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Completed

NCT Number: NCT05950633

Postoperative Active Recovery

This is a study evaluating a novel active recovery program in the immediate postoperative period following pelvic reconstructive surgery.

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OHSU

Portland, Oregon, 97239, United States

About this study

This is a randomized controlled trial comparing usual care postoperative restrictions and a novel new active recovery program to look at differences in pelvic floor function, patient quality of life, and mental health in between groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between the ages of 18 and 89
  • Undergoing minimally invasive apical prolapse reconstructive procedure at OHSU. This includes laparoscopic and robotic-assisted sacrocolpopexy, laparoscopic and vaginal uterosacral ligament suspension, and vaginal sacrospinous ligament fixation. We will include patients undergoing concomitant procedures such as hysterectomy and incontinence procedures.
  • Have access to reliable email for communication and questionnaires.

Exclusion criteria

  • Unable to consent
  • Unable to read and complete questionnaires in English
  • Unable to sustain 30 minutes of moderate walking/activity at baseline (self-reported)
  • Use a mobility assistance device such as a walker/cane at baseline
  • Balance or stability problems
  • Patients on chronic opioids

Treatment and study plan

Standard of care

Other

Participants will receive standard of care postoperative instructions

Active Recovery

Other

Participants will receive instructions to increase their fitness to walking at least 30 minutes a day for 5 days a week following surgery and abdominal and pelvic floor exercises will focus on abdominal wall strengthening and abdominal pressure management, urinary urgency and retention, bowel and constipation management

Primary outcomes

  1. Change in the Pelvic Floor Distress Inventory-20 (PFDI-20)

    Time frame: Baseline to 12 weeks post-surgery

    The change in the Pelvic Floor Distress Inventory-20 (PFDI-20) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate how much symptoms bother them from 0 (not at all) to 4 (quite a bit)

  2. Change in the Short Form Health Survey (SF-36)

    Time frame: Baseline to 12 weeks

    The change in the Short Form Health Survey (SF-36) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate their overall health. Scores can range from 0 to 100

  3. Change in the Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline to 12 weeks post-surgery

    The change in the Patient Health Questionnaire (PHQ-9) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate how frequently problems have bothered them from 0 (not at all) to 4 (nearly every day)

  4. Change in the Patient Global Impression of Improvement (PGI-I)

    Time frame: Baseline to 12 weeks post-surgery

    The change in the Patient Global Impressions of Improvement (PGI-I) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate their symptoms from 1 (very much better) to 7 (very much worse)

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Evaluating a Novel Active Recovery Program in the Immediate Postoperative Period Following Pelvic Reconstructive Surgery: A Randomized Control Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2023
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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