Vaginal Orthosis Use After Vaginal Reconstructive Surgery

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Apr 13, 2023

Keywords

ClinConnect Summary

Background/Rationale:

Pelvic Organ Prolapse (POP) is the bulging or herniation of one or more pelvic organs into or out of the vagina. A woman's estimated lifetime risk of POP is 30-50%, with 2-4% of women being symptomatic. Approximately 300,000 women undergo surgical procedures in the United States to repair POP every year. Recurrence rates of POP after native tissue repair utilizing Sacrospinous Ligament Fixation (SSLF) or Uterosacral Ligament Suspension (USLS) vary based on the definition of surgical or anatomic failure used, however a large RCT reports rate of reoperation at 5 years o...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. POP-Q stage 2 to 4 pelvic organ prolapse
• 2. Vaginal bulge symptoms as indicated by an affirmative response to either question 4 or 5 of the PFDI:
• • 1. Do you usually have a sensation of bulging or protrusion from the vaginal area?
• • 2. Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?
• • 3. Undergoing reconstructive vaginal surgery for POP-Q stage 2 to 4 pelvic organ prolapse that must include anterior compartment repair and apical suspension.
• • 4. Willing and able to use and self-manage novel vaginal orthosis after POP surgery from 2 weeks post-operative to 12 weeks post-operative.
• • 5. Available for 2 and 6 weeks, 3, 6, and 12 months follow-up.
• • 6. Able to complete study assessments, per clinician judgement.
• • 7. Able and willing to provide written informed consent.
• Exclusion Criteria:
• • 1. Contraindication to surgical intervention as planned in the opinion of the treating surgeon (ie undergoing obliterative procedure).
• • 2. History of previous vaginal reconstructive surgery with or without hysterectomy for POP.
• • 3. Allergy to silicone used in Novel Vaginal Orthosis.
• • 4. Allergy or contraindication to low-dose vaginal estrogen use.