Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 7/11/2015 |
| Start Date: | August 2011 |
| End Date: | April 2019 |
| Contact: | Marianna Alperin, MD, MS |
| Email: | malperin@ucsd.edu |
| Phone: | 617-970-3164 |
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.
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.
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.
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