NCT07265973 · University of New Mexico
PREPARE: Perioperative REhabilitation Around Vaginal Prolapse RepAir Surgery for Recovery Enhancement
(PREPARE)
What this study is about
Pelvic organ prolapse is a common problem faced by millions of patients in the United States, leading to an estimated 200,000 surgeries per year. The majority of patients in the US undergoing vaginal suspension between the ages of 60-79. Deconditioning and decreased functional status after surgery can be more pronounced in elderly populations.
View original scientific description
Pelvic organ prolapse is a common problem faced by millions of patients in the United States, leading to an estimated 200,000 surgeries per year. The majority of patients in the US undergoing vaginal suspension between the ages of 60-79. Deconditioning and decreased functional status after surgery can be more pronounced in elderly populations. It is important to explore ways to improve postoperative functioning for this vulnerable population. This research study is about how good your physical functioning is after surgery. The physical functioning we are studying consist of normal daily activities, such as walking up and down stairs. This study is for patients with pelvic organ prolapse who are getting vaginal surgery to correct the prolapse. By doing this study, we hope to learn more about ways to improve physical functioning after vaginal prolapse repair surgery. Patients will be chosen at random to participate in or not to participate in a home daily exercise program for 6 weeks. We have participants who do not participate in the home exercise program so that we can compare their physical functioning to the participants who do exercise at home. By doing this comparison, we can find out if the home exercise program helps postoperative physical functioning. If you are in the home exercise group, a possible benefit is to have better physical functioning after surgery. If you are not assigned to the exercise group, the benefit is being a part of a study that could potentially help other women and yourself in the future to have better physical functioning after surgery. Patients will be enrolled in teh study only if they are undergoing specific surgeries at the University of New Mexico to correct their pelvic organ prolapse.
Interventions
OTHER
Pelvic floor Home Exercise Program, this intervention is comprised of specific exercises that are easy to complete at home
Many exercise regimens focus on strengthening your pelvic floor. The intervention for this study is a novel pelvic floor physical therapy program that focuses on relaxing, stretching, and protecting the pelvic floor.
Primary outcome measures
Postoperative physical functioning
Time frame: Physical functioning will be assessed at baseline when patint is enrolled. Physical functioning will also be assessed postoperatively at 1, 2, and 6 weeks after surgery.
Postoperative physical functioning will be assessed using a questionnaire. The specific questionnaire is the Patient Reported Outcomes Measurement Information Systems (PROMIS) Physical Function Short Form 20a.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects are ≥ 18 years of age
- English or Spanish speaking
- Stage 2, 3 or 4 uterovaginal or vaginal vault prolapse.
- Patient scheduled to undergo transvaginal sacrospinous ligament suspension, uterosacral ligament suspension, or Manchester procedure at The University of New Mexico Hospital.
Exclusion criteria
- Inability to speak English or Spanish
- Currently enrolled in Pelvic floor physical therapy
- Inability to perform the home exercises
- Inability to fill out questionnaires
- Inability to access video via internet
- Undergoing concomitant surgeries that involve: InterStim, bladder hydrodistension/fulguration, pelvic floor Botox, mesh excision/complications.
Where
- Albuquerque, New Mexico
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 22, 2025 · Source of record for eligibility and locations