The Effect of Preoperative Pelvic Floor Physical Therapy (Prehabilitation) on Postoperative Pain Following Endometriosis Surgery: A Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Structured pre-operative pelvic floor physiotherapy program (prehabilitation)

    Other intervention

    Two to three structured pre-operative pelvic floor physiotherapy program (prehabilitation) by physiotherapist specializing in chronic pelvic pain

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Endometriosis Health Profile (EHP)-30 score

Endometriosis Health Profile (EHP)-30 score (validated questionnaire measuring pain and quality of life)

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

Secondary outcomes

1

Chronic pelvic pain

Chronic pelvic pain measured by numeric rating scale

Time frame
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
2

Dysmenorrhea

Dysmenorrhea measured by numeric rating scale

Time frame
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
3

Dyspareunia

Dyspareunia measured by numeric rating scale

Time frame
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
4

Irritable Bowel Syndrome (IBS)

Presence or absence of IBS

Time frame
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively

Other outcomes

Sponsors and contacts

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University of Alberta

Lead sponsor

Women and Children's Health Research Institute, Canada

Collaborator

This trial is not recruiting at the moment. You can still explore other options: