NCT07127783

Brief Summary

This is a randomized controlled pilot study comparing a home pelvic floor physical therapy program to routine post-operative care for patients undergoing endometriosis excisional surgery without hysterectomy. Quality of life and endometriosis symptoms will be compared following the recovery period.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

August 28, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

August 11, 2025

Last Update Submit

September 30, 2025

Conditions

Keywords

Active Recovery

Outcome Measures

Primary Outcomes (2)

  • Short Form Survey (SF-36)

    The Short Form Survey (SF-36) is a 36-item survey regarding general health and pain and its impact on quality of life including physical activities, work, social activities, and emotional well-being over the last four weeks. Scores range from 0 to 100 with a higher score representing a more favorable health state.

    Collected immediately following surgery, 6 weeks following surgery, and 12 weeks following surgery

  • Pelvic Floor Impact Questionnaire (PFIQ)

    The Pelvic Floor Impact Questionnaire (PFIQ) asks about how bladder, bowel, and pelvic symptoms affect the ability to do physical activities as well as their impact on emotional well-being over the last 3 months. Scores range from 0 to 300 with a lower score representing a lesser impact on quality of life.

    Collected immediately following surgery and 12 weeks following surgery

Secondary Outcomes (2)

  • Pain Scores

    Collected at baseline, 6 weeks following surgery, and 12 weeks following surgery.

  • Endometriosis Health Profile (EHP-5)

    Collected at baseline, 6 weeks following surgery, and 12 weeks following surgery.

Study Arms (2)

Standard Postoperative Instructions

ACTIVE COMPARATOR

Participants will receive standard postoperative recovery instructions

Behavioral: Standard Postoperative Instructions

Active Recovery

EXPERIMENTAL

Participants will receive postoperative instructions to follow an active recovery protocol focused on increasing activity level, core strength exercises, and pelvic floor exercises focused on urinary and bowel symptoms. Exercises are to be completed twice per day for the 12 weeks following surgery.

Behavioral: Active Recovery

Interventions

Active RecoveryBEHAVIORAL

Participants will receive postoperative instructions to follow an active recovery protocol focused on increasing activity level, core strength exercises, and pelvic floor exercises focused on urinary and bowel symptoms. Exercises are to be completed twice per day for the 12 weeks following surgery.

Active Recovery

Standard of care postoperative instructions covering incision care, pain control, dietary instructions, and emergency precautions. Also includes guidelines regarding pelvic rest and lifting restrictions.

Standard Postoperative Instructions

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal
  • English speaking
  • Undergoing endometriosis excision surgery without hysterectomy at Legacy Health with subspecialty-trained surgeons specializing in endometriosis care
  • History of chronic pelvic pain (defined as \>= 6 months of pain in the anatomic pelvis)
  • Diagnosis of high tone pelvic floor dysfunction on examiniation
  • Have access to reliable email and phone for study-related communication

You may not qualify if:

  • Non-English speaking
  • Unable to consent
  • Unable to sustain 30 minutes of moderate activity at baseline
  • Uses a mobility assistive device at baseline
  • Chronic opioid use
  • No histologic diagnosis of endometriosis on surgical pathology
  • Need for additional pelvic rest (\>2 weeks) postoperatively
  • Pregnancy or planning to pursue pregnancy or undergo fertility treatments within 12 weeks postoperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Jacqueline Wong

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Women's Health Research Unit Department of Ob/Gyn

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized in a 1:1 ratio to either standard postoperative instructions or the active recovery intervention group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 17, 2025

Study Start

August 28, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

October 6, 2025

Record last verified: 2025-09

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