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

Kaiser Permanente

Status

Unknown

Conditions

Prolapse of Vaginal Vault After Hysterectomy

Treatments

Procedure: uterosacral ligament suspension colpopexy bilateral

Study type

Interventional

Funder types

Other

Identifiers

NCT01364025

PULS

Details and patient eligibility

About

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.

Enrollment

800 estimated patients

Sex

Female

Ages

21 to 99 years old

Volunteers

No Healthy Volunteers

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.