Pelvic Floor Exercises for Recovery

(PREPARE Trial)

Overseen By Karen Clinical Reseach Manager

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of New Mexico

Disqualifiers: Dementia, Pelvic floor therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

92 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how pelvic floor exercises might help women enhance their physical functioning after surgery for pelvic organ prolapse. Participants will be randomly assigned to either a group performing daily home exercises for six weeks or a group that does not. Researchers will compare the two groups to determine if the exercises lead to better recovery. This study targets women planning specific surgeries for pelvic prolapse at the University of New Mexico Hospital. Ideal candidates frequently face challenges with daily activities due to severe uterine or vaginal prolapse. As an unphased trial, this study offers participants the chance to contribute to valuable research that could improve recovery methods for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise program is safe for postoperative recovery?

Research shows that pelvic floor exercises are generally safe for most people. Studies have found that these exercises can improve quality of life and help with issues like urinary incontinence. For example, one study showed a moderate positive effect on quality of life. Another study confirmed that pelvic floor exercises are safe and helpful for pregnant women.

While these exercises offer many benefits, they can sometimes complicate childbirth. However, this is not a concern for this study, which focuses on women undergoing surgery for pelvic organ prolapse. Overall, pelvic floor exercises are well-tolerated and have few side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pelvic Floor Home Exercise Program because it offers a non-invasive, at-home approach to recovery that empowers patients to take charge of their own health. Unlike traditional treatments that may involve in-clinic physical therapy sessions, this program allows individuals to perform exercises in the comfort of their own homes, which can improve adherence and convenience. Additionally, the personalized nature of the exercise program could lead to more effective outcomes tailored to individual needs, potentially speeding up recovery times and enhancing overall pelvic floor function.

What evidence suggests that the Pelvic Floor Home Exercise Program is effective for improving physical functioning after surgery?

Research shows that pelvic floor exercises can aid women's recovery after pelvic surgeries. In this trial, participants in the "Home Exercise Program" arm will perform pelvic floor muscle training (PFMT), which studies have found often reduces symptoms and enhances quality of life. For instance, a three-month PFMT program consistently led to positive outcomes in similar recovery situations. Starting pelvic floor exercises early can also promote better functional recovery. Overall, these exercises effectively help women recover by strengthening pelvic muscles and improving daily activities. ^{2 5 6 7 8}

Who Is on the Research Team?

Sarah Jeney, MD

Principal Investigator

Are You a Good Fit for This Trial?

The PREPARE trial is for patients with pelvic organ prolapse who are scheduled for vaginal surgery at the University of New Mexico. It aims to improve postoperative physical functioning, focusing on elderly populations who may experience deconditioning after surgery.

Inclusion Criteria

I am 18 years old or older.

I speak English or Spanish.

My condition is a moderate to severe pelvic organ prolapse.

Exclusion Criteria

Currently enrolled in Pelvic floor physical therapy

Dementia

Inability to fill out questionnaires

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 months

Pre-surgery Exercise

Participants in the exercise group begin a home exercise program 2 weeks prior to surgery

2 weeks

Surgery

Participants undergo transvaginal prolapse repair surgery

Post-surgery Exercise

Participants in the exercise group continue the home exercise program for 4 weeks after surgery

4 weeks

Follow-up

Participants are monitored for postoperative physical functioning at 1, 2, and 6 weeks after surgery

6 weeks

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Pelvic floor Home Exercise Program

Trial Overview This study tests a Pelvic floor Home Exercise Program designed to enhance recovery after vaginal prolapse repair surgery. Participants will be randomly assigned to either follow this home exercise regimen or not, allowing researchers to compare outcomes and assess the program's effectiveness.

How Is the Trial Designed?

Group I: Home Exercise Program Experimental Treatment 1 Intervention

This arm consists of subjects who are assigned to perform the home exercise intervention

Group II: Routine Perioperative Care Active Control 1 Intervention

This arm consists of control subjects who are not assigned to an intervention

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10301414/

Effectiveness of Pelvic Floor Muscle Training on Quality ... In their results, they concluded that the home-based PFMT was effective in reducing the severity of the symptoms and improving the QOL in women ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1462388925001425/pdf

Effectiveness of pelvic floor muscle training in the recovery ... Three-month PFMT interventions showed the most consistent positive outcomes. •. Early rehabilitation may support functional recovery after rectal surgery.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9517758/

Effect of Pelvic Floor Workout on Pelvic Floor Muscle ... In conclusion, this study is expects that the 12-week online PEFLOW is a cost-effective training for the recovery of Pelvic floor muscle function, which is ...

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/aogs.14744

Influence of pelvic floor muscle training alone or as part of a ... The current systematic review and meta-analyses confirmed the effect of PFMT alone or included as part of a general exercise program during ...

5. urology.stanford.edu urology.stanford.edu/content/dam/sm/urology/JJimages/publications/Pelvic-floor-physical-therapy-in-the-treatment-of-pelvic-floor-dysfunction-in-women.pdf

Pelvic floor physical therapy in the treatment of pelvic floor ... Based on the available evidence, PFPT with or without supplemental modalities can improve or cure symptoms of urinary incontinence, POP, fecal incontinence, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7018791/

Is Physical Activity Good or Bad for the Female Pelvic Floor ... Exercise decreases the risk of urinary incontinence, anal incontinence and pelvic organ prolapse, but negatively affects the ease and safety of childbirth.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211525010607

The effect of pelvic floor exercises on the quality of life in ... Pelvic floor muscle exercises demonstrated a moderate positive effect on quality of life (95 % CI: 0.373–0.647, p < 0.001). High heterogeneity ...

8. paahjournal.com paahjournal.com/articles/10.5334/paah.64

The Effect of Pelvic Floor Muscle Training on ... Therefore, it is beneficial and safe for pregnant women to carry out PFMT during pregnancy, and pregnant women can be encouraged to perform PFMT from the middle ...