Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal … (NCT01377142) | Clinical Trial Compass
CompletedNot Applicable
Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse
United States148 participantsStarted 2011-06
Plain-language summary
The purpose of this study is to evaluate surgical success or failure one year after surgery for pelvic organ prolapse.
Who can participate
Age range40 Years – 75 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Desires surgical treatment for uterovaginal prolapse.
* Symptomatic stage II-IV POP including:
* cystocele (AA or BA \> or = 0) by POP-Q and
* apical descent below the mid-vagina (point C \> -(TVL / 2)) by the POP-Q and
* a positive response to questions 3 of the PFDI 20: Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? (Appendix A)
* Eligible for and undergoing one of the following procedures: laparoscopic sacral hysteropexy (LSHP) or Vaginal Uphold hysteropexy (VUHP)
* Female age 40 to 75.
* Completed childbearing confirmed by subject or practicing reliable form of birth control defined as permanent sterilization, hormonal contraception, abstinence, IUD.
* Normal size uterus (length less than 10 cm) on bimanual exam or ultrasound within the past 6 months.
Exclusion Criteria:
* Prior hysterectomy.
* Patient with synthetic material placed to augment previous pelvic organ prolapse repair. (previous prolapse repair without synthetic mesh is acceptable).
* Current vaginal or pelvic foreign body complications (including but not limited to erosion, fistula, abscess). This includes foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft).
* Desires hysterectomy at the time of prolapse repair.
* Cervical elongation with anticipated need for cervical shortening at the time of prolapse repair as determined by surgeon.
* History of cervical dysplasia (diagnosed within the past 5 ye…
What they're measuring
1
The primary outcome measure will be surgical "success" or "failure" as a dichotomous outcome 1 year after surgery. Subjects will be considered a success if they meet the definitions of anatomic cure and deny vaginal bulging symptoms.