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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new silicone device, called a vaginal orthosis, designed to aid women in healing after surgery for pelvic organ prolapse (a condition where pelvic organs drop from their normal position). The trial aims to determine if using this device daily from week 2 to week 12 post-surgery improves recovery compared to standard care, which involves resting and avoiding strenuous activities. Women who have undergone pelvic organ prolapse surgery, experience bulging symptoms, and are willing to use the device during recovery may be suitable candidates for this study. As an unphased trial, this study allows participants to contribute to innovative research that could enhance recovery options for future patients.

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.

What prior data suggests that this vaginal orthosis is safe for post-operative use?

Research has shown that using a vaginal orthosis, a type of supportive device, can safely treat prolapse. One study with 39 women found that 81.5% experienced improvement in their prolapse condition after using a similar device, the Colpexin Sphere, for 16 weeks. This suggests that many people tolerate these devices well.

Although specific safety data for the silicone vaginal orthosis in this trial is unavailable, similar devices have been used without major issues. In the absence of detailed safety data, it is important to consider information from similar treatments. When a treatment is labeled experimental, it is still under study for safety and effectiveness. Prospective trial participants should ask the study team any questions about potential risks or side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the vaginal orthosis for prolapse because it offers a new, hands-on approach to managing this condition. Unlike the standard care, which involves pelvic rest and light activities post-surgery, this device is used daily and provides direct support to the pelvic area. This means it could potentially offer more immediate relief and support compared to waiting for natural healing with standard care. By directly addressing the physical aspect of prolapse, the vaginal orthosis might help improve recovery and overall comfort for patients.

What evidence suggests that this vaginal orthosis is effective for prolapse?

Research has shown that using vaginal devices, such as implants, can lead to better long-term results for pelvic organ prolapse compared to surgery alone. Some studies have found that these devices offer more support and result in fewer problems over time. Women report feeling better and noticing improvements when using these supportive devices. In this trial, participants in the "Device Use" arm will use a vaginal orthosis, designed to provide extra support and aid healing after surgery. Early evidence suggests that these support devices effectively improve recovery and overall outcomes. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 having surgery for moderate to severe pelvic organ prolapse, including repair of the front wall and top support of my vagina.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7854402/

Long-term outcomes of pelvic organ prolapse repair using a ... The aim of this study was to compare long-term effects of high-volume surgery at a single-center to multicenter use when using a mesh-capturing device for ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405456923002432

Safety and Efficacy of Vaginal Implants in Pelvic Organ ... Despite higher complication rates, vaginal implants provide better long-term results overall than surgery without implants.

3. gpm.amegroups.org gpm.amegroups.org/article/view/10109/html

Patient-reported outcomes in pelvic organ prolapse repair Evaluation and acceptability of patient-reported outcome measures in women following pelvic organ prolapse procedures.

4. pelviperineology.org pelviperineology.org/articles/vaginal-reconstruction-effectiveness-and-safety-comparison-of-anterior-versus-posterior-pelvic-floor-compartment-reinforcement-with-partially-absorbable-mini-mesh-implant-in-500-cases-of-apical-pelvic-organ-prolapse/PPj.2025.44.01.2024-9-1

Comparison of anterior versus posterior pelvic floor ... To assess the vaginal reconstruction effectiveness and safety, comparing anterior versus posterior pelvic floor compartment reinforcement with ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2799654

Effect of Pessary vs Surgery on Patient-Reported ... A recent observational cohort study performed by this research group, reported that more women reported subjective improvement following surgery ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11353278/

Long-Term Outcomes (10 Years) of Sacrospinous Ligament ... Transvaginal repair with sacrospinous fixation is a long-lasting option for prolapse repair, with improvement in every POP-q parameter.

7. withpower.com withpower.com/trial/phase-prolapse-8-2023-ab911

Vaginal Orthosis for Prolapse (NOVa Trial) 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, ...

8. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/aogs.15170

Efficacy and safety of laparoscopic lateral suspension with ... LLS demonstrates favorable anatomical and subjective success rates, indicating its reliability and safety for pelvic organ prolapse treatment.

9. mdpi.com mdpi.com/2077-0383/14/1/159

The Impact of Pelvic Organ Prolapse on the Long-Term ... Our research revealed an 8.7% overall revision rate and a 2.6% mesh-related complication rate for all TOT operations conducted at the specialized incontinence ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521693405001124

The use of prosthetics in pelvic reconstructive surgery The lifetime risk of undergoing prolapse or incontinence surgery in the USA is 1 in 11. With a recognized reoperation rate exceeding 30% for prolapse surgery, ...