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

Completed

Conditions studied: Pelvic Organ Prolapse

In brief

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

Key facts

Study ID

NCT01377142

Run by

The Cleveland Clinic

People needed

148

Starts

2011-06-01

Expected to finish

2015-12-01

Last updated by the study team

2016-06-14

Who can join

Age: 40 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

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).

Where it is running

• Stanford University — Stanford, California, United States
• Washington Hospital — Washington D.C., District of Columbia, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• UNC — Chapel Hill, North Carolina, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Women & Infant's Hospital — Providence, Rhode Island, United States
• Providence Healthcare — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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