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 States, Canada148 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 range
40 Years – 75 Years
Sex
FEMALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.