Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse

Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse (PULS)

Is routine uterosacral ligament suspension an appropriate clinical adjunct at the time of hysterectomy?

The answers to these questions will facilitate the treatment of many American women. With the results of this study, the investigators would anticipate a reduction in the number of surgeries for pelvic organ prolapse. In addition, if uterosacral ligament suspension was shown to be ineffective, it would not be used routinely in the setting of hysterectomy and women will be spared the additional procedure and possibility of side effects or complications.

The relative risks and benefits of adding a prophylactic uterosacral ligament suspension at the time of hysterectomy in women without symptomatic prolapse symptoms have never been studied prospectively.

Study Overview

• Status: Unknown
• Conditions: Prolapse of Vaginal Vault After Hysterectomy
• Intervention / Treatment: Procedure: uterosacral ligament suspension colpopexy bilateral

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92110
      • Kaiser Permanente San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Eligibility for primary procedure (hysterectomy either total or supracervical, performed either vaginally or abdominally, via laparoscopic or open approach)
• Eligibility for secondary procedure (uterosacral ligament suspension colpopexy)
• Prolapse in any compartment not extending beyond the hymen as measured by Pelvic Organ Prolapse Quantitative system
• No subjective complaints of Pelvic Organ Prolapse as determined by answer "no" to questions #3 of the short form of Pelvic Floor Distress Inventory: #3. Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?

Exclusion Criteria:

• Contraindication for uterosacral ligament suspension colpopexy. (Surgeon's judgment that a contraindication to uterosacral ligament suspension colpopexy exists).
• Anticipated geographic relocation within the 12 months after surgery
• Inability to provide informed consent or to complete testing or data collection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: uterosacral ligament suspension; uterosacral ligament suspension colpopexy sutures will be placed bilaterally at the time of hysterectomy	Procedure: uterosacral ligament suspension colpopexy bilateral; Uterosacral ligament suspension colpopexy bilateral; Other Names: uterosacral ligament suspension at the time of hysterectomy
No Intervention: hysterectomy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare the occurrence of objective findings of pelvic organ prolapse beyond hymen after uterosacral ligament suspension of the vaginal apex at the time of hysterectomy vs. hysterectomy alone using Pelvic Floor Quantitative Examination	one year and annual thereafter for 5 years

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Massachusetts General Hospital
• Investigators: Principal Investigator: Marianna Alperin, MD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): February 21, 2021
• Study Completion (Anticipated): February 21, 2021

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 2, 2011

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: PULS