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Vaginal Orthosis for Prolapse (NOVa Trial)

N/A
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing reconstructive vaginal surgery for POP-Q stage 2 to 4 pelvic organ prolapse that must include anterior compartment repair and apical suspension.
Vaginal bulge symptoms as indicated by an affirmative response to either question 4 or 5 of the PFDI: Do you usually have a sensation of bulging or protrusion from the vaginal area? Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?
Must not have
History of previous vaginal reconstructive surgery with or without hysterectomy for POP.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will use a special silicone device called a vaginal splint to support the healing process after vaginal reconstruction surgery for 10 weeks.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of using the vaginal orthosis may include discomfort, irritation or allergic reactions at the site of application, and possible interference with wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having surgery for moderate to severe pelvic organ prolapse, including repair of the front wall and top support of my vagina.
Select...
I feel or see something bulging from my vaginal area.
Select...
My pelvic organ prolapse is moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had surgery to repair pelvic organ prolapse, with or without uterus removal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective recurrent anterior prolapse
Secondary study objectives
Device use complications
Objective recurrent prolapse
Subjective recurrent prolapse

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Device UseExperimental Treatment1 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 CareActive Control1 Intervention
Patient's will proceed with normal standard of care post-operative management which is pelvic rest and light acitvity.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,635 Previous Clinical Trials
2,305,129 Total Patients Enrolled
4 Trials studying Pelvic Organ Prolapse
546 Patients Enrolled for Pelvic Organ Prolapse
~13 spots leftby Jun 2025
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