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

NeuroTherapia, Inc.

Status

Completed

Conditions

Pelvic Organ Prolapse

Treatments

Device: Laparoscopic sacral hysteropexy

Device: Vaginal mesh hysteropexy

Study type

Observational

Funder types

Other

Identifiers

NCT01377142

11-409

Details and patient eligibility

About

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

Full 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.

Enrollment

148 patients

Sex

Female

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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).