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

2026年9月14日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

150

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Alicia Long, MD, MSc, FRCSC
  • 電話番号:1-780-934-5433
  • メール:ajlong1@ualberta.ca

研究連絡先のバックアップ

  • 名前:Anastasia Sizov, MD
  • 電話番号:1-403-471-2237
  • メール:sizov@ualberta.ca

研究場所

    • Alberta
      • Edmonton、Alberta、カナダ
        • University of Alberta
        • コンタクト:
        • 主任研究者:
          • Alicia Long, MD, MSc, FRCSC

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
介入なし:Control Group
Standard perioperative and surgical care
実験的: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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Endometriosis Health Profile (EHP)-30 score
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Chronic pelvic pain
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Alicia Long, MD, MSc, FRCSC、University of Alberta

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年3月1日

一次修了 (推定)

2030年3月1日

研究の完了 (推定)

2030年9月1日

試験登録日

最初に提出

2026年9月14日

QC基準を満たした最初の提出物

2026年9月14日

最初の投稿 (実際)

2026年9月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月18日

QC基準を満たした最後の更新が送信されました

2026年9月14日

最終確認日

2026年9月1日

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