- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07660068
HoLEP Sexual Survivorship
Patient Perspectives on the Trade-off Between Voiding Improvement and Sexual Dysfunction Following HoLEP
The objective of this study is to evaluate how sexual function, ejaculatory function, and overall sexual satisfaction change following Holmium Laser Enucleation of the Prostate (HoLEP).
In doing so, the study team will examine the trade-off between relief of lower urinary tract symptoms and changes in sexual function.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The objective of this study is to evaluate how sexual function, ejaculatory function, and overall sexual satisfaction change following Holmium Laser Enucleation of the Prostate (HoLEP).
Retrograde ejaculation is a common and expected consequence of the procedure and meaningfully influences surgical decision-making. Through the study team's findings, the study team aims to characterize the longitudinal impact of HoLEP and if it induces patient regret.
In doing so, the study team will examine the trade-off between relief of lower urinary tract symptoms and changes in sexual function. This study seeks to generate patient-centered data to inform shared decision-making for men considering HoLEP.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Males 18-100 years old
- Electing to undergo HoLEP for the treatment of bothersome lower urinary tract symptoms
- Currently have present antegrade ejaculation (the standard, male ejaculatory process where semen is propelled forward and out through the urethra during orgasm).
Exclusion Criteria:
Patients with any of the following:
- Indwelling urinary catheter prior to surgery
- Neurological disease
- History of prior prostatic/urethral surgery that may impact ejaculation
- Patients who lack decisional capacity
- Patients unable to read, understand, and speak English
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Focus Group
To better assess what questions are pertinent to patient sexual satisfaction post-HoLEP, the study team will first conduct a preliminary study of 15 patients who are currently sexually active after the HoLEP procedure.
The preliminary study will be conducted by a one-time 30-45-minute telephone interview and discussion regarding the participants' after HoLEP experience and sexual satisfaction following HoLEP.
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A one-time 30-45-minute telephone interview and discussion regarding the participants' after HoLEP experience and sexual satisfaction following HoLEP.
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Longitudinal Cohort
The main longitudinal study in which the study team will follow HoLEP patients for 24 months post-operatively.
The longtiudinal study cohort is powered to detect a clinically meaningful discrepancy in symptoms after the HoLEP procedure and patient reported ratings.
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Participants will complete questionnaires at 1, 3, 6, 12, and 24 months post-operatively
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Ejaculatory function
Periodo de tiempo: 1 year
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Patient reported satisfaction of ejaculation using Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD) questionnaire. The MSHQ-EjD-SF evaluates the following parameters in regards to ejaculation: Frequency, Force, Volume and Bother (How much are you bothered by any ejaculation difficulties) on a 6-point Likert scale (typically scored 0 to 5). Interpretation: Higher scores indicate better ejaculatory function, while lower scores denote dysfunction and a greater level of personal distress regarding one's ejaculatory function. |
1 year
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Ejaculatory bother
Periodo de tiempo: 1 year
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Patient reported bothersome of ejaculation quality using Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD) questionnaire. The MSHQ-EjD-SF evaluates the following parameters in regards to ejaculation: Frequency, Force, Volume and Bother (How much are you bothered by any ejaculation difficulties) on a 6-point Likert scale (typically scored 0 to 5). Interpretation: Higher scores indicate better ejaculatory function, while lower scores denote dysfunction and a greater level of personal distress regarding one's ejaculatory function. |
1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Erectile function
Periodo de tiempo: 2 years
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Patient reported satisfaction of sexual function and overall sexual satisfaction using the International Index of Erectile Function-5 (IIEF-5). The IIEF (International Index of Erectile Function) is a 15-question, self-administered survey used globally as a clinical "gold standard" to diagnose the presence and severity of erectile dysfunction (ED) and track sexual health outcomes. Interpretation: The IIEF-5 exclusively assesses erectile and intercourse satisfaction, with scores ranging from 5 to 25. Higher scores generally indicate mild to no erectile dysfunction. Lower scores represent declining erectile function. |
2 years
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Sexual function
Periodo de tiempo: 2 years
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Patient reported satisfaction of sexual function and overall sexual satisfaction using the SFI (Brief Sexual Function Inventory). The SFI is an 11-item, administered questionnaire used to evaluate male sexual function and how it is impacted by conditions like Lower Urinary Tract Symptoms (LUTS). Interpretation: Each of the 11 items is rated on a Likert scale (typically 0 to 4 points). The total score is the sum of the responses, with higher scores generally indicating better sexual function and lower scores highlighting more severe impairment or dysfunction. |
2 years
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Sexual function and sexual satisfaction
Periodo de tiempo: 2 years
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Patient reported satisfaction of sexual function and overall sexual satisfaction using the MSF-4 (Male Sexual Function-4). The MSF-4 (Male Sexual Function-4) is a four-question survey designed to evaluate male sexual health in clinical urology settings. It is primarily used to track changes in sexual function for men dealing with Lower Urinary Tract Symptoms (LUTS) or Benign Prostatic Hyperplasia (BPH). Interpretation: Each of the 4 items uses a Likert-type scale (typically ranging from 1 to 4 or 1 to 5). Higher scores generally indicate better sexual functioning and higher satisfaction. Lower scores represent worsening sexual function or increased sexual dysfunction (such as erectile or ejaculatory issues). |
2 years
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones Urológicas
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Comportamiento Sexual
- Síntomas del tracto urinario inferior
- Orgasmo
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Recopilación de datos
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Entrevistas como tema
Otros números de identificación del estudio
- STU00226001
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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