NCT07218016 Accelerometer Measured Early Recovery After Prolapse Surgery
| NCT ID | NCT07218016 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NICHD Pelvic Floor Disorders Network |
| Condition | Pelvic Organ Prolapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 288 participants |
| Start Date | 2025-10-02 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 288 participants in total. It began in 2025-10-02 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The AccelERate study will evaluate the physical recovery of patients who have undergone Pelvic Organ Prolapse (POP) surgery. This will be evaluated via a self-reported recovery questionnaire completed daily. Participants will wear an accelerometer device on their non-dominant wrist and be given either routine or exercise-focused postoperative instructions. The primary outcome will be a comparison of the number of days needed to reach self-reported "mostly recovered" status between randomly assigned instruction groups.
Eligibility Criteria
Inclusion Criteria: * Subject has provided written informed consent * Ambulatory women undergoing laparoscopic, robotic, or vaginal reconstructive or obliterative surgery for apical prolapse * POP-Q \>= Stage III * Willing to participate in a postoperative exercise regimen * Able to read and consent in English or Spanish * Willing and able to wear an accelerometer prior to and after surgery (including agreeing to the terms of service), use an electronic data capture software, and record daily events * Willing and able to install and use study-related smartphone app(s) * Anticipated hospital discharge \<= postoperative day 1 Exclusion Criteria: * Inability or unwillingness to adhere to the exercise intervention * Contraindication to medium-intensity exercise * Comorbidities preventing physical activity * Planned abdominal approach with laparotomy
Frequently Asked Questions
Who can join the NCT07218016 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 99 Years, studying Pelvic Organ Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07218016 currently recruiting?
Yes, NCT07218016 is actively recruiting participants. Visit ClinicalTrials.gov or contact NICHD Pelvic Floor Disorders Network to inquire about joining.
Where is the NCT07218016 trial being conducted?
This trial is being conducted at San Diego, United States, San Diego, United States, Chicago, United States, Durham, United States and 3 additional locations.
Who is sponsoring the NCT07218016 clinical trial?
NCT07218016 is sponsored by NICHD Pelvic Floor Disorders Network. The trial plans to enroll 288 participants.