Postoperative Exercise for Pelvic Organ Prolapse

(AccelERate Trial)

Recruiting at 5 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NICHD Pelvic Floor Disorders Network

Disqualifiers: Physical activity limitations, others

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

Compensation: Varies

Number of Visits: 2

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how exercise affects recovery after surgery for pelvic organ prolapse, a condition where pelvic organs drop from their normal position. Researchers will compare the speed of recovery between participants following standard care and those following a special postoperative exercise regimen. Daily recovery questionnaires and a wrist-worn fitness tracker will be used for this comparison. Women who have undergone surgery for severe pelvic organ prolapse and can engage in moderate exercise might be suitable for this trial. Participants must be willing to use a smartphone app and wear an activity tracker. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance recovery protocols 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 the postoperative exercise regimen is safe for patients recovering from pelvic organ prolapse surgery?

Research has shown that exercising after pelvic organ prolapse surgery is generally safe. One study found that women who began physical activity soon after surgery did not experience worse outcomes than those who waited longer. In fact, some women reported fewer issues with their pelvic floor, the group of muscles and tissues supporting the pelvic organs.

Another study found that increased activity did not lead to more complications. This suggests that starting exercise sooner is as effective for recovery as the usual approach.

These findings indicate that beginning exercise after this type of surgery is well-tolerated and does not appear to increase the risk of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the postoperative exercise regimen for pelvic organ prolapse because it offers a non-surgical approach to recovery that could enhance healing and improve quality of life. Unlike the standard treatment options like surgery and pessaries, which primarily focus on structural support or repair, this regimen emphasizes strengthening the pelvic floor muscles, potentially reducing the risk of recurrence. By integrating targeted exercises into recovery, patients may experience improved outcomes with fewer complications and a faster return to normal activities.

What evidence suggests that this postoperative exercise regimen is effective for pelvic organ prolapse recovery?

This trial will compare a Postoperative Exercise regimen with Standard of Care for recovery after pelvic organ prolapse surgery. Studies have shown mixed results regarding the benefits of exercise after such surgery. Some research suggests that exercises can speed up recovery, reducing hospital stay and catheter use. However, other studies found that pelvic floor exercises did not significantly impact symptoms or recovery. While exercise is generally beneficial for health, its specific advantages for recovery from this surgery remain unproven. Effectiveness may depend on personal factors and the type of exercise program followed. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

The AccelERate Trial is for women who can read and consent in English or Spanish, are willing to use a smartphone app, participate in postoperative exercises, wear an accelerometer device, and record daily events. They must be ambulatory patients undergoing certain types of surgery for Pelvic Organ Prolapse (POP-Q >= Stage III) with expected discharge by postoperative day 1.

Inclusion Criteria

Able to read and consent in English or Spanish

Subject has provided written informed consent

Willing and able to install and use study-related smartphone app(s)

Exclusion Criteria

Inability or unwillingness to adhere to the exercise intervention

Contraindication to medium-intensity exercise

I have health conditions that stop me from being physically active.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline Evaluation

Participants undergo a baseline surgical evaluation including a POP-Q exam and PFDI-20 and PFIQ-7, complete AAS and record their physical activity for one week.

1 week

Postoperative Treatment

Participants in the intervention arm perform 30 minutes of medium-intensity exercise starting on postoperative day 3, continuing at least 5 times weekly for 6 weeks. Control group receives liberalized postoperative instructions.

6 weeks

Continuous monitoring via accelerometer

Follow-up

Participants are monitored for recovery status and adherence to exercise regimen. Data collected remotely via app until 12 weeks. In-office evaluation at 12 weeks and 1 year.

12 weeks

2 visits (in-person at 12 weeks and 1 year)

What Are the Treatments Tested in This Trial?

Interventions

• Postoperative Exercise regimen

Trial Overview This study tests the effectiveness of routine versus exercise-focused instructions after POP surgery on physical recovery. Participants will complete a daily self-reported recovery questionnaire and wear an accelerometer to monitor activity levels as part of the evaluation process.

How Is the Trial Designed?

Group I: Standard of Care Active Control 1 Intervention

Group II: Postoperative Exercise regimen Active Control 1 Intervention

Who Is Running the Clinical Trial?

NICHD Pelvic Floor Disorders Network

Lead Sponsor

Trials

16

Recruited

4,900+

RTI International

Collaborator

Trials

201

Recruited

942,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Women and Infants Hospital of Rhode Island

Collaborator

Trials

119

Recruited

59,200+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9142907/

Effects of Pelvic-Floor Muscle Training in Patients with ... This review shows that PFMT program is effective for improving POP-associated pelvic, urinary, and intestinal symptoms and quality of life ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S183695531930133X

Perioperative pelvic floor muscle training did not improve ... Research. Perioperative pelvic floor muscle training did not improve outcomes in women undergoing pelvic organ prolapse surgery: a randomised trial.

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1118794/full

Analysis of the effectiveness of the application of pelvic ... Results: The time of first anal exhaust, urine tube retention and hospitalization after surgery were shorter in the exercise group than in the ...

4. urotoday.com urotoday.com/video-lectures/bladder-health/video/4532-cochrane-review-highlights-benefits-of-pelvic-floor-exercises-for-prolapse-suzanne-hagen.html

Cochrane Review Highlights Benefits of Pelvic Floor ... And essentially, in summary, we found no effect of pelvic floor muscle training for any outcome in primary prevention trials. These were the ...

5. journals.lww.com journals.lww.com/10.1097/SPV.0000000000000922

Urogynecology There were no significant differences in anatomic and functional outcomes at 12 months after surgery in women who resume postoperative activity liberally and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40693510/

Perioperative interventions in pelvic organ prolapse surgery The main goal of perioperative interventions is to reduce the rate of adverse events while improving women's outcomes following surgical intervention for ...

7. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2805403

Standard Restrictions vs Expedited Activity After Pelvic ... The findings demonstrate that expedited activity after prolapse surgery results in noninferior anatomic and symptomatic prolapse outcomes.

8. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/rethinking-activity-after-pelvic-prolapse-surgery

Rethinking Activity After Pelvic Prolapse Surgery - Consult QD A recent survey shows that most gynecologic surgeons continue to recommend limiting activity after surgery.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10233453/

Standard Restrictions vs Expedited Activity After Pelvic ... This randomized clinical trial evaluates whether expedited vs standard restricted activity results in noninferior outcomes after pelvic organ prolapse surgery.