The purpose of this study is to evaluate surgical success or failure one year after surgery for pelvic organ prolapse.
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.
Study Type
OBSERVATIONAL
Enrollment
148
Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance
Uphold device used which includes sacrospinous ligament fixation
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 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.
Time frame: 12 months
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.
Time frame: 12 months
Symptomatic improvement
Relief of symptoms of pelvic floor disorders, including incontinence, voiding dysfunction, pelvic organ prolapse, fecal incontinence defecation disorders and sexual dysfunction using validated instruments collected postoperatively at 3 months, and 1 year.
Time frame: 3months and 12 months
Shortterm morbidity
We will compare the treatment groups with respect to perioperative morbidity and mortality. Perioperative morbidity will be recorded at completion of surgery and at hospital discharge. Postoperative morbidity will be recorded at any time after discharge- 6 weeks, 3 months and 1 year and all adverse events will be documented. Perioperative measures of morbidity will include operative time, estimated blood loss, and complications. Length of hospital stay will also be recorded. Complications will be categorized using the Dindo surgical complication grading scale.
Time frame: 6 weeks, 3 months, 12 months
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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
Pain and functional activity
Postoperative pain- subjects will complete the modified surgical pain scale and a diary of pain medication use preoperatively, then daily for two weeks after surgery, then again at 6 weeks postoperatively. Postoperative functional activity level- subjects will complete the activity assessment scale which measures postoperative functional activity preoperatively, 2 weeks, 6 weeks and 6 months after surgery.
Time frame: 6 weeks and 6 months