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Impact of Anterior Urethral Suspension Combined With Pelvic Fascia Reconstruction During Robot-Assisted Radical Prostatectomy on Early Postoperative Urinary Continence Recovery: A Single-Center, Prospective, Single-Arm Clinical Study (IAPREA)

21 de julio de 2026 actualizado por: Xiongjun Ye, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
This is a single-center prospective cohort study enrolling 60 to 100 patients with prostate cancer treated at The Cancer Hospital of the Chinese Academy of Medical Sciences between December 2025 and July 2026, who will receive modified RARP combined with anterior urethral suspension and pelvic fascia reconstruction. The primary endpoint is the 3-month postoperative urinary continence recovery rate. Secondary endpoints include positive surgical margin rate, intraoperative blood loss, operative duration, postoperative complications, biochemical recurrence and other indicators. Standardized surgical procedures, standardized follow-up and multi-dimensional statistical analyses will be performed to clarify the functional benefits and oncological safety of this modified technique, so as to optimize surgical strategies for locally advanced prostate cancer.

Descripción general del estudio

Descripción detallada

This single-center prospective cohort study will enroll patients with localized and locally advanced prostate cancer at The Cancer Hospital of the Chinese Academy of Medical Sciences from December 2025 to July 2026. All participants will undergo modified robot-assisted radical prostatectomy combining anterior urethral suspension and pelvic fascia reconstruction. Eligible patients are aged 40-75 years with pathologically confirmed T2-T3 prostate cancer, candidates for robotic radical prostatectomy, complete clinical and imaging data, willingness to attend regular follow-up, and signed written informed consent. Exclusion criteria include prior pelvic radiotherapy or prostate surgery, severe organ dysfunction incompatible with general anesthesia, preoperative neurogenic bladder or persistent urinary incontinence, and refusal to complete the full follow-up schedule. All surgeries will be performed by the same senior urologist following standardized protocols. The core modified technique consists of anterior urethral suspension combined with pelvic fascia reconstruction to facilitate early postoperative urinary continence recovery; urinary continence is defined as using no more than one absorbent pad per day. Intraoperative blood loss and operative duration will be fully documented in real time. Patients will receive telephone follow-up at 1, 2 and 3 months postoperatively. Urinary continence status will be assessed at each contact, and serum PSA testing will be performed regularly to monitor biochemical recurrence, which is defined as sustained PSA levels exceeding 0.1 ng/mL. All perioperative and long-term postoperative complications will be documented in detail. All clinical data will be entered into a standardized electronic database for statistical analyses. The primary endpoint is the rate of urinary continence recovery at 3 months after surgery, while secondary endpoints cover the oncological safety and perioperative risks of the modified procedure. This study aims to verify whether this improved surgical technique can achieve a favorable balance between postoperative urinary functional recovery and oncological tumor control.

Tipo de estudio

Intervencionista

Inscripción (Actual)

60

Fase

  • No aplica

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

      • Beijing, Porcelana
        • Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • 1. Pathologically confirmed prostate cancer;

    2. Scheduled to undergo modified robot-assisted radical prostatectomy;

    3. Able to complete regular postoperative follow-up and functional assessment;

    4. Voluntarily sign written informed consent.

Exclusion Criteria:

  • 1. Previous history of pelvic radiotherapy or prostate surgery;

    2. Severe cardiac, pulmonary, cerebrovascular, hepatic or renal dysfunction that cannot tolerate general anesthesia and surgery;

    3. Neurogenic bladder or severe preoperative urinary incontinence;

    4. Cognitive impairment making follow-up assessment impossible.

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

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction
This single-arm group receives modified robot-assisted radical prostatectomy (RARP). The surgical modification includes anterior urethral suspension and pelvic fascia reconstruction during vesicourethral anastomosis, aiming to improve early urinary continence after surgery. All enrolled patients will undergo this unified modified surgical procedure, followed by routine postoperative follow-up for functional outcomes assessment.
This single-arm group receives modified robot-assisted radical prostatectomy (RARP). The surgical modification includes anterior urethral suspension and pelvic fascia reconstruction during vesicourethral anastomosis, aiming to improve early urinary continence after surgery. All enrolled patients will undergo this unified modified surgical procedure, followed by routine postoperative follow-up for functional outcomes assessment.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Early urinanry continence recovery rate
Periodo de tiempo: 3 consecutive months postoperatively
Urinary continence is defined as the use of no more than one absorbent pad within 24 hours. The primary endpoint is the proportion of patients who achieve urinary continence for three consecutive months after modified robot-assisted radical prostatectomy, which reflects the early functional recovery of the lower urinary tract following surgery.
3 consecutive months postoperatively
Urinary continence recovery rate
Periodo de tiempo: 3 consecutive months postoperatively
Urinary continence is defined as the use of no more than one absorbent pad within 24 hours. The primary endpoint is the proportion of patients who achieve urinary continence for three consecutive months after modified robot-assisted radical prostatectomy, which reflects the early functional recovery of the lower urinary tract following surgery.
3 consecutive months postoperatively

Colaboradores e Investigadores

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

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)

12 de diciembre de 2025

Finalización primaria (Actual)

10 de julio de 2026

Finalización del estudio (Actual)

11 de julio de 2026

Fechas de registro del estudio

Enviado por primera vez

21 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de julio de 2026

Publicado por primera vez (Actual)

24 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de julio de 2026

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

21 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

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.

No

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