Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

— VAULT  

Official title:

Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377142
• Other study ID #: 11-409
• Status: Completed
• Phase: N/A
• First received: June 10, 2011
• Last updated: June 13, 2016
• Start date: June 2011
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• Laparoscopic sacral hysteropexy
Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance
• Vaginal mesh hysteropexy
Uphold device used which includes sacrospinous ligament fixation

Locations

Country	Name	City	State
Canada	Providence Healthcare	Vancouver	British Columbia
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	UNC	Chapel Hill	North Carolina
United States	The Christ Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Women & Infant's Hospital	Providence	Rhode Island
United States	Stanford University	Stanford	California
United States	Washington Hospital	Washington	District of Columbia

Sponsors (8)

Lead Sponsor	Collaborator
The Cleveland Clinic	Greater Baltimore Medical Center, Providence HealthCare, Stanford University, The Christ Hospital, University of North Carolina, Washington Hospital Center, Women and Infants Hospital of Rhode Island

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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.	3months and 12 months	No
Secondary	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.	6 weeks, 3 months, 12 months	Yes
Secondary	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.	6 weeks and 6 months	No