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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Christ Hospital
Washington Hospital Center
Providence Healthcare in British Columbia
Stanford University
Women and Infants Hospital of Rhode Island
Greater Baltimore Medical Center
University of North Carolina
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01377142
First received: June 10, 2011
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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


Condition
Pelvic Organ Prolapse

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • Anatomic outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Symptomatic improvement [ Time Frame: 3months and 12 months ] [ Designated as safety issue: No ]
    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.

  • Shortterm morbidity [ Time Frame: 6 weeks, 3 months, 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Pain and functional activity [ Time Frame: 6 weeks and 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 144
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Laparoscopic sacral hysteropexy treatment
Vaginal uphold hysteropexy treatment

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders 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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377142

Locations
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
UNC
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 in British Columbia
Stanford University
Women and Infants Hospital of Rhode Island
Greater Baltimore Medical Center
University of North Carolina
Investigators
Principal Investigator: Robert E Gutman, MD Washington Hospital Center
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01377142     History of Changes
Other Study ID Numbers: 11-409
Study First Received: June 10, 2011
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Uterovaginal prolapse
hysteropexy
mesh

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

ClinicalTrials.gov processed this record on October 23, 2014