GYN | VAULT study for pelvic organ prolapse

STUDY BRIEF | The purpose of this research study is to learn about the effectiveness of 2 surgical techniques for treatment of uterovaginal prolapse: Laparoscopic/ robotic-assisted sacral hysteropexy and Vaginal Uphold Hysteropexy will be compared. Both procedures leave the uterus in place and use mesh to support the uterus and vagina. The cure rates, complications, and improvement of symptoms after these two procedures will be compared.

Name of Study
VAULT - Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Uterovaginal Pelvic Organ Prolapse

Principal Investigator

C. Matthews MD - Division Chief for Urogynecology & Reconstructive Pelvic Surgery

Recruitment Length
November 2011 -

Participation Details
Total participation in the study will be completed 1 year after surgery. Assessment with exam and questionnaires will be made at baseline, 3 months, and 12 months after surgery. You will have a routine postoperative examination at 6 weeks after surgery.

Compensation available?
Yes.  Up to $150

Qualifiers for the study
Desires surgical treatment for uterovaginal prolapse; Symptmatic stage II-IV Pelvic Organ Prolapse; Eligible for and undergoing one of the following procedures: laparoscopic sacral hysteropexy (LSHP) or Vaginal Uphold hysteropexy (VUHP); Female age 35-80;

Exclusion Criteria
Contact study coordinator for a brief survey to determine your eligibility

Study Contact Number
919-843-2574

IRB Approval Number

11-2274

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