10-2021-e948b

Biologic Mesh for Pelvic Organ Prolapse · Info for Participants The solvent-dehydrated dermal allograft (AXIS™) used for pelvic organ prolapse repair has shown an improved safety profile in long-term studies. However, some ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28039517/

Solvent-dehydrated dermal allograft (AXIS™) augmented ... These results indicate that SDDG augmented cystocele repair is a safe procedure, with low morbidity, and it's success is comparable to other techniques.

5. coloplastprofessional.us coloplastprofessional.us/globalassets/hcp/interventional-urology/pdfs/female-continence/axis-dermis_clinical-summary_juma-12month_pm-04720.pdf

Solvent-Dehydrated Dermal Allograft (AXIS™) Augmented ... Solvent-dehydrated dermal allograft. (SDDG) has an improved safety profile. We evaluated the long-term safety and efficacy of. SDDG use for cystocele repair.

6. iu.coloplast.us iu.coloplast.us/wp-content/uploads/2022/06/USIU_WH_AllograftAxisDermisSuspendFasciaLataBrochure_PM-22801.pdf

Axis™ Dermis and Suspend® Fascia Lata Saad Juma and Omer Raheem, “MP81-17 solvent dehydrated dermal allograft (Axis™) augmented cystocele repair: longitudinal long-term results,” J of Urol 2015 ...