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

NCT01377142 | Completed DMC

• 1 other identifier: 11-409
• Study Type: observational
• Target: 148
• Locations: 2 countries
• Sites: 8

Brief Summary

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

Conditions

Pelvic Organ Prolapse

Keywords

Uterovaginal prolapse; hysteropexy; mesh

Outcome Measures

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.

  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 Outcomes (4)

• Anatomic outcomes

  12 months

• Symptomatic improvement

  3months and 12 months

• Shortterm morbidity

  6 weeks, 3 months, 12 months

• Pain and functional activity

  6 weeks and 6 months

Study Arms (2)

Laparoscopic sacral hysteropexy

Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance

Device: Laparoscopic sacral hysteropexy

Vaginal mesh hysteropexy

Vaginal Mesh Hysteropexy using the Uphold device which includes Sacrospinous Ligament Fixation

Device: Vaginal mesh hysteropexy

Interventions

Laparoscopic sacral hysteropexy DEVICE

Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance

Laparoscopic sacral hysteropexy

Vaginal mesh hysteropexy DEVICE

Uphold device used which includes sacrospinous ligament fixation

Vaginal mesh hysteropexy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (8)

Stanford University

Stanford, California, 94305, United States

Location

Washington Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

UNC

Chapel Hill, North Carolina, 27599, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45069, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Women & Infant's Hospital

Providence, Rhode Island, 02903, United States

Location

Providence Healthcare

Vancouver, British Columbia, V6Z1Y6, Canada

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert E Gutman, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2011
• First Posted: June 21, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 14, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (7)