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Completed

NCT Number: NCT01377142

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

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

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

40 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Providence Healthcare, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Laparoscopic sacral hysteropexy

Device

Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance

Vaginal mesh hysteropexy

Device

Uphold device used which includes sacrospinous ligament fixation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Greater Baltimore Medical Center
  • Medstar Health Research Institute
  • Providence Healthcare
  • Stanford University
  • The Christ Hospital
  • University of North Carolina
  • Women and Infants Hospital of Rhode Island

Registry information

Acronym: VAULT

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 21, 2011
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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