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

Prolapse of Vaginal Vault After Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01364025
• Other study ID #: PULS
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2011
• Est. completion date: February 21, 2021

Study information

• Verified date: February 2020
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: February 21, 2021
• Est. primary completion date: February 21, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Prolapse of Vaginal Vault After Hysterectomy

Intervention

Procedure:
• uterosacral ligament suspension colpopexy bilateral
Uterosacral ligament suspension colpopexy bilateral

Locations

Country	Name	City	State
United States	Kaiser Permanente San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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