PREPARE: Perioperative REhabilitation Around Vaginal Prolapse RepAir Surgery for Recovery Enhancement (PREPARE)

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Physical Functioning
• Intervention / Treatment: Other: Pelvic floor Home Exercise Program, this intervention is comprised of specific exercises that are easy to complete at home

Detailed Description

The objective of this study is to compare postsurgical physical functioning after transvaginal native tissue prolapse repair between patients undergoing normal perioperative care and patients utilizing a standardized perioperative pelvic floor home exercise program. This objective will be accomplished by randomizing women undergoing sacrospinous ligament suspension, uterosacral ligament suspension, or the Manchester procedure to standard perioperative care or standard perioperative care accompanied by a home exercise program using a 1:1 randomization ratio.

The central hypothesis is that the use of a perioperative exercise program will improve patients' postoperative physical functioning. The resulting positive impact that could come from this study is a standardized method to improve physical functioning and possibly improve deconditioning for patients undergoing transvaginal prolapse repair.

Studies previously mentioned involving PFPT have a high level of heterogeneity of exercises, and the exercises are individualized. One commonality between many studies utilizing PFPT programs is a large strengthening component. This strengthening consists of contractions of the pelvic floor muscles with home exercises often involving daily sets of pelvic floor muscle contractions. Strengthening exercises consisting of daily contractions were not utilized in this exercise program as data does not support a significant positive impact of these exercises. In cooperation with UNM pelvic floor Physical Therapists we developed a novel home PFPT exercise program focused on relaxing, stretching, and protecting the pelvic floor.

Participants will be assigned to either a home exercise group or a standard care group 1-2 months prior to their surgical date. This assignment will be random using a 1:1 ratio. The intervention group will be assigned daily home exercises, these daily exercises are to be started 2 weeks prior to surgery and continue 4 weeks after surgery. An exercise video and written instructions of all that is in the video will be provided in order for the home exercise group to have guidance on how to perform the exercises correctly. The second group, the control/standard care group, will not be provided with exercises and that group is to do their normal daily activities before and after surgery. The standard care group will be provided exercises 6 weeks after surgery, once their participation in the study is complete.

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel E Moore, MD; Phone Number: 720-394-9986; Email: racemoore@salud.unm.edu
• Study Contact Backup: Name: Karen Clinical Reseach Manager; Phone Number: 505-272-7541; Email: kataylor@salud.unm.edu

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Recruiting
      • University of New Mexico Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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
• Dementia
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine Perioperative Care; This arm consists of control subjects who are not assigned to an intervention
Experimental: Home Exercise Program; This arm consists of subjects who are assigned to perform the home exercise intervention	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative physical functioning	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.	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.

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Principal Investigator: Sarah Jeney, MD

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): June 25, 2027
• Study Completion (Estimated): June 25, 2028

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Estimated): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 25-258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No