Postoperative Active Recovery

NCT05950633 | Completed

• 1 other identifier: OHSU IRB 25625
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (4)

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

  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)

  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)

  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)

  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

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Participants will receive standard postoperative instructions only

Other: Standard of Care

Active Recovery

ACTIVE COMPARATOR

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

Other: Active Recovery

Interventions

Standard of Care OTHER

Participants will receive standard of care postoperative instructions

Standard of Care

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

Active Recovery

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sara Cichowski, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 18, 2023
• Study Start: September 1, 2023
• Primary Completion: May 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-03

Locations

US (1)