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Recruiting NCT07127783

Physical Therapy After Endometriosis Excision

No phase Interventional Endometriosis Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active Recovery, Standard Postoperative Instructions.
Who it may be relevant to
Registry conditions: Endometriosis, Surgery. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Role of a Postoperative Home Physical Therapy Program for the Treatment of Pelvic Pain in Patients Undergoing Endometriosis Excision

Overview

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.

Detailed description

This is a randomized controlled pilot study conducted at a single institution comparing a home pelvic floor physical therapy program to routine post-operative care for patients undergoing endometriosis excisional surgery without hysterectomy. Patients will be recruited from a referral gynecological surgery group specializing in the diagnosis and treatment of pelvic pain and endometriosis. The goal is to assess the role of the active recovery program on quality of life and on pain and endometriosis symptoms.

Subjects will be randomized to routine post-operative care or to a home physical therapy program, in which they will receive written instruct ions and videos of exercises to complete immediately after surgery. The home exercise program was developed by the Department of Urogynecology in conjunction with pelvic floor physical therapists, and includes videos created by the education communications division. Quality of life, pain score, and endometriosis symptoms will be assessed at their pre-operative appointment, and at 6 and 12 weeks postoperatively.

Interventions

  • Behavioral Active Recovery
    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 Standard Postoperative Instructions
    Standard of care postoperative instructions covering incision care, pain control, dietary instructions, and emergency precautions. Also includes guidelines regarding pelvic rest and lifting restrictions.

Primary outcome measures

  • Short Form Survey (SF-36) [Time frame: Collected immediately following surgery, 6 weeks following surgery, and 12 weeks following surgery]
  • Pelvic Floor Impact Questionnaire (PFIQ) [Time frame: Collected immediately following surgery and 12 weeks following surgery]
Secondary outcome measures (2)
  • Pain Scores [Time frame: Collected at baseline, 6 weeks following surgery, and 12 weeks following surgery.]
  • Endometriosis Health Profile (EHP-5) [Time frame: Collected at baseline, 6 weeks following surgery, and 12 weeks following surgery.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Oregon Health & Science University — Portland

Identifiers

NCT: NCT07127783 · STUDY00028168

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗