Impact of Vaginal Estrogen in the Treatment of Symptomatic Mild Pelvic Organ Prolapse With Pelvic Floor Physical Therapy
Vaginal estrogen
+ Placebo
Prolapso
+ Condiciones Patológicas, Signos y Síntomas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 2012
Fecha en la que se inscribió al primer participante.The pathogenesis of pelvic organ prolapse (POP) is unknown. Few studies have correlated patient symptoms and amount of prolapse with biomarkers. POP has traditionally been managed with a pessary or surgery. Recent studies suggest a reduction in POP symptoms following Pelvic Floor Physical Therapy (PFPT). Vaginally delivered hormones are also commonly used to treat prolapse symptoms, with little evidence supporting a clinical benefit. The investigators hypothesize that the optimal approach to improving prolapse symptoms in the patient with mild prolapse requires re-alignment and strengthening of levator muscles via PFPT, and optimization of tissue integrity via local estrogen therapy. The investigators propose to test this hypothesis in a randomized controlled trial in which women with symptomatic mild prolapse opting for PFPT, receive treatment with PFPT in combination with vaginal estrogen versus placebo. The investigators predict that the combined approach will lead to decreased symptoms and improved anatomical support corroborated by biomarker data.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 21 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.De 40 a 80 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Women in good health aged 40-80 * Has symptoms of pelvic organ prolapse; answers yes to at least 1 of the following questions: Do you feel or see a vaginal bulge? Do you feel pressure in the vagina? * Meets POP-Q criteria on exam for stage I, II, or III prolapse * Interested in PFPT for management of POP * Normal mammogram within 1 year of enrollment Exclusion Criteria: * Prior surgery for prolapse or incontinence * Other prior interventions for prolapse (e.g. pessary, PFPT) * Previous bilateral salpingo-oophorectomy (women with 1 ovary will be eligible) * Known liver dysfunction * Connective tissue diseases known to affect collagen or elastin remodeling (including: Lupus, Rheumatoid Arthritis, Scleroderma, Sjogrens syndrome, Marfan syndrome, and Ehlers-Danlos syndrome) * Unevaluated abnormal vaginal bleeding or abnormal pap smear in the previous year * BMI \> 35 kg/m2 * Estrogen therapy (including birth control) in the previous year * Current or prior breast or pelvic malignancy (ovarian, tubal, uterine, cervical or vaginal) * Contraindication to hormone use (i.e. thromboembolic disorder, use of anti-coagulants, coronary artery disease, history of stroke)
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboObjetivos del Estudio
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Magee-Womens Hospital, University of Pittsburgh
Pittsburgh, United StatesAbrir Magee-Womens Hospital, University of Pittsburgh en Google Maps