Wrist activity tracking to guide early recovery after pelvic organ prolapse surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

AccelERate is a single-masked randomized controlled study comparing a prescribed early exercise regimen to standard postoperative recommendations for women undergoing minimally invasive or vaginal surgery for pelvic organ prolapse. Participants will wear an accelerometer on the non-dominant wrist, complete a daily self-reported recovery questionnaire, and be randomly assigned to routine or exercise-focused postoperative instructions. The exercise arm is asked to perform about 30 minutes of medium-intensity activity daily, and the primary outcome is the number of days to report being "mostly recovered." The study will also collect performance-based tests and clinical assessments to compare objective activity data with patient-reported and clinical outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Kaiser Permanente -- San Diego
  San Diego, California, United States Recruiting
• University of California - San Diego
  San Diego, California, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting
• Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
  Durham, North Carolina, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery
  Providence, Rhode Island, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing the Manchester procedure versus vaginal hysterectomy for uterine prolapse

  This study tests whether the Manchester procedure or vaginal hysterectomy works better for women with symptomatic uterine prolapse over a two-year follow-up.

  Recruiting at 6 sites Tampere University Hospital · Helsinki and 5 other locations · NCT07566949

• Vaginal versus robotic-assisted abdominal mesh repair for apical prolapse

  This study will test whether vaginal mesh repair works as well and is as safe as robotic-assisted abdominal mesh repair for women with stage II or higher apical pelvic organ prolapse.

  Recruiting University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT07359755

• Improving Uroflowmetry: Do Pre-Procedure Reminders Help Women Undergoing Urodynamics

  This study tests whether sending reminder calls before a urodynamics test helps women with pelvic floor disorders feel more prepared and less anxious, and whether it makes the procedure go more smoothly.

  Recruiting Ohio State University · Columbus, Ohio · NCT07692789

• Risk predictor for new urinary incontinence after prolapse surgery

  This study tests a model to predict which women might develop new stress urinary incontinence after pelvic organ prolapse repair.

  Recruiting Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai, Shanghai Municipality · NCT07601282

• Poly-L-lactic acid injections for vulvovaginal tissue regeneration

  This trial will try injections of poly-L-lactic acid (PLLA) versus placebo to see if they strengthen vaginal tissue and reduce bulge symptoms and sexual problems in women with stage II anterior vaginal wall prolapse (cystocele).

  Recruiting Duke University · Durham, North Carolina · NCT07544667

• Vaginal Vault Support at Hysterectomy

  This trial tests a new double-ligament vault suspension during hysterectomy to help prevent vaginal apex prolapse in women undergoing the procedure.

  Recruiting Assiut University · Asyut · NCT07517965

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.