EndometriosisNCT07127783
Physical Therapy After Endometriosis Excision
A study testing Active Recovery and Standard Postoperative Instructions in people with Endometriosis and Surgery, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Surgery
- What is being tested?
- Active Recovery and Standard Postoperative Instructions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Women's Health Research Unit, 503-494-3666, whru@ohsu.edu
Jacqueline Wong
About this study
Official title: The Role of a Postoperative Home Physical Therapy Program for the Treatment of Pelvic Pain in Patients Undergoing Endometriosis Excision
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.
Read the 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.
- Conditions
- Endometriosis, Surgery
- Being tested
- Active Recovery, Standard Postoperative Instructions
- Keywords
- Active Recovery
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active RecoveryBehavioural
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.
Standard Postoperative InstructionsBehavioural
Standard of care postoperative instructions covering incision care, pain control, dietary instructions, and emergency precautions. Also includes guidelines regarding pelvic rest and lifting restrictions.
| Study group | Role | What they receive |
|---|---|---|
| Standard Postoperative Instructions | Active comparator | Participants will receive standard postoperative recovery instructions Receives: 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. Receives: Behavioral: Active Recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Collected immediately following surgery and 12 weeks following surgery
Secondary outcomes (2)
Pain Scores
Pain measured using a Visual Analog Scale (VAS). This scale asks patients to rate their pelvic pain and dyspareunia over the last 4 weeks. Responses are on a scale from 0 to 10, with 10 being the worst pain.
Measured: Collected at baseline, 6 weeks following surgery, and 12 weeks following surgery.
Endometriosis Health Profile (EHP-5)
The Endometriosis Health Profile (EHP-5) is a 5-item questionnaire asking about the perception of endometriosis symptoms on physical ability, emotional well-being, mood, social isolation, and appearance over the last four weeks. Scores range from 0 to 100 where 0 indicates the best health status.
Measured: Collected at baseline, 6 weeks following surgery, and 12 weeks following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start28 Aug 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to either standard postoperative instructions or the active recovery intervention group.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline Wong, Oregon Health and Science University
- Investigators
- Jacqueline Wong, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127783
- Sponsor's protocol ID
- STUDY00028168
- Status last verified
- Sep 2025
- First submitted
- 11 Aug 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a Postoperative Home Physical Therapy Program for the Treatment of Pelvic Pain in Patients Undergoing Endometriosis Excision
- ClinicalTrials.gov ID
- NCT07127783
- Acronym / sponsor ID
- STUDY00028168
- Conditions
- Endometriosis, Surgery
- Keywords
- Active Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to either standard postoperative instructions or the active recovery intervention group.
| Arm | Type | Receives |
|---|---|---|
| Standard Postoperative Instructions | Active comparator | Behavioral: Standard Postoperative InstructionsParticipants will receive standard postoperative recovery instructions |
| Active Recovery | Experimental | Behavioral: Active RecoveryParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active RecoveryParticipants 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. | Behavioural | Active Recovery |
| Standard Postoperative InstructionsStandard of care postoperative instructions covering incision care, pain control, dietary instructions, and emergency precautions. Also includes guidelines regarding pelvic rest and lifting restrictions. | Behavioural | Standard Postoperative Instructions |
Primary outcome
Short Form Survey (SF-36)
Time frame: Collected immediately following surgery, 6 weeks following surgery, and 12 weeks following surgery
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.
Pelvic Floor Impact Questionnaire (PFIQ)
Time frame: Collected immediately following surgery and 12 weeks following surgery
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacqueline Wong principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Recovery and Standard Postoperative Instructions in people with Endometriosis and Surgery, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Women's Health Research Unit Department of Ob/Gyn (503-494-3666, whru@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form Survey (SF-36) (time frame: Collected immediately following surgery, 6 weeks following surgery, and 12 weeks following surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.