Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse (VAULT)
The purpose of this study is to evaluate surgical success or failure one year after surgery for pelvic organ prolapse.
Pelvic Organ Prolapse
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse|
- 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
- Anatomic outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Symptomatic improvement [ Time Frame: 3months and 12 months ] [ Designated as safety issue: No ]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.
- Shortterm morbidity [ Time Frame: 6 weeks, 3 months, 12 months ] [ Designated as safety issue: Yes ]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.
- Pain and functional activity [ Time Frame: 6 weeks and 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
|Laparoscopic sacral hysteropexy treatment|
|Vaginal uphold hysteropexy treatment|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377142
|Contact: Matthew D. Barber, MD, MHSemail@example.com|
|Contact: Geetha Krishnan, RNfirstname.lastname@example.org|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Tine Bjornlund 650-724-7826 email@example.com|
|Principal Investigator: Eric Sokol, MD|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20010|
|Contact: Joanna Peterson, RN 202-877-0526 firstname.lastname@example.org|
|Principal Investigator: Robert E. Gutman, MD|
|United States, Maryland|
|Greater Baltimore Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21204|
|Contact: Sue Aumiller 443-849-8049 email@example.com|
|Principal Investigator: Joan Blomquist, MD|
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Vanessa Hightower-Corbett 919-843-1862 firstname.lastname@example.org|
|Principal Investigator: Catherine Matthews, MD|
|United States, Ohio|
|The Christ Hospital||Recruiting|
|Cincinnati, Ohio, United States, 45069|
|Contact: Marsha Zartman 513-463-2509 email@example.com|
|Contact: Sharon Lamping 513-463-2500 firstname.lastname@example.org|
|Principal Investigator: Mickey Karram, MD|
|Cleveland, Ohio, United States, 44195|
|Contact: Geetha Krishnan, RN, MSN 216-445-8090 email@example.com|
|Principal Investigator: Matthew D. Barber, MD, MHS|
|United States, Rhode Island|
|Women & Infant's Hospital||Recruiting|
|Providence, Rhode Island, United States, 02903|
|Contact: Ann Mears, RN 401-274-1122 ext 2811 firstname.lastname@example.org|
|Contact: Samantha Douglas 401-276-7869 email@example.com|
|Principal Investigator: Charles Rardin, MD|
|Canada, British Columbia|
|Vancouver, British Columbia, Canada, V6Z1Y6|
|Contact: Nikki Koenig 604-806-9829 firstname.lastname@example.org|
|Principal Investigator: Geoffrey Cundiff, MD|
|Principal Investigator:||Robert E Gutman, MD||Washington Hospital Center|