Dynamic Magnetic Resonance Imaging Before and After Vaginal Prolapse Repair
Dynamic Magnetic Resonance Imaging Following Vaginal Reconstructive Surgery; a Prospective Study to Describe Anatomy
Descripción general del estudio
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Descripción detallada
Approximately 1 in 11 women will undergo surgery for POP by age 80 years. POP occurs due to a defect or weakness of the pelvic floor, resulting in the herniation of pelvic organs through the vagina. The goal of surgical interventions has historically been thought to restore normal pelvic anatomy. Restoration of pelvic anatomy has been demonstrated following pelvic reconstructive surgery by way of significantly improved postoperative Pelvic Organ Prolapse Quantification (POPQ) scale measurements. Furthermore, improved POPQ measurements have also been shown to be positively correlated with improved patient satisfaction.
More recently, attention has turned toward using imaging studies to describe the postoperative anatomical changes seen in pelvic reconstructive surgery. The purpose of this study is to describe the impact of vaginal reconstruction, including an intraperitoneal vaginal vault suspension for POP on pelvic anatomy using dynamic MRI of the pelvis.
The primary aim is to compare postoperative dynamic pelvic MRI measurements to preoperative measurements in patients who undergo prolapse repair vaginally including anterior, posterior and intraperitoneal vaginal vault suspension repairs for POP.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45220
- TriHealth - Cincinnati Urogynecology Associates
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Criterios de participación
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Descripción
Inclusion Criteria:
- Adults 18 years of age or older
- English-speaking
- Undergoing anterior, posterior and intraperitoneal vaginal vault suspension by a physician at Cincinnati Urogynecology Associates, TriHealth for the treatment of symptomatic POP
- Concomitant procedures such as hysterectomy, suburethral sling, bilateral salpingectomy or salpingooophorectomy
- Willingness to participate in study
Exclusion Criteria:
- Unwillingness to participate in the study
- Pregnancy
- Contraindication to pelvic MRI, such as a metal implanted device (excluding titanium) or claustrophobia
- Previous surgery for apical prolapse such as sacrocolpopexy or vaginal vault suspension, or transvaginal mesh for prolapse
- Physical or mental impairment that would affect the subject's ability to complete the dynamic MRI, including patient's with dementia or those who have impaired mobility
- Known findings that may distort pelvic anatomy, such as a pelvic mass, congenital anomaly, or history of pelvic radiation
Plan de estudios
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Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in H-line, Dynamic MRI measurement between pre- and post
Periodo de tiempo: Before surgery and 12 weeks after surgery
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The distance from pubic symphysis to the posterior anal canal
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Before surgery and 12 weeks after surgery
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Change in M-line, Dynamic MRI measurement
Periodo de tiempo: Before surgery and 12 weeks after surgery
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The descent of the levator plate from the pubococyygeal line (PCL)
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Before surgery and 12 weeks after surgery
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Change in O classification
Periodo de tiempo: Before surgery and 12 weeks after surgery
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The type of visceral prolapse (cystocele, rectocele, enterocele and the degree beyond the H-line
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Before surgery and 12 weeks after surgery
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Colaboradores e Investigadores
Patrocinador
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Publicado por primera vez (Actual)
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
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Otros números de identificación del estudio
- 17-061
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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