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

NCT01364025 | Unknown

• 1 other identifier: PULS
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prolapse of Vaginal Vault After Hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

uterosacral ligament suspension

EXPERIMENTAL

uterosacral ligament suspension colpopexy sutures will be placed bilaterally at the time of hysterectomy

Procedure: uterosacral ligament suspension colpopexy bilateral

hysterectomy alone

NO INTERVENTION

Interventions

uterosacral ligament suspension colpopexy bilateral PROCEDURE

Uterosacral ligament suspension colpopexy bilateral

Also known as: uterosacral ligament suspension at the time of hysterectomy

uterosacral ligament suspension

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Kaiser Permanente San Diego

San Diego, California, 92110, United States

Location

Study Officials

• Marianna Alperin, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 2, 2011
• Study Start: August 1, 2011
• Primary Completion: February 21, 2021
• Study Completion: February 21, 2021
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

US (1)