Vaginal Electrical Stimulation Versus Neuromodulation (Estim)
Vaginal Electrical Stimulation Versus Sacral Neuromodulation for the Treatment of Refractory Overactive Bladder: A Pilot Study
This prospective study compares quality of life measures of patients with refractory overactive bladder, between two modes of neuromodulation: vaginal electrical stimulation (Group A) and sacral nerve stimulation (Group B).
The specific aims are:
1. To characterize patient symptom bother score, quality of life, and body image scores in patients obtaining sacral nerve stimulation, as compared to vaginal electrical stimulation.
- Hypothesis 1: Both modes of neuromodulation will impact patients' scores in quality of life, patient symptoms, and body image questionnaires.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
All participants will have a standardized intake history which will include age, weight, history of prior treatment for incontinence, medication list, obstetric and gynecologic history, medical history, and surgical history, as well as a complete review of systems. The physical examination will include vital signs (including BMI), genitourinary exam, including Pelvic Organ Prolapse Quantification (POPQ), and neurologic exam. All patients will undergo spontaneous uroflowmetry, urine dipstick from catheterized specimen, multichannel urodynamics, and 3-day voiding diary. Measurement of post-void residual will also be obtained. Completion of the UDI-69, King's Health Questionnaire10, and the Modified Body Image Perception Scale (MBIS) will also be part of the initial visit 11,12.
All participants taking anticholinergics will undergo a 2 week flush-out period prior to the intake assessment. After the intake assessment, the provider will determine which treatment option is appropriate to the participant, and they will then be assigned to one of the two treatment arms: Group A will use vaginal electrical stimulation using the Empi Intravaginal Stimulation Unit Minnova (Empi, St. Paul, MN, USA) and participants in Group B will receive sacral neuromodulation using InterStim (Medtronic, Minneapolis, MN, USA).
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Estados Unidos, 73104
- University of Oklahoma Health Sciences Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Diagnosis of refractory OAB (+/- UUI)*
- Female Gender
- Eligible for both treatment interventions
- Available for 8 weeks of follow-up
- Able to complete study assessments
- Must discontinue anticholinergics within 2 weeks of intervention
Exclusion Criteria:
- Age < 21
- Pregnancy
- Stage 3 or 4 pelvic organ prolapse
- Current use of anticholinergics
- Urinary tract infection
- Undergoing concurrent treatment for pelvic organ prolapse
- Unstable or serious cardiac arrhythmia
- Implanted pacemaker
- Postvoid residual > 100ml
- Unstable seizure disorder
- Dementia or inability to follow instructions
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Electrical Stimulation
Participants will have a dedicated visit with a pelvic floor physical therapist during which instructions on usage and technique for the Minnova unit will be given.
The electrical parameters selected will be: 10 Hertz frequency, 5-second on/10=second off cycle, and a pulse width of 0.4 milliseconds.
The bipolar square will be delivered over a range that varies from 0 to 100 milliamps, depending on the maximum current intensity comfortably tolerated by the patient.
The participant will perform each treatment session for 20 minutes twice daily for 8 weeks.
Participants will be asked to keep a log recording the dates, times, and duration of each treatment session.
|
|
Interstim device
Participants assigned to the sacral neuromodulation group will undergo InterStim device placement by one of the three Urogynecologists at OUHSC using a staged implant technique according to manufacturer's specifications.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Symptom improvement
Periodo de tiempo: 3 months
|
>50% improvement in symptoms and decrease in frequency of voids and episodes of nocturia.
Subjective outcomes will be measured by improvement in scores on the UDI-6, KHG, and MBIS.
|
3 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: S. Abbas Shobeiri, MD, Univerisity of Oklahoma Health Sciences Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1104
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. .