Postoperative Active Recovery

Pelvic Floor Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950633
• Other study ID #: OHSU IRB 25625
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2023
• Source: Oregon Health and Science University
• Contact: Women's Health Research Unit Department of Ob/Gyn
• Phone: 503-494-3666
• Email: whru[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Other:
• Standard of Care
Participants will receive standard of care postoperative instructions
• 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

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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