Postoperative Physical FunctioningPREPARENCT07265973
PREPARE: Perioperative REhabilitation Around Vaginal Prolapse RepAir Surgery for Recovery Enhancement
A study testing Pelvic floor Home Exercise Program, this intervention is comprised of specific exercises that are easy to complete at home in people with Postoperative Physical Functioning, run by University of New Mexico at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Physical Functioning
- What is being tested?
- Pelvic floor Home Exercise Program, this intervention is comprised of specific exercises that are easy to complete at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2025to 25 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of New Mexico Hospital
Albuquerque, New Mexico, 87106
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Postoperative Physical Functioning
- Being tested
- Pelvic floor Home Exercise Program, this intervention is comprised of specific exercises that are easy to complete at home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor Home Exercise Program, this intervention is comprised of specific exercises that are easy to complete at homeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Perioperative Care | No intervention | This arm consists of control subjects who are not assigned to an intervention |
| Home Exercise Program | Experimental | This arm consists of subjects who are assigned to perform the home exercise intervention Receives: Other: Pelvic floor Home Exercise Program, this intervention is comprised of specific exercises that are easy to complete at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start24 Nov 2025
- Primary completion25 Jun 2027 (estimated)
- Study completion25 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Physical FunctioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate V Meriwether, MD, University of New Mexico
- Investigators
- Kate Meriwether, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265973
- Sponsor's protocol ID
- 25-258
- Acronym
- PREPARE
- Status last verified
- Aug 2026
- First submitted
- 24 Nov 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREPARE: Perioperative REhabilitation Around Vaginal Prolapse RepAir Surgery for Recovery Enhancement
- ClinicalTrials.gov ID
- NCT07265973
- Acronym / sponsor ID
- PREPARE / 25-258
- Conditions
- Postoperative Physical Functioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 25 Jun 2027 (estimated)
- Study completion
- 25 Jun 2028 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Perioperative Care | No intervention | –This arm consists of control subjects who are not assigned to an intervention |
| Home Exercise Program | Experimental | Other: Pelvic floor Home Exercise Program, this intervention is comprised of specific exercises that are easy to complete at homeThis arm consists of subjects who are assigned to perform the home exercise intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor Home Exercise Program, this intervention is comprised of specific exercises that are easy to complete at homeMany 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. | Other | Home Exercise Program |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kate Meriwether, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor Home Exercise Program, this intervention is comprised of specific exercises that are easy to complete at home in people with Postoperative Physical Functioning, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel E Moore, MD (720-394-9986, racemoore@salud.unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.