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

14 сентября 2026 г. обновлено: 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.

Обзор исследования

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

150

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Alicia Long, MD, MSc, FRCSC
  • Номер телефона: 1-780-934-5433
  • Электронная почта: ajlong1@ualberta.ca

Учебное резервное копирование контактов

  • Имя: Anastasia Sizov, MD
  • Номер телефона: 1-403-471-2237
  • Электронная почта: sizov@ualberta.ca

Места учебы

    • Alberta
      • Edmonton, Alberta, Канада
        • University of Alberta
        • Контакт:
        • Главный следователь:
          • Alicia Long, MD, MSc, FRCSC

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый

Принимает здоровых добровольцев

Нет

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Без вмешательства: Control Group
Standard perioperative and surgical care
Экспериментальный: 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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Endometriosis Health Profile (EHP)-30 score
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Chronic pelvic pain
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Следователи

  • Главный следователь: Alicia Long, MD, MSc, FRCSC, University of Alberta

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 марта 2027 г.

Первичное завершение (Оцененный)

1 марта 2030 г.

Завершение исследования (Оцененный)

1 сентября 2030 г.

Даты регистрации исследования

Первый отправленный

14 сентября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

14 сентября 2026 г.

Первый опубликованный (Действительный)

18 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

18 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

14 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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