CompletedNot Applicable

Difference in Pain, Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Versus Robotic Colpopexy?

United States78 participantsStarted 2014-01

Plain-language summary

The purpose of this study is to to determine if there is a difference in patient related outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse repair compared to robotic-assisted repair. We hypothesize that pain and quality of life following robotic-assisted repair will be similar to that following vaginal reconstruction, when performed in conjunction with vaginal hysterectomy.

Who can participate

Age range

18 Years – 90 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: * patients of Cincinnati Urogynecology Associates * aged 18-90 * planning to undergo a vaginal hysterectomy with robotic or vaginal reconstructive surgery for pelvic organ prolapse as well as a posterior/rectocele repair, with or without a suburethral sling or ovarian removal. * undergoing general anesthesia * able to speak and read English * able to understand the informed consent statement Exclusion Criteria: * scheduled for repairs not involving a hysterectomy * use of mesh in the vaginal prolapse repair * obliterative procedures to the vagina * concurrent removal of a suburethral sling * anterior, posterior or apical vaginal mesh kit at the time of their surgery * performance of vaginal 'relaxing incisions' at the time of vaginal surgery * concurrent anal incontinence repair such as a sphincteroplasty * presence of uterine, cervical or ovarian malignancy * use of regional anesthesia for their surgery.

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

Subjective assessment of pain on the morning of post-operative day 1

Timeframe: One day (the day after surgery)

Trial details

NCT IDNCT02049996

SponsorTriHealth Inc.

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-05

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials