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

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ClinicalTrials.gov Identifier: NCT01377142
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : June 14, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Pelvic Organ Prolapse 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 Design

Study Type : Observational
Actual Enrollment : 148 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse
Study Start Date : June 2011
Primary Completion Date : December 2015
Study Completion Date : December 2015

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U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]

    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.

Secondary Outcome Measures :
  1. Anatomic outcomes [ Time Frame: 12 months ]
    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.

  2. Symptomatic improvement [ Time Frame: 3months and 12 months ]
    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.

  3. Shortterm morbidity [ Time Frame: 6 weeks, 3 months, 12 months ]
    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.

  4. Pain and functional activity [ Time Frame: 6 weeks and 6 months ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult women with symptomatic uterovaginal prolapse planning to undergo laparsocopic sacral hysteropexy or vaginal uphold hysteropexy

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377142

United States, California
Stanford University
Stanford, California, United States, 94305
United States, District of Columbia
Washington Hospital
Washington, District of Columbia, United States, 20010
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45069
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Rhode Island
Women & Infant's Hospital
Providence, Rhode Island, United States, 02903
Canada, British Columbia
Providence Healthcare
Vancouver, British Columbia, Canada, V6Z1Y6
Sponsors and Collaborators
The Cleveland Clinic
The Christ Hospital
Washington Hospital Center
Providence HealthCare
Stanford University
Women and Infants Hospital of Rhode Island
Greater Baltimore Medical Center
University of North Carolina
Principal Investigator: Robert E Gutman, MD Washington Hospital Center
More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01377142     History of Changes
Other Study ID Numbers: 11-409
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
Uterovaginal prolapse

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Pathological Conditions, Anatomical