Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The Cleveland Clinic
With
The Christ Hospital
Medstar Health Research Institute
Providence Healthcare
Stanford University
Women and Infants Hospital of Rhode Island
Greater Baltimore Medical Center
University of North Carolina
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.
Age
40–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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).
Clareo Health | Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse
