Postoperative Active Recovery

August 1, 2025 updated by: Sara Cichowski, Oregon Health and Science University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Women's Health Research Unit Department of OB/GYN
  • Phone Number: 503-494-3666
  • Email: whru@ohsu.edu

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Between the ages of 18 and 89
  2. 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.
  3. Have access to reliable email for communication and questionnaires.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard of Care
Participants will receive standard postoperative instructions only
Other: Standard of Care
Participants will receive standard of care postoperative instructions
Active Comparator: Active Recovery
Participants will receive active recovery instructions with specific walking goals, abdominal strengthening exercises, and pelvic floor exercises
Other: Active Recovery
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline to 12 weeks post-surgery
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
Baseline to 12 weeks
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)
Baseline to 12 weeks post-surgery
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)
Baseline to 12 weeks post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara Cichowski, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OHSU IRB 25625

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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