Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hyster... | NCT01377142

Status Module

Name	Class
The Christ Hospital	OTHER
Medstar Health Research Institute	OTHER
Providence Healthcare	OTHER
Stanford University

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic sacral hysteropexy	Device	Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance	Laparoscopic sacral hysteropexy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Anatomic outcomes	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.	12 months

Eligibility Module

Eligibility Criteria

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).

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Stanford	California	94305	United States
Washington Hospital

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms