Clinical trial NCT01377142: Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse
Official title: Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Uterovaginal prolapse
hysteropexy
mesh
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: The Christ Hospital
name: Medstar Health Research Institute
name: Providence Healthcare
name: Stanford University
name: Women and Infants Hospital of Rhode Island
name: Greater Baltimore Medical Center
name: University of North Carolina
First posted: 2011-06-21
Enrollment: 148
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women with symptomatic uterovaginal prolapse planning to undergo laparsocopic sacral hysteropexy or vaginal uphold hysteropexy

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

Detailed 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.

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).

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Anatomic outcomes
timeFrame: 12 months
measure: Symptomatic improvement
timeFrame: 3months and 12 months
measure: Shortterm morbidity
timeFrame: 6 weeks, 3 months, 12 months
measure: Pain and functional activity
timeFrame: 6 weeks and 6 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Washington
country: United States
facility: Washington Hospital
state: District of Columbia
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Chapel Hill
country: United States
facility: UNC
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Providence
country: United States
facility: Women & Infant's Hospital
state: Rhode Island
city: Vancouver
country: Canada
facility: Providence Healthcare
state: British Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Robert E Gutman, MD
role: PRINCIPAL_INVESTIGATOR
References: