Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Terapia con láser para el tratamiento de los síntomas urogenitales en mujeres

29 de junio de 2026 actualizado por: Kenneth M Peters, MD, Corewell Health East

Terapia con láser de dióxido de carbono fraccionado de la vagina para el tratamiento de los síntomas urogenitales en mujeres

Este es un estudio observacional prospectivo de mujeres sometidas a tratamiento vaginal con láser de dióxido de carbono fraccionado (fCO2) para diversos síntomas urogenitales.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

El tratamiento con láser de dióxido de carbono fraccionado (fCO2) del tejido vaginal se ha propuesto como tratamiento para varios síntomas genitourinarios, que incluyen picazón vaginal, ardor, sequedad, dispareunia (relaciones sexuales difíciles o dolorosas), disuria (micción dolorosa o difícil), nocturia ( despertarse por la noche para orinar), incontinencia (pérdida involuntaria de orina), polaquiuria, urgencia urinaria e infección del tracto urinario (ITU).

Los informes de casos y los datos de series de casos sugieren que el tratamiento con láser de los tejidos vaginales es bien tolerado por las pacientes y no presenta riesgos graves para la paciente. Varias series de casos demuestran mejoras en los síntomas vulvovaginales y urinarios, y en la función sexual. Sin embargo, estos estudios son de unos pocos centros selectos, son pequeños y también están sesgados en el sentido de que el tratamiento con láser solo está disponible para los pacientes que pueden pagarlo. Además, la mayoría de los estudios solo informan sobre los síntomas vulvovaginales, a pesar del aumento del uso del láser para los síntomas urinarios. Varios editoriales recientes han solicitado estudios más amplios con un seguimiento más prolongado y medidas de resultado de alta calidad. Este estudio ha sido diseñado para abordar estas necesidades.

Este es un estudio observacional prospectivo de mujeres sometidas a tratamiento vaginal con el láser fCO2 para una amplia gama de pacientes con molestias vulvovaginales, sexuales y/o urológicas. Los efectos de la terapia con fCO2 se evaluarán mediante varias evaluaciones físicas y cuestionarios para pacientes.

Tipo de estudio

De observación

Inscripción (Actual)

100

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.

Ubicaciones de estudio

  • Estados Unidos
    • Michigan
      • Royal Oak, Michigan, Estados Unidos, 48073
        • Corewell Health William Beaumont University Hospital

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

18 años a 90 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Las mujeres que cumplan con todos los criterios de inclusión y ninguno de los criterios de exclusión pueden inscribirse en el estudio.

Descripción

Criterios de inclusión:

  1. Femenino
  2. 18 años de edad o más y 90 años de edad o menos

  3. Una o más de las siguientes indicaciones para el tratamiento con láser fCO2:

    1. Síntomas genitourinarios de la menopausia, incluso después de la menopausia natural, inducida médicamente o quirúrgica
    2. Sequedad vaginal, ardor, picazón o dispareunia no relacionada con la menopausia
    3. Incontinencia urinaria de esfuerzo
    4. Infecciones recurrentes del tracto urinario (ITU), definidas como 4 o más en un año
    5. Vejiga hiperactiva
  4. Debe firmar el consentimiento informado
  5. Debe estar dispuesto a cumplir con el protocolo de estudio.

Criterio de exclusión:

  1. Contraindicaciones para el tratamiento con láser fCO2, tales como:

    1. Malla, cabestrillo o cinta pélvica sintética implantada actualmente
    2. Cánceres genitales actuales o anteriores
    3. Radiación al tejido vaginal o colorrectal
    4. Actualmente embarazada o menos de 3 meses después del embarazo
    5. Lesiones vaginales o cervicales no diagnosticadas
  2. Pacientes que han recibido tratamiento con láser fCO2 vaginal en los últimos 12 meses
  3. Pacientes tratadas con estrógeno vaginal en los últimos 3 meses
  4. Pacientes con sangrado vaginal no diagnosticado
  5. Infección vulvar o vaginal activa, incluyendo herpes, candidiasis, etc.
  6. Infección actual del tracto urinario (ITU), confirmada por cultivo de orina positivo y síntomas informados por el paciente
  7. Cirugía pélvica o vaginal en los últimos 9 meses
  8. Prolapso de órganos pélvicos más allá del introito
  9. El paciente posee cualquier otra característica que, a juicio del investigador, las considere inadecuadas (es decir, puede aumentar el riesgo del paciente, puede afectar la realización del estudio, etc.) para el tratamiento y/o estudio
  10. Participación en un ensayo de investigación que utilizó un tratamiento, medicamento o producto biológico del estudio dentro de los 6 meses o menos anteriores a la fecha de la visita de selección

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

  • Modelos observacionales: Grupo
  • Perspectivas temporales: Futuro

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Grupo de Terapia Láser fCO2
Mujeres tratadas con el láser fCO2
Dispositivo: Grupo de Terapia Láser fCO2
Las mujeres inscritas en el estudio recibirán tres tratamientos con el láser de dióxido de carbono fraccionado (fCO2). El intervalo entre tratamientos es de aproximadamente seis semanas. Los tratamientos con láser intravaginal se administrarán en 8 puntos en cada nivel de la pared vaginal.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Puntuación de la impresión global de mejora (PGI-I) del paciente a las 4 semanas después del tratamiento inicial
Periodo de tiempo: 4 semanas después del tratamiento inicial
La puntuación PGI-I se registra 4 semanas después de completar el tratamiento inicial. El PGI-I pide al paciente que "marque la casilla que mejor describa cómo son sus síntomas urinarios y/o vaginales ahora, en comparación con cómo eran sus síntomas antes de comenzar este estudio". Hay 7 respuestas posibles que van del 1 al 7, donde 1 es "Mucho mejor", 2 es "Mucho mejor", 3 es "Un poquito mejor", 4 es "Sin cambios", 5 es "Un poco peor". 6 es "mucho peor" y 7 es "mucho peor". Una puntuación de 1 a 3 indicaría mejoría.
4 semanas después del tratamiento inicial

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Patient Global Impression of Improvement (PGI-I) Score at 6 Months After Initial Treatment
Periodo de tiempo: 6 months post-initial treatment
The average change in patients' PGI-I scores from baseline to 6 months and 36 months post-treatment. The PGI-I asks the patient to "check the one number that best describes how your urinary tract condition is now compared with how it was before your treatment." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better" and 7 is "Very Much Worse". A lower score would represent improvement and a favorable outcome.
6 months post-initial treatment
Change in Vaginal pH and Overall Vaginal Health on Physical Exam as Measured by the Vaginal Health Inventory Score (VHIS) at 6 Months Post-initial Treatment.
Periodo de tiempo: 6 months post-initial treatment
The Vaginal Health Inventory Score (VHIS) is an assessment tool, used by providers, to determine if vaginal atrophy is present. Providers perform a vaginal exam and give a score of 1-5 (abnormal to normal, respectively) on each of the following vaginal parameters: elasticity, secretion/fluid volume, vaginal pH, integrity of the epithelium, and lubrication/moisture of the vaginal wall. The total VHIS score is a sum of the individual scores of these 5 vaginal parameters. The minimum score is 5 and the maximum score is 25. A score of 5-14 indicates the presence of vaginal atrophy, while a score of 15-25 indicates normal healthy vaginal tissue. For this outcome measure we reported the change in VHIS between 6 months and baseline. A positive number means that vaginal tissue is healthier at 6 months compared to baseline.
6 months post-initial treatment
Change in Urinary Symptoms Specifically Stress Urinary Incontinence Score as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID) at 6 Months Post-initial Treatment.
Periodo de tiempo: 6 months post-initial treatment
The Questionnaire for Urinary Incontinence Diagnosis (QUID) consists of 2 sections: section 1 are three questions related to stress urinary incontinence (SUI) and section 2 are three questions related to Urge Urinary Incontinence (UUI). This outcome measure is focused on the SUI score only (QUID-SUI). Patients are asked how often they leak urine in three different situations. Responses range from 0 = none of the time, to 5 = all of the time. The total QUID-SUI score ranges from 0 - 15, with a higher score meaning more frequent urinary leakage in response to a stress event (e.g. cough, lifting, exercise). Here we report the change in QUID-SUI score from 6 months to baseline. A negative number means the QUID stress urinary incontinence score has gone down and severity of SUI his better at 6 months compared to baseline.
6 months post-initial treatment
Change in Overactive Bladder (OAB) Symptoms, Specifically Symptom Bother as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) at 6 Months After Initial Treatment.
Periodo de tiempo: 6 months post-initial treatment
For this outcome measure, we used the OAB-q SF, which consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. In this outcome measure we specifically look at the symptom bother scale that consists of 6 questions. Each question asks about the level of bother related to a specific symptom (e.g. urgency, frequency, nighttime urination and leakage). The patient rates the degree of bother on a 6-point scale with 1 = Not at all and 6 = A very great deal. The scores of the 6 questions are added and converted to a 100-point scale. The symptom bother score ranges from 0-100. A higher score is associated with a high degree of bother. For this outcome measure, we report the change in the mean symptom bother scale from 6 months to baseline. A negative change means that the degree of symptom bother decreased at 6 months compared to before treatment.
6 months post-initial treatment
Change in Number of Voids as Recorded on Voiding Diary at 6 Months Post-initial Treatment.
Periodo de tiempo: 6 months post-initial treatment
A 3-day voiding diary will be completed by the patient and evaluated to describe urinary frequency (number of voids) and incontinence episodes. The change in number of voids over a 3 day period at 6 months minus baseline will be measured. A negative number means the number of voids went down compared to baseline.
6 months post-initial treatment
Change in Sexual Function, Including Dyspareunia Symptoms, as Measured by the Female Sexual Function Inventory (FSFI) at 6 Months Post-initial Treatment.
Periodo de tiempo: 6 months post-initial treatment
The FSFI consists of 6 subscales related to sexual desire (2 Qs scale 1 worst - 5 best), arousal (4Qs 0 worst - 5 best), lubrication (4Qs 0 worst-5 best), orgasm (3Qs 0 worst - 5 best), satisfaction ( 3Qs 0 worst - 5 best), and pain (3 Qs 0 worst - 5 best). Higher scores indicate higher sexual functioning. Scores range from 2-36. A score of 26.55 has been clinically selected as the cut-off for sexual dysfunction. Scores below this value indicate sexual dysfunction. The overall change is measured at 6 months minus baseline. A positive score means the sexual dysfunction symptoms are getting worse. Only people that had sexual activity were included.
6 months post-initial treatment
Frequency of Urinary Tract Infection (UTI) Occurrences, as Measured by a Positive Urine Culture Test at 6 Months Post-initial Treatment.
Periodo de tiempo: 6 months post-initial treatment
A clean catch urine specimen will be collected at each visit. A positive urine dipstick test will have the presence of leukocytes and nitrites accompanied by symptoms (dysuria, bladder pain, and/or urinary frequency) and will be sent for a culture. A positive urine culture has the presence of bacterial growth. Only patients that reported recurrent UTI's - 4 or more in the past year (i.e. had 4 or more positive urine cultures in a year) at baseline with an occurrence of a positive urine culture at or before 6 months post-initial treatment will be counted.
6 months post-initial treatment
Change in Mental Health Status as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7) at 6 Months Post-initial Treatment.
Periodo de tiempo: 6 months post-initial treatment
The GAD-7 is a self-reported questionnaire for screening and measuring severity of generalized anxiety disorder. There are 7 questions total asking how often the patient has been bothered by certain problems over the past 2 weeks. Each answer is scored on a scale from 0 = not at all to 3 = nearly every day. All scores are added up to calculate the total score which ranges from 0 - 21. Total scores greater than or equal to 10 indicate moderate anxiety and further assessment is recommended. In this outcome measure we report the change in GAD-7 score between 6 months and baseline. A negative number means a reduction in GAD-7 score and therefore a reduction in anxiety/depression at 6 months compared to before treatment.
6 months post-initial treatment
Change in Mental Health Status as Measured by the Patient Health Questionnaire (PHQ-8) at 6 Months Post-initial Treatment.
Periodo de tiempo: 6 months post-initial treatment
The PHQ-8 is an eight-item questionnaire that measures the severity of depression symptoms over the past 2 weeks. For each of the questions, the patient is asked the rate how often they are bothered by a specific problem (e.g. sleep disturbance, fatigue, appetite change, low-self esteem, poor concentration). Each question is scored from 0 = not at all to 3 = nearly every day. The scores of each question are added together to form the total score, which ranges from 0 - 24. The higher the score, the more severe depressive symptoms are. A score of 10 or greater is commonly used to indicate the presence of clinically significant depressive symptoms. Here we report the change in score between 6 months and baseline. A negative number means there is a reduction in PHQ8 score at 6 months compared to before treatment and therefore a reduction in depression.
6 months post-initial treatment
Change in Life and Sexual Impact of Vulvovaginal Skin Symptoms as Measured by the Incontinence Quality of Life Questionnaire (I-QOL) at 6 Months.
Periodo de tiempo: 6 months post-initial treatment
The Incontinence Quality of Life Questionnaire (I-QOL) is a validated tool to assess the impact of urinary incontinence problems. The I-QOL has 22 incontinent-specific quality of life items. The 22 items are broken down into 3 subscales: Avoidance and Limiting Behaviors Score (8 of the 22 items), Psychosocial Impacts Score (9 of the 22 items), and Social Embarrassment Score (5 of the 22 items). Each question has a five-point ordinal response scale: 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All. All 22 items are summed up, and the sum is converted to a 100-point scale. The range of the score is 0-100, with a high score indicating a better quality of life. In this outcome measure we report the change in the I-QOL score at 6 months minus the score at baseline. A positive score indicates that the quality of life improved at 6 months compared to before treatment.
6 months post-initial treatment
The Presence of Lactobacillus, Assessed by Vaginal Swab at 6 Months.
Periodo de tiempo: 6 months post-initial treatment
A vaginal exam is completed at 6 months. In some cases the 6 month visit was completed remotely and thus a vaginal exam was not completed. Presence or absence of lactobacillus will be collected by the physician via a vaginal swab and assessed under the microscope of the patients that had a vaginal exam completed. This is the total number of patients positive for lactobacillus at 6 months.
6 months post-initial treatment
Change in Patient Global Impression of Improvement (PGI-I) Score at 36 Months.
Periodo de tiempo: 36 months post-initial treatment
The average change in patients' PGI-I scores from baseline to 6 months and 36 months post-treatment. The PGI-I asks the patient to "check the one number that best describes how your urinary tract condition is now compared with how it was before your treatment." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better" and 7 is "Very Much Worse". A lower score would represent improvement and a favorable outcome.
36 months post-initial treatment
Change in Vaginal pH and Overall Vaginal Health on Physical Exam as Measured by the Vaginal Health Inventory Score (VHIS) at 36 Month Post-initial Treatment.
Periodo de tiempo: 36 months post-initial treatment
The Vaginal Health Inventory Score (VHIS) is an assessment tool, used by providers, to determine if vaginal atrophy is present. Providers perform a vaginal exam and give a score of 1-5 (abnormal to normal, respectively) on each of the following vaginal parameters: elasticity, secretion/fluid volume, vaginal pH, integrity of the epithelium, and lubrication/moisture of the vaginal wall. The total VHIS score is a sum of the individual scores of these 5 vaginal parameters. The scale ranges from 5-25. A score of 5-14 indicates the presence of vaginal atrophy, while a score of 15-25 indicates normal/healthy vaginal tissue. For this outcome measure we reported the change in VHIS between 36 months and baseline. A positive number means that vaginal tissue is healthier at 36 months compared to baseline.
36 months post-initial treatment
Change in Urinary Symptoms, Specifically Stress Urinary Incontinence as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID) at 36 Months Post-inital Treatment.
Periodo de tiempo: 36 months post-initial treatment
The Questionnaire for Urinary Incontinence Diagnosis (QUID) consists of 2 sections: section 1 are three questions related to stress urinary incontinence (SUI) and section 2 are three questions related to Urge Urinary Incontinence (UUI). This outcome measure is focused on the SUI score only (QUID-SUI). Patients are asked how often they leak urine in three different situations. Responses range from 0 = none of the time, to 5 = all of the time. The total QUID-SUI score ranges from 0 - 15, with a higher score meaning more frequent urinary leakage in response to a stress event (e.g. cough, lifting, exercise). Here we report the change in QUID-SUI score from 36 months to baseline. A negative number means the QUID stress urinary incontinence score has gone down and severity of SUI his better at 36 months compared to baseline.
36 months post-initial treatment
Change in Urinary Symptoms Specifically Urge Urinary Incontinence Score as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID) at 6 Months Post-initial Treatment.
Periodo de tiempo: 6 months post-initial treatment
The Questionnaire for Urinary Incontinence Diagnosis (QUID) consists of 2 sections: section 1 are three questions related to stress urinary incontinence (SUI) and section 2 are three questions related to Urge Urinary Incontinence (UUI). This outcome measure is focused on the UUI score only (QUID-UUI). Patients are asked how often they leak urine in three different situations related to urgency. Responses range from 0 = none of the time, to 5 = all of the time. The total QUID-UUI score ranges from 0 - 15, with a higher score meaning more frequent urinary leakage due to urgency. Here we report the change in QUID-UUI score from 6 months to baseline. A negative number means the QUID urge urinary incontinence score has gone down and severity of UUI has improved at 6 months compared to before treatment.
6 months post-initial treatment
Change in Urinary Symptoms Specifically Urge Urinary Incontinence Score as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID) at 36 Months Post-initial Treatment.
Periodo de tiempo: 36 months post-initial treatment
The Questionnaire for Urinary Incontinence Diagnosis (QUID) consists of 2 sections: section 1 are three questions related to stress urinary incontinence (SUI) and section 2 are three questions related to Urge Urinary Incontinence (UUI). This outcome measure is focused on the UUI score only (QUID-UUI). Patients are asked how often they leak urine in three different situations related to urgency. Responses range from 0 = none of the time, to 5 = all of the time. The total QUID-UUI score ranges from 0 - 15, with a higher score meaning more frequent urinary leakage due to urgency. Here we report the change in QUID-UUI score from 36 months to baseline. A negative number means the QUID urge urinary incontinence score has gone down and severity of UUI has improved at 36 months compared to before treatment.
36 months post-initial treatment
Change in Overactive Bladder (OAB) Symptoms, Specifically Health-related Quality of Life (HR-QOL) as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) at 36 Months Post-initial Treatment.
Periodo de tiempo: 36 months post-initial treatment
For this outcome measure, we used the OAB-q SF, which consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. In this outcome measure we specifically look at the health-related quality of life (HR-QOL) scale that consists of 13 questions. Each question asks how the patient's quality of life has been impacted. The patient rates the degree of impact on a 6-point scale with 1 = Not at all and 6 = A very great deal. The scores of the 13 questions are added and converted to a 100-point scale. The HR-QOL score ranges from 0-100. A higher score is associated with a better quality of life. For this outcome measure, we report the change in the mean HR-QOL score for 36 months minus baseline. A positive change means that the quality of life became better by 36 months as compared to before treatment.
36 months post-initial treatment
Change in Overactive Bladder (OAB) Symptoms, Specifically Symptom Bother as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) at 36 Months Post-initial Treatment.
Periodo de tiempo: 36 months post-initial treatment
For this outcome measure, we used the OAB-q SF, which consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. In this outcome measure we specifically look at the symptom bother scale that consists of 6 questions. Each question asks about the level of bother related to a specific symptom (e.g. urgency, frequency, nighttime urination and leakage). The patient rates the degree of bother on a 6-point scale with 1 = Not at all and 6 = A very great deal. The scores of the 6 questions are added and converted to a 100-point scale. The symptom bother score ranges from 0-100. A higher score is associated with a high degree of bother. For this outcome measure, we report the change in the mean symptom bother scale from 36 months to baseline. A negative change means that the degree of symptom bother decreased at 36 months compared to before treatment.
36 months post-initial treatment
Change in Overactive Bladder (OAB) Symptoms, Specifically Health-related Quality of Life (HR-QOL) as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) at 6 Months Post-initial Treatment.
Periodo de tiempo: 6 months post-initial treatment
For this outcome measure, we used the OAB-q SF, which consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. In this outcome measure we specifically look at the health-related quality of life (HR-QOL) scale that consists of 13 questions. Each question asks how the patient's quality of life has been impacted. The patient rates the degree of impact on a 6-point scale with 1 = Not at all and 6 = A very great deal. The scores of the 13 questions are added and converted to a 100-point scale. The HR-QOL score ranges from 0-100. A higher score is associated with a better quality of life. For this outcome measure, we report the change in the mean HR-QOL score for 6 months minus baseline. A positive change means that the quality of life became better by 6 months as compared to before treatment.
6 months post-initial treatment
Change in Number of Voids as Recorded on Voiding Diary at 36 Months Post-initial Treatment.
Periodo de tiempo: 36 months post-initial treatment
A 3-day voiding diary will be completed by the patient and evaluated to describe urinary frequency (number of voids) and incontinence episodes. The change in number of voids over a 3 day period at 36 months minus baseline will be measured. A negative number means the number of voids went down compared to baseline.
36 months post-initial treatment
Change in Number of Stress Urinary Incontinence Events as Recorded on Voiding Diary at 6 Months Post-initial Treatment.
Periodo de tiempo: 6 months post-initial treatment
A 3-day voiding diary will be completed by the patient and evaluated to describe incontinence episodes (number of stress urinary incontinence occurrences). The change in number of stress urinary incontinence episodes over a 3 day period at 6 months minus baseline will be measured. A negative number means the number of stress urinary incontinence events went down compared to baseline.
6 months post-initial treatment
Change in Number of Stress Urinary Incontinence Events as Recorded on Voiding Diary at 36 Months Post-initial Treatment.
Periodo de tiempo: 36 months post-initial treatment
A 3-day voiding diary will be completed by the patient and evaluated to describe incontinence episodes (number of stress urinary incontinence occurrences). The change in number of stress urinary incontinence episodes over a 3 day period at 36 months minus baseline will be measured. A negative number means the number of stress urinary incontinence events went down compared to baseline.
36 months post-initial treatment
Change in Number of Urge Urinary Incontinence Events as Recorded on Voiding Diary at 6 Months Post-initial Treatment.
Periodo de tiempo: 6 months post-initial treatment
A 3-day voiding diary will be completed by the patient and evaluated to describe incontinence episodes (number of urge urinary incontinence events). The change in number of urge urinary incontinence events over a 3 day period at 6 months minus baseline will be measured. A negative number means the number of urge urinary incontinence events went down compared to baseline.
6 months post-initial treatment
Change in Number of Urge Urinary Incontinence Events as Recorded on Voiding Diary at 36 Months Post-initial Treatment.
Periodo de tiempo: 36 months post-initial treatment
A 3-day voiding diary will be completed by the patient and evaluated to describe incontinence episodes (number of urge urinary incontinence events). The change in number of urge urinary incontinence events over a 3 day period at 36 months minus baseline will be measured. A negative number means the number of urge urinary incontinence events went down compared to baseline.
36 months post-initial treatment
Change in Mental Health Status as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7) at 36 Months Post-initial Treatment.
Periodo de tiempo: 36 months post-initial treatment
The GAD-7 is a self-reported questionnaire for screening and measuring severity of generalized anxiety disorder. There are 7 questions total asking how often the patient has been bothered by certain problems over the past 2 weeks. Each answer is scored on a scale from 0 = not at all to 3 = nearly every day. All scores are added up to calculate the total score which ranges from 0 - 21. Total scores greater than or equal to 10 indicate moderate anxiety and further assessment is recommended. In this outcome measure we report the change in GAD-7 score between 36 months and baseline. A negative number means a reduction in GAD-7 score and therefore a reduction in anxiety/depression at 36 months compared to before treatment.
36 months post-initial treatment
Change in Mental Health Status as Measured by the Patient Health Questionnaire (PHQ-8) at 36 Months Post-initial Treatment.
Periodo de tiempo: 36 months post-initial treatment
The PHQ-8 is an eight-item questionnaire that measures the severity of depression symptoms over the past 2 weeks. For each of the questions, the patient is asked the rate how often they are bothered by a specific problem (e.g. sleep disturbance, fatigue, appetite change, low-self esteem, poor concentration). Each question is scored from 0 = not at all to 3 = nearly every day. The scores of each question are added together to form the total score, which ranges from 0 - 24. The higher the score, the more severe depressive symptoms are. A score of 10 or greater is commonly used to indicate the presence of clinically significant depressive symptoms. Here we report the change in score between 36 months and baseline. A negative number means there is a reduction in PHQ8 score at 36 months compared to before treatment and therefore a reduction in depression.
36 months post-initial treatment
Change in Sexual Function, Including Dyspareunia Symptoms, as Measured by the Female Sexual Function Inventory (FSFI) at 36 Months Post-initial Treatment.
Periodo de tiempo: 36 months post-initial treatment
The FSFI consists of 6 subscales related to sexual desire (2 Qs scale 1 worst - 5 best), arousal (4Qs 0 worst - 5 best), lubrication (4Qs 0 worst-5 best), orgasm (3Qs 0 worst - 5 best), satisfaction ( 3Qs 0 worst - 5 best), and pain (3 Qs 0 worst - 5 best). Higher scores indicate higher sexual functioning. Scores range from 2-36. A score of 26.55 has been clinically selected as the cut-off for sexual dysfunction. Scores below this value indicate sexual dysfunction. The change is measured as the difference at 36 months minus baseline. A positive score means the sexual dysfunction symptoms are getting worse. Only people that had sexual activity were included.
36 months post-initial treatment
Frequency of Urinary Tract Infection (UTI) Occurrences, as Measured by a Positive Urine Culture Test at 36 Months Post-initial Treatment.
Periodo de tiempo: 36 months post-initial treatment
A clean catch urine specimen will be collected at each visit. A positive urine dipstick test will have the presence of leukocytes and nitrites accompanied by symptoms (dysuria, bladder pain, and/or urinary frequency) and will be sent for a culture. A positive urine culture has the presence of bacterial growth. Only patients that reported recurrent UTI's - 4 or more in the past year (i.e. had 4 or more positive urine cultures in a year) at baseline with an occurrence of a positive urine culture after 6 months but before or at 36 months post-initial treatment will be counted.
36 months post-initial treatment
The Presence of Lactobacillus, Assessed by Vaginal Swab at 36 Months.
Periodo de tiempo: 36 months post-initial treatment
A vaginal exam is completed at 36 months. In some cases the 36 month visit was completed remotely and thus a vaginal exam was not completed. Presence or absence of lactobacillus will be collected by the physician via a vaginal swab and assessed under the microscope of the patients that had a vaginal exam completed. This is the total number of patients positive for lactobacillus at 36 months.
36 months post-initial treatment
Change in Life and Sexual Impact of Vulvovaginal Skin Symptoms as Measured by the Incontinence Quality of Life Questionnaire (I-QOL) at 36 Months.
Periodo de tiempo: 36 months post-initial treatment
The Incontinence Quality of Life Questionnaire (I-QOL) is a validated tool to assess the impact of urinary incontinence problems. The I-QOL has 22 incontinent-specific quality of life items all having the following five-point ordinal response scale: 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All. All 22 items are summed up, and the sum is converted to a 100-point scale. The range of the score is 0-100, with a high score indicating a better quality of life. In this outcome measure we report the change in the I-QOL score at 36 months minus the score at baseline. A positive score indicates that the quality of life improved at 36 months compared to before treatment.
36 months post-initial treatment

Colaboradores e Investigadores

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

Patrocinador

Corewell Health East

Investigadores

  • Investigador principal: Kenneth Peters, MD, Corewell Health William Beaumont University Hospital

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 (Actual)

8 de octubre de 2018

Finalización primaria (Actual)

15 de diciembre de 2022

Finalización del estudio (Actual)

10 de junio de 2025

Fechas de registro del estudio

Enviado por primera vez

3 de agosto de 2018

Primero enviado que cumplió con los criterios de control de calidad

20 de septiembre de 2018

Publicado por primera vez (Actual)

24 de septiembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de agosto de 2026

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

29 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2018-142

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.

Sí

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. .

Suscribir