Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse (PULS)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Kaiser Permanente
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 99 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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: #
- •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.
Arms & Interventions
hysterectomy alone
uterosacral ligament suspension
uterosacral ligament suspension colpopexy sutures will be placed bilaterally at the time of hysterectomy
Intervention: uterosacral ligament suspension colpopexy bilateral (Procedure)
Outcomes
Primary Outcomes
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
Time Frame: one year and annual thereafter for 5 years
Secondary Outcomes
No secondary outcomes reported