Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate surgical success or failure one year after surgery for pelvic organ prolapse.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse

NCT05063331

Uterine Prolapse

RECRUITING NA

Intraoperative Costs and Patient Perceptions in Sacrocolpopexy for Prolapse

NCT04179955

Pelvic Organ Prolapse

ACTIVE_NOT_RECRUITING

Vaginal Hysterectomy vs Supracervical Hysterectomy at the Time of Sacrocolpopexy

NCT04797585

Vaginal Hysterectomy Laparoscopic Supracervical Hysterectomy

TERMINATED NA

Evaluation of the Results of Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh in the Surgical Treatment of Pelvic Organ Prolapse

NCT06176521

Pelvic Organ Prolapse

COMPLETED NA

Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design

NCT02676973

Visceral Prolapse

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This will be a prospective parallel cohort study comparing a laparoscopic sacral hysteropexy (LSHP) to a vaginal Uphold hysteropexy (VUHP). Symptomatic and anatomic improvement of pelvic organ prolapse will be evaluated at 3 months and 1 year.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Organ Prolapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laparoscopic sacral hysteropexy

Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance

Laparoscopic sacral hysteropexy

Intervention Type DEVICE

Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance

Vaginal mesh hysteropexy

Vaginal Mesh Hysteropexy using the Uphold device which includes Sacrospinous Ligament Fixation

Vaginal mesh hysteropexy

Intervention Type DEVICE

Uphold device used which includes sacrospinous ligament fixation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laparoscopic sacral hysteropexy

Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance

Intervention Type DEVICE

Vaginal mesh hysteropexy

Uphold device used which includes sacrospinous ligament fixation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 years) or increased risk of cervical dysplasia (HIV, immunocompromise, DES exposure), chronic pelvic pain, uterine abnormalities (symptomatic uterine fibroids, polyps, endometrial hyperplasia, cancer) or any uterine disease that would preclude prolapse repair with uterine preservation in the opinion of the surgeon.
* Any postmenopausal bleeding in the past 12 months (regardless of endometrial biopsy or ultrasound results) or any postmenopausal bleeding more than 12 months prior without adequate evaluation in the opinion of the investigator.
* Premenopausal women with menstrual issues including irregular bleeding, menorrhagia, dysmenorrhea,
* Pregnancy (confirmed before surgery with a pregnancy test).

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No