EndometriosisNCT07827794
The Effect of Preoperative Pelvic Floor Physical Therapy (Prehabilitation) on Postoperative Pain Following Endometriosis Surgery: A Randomized Controlled Trial
A study testing Structured pre-operative pelvic floor physiotherapy program (prehabilitation) in people with Endometriosis and Chronic Pelvic Pain, run by University of Alberta at 1 site in Canada.
Trial summary
Endometriosis is a chronic inflammatory condition where there is abnormal tissue growing in the pelvis or other places in the body that resembles the lining of the uterus (endometrium), and is a common cause of long lasting pelvic pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Chronic Pelvic Pain
- What is being tested?
- Structured pre-operative pelvic floor physiotherapy program (prehabilitation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2027to 1 Sep 2030
- 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
- Presence of chronic pelvic pain (>6 months)
- Diagnosis of endometriosis (clinical, laparoscopic, or imaging-based diagnosis)
- Scheduled for fertility-sparing endometriosis surgery or hysterectomy with excision of endometriosis
Who cannot join
- Undergoing gynecologic surgery in the absence of pelvic pain
- Patients undergoing laparotomy or conversion to laparotomy
- Have undergone endometriosis related surgery in the past 12 months
- Have engaged in pelvic physiotherapy in the past 12 months
- Non-English speakers (if validated tools unavailable)
- Active malignancy
Show all 9Show fewer
- Post-menopausal
- Prior oophorectomy
- Prior hysterectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Alberta
Edmonton, Alberta
Shauna Littlefair-Beamish, BSc, RN, 1-780-735-5420, shauna.littlefair-beamish@ahs.ca
Alicia Long, MD, MSc, FRCSC
About this study
Endometriosis is a chronic inflammatory condition where there is abnormal tissue growing in the pelvis or other places in the body that resembles the lining of the uterus (endometrium), and is a common cause of long lasting pelvic pain. Surgery is sometimes done for endometriosis to help people with pain, however it is common for people to have some pain after surgery that doesn't go away. This may be related to other painful things like muscle pain in the pelvis, bowel or bladder issues, or mental health conditions.
Researchers would like to know if doing pelvic floor physiotherapy before surgery for endometriosis will help people with long lasting pain after surgery.
Participants in the study will be randomly put into one of two groups: the intervention group, who will receive two to three structured in-person pelvic floor physiotherapy sessions prior to surgery ("prehabilitation"), in addition to usual surgical care, or the control group, who will receive usual surgical care, and may still access physiotherapy outside of the study if they want to. All participants will complete questionnaires before surgery, after completing prehabilitation or immediately before surgery if they are part of the control group, approximately 6 weeks after surgery, 6 months after surgery, and 12 months after surgery. The questionnaires ask about endometriosis-related pain, quality of life, bladder and bowel symptoms, and mental well-being.
Read the detailed description
Introduction: Endometriosis is a chronic inflammatory gynecologic condition characterized by growth of ectopic endometrial-like tissue within and outside of the pelvis, and is a common cause of chronic pelvic pain. Surgical management, including fertility-sparing endometriosis surgery or hysterectomy, is frequently performed with the goal of improving pain and quality of life; however, persistent or recurrent pain after endometriosis surgery is not uncommon. Factors contributing to ongoing pain may include conditions that are present before surgery including myofascial pelvic pain, psychological factors, or the presence of other comorbid chronic pain conditions, sometimes culminating in complex pain syndromes and central nervous system sensitization. "Prehabilitation", defined a structured intervention such as physiotherapy, exercise, and dietary changes, have been shown to improve perioperative outcomes in several surgical specialties, including gynecologic oncology, colorectal surgery, and orthopedic surgery. Pelvic floor physiotherapy has been shown to improve endometriosis-related pain symptoms and functional outcomes. Despite indirect data showing benefits, the quantitative and qualitative effect of prehabilitation in individuals undergoing endometriosis surgery for pelvic pain remains unknown.
Aim: To investigate the impact of structured preoperative pelvic physiotherapy in patients with pelvic pain undergoing endometriosis surgery (fertility sparing surgery and hysterectomy)
Objectives:
- Determine the effect of pelvic physiotherapy prehabilitation on quality of life, measured by Endometriosis Health Profile (EHP)-30 scale (primary outcome)
- Examine the impact of pelvic physiotherapy prehabilitation on chronic pelvic, dysmenorrhea, dyspareunia, symptoms of irritable bowel syndrome (IBS) and painful bladder syndrome (PBS), and psychologic indices including depression, anxiety and pain catastrophizing (secondary outcomes) Hypothesis: Patients receiving structured preoperative pelvic floor physiotherapy ("prehabilitation") will have improved post-operative pain scores and improved quality of life compared to those receiving standard care.
Methods: This study is a prospective, single-center, double arm, non-blinded randomized controlled trial evaluating the effect of preoperative pelvic floor physiotherapy ("prehabilitation") on pre- and post- operative pain and quality of life outcomes in patients with pelvic pain undergoing surgery for endometriosis (fertility sparing or hysterectomy). Participants aged 18-50 will be screened for eligibility from the Chronic Pelvic Pain (CPP) clinic in Edmonton, Alberta at the Lois Hole Hospital for Women. Eligible and willing participants will undergo randomization in a 1:1 ratio to receive either structured preoperative pelvic floor physiotherapy (2-3 sessions within 6 months leading up to surgery), in addition to standard perioperative care (intervention group) or standard perioperative care alone (control group). Surgery will be performed by fellowship trained minimally invasive gynecologic surgeons at the Royal Alexandra Hospital in Edmonton, AB. Participants will complete questionnaires at baseline, after prehabilitation is complete before surgery, 6-8 weeks post operatively, and 6 months and 12 months post operatively. Baseline demographic information will be collected including age, BMI, gynecologic surgical history, hormone use, and analgesic use. The primary outcome measure of this study is the Endometriosis Health Profile (EHP)-30 score (measures quality of life) over these timepoints. Secondary outcomes include measurements of chronic pelvic pain, dysmenorrhea, dyspareunia (numerical rating scale), presence of IBS and PBS, Central Sensitization Inventory (CSI), Pain Catastrophizing Scale (PCS), and assessment for depression through the Patient Health Questionnaire-9 (PHQ-9), and presence of generalized anxiety disorder through the GAD-7 questionnaire. Data will be stratified by the type of surgery patients received (hysterectomy or fertility-sparing endometriosis surgery) and stage of endometriosis (stage I/II or stage III/IV).
Expected outcomes and significance: If effective, preoperative pelvic floor physiotherapy may represent a low-risk intervention to improve overall pain and quality of life in patients undergoing endometriosis surgery. Findings could inform the creation of standardized care pathways for patients seeking care for chronic pelvic pain, improve outcomes in patients undergoing surgery for endometriosis, and decrease healthcare utilization after surgery which could have a major positive economic impact as well.
- Conditions
- Endometriosis, Chronic Pelvic Pain
- Being tested
- Structured pre-operative pelvic floor physiotherapy program (prehabilitation)
- Keywords
- endometriosis, chronic pelvic pain, pelvic physiotherapy, prehabilitation, endometriosis surgery
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured pre-operative pelvic floor physiotherapy program (prehabilitation)Other
Two to three structured pre-operative pelvic floor physiotherapy program (prehabilitation) by physiotherapist specializing in chronic pelvic pain
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Standard perioperative and surgical care |
| Intervention Group | Experimental | Structured pre-operative pelvic floor physiotherapy program (prehabilitation) plus standard perioperative and surgical care Receives: Other: Structured pre-operative pelvic floor physiotherapy program (prehabilitation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometriosis Health Profile (EHP)-30 score
Endometriosis Health Profile (EHP)-30 score (validated questionnaire measuring pain and quality of life)
Measured: Endometriosis Health Profile (EHP)-30 score measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Secondary outcomes (9)
Chronic pelvic pain
Chronic pelvic pain measured by numeric rating scale
Measured: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Dysmenorrhea
Dysmenorrhea measured by numeric rating scale
Measured: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Dyspareunia
Dyspareunia measured by numeric rating scale
Measured: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Irritable Bowel Syndrome (IBS)
Presence or absence of IBS
Measured: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Painful bladder syndrome (PBS)
Presence or absence of PBS
Measured: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Central Sensitization Inventory (CSI)
Central sensitization score measured by CSI (validated questionnaire)
Measured: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Pain Catastrophizing Scale (PCS)
PCS score (validated questionnaire)
Measured: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Depression
Depression as measured by PHQ-9 score
Measured: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Generalized anxiety
Generalized anxiety as measured by GAD-7 questionnaire
Measured: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Mar 2027 (estimated)
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Sep 2030 (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.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Children's Health Research Institute, Canada
- Responsible party
- Principal investigator, Alicia Long, University of Alberta
- Investigators
- Alicia Long, MD, MSc, FRCSC, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827794
- Sponsor's protocol ID
- 00167703
- Other IDs
- Pro00167703
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Pelvic Floor Physical Therapy (Prehabilitation) on Postoperative Pain Following Endometriosis Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07827794
- Acronym / sponsor ID
- 00167703
- Conditions
- Endometriosis, Chronic Pelvic Pain
- Keywords
- endometriosis, chronic pelvic pain, pelvic physiotherapy, prehabilitation, endometriosis surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Women and Children's Health Research Institute, Canada
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 18 Sep 2026 (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.
Endometriosis is a chronic inflammatory condition where there is abnormal tissue growing in the pelvis or other places in the body that resembles the lining of the uterus (endometrium), and is a common cause of long lasting pelvic pain. Surgery is sometimes done for endometriosis to help people with pain, however it is common for people to have some pain after surgery that doesn't go away. This may be related to other painful things like muscle pain in the pelvis, bowel or bladder issues, or mental health conditions.
Researchers would like to know if doing pelvic floor physiotherapy before surgery for endometriosis will help people with long lasting pain after surgery.
Participants in the study will be randomly put into one of two groups: the intervention group, who will receive two to three structured in-person pelvic floor physiotherapy sessions prior to surgery ("prehabilitation"), in addition to usual surgical care, or the control group, who will receive usual surgical care, and may still access physiotherapy outside of the study if they want to. All participants will complete questionnaires before surgery, after completing prehabilitation or immediately before surgery if they are part of the control group, approximately 6 weeks after surgery, 6 months after surgery, and 12 months after surgery. The questionnaires ask about endometriosis-related pain, quality of life, bladder and bowel symptoms, and mental well-being.
Detailed description
Introduction: Endometriosis is a chronic inflammatory gynecologic condition characterized by growth of ectopic endometrial-like tissue within and outside of the pelvis, and is a common cause of chronic pelvic pain. Surgical management, including fertility-sparing endometriosis surgery or hysterectomy, is frequently performed with the goal of improving pain and quality of life; however, persistent or recurrent pain after endometriosis surgery is not uncommon. Factors contributing to ongoing pain may include conditions that are present before surgery including myofascial pelvic pain, psychological factors, or the presence of other comorbid chronic pain conditions, sometimes culminating in complex pain syndromes and central nervous system sensitization. "Prehabilitation", defined a structured intervention such as physiotherapy, exercise, and dietary changes, have been shown to improve perioperative outcomes in several surgical specialties, including gynecologic oncology, colorectal surgery, and orthopedic surgery. Pelvic floor physiotherapy has been shown to improve endometriosis-related pain symptoms and functional outcomes. Despite indirect data showing benefits, the quantitative and qualitative effect of prehabilitation in individuals undergoing endometriosis surgery for pelvic pain remains unknown.
Aim: To investigate the impact of structured preoperative pelvic physiotherapy in patients with pelvic pain undergoing endometriosis surgery (fertility sparing surgery and hysterectomy)
Objectives:
- Determine the effect of pelvic physiotherapy prehabilitation on quality of life, measured by Endometriosis Health Profile (EHP)-30 scale (primary outcome)
- Examine the impact of pelvic physiotherapy prehabilitation on chronic pelvic, dysmenorrhea, dyspareunia, symptoms of irritable bowel syndrome (IBS) and painful bladder syndrome (PBS), and psychologic indices including depression, anxiety and pain catastrophizing (secondary outcomes) Hypothesis: Patients receiving structured preoperative pelvic floor physiotherapy ("prehabilitation") will have improved post-operative pain scores and improved quality of life compared to those receiving standard care.
Methods: This study is a prospective, single-center, double arm, non-blinded randomized controlled trial evaluating the effect of preoperative pelvic floor physiotherapy ("prehabilitation") on pre- and post- operative pain and quality of life outcomes in patients with pelvic pain undergoing surgery for endometriosis (fertility sparing or hysterectomy). Participants aged 18-50 will be screened for eligibility from the Chronic Pelvic Pain (CPP) clinic in Edmonton, Alberta at the Lois Hole Hospital for Women. Eligible and willing participants will undergo randomization in a 1:1 ratio to receive either structured preoperative pelvic floor physiotherapy (2-3 sessions within 6 months leading up to surgery), in addition to standard perioperative care (intervention group) or standard perioperative care alone (control group). Surgery will be performed by fellowship trained minimally invasive gynecologic surgeons at the Royal Alexandra Hospital in Edmonton, AB. Participants will complete questionnaires at baseline, after prehabilitation is complete before surgery, 6-8 weeks post operatively, and 6 months and 12 months post operatively. Baseline demographic information will be collected including age, BMI, gynecologic surgical history, hormone use, and analgesic use. The primary outcome measure of this study is the Endometriosis Health Profile (EHP)-30 score (measures quality of life) over these timepoints. Secondary outcomes include measurements of chronic pelvic pain, dysmenorrhea, dyspareunia (numerical rating scale), presence of IBS and PBS, Central Sensitization Inventory (CSI), Pain Catastrophizing Scale (PCS), and assessment for depression through the Patient Health Questionnaire-9 (PHQ-9), and presence of generalized anxiety disorder through the GAD-7 questionnaire. Data will be stratified by the type of surgery patients received (hysterectomy or fertility-sparing endometriosis surgery) and stage of endometriosis (stage I/II or stage III/IV).
Expected outcomes and significance: If effective, preoperative pelvic floor physiotherapy may represent a low-risk intervention to improve overall pain and quality of life in patients undergoing endometriosis surgery. Findings could inform the creation of standardized care pathways for patients seeking care for chronic pelvic pain, improve outcomes in patients undergoing surgery for endometriosis, and decrease healthcare utilization after surgery which could have a major positive economic impact as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Standard perioperative and surgical care |
| Intervention Group | Experimental | Other: Structured pre-operative pelvic floor physiotherapy program (prehabilitation)Structured pre-operative pelvic floor physiotherapy program (prehabilitation) plus standard perioperative and surgical care |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of chronic pelvic pain (>6 months)
- Diagnosis of endometriosis (clinical, laparoscopic, or imaging-based diagnosis)
- Scheduled for fertility-sparing endometriosis surgery or hysterectomy with excision of endometriosis
Key exclusion criteria (9 listed)
- Undergoing gynecologic surgery in the absence of pelvic pain
- Patients undergoing laparotomy or conversion to laparotomy
- Have undergone endometriosis related surgery in the past 12 months
- Have engaged in pelvic physiotherapy in the past 12 months
- Non-English speakers (if validated tools unavailable)
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 |
|---|---|---|
| Structured pre-operative pelvic floor physiotherapy program (prehabilitation)Two to three structured pre-operative pelvic floor physiotherapy program (prehabilitation) by physiotherapist specializing in chronic pelvic pain | Other | Intervention Group |
Primary outcome
Endometriosis Health Profile (EHP)-30 score
Time frame: Endometriosis Health Profile (EHP)-30 score measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Endometriosis Health Profile (EHP)-30 score (validated questionnaire measuring pain and quality of life)
9 secondary outcomes
Chronic pelvic pain
Time frame: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Dysmenorrhea
Time frame: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Dyspareunia
Time frame: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Irritable Bowel Syndrome (IBS)
Time frame: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Painful bladder syndrome (PBS)
Time frame: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Central Sensitization Inventory (CSI)
Time frame: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Pain Catastrophizing Scale (PCS)
Time frame: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Depression
Time frame: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Generalized anxiety
Time frame: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
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 18 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Alicia Long, MD, MSc, FRCSC principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured pre-operative pelvic floor physiotherapy program (prehabilitation) in people with Endometriosis and Chronic Pelvic Pain, run by University of Alberta at 1 site in Canada.
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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 18 Sep 2026. 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 Canada. 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 Alicia Long, MD, MSc, FRCSC (1-780-934-5433, ajlong1@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometriosis Health Profile (EHP)-30 score (time frame: Endometriosis Health Profile (EHP)-30 score measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively). 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 18 Sep 2026.