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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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: * Is the leading edge of the prolapse above the hymen * Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure.

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 data supports the effectiveness of the treatment Axis(TM) Solvent-dehydrate Dermal Allograft for pelvic organ prolapse?

Research on the solvent-dehydrated dermal allograft (SDDG) used for cystocele repair, a type of pelvic organ prolapse, shows that it has a good safety profile and is effective in the long term. This suggests that the Axis(TM) treatment, which uses a similar approach, may also be effective for pelvic organ prolapse. ^{1 2 3 4 5}

Is the biologic mesh for pelvic organ prolapse safe for humans?

The solvent-dehydrated dermal allograft (AXIS™) used for pelvic organ prolapse repair has shown an improved safety profile in long-term studies. However, some studies on similar materials have reported complications like graft erosion and pain, indicating that safety can vary depending on the specific material and surgical technique used. ^{1 4 6 7 8}

How is the Axis(TM) Solvent-dehydrate Dermal Allograft treatment different from other treatments for pelvic organ prolapse?

The Axis(TM) Solvent-dehydrate Dermal Allograft is unique because it uses a biologic mesh that has an improved safety profile compared to synthetic meshes, which have been associated with complications like erosion and infection. This treatment aims to provide better tissue integration and fewer adverse reactions, making it a safer alternative for pelvic organ prolapse repair. ^{1 5 9 10 11}

Research Team

Salil Khandwala, MD

Principal Investigator

Michigan Institution of Women's Health PC

Eligibility Criteria

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

My pelvic organ prolapse is stage II or higher.

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

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

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

Treatment Details

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.

Participant Groups

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

References

1. England pubmed.ncbi.nlm.nih.gov

Solvent-dehydrated dermal allograft (AXIS™) augmented cystocele repair: longitudinal results. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Evaluating the porcine dermis graft InteXen in three-compartment transvaginal pelvic organ prolapse repair. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Graft and Mesh Use in Transvaginal Prolapse Repair: A Systematic Review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of the 2011 FDA transvaginal mesh safety update on AUGS members' use of synthetic mesh and biologic grafts in pelvic reconstructive surgery. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Host-biomaterial interactions in mesh complications after pelvic floor reconstructive surgery. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Absorbable mesh augmentation compared with no mesh for anterior prolapse: a randomized controlled trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Long-term outcome of porcine skin graft in surgical treatment of recurrent pelvic organ prolapse. An open randomized controlled multicenter study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Evaluation of the bioactivity about anti-sca-1/basic fibroblast growth factor-urinary bladder matrix scaffold for pelvic reconstruction. [2020]

10. England pubmed.ncbi.nlm.nih.gov

PelviSoft BioMesh augmentation of rectocele repair: the initial clinical experience in 35 patients. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Stress Urinary Incontinence and Pelvic Organ Prolapse: Biologic Graft Materials Revisited. [2021]