Vaginal Orthosis for Prolapse

(NOVa Trial)

Overseen By Holly Richter, PhD, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Low-dose estrogen

Disqualifiers: Previous vaginal surgery, Silicone allergy, others

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

Compensation: Varies

Number of Visits: 4

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is the Vaginal Orthosis safe for treating prolapse?

The Colpexin Sphere, a type of vaginal orthosis, was generally safe in a study with 39 women, though some experienced minor issues like urination and bowel movement problems due to device movement. Two women had minor vaginal sores that healed on their own, and no major side effects were reported. ^{1 2 3 4 5}

How does the vaginal orthosis for prolapse treatment differ from other treatments for prolapse?

The vaginal orthosis for prolapse is unique because it is a non-surgical device designed to support the vaginal walls, unlike traditional surgical methods that involve mesh or sutures to physically lift and secure the prolapsed organs. This approach may offer a less invasive option with potentially fewer complications and a quicker recovery time. ^{6 7 8 9 10}

What is the purpose of this trial?

A novel vaginal orthosis, or splint, made of silicone will be used daily to help support the healing vaginal reconstruction during the post-operative phase from week 2 to week 12.

Eligibility Criteria

This trial is for individuals with stage 2 to 4 pelvic organ prolapse who often feel a bulge in the vaginal area. Participants must be undergoing reconstructive surgery that includes anterior and apical repairs, able to use a silicone splint post-surgery from weeks 2-12, and can attend follow-ups up to one year.

Inclusion Criteria

I feel like something is bulging from my vaginal area.

I can see or feel a bulge in my vaginal area.

I am capable of completing the study assessments as per my doctor's opinion.

Exclusion Criteria

Allergy or contraindication to low-dose vaginal estrogen use.

My surgeon advises against surgery for me.

I have had surgery to repair pelvic organ prolapse, with or without uterus removal.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-operative Management

Participants undergo standard post-operative management including pelvic rest and light activity

2 weeks

1 visit (in-person)

Device Use

Participants use the vaginal orthosis daily from week 2 to week 12 post-operative

10 weeks

Regular check-ins as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

3 visits (in-person) at 3, 6, and 12 months

Treatment Details

Interventions

• Vaginal Orthosis

Trial Overview The study tests a new silicone vaginal orthosis (splint) used daily after vaginal reconstructive surgery. It aims to support healing from week 2 until week 12 post-operation.

Participant Groups

Group I: Device Use Experimental Treatment 1 Intervention

Patient's will use vaginal orthosis daily from the start of week 2 post-operative to week 12 post-operative.

Group II: Standard of Care Active Control 1 Intervention

Patient's will proceed with normal standard of care post-operative management which is pelvic rest and light acitvity.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

In a clinical trial with 39 women suffering from advanced genital prolapse, 81.5% showed improvement in prolapse after using the Colpexin Sphere for 16 weeks, indicating its effectiveness as a treatment option.

The device was well-received, with 92.6% of participants willing to recommend it, although some reported minor issues with urination and defecation due to displacement, and two cases of superficial vaginal ulceration that resolved on their own.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of Colpexin Sphere in the treatment of pelvic organ prolapse. Lukban, JC., Aguirre, OA., Davila, GW., et al.[2018]

References

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

Safety and effectiveness of Colpexin Sphere in the treatment of pelvic organ prolapse. [2018]

2. China pubmed.ncbi.nlm.nih.gov

[Analysis on 567 cases of adverse events of the vaginal dilator]. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Apical prolapse. [2022]

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

A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery. [2022]

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

Comparative analysis of early adverse events of pelvic organ prolapse repair with or without transvaginal mesh using Clavien-Dindo classification. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Advanced utero-vaginal prolapse and vaginal vault suspension: synthetic mesh vs native tissue repair. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

Abdominal repair of vaginal prolapse and the postoperative outcome as judged by a scoring system and X-ray colpography. [2019]

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

Modification of abdominal sacrocolpopexy using a suture anchor system. [2005]

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

The surgical management of vaginal vault prolapse. [2019]

10. Czech Republic pubmed.ncbi.nlm.nih.gov

[Fixation of the prolapsed vagina to the sacrospinous ligament after hysterectomy--the Amreich II-Richter vaginal fixation operation]. [2016]