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

14 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

150

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Alicia Long, MD, MSc, FRCSC
  • Número de teléfono: 1-780-934-5433
  • Correo electrónico: ajlong1@ualberta.ca

Copia de seguridad de contactos de estudio

  • Nombre: Anastasia Sizov, MD
  • Número de teléfono: 1-403-471-2237
  • Correo electrónico: sizov@ualberta.ca

Ubicaciones de estudio

    • Alberta
      • Edmonton, Alberta, Canadá
        • University of Alberta
        • Contacto:
        • Investigador principal:
          • Alicia Long, MD, MSc, FRCSC

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Endometriosis Health Profile (EHP)-30 score
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Chronic pelvic pain
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Alicia Long, MD, MSc, FRCSC, University of Alberta

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de marzo de 2027

Finalización primaria (Estimado)

1 de marzo de 2030

Finalización del estudio (Estimado)

1 de septiembre de 2030

Fechas de registro del estudio

Enviado por primera vez

14 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Publicado por primera vez (Actual)

18 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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