Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse (VAULT)

The purpose of this study is to evaluate surgical success or failure one year after surgery for pelvic organ prolapse.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: Laparoscopic sacral hysteropexy; Device: Vaginal mesh hysteropexy

Detailed Description

This will be a prospective parallel cohort study comparing a laparoscopic sacral hysteropexy (LSHP) to a vaginal Uphold hysteropexy (VUHP). Symptomatic and anatomic improvement of pelvic organ prolapse will be evaluated at 3 months and 1 year.

• Study Type: Observational
• Enrollment (Actual): 148

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • Providence Healthcare
• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC
  • Ohio
    • Cincinnati, Ohio, United States, 45069
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Women & Infant's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Adult women with symptomatic uterovaginal prolapse planning to undergo laparsocopic sacral hysteropexy or vaginal uphold hysteropexy

Description

Inclusion Criteria:

• Desires surgical treatment for uterovaginal prolapse.
• Symptomatic stage II-IV POP including:
• cystocele (AA or BA > or = 0) by POP-Q and
• apical descent below the mid-vagina (point C > -(TVL / 2)) by the POP-Q and
• a positive response to questions 3 of the PFDI 20: Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? (Appendix A)
• Eligible for and undergoing one of the following procedures: laparoscopic sacral hysteropexy (LSHP) or Vaginal Uphold hysteropexy (VUHP)
• Female age 40 to 75.
• Completed childbearing confirmed by subject or practicing reliable form of birth control defined as permanent sterilization, hormonal contraception, abstinence, IUD.
• Normal size uterus (length less than 10 cm) on bimanual exam or ultrasound within the past 6 months.

Exclusion Criteria:

• Prior hysterectomy.
• Patient with synthetic material placed to augment previous pelvic organ prolapse repair. (previous prolapse repair without synthetic mesh is acceptable).
• Current vaginal or pelvic foreign body complications (including but not limited to erosion, fistula, abscess). This includes foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft).
• Desires hysterectomy at the time of prolapse repair.
• Cervical elongation with anticipated need for cervical shortening at the time of prolapse repair as determined by surgeon.
• History of cervical dysplasia (diagnosed within the past 5 years) or increased risk of cervical dysplasia (HIV, immunocompromise, DES exposure), chronic pelvic pain, uterine abnormalities (symptomatic uterine fibroids, polyps, endometrial hyperplasia, cancer) or any uterine disease that would preclude prolapse repair with uterine preservation in the opinion of the surgeon.
• Any postmenopausal bleeding in the past 12 months (regardless of endometrial biopsy or ultrasound results) or any postmenopausal bleeding more than 12 months prior without adequate evaluation in the opinion of the investigator.
• Premenopausal women with menstrual issues including irregular bleeding, menorrhagia, dysmenorrhea,
• Pregnancy (confirmed before surgery with a pregnancy test).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopic sacral hysteropexy; Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance	Device: Laparoscopic sacral hysteropexy; Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance
Vaginal mesh hysteropexy; Vaginal Mesh Hysteropexy using the Uphold device which includes Sacrospinous Ligament Fixation	Device: Vaginal mesh hysteropexy; Uphold device used which includes sacrospinous ligament fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome measure will be surgical "success" or "failure" as a dichotomous outcome 1 year after surgery. Subjects will be considered a success if they meet the definitions of anatomic cure and deny vaginal bulging symptoms.	Anatomic sure is defined as cervix above mid-vagina, and no prolapse beyond the hymen and no surgical treatment for pelvic organ prolapse or pessary use. Symptomatic cure is defined as the absence of vaginal bulge symptoms as indicated by a negative response question 3 of the pelvic floor distress inventory- 20.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomic outcomes	Evaluation of the anterior and posterior walls using point Aa, Ba, Ap and Bp, C, posterior fornix D and total vaginal length TVL; evaluate the size of the genital hiatus and perineal body; evaluation of cervical elongation and record any additional surgical procedures for anterior and posterior vaginal wall prolapse.	12 months
Symptomatic improvement	Relief of symptoms of pelvic floor disorders, including incontinence, voiding dysfunction, pelvic organ prolapse, fecal incontinence defecation disorders and sexual dysfunction using validated instruments collected postoperatively at 3 months, and 1 year.	3months and 12 months
Shortterm morbidity	We will compare the treatment groups with respect to perioperative morbidity and mortality. Perioperative morbidity will be recorded at completion of surgery and at hospital discharge. Postoperative morbidity will be recorded at any time after discharge- 6 weeks, 3 months and 1 year and all adverse events will be documented. Perioperative measures of morbidity will include operative time, estimated blood loss, and complications. Length of hospital stay will also be recorded. Complications will be categorized using the Dindo surgical complication grading scale.	6 weeks, 3 months, 12 months
Pain and functional activity	Postoperative pain- subjects will complete the modified surgical pain scale and a diary of pain medication use preoperatively, then daily for two weeks after surgery, then again at 6 weeks postoperatively. Postoperative functional activity level- subjects will complete the activity assessment scale which measures postoperative functional activity preoperatively, 2 weeks, 6 weeks and 6 months after surgery.	6 weeks and 6 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Stanford University; The Christ Hospital; Medstar Health Research Institute; Women and Infants Hospital of Rhode Island; Greater Baltimore Medical Center; University of North Carolina; Providence Healthcare
• Investigators: Principal Investigator: Robert E Gutman, MD, Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 10, 2011
• First Submitted That Met QC Criteria: June 20, 2011
• First Posted (Estimate): June 21, 2011

Study Record Updates

• Last Update Posted (Estimate): June 14, 2016
• Last Update Submitted That Met QC Criteria: June 13, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: mesh; Uterovaginal prolapse; hysteropexy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 11-409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No