Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
FEMALE
ID07218016

Accelerometer Measured Early Recovery After Prolapse Surgery Comparing Postoperative Exercise to Standard Care

Led by NICHD Pelvic Floor Disorders Network · Updated on 2026-04-27

288

Participants Needed

7

Research Sites

39 weeks

Total Duration

On this page

Sponsors

N

NICHD Pelvic Floor Disorders Network

Lead Sponsor

R

RTI International

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the physical recovery of women undergoing minimally invasive surgery for Pelvic Organ Prolapse (POP). This study compares recovery times between women who receive routine postoperative instructions and those who follow a prescribed exercise program. The goal is to see if early exercise after surgery leads to faster recovery without negatively affecting pelvic floor health or surgical outcomes. Participants will be randomly assigned to either a control group receiving standard postoperative advice or an intervention group instructed to perform 30 minutes of medium-intensity exercise starting on postoperative day 3, at least five times weekly for six weeks. All participants will wear an accelerometer on their non-dominant wrist to objectively measure physical activity before and after surgery. Recovery progress will be tracked daily through a mobile app until participants report feeling mostly recovered. During the study, participants will complete physical tests and questionnaires at baseline, 2, 6, and 12 weeks post-surgery, with a final assessment one year after surgery. Researchers will monitor recovery status, pelvic floor symptoms, activity adherence, and anatomical outcomes. Data collection includes self-reported recovery, accelerometer readings, physical performance tests, and clinical evaluations, with safety and adverse events recorded throughout the study period.

CONDITIONS

Brief Title

Accelerometer Measured Early Recovery After Prolapse Surgery

Who Can Participate

Age: 18Years - 99Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject has provided written informed consent
  • Ambulatory women undergoing laparoscopic, robotic, or vaginal reconstructive or obliterative surgery for apical prolapse
  • Pelvic Organ Prolapse Quantification (POP-Q) stage III or higher
  • Willing to participate in a postoperative exercise regimen
  • Able to read and consent in English or Spanish
  • Willing and able to wear an accelerometer before and after surgery, use electronic data capture software, and record daily events
  • Willing and able to install and use study-related smartphone app(s)
  • Anticipated hospital discharge on or before postoperative day 1
Not Eligible

You will not qualify if you...

  • Inability or unwillingness to adhere to the exercise intervention
  • Contraindication to medium-intensity exercise
  • Comorbidities preventing physical activity
  • Planned abdominal surgery with laparotomy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Up to 1 day

Participants undergo minimally invasive surgery for pelvic organ prolapse followed by initial postoperative recovery.

1 hospital stay (in-person)

Treatment

Duration - 6 weeks

Participants follow either a prescribed early exercise regimen starting on postoperative day 3 or receive standard postoperative care with gradual resumption of activity.

Continuous accelerometer wear during waking hours, daily mobile app queries, and 2 in-person visits at 2 and 6 weeks for data collection

Follow-up

Duration - Up to 1 year after surgery

Participants are monitored remotely via a mobile app until 12 weeks post surgery and attend in-office evaluations at 12 weeks and 1 year to assess recovery and outcomes.

In-person visits at 12 weeks and 1 year

Trial Site Locations

Total: 7 locations

1

Kaiser Permanente -- San Diego

San Diego, California, United States, 92110

Actively Recruiting

2

University of California - San Diego

San Diego, California, United States, 92121

Actively Recruiting

3

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

4

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Durham, North Carolina, United States, 27707

Actively Recruiting

5

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

6

Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery

Providence, Rhode Island, United States, 02903

Actively Recruiting

7

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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