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

14. September 2026 aktualisiert von: Alicia Long, University of Alberta

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.

Studienübersicht

Detaillierte Beschreibung

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:

  1. Determine the effect of pelvic physiotherapy prehabilitation on quality of life, measured by Endometriosis Health Profile (EHP)-30 scale (primary outcome)
  2. 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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

150

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

    • Alberta
      • Edmonton, Alberta, Kanada
        • University of Alberta
        • Kontakt:
        • Hauptermittler:
          • Alicia Long, MD, MSc, FRCSC

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Post-menopausal
  • Prior oophorectomy
  • Prior hysterectomy

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Control Group
Standard perioperative and surgical care
Experimental: Intervention Group
Structured pre-operative pelvic floor physiotherapy program (prehabilitation) plus standard perioperative and surgical care
Two to three structured pre-operative pelvic floor physiotherapy program (prehabilitation) by physiotherapist specializing in chronic pelvic pain

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Endometriosis Health Profile (EHP)-30 score
Zeitfenster: 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)
Endometriosis Health Profile (EHP)-30 score measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Chronic pelvic pain
Zeitfenster: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Chronic pelvic pain measured by numeric rating scale
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Dysmenorrhea
Zeitfenster: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Dysmenorrhea measured by numeric rating scale
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Dyspareunia
Zeitfenster: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Dyspareunia measured by numeric rating scale
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Irritable Bowel Syndrome (IBS)
Zeitfenster: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Presence or absence of IBS
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Painful bladder syndrome (PBS)
Zeitfenster: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Presence or absence of PBS
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Central Sensitization Inventory (CSI)
Zeitfenster: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Central sensitization score measured by CSI (validated questionnaire)
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Pain Catastrophizing Scale (PCS)
Zeitfenster: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
PCS score (validated questionnaire)
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Depression
Zeitfenster: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Depression as measured by PHQ-9 score
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Generalized anxiety
Zeitfenster: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
Generalized anxiety as measured by GAD-7 questionnaire
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Alicia Long, MD, MSc, FRCSC, University of Alberta

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. März 2027

Primärer Abschluss (Geschätzt)

1. März 2030

Studienabschluss (Geschätzt)

1. September 2030

Studienanmeldedaten

Zuerst eingereicht

14. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. September 2026

Zuerst gepostet (Tatsächlich)

18. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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