Postoperative Active Recovery

NCT ID: NCT05950633

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-07-31

Brief Summary

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

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.

Conditions

Pelvic Floor Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

Participants will receive standard postoperative instructions only

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Participants will receive standard of care postoperative instructions

Active Recovery

Participants will receive active recovery instructions with specific walking goals, abdominal strengthening exercises, and pelvic floor exercises

Group Type: ACTIVE_COMPARATOR

Active Recovery

Intervention Type: 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

Interventions

Standard of Care

Participants will receive standard of care postoperative instructions

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Sara Cichowski

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Cichowski, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

OHSU

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU IRB 25625

Identifier Type: -

Identifier Source: org_study_id