Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Urinary Retention

Официальное название

Evaluation of the Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Indwelling Catheters Due to Urinary Retention: A Multicenter Study of the Minimally Invasive Urology Society

Обзор

Benign Prostatic Obstruction (BPO) is a common condition in aging men that can lead to urinary retention, often requiring the use of an indwelling urinary catheter. While laser enucleation of the prostate (such as HoLEP, ThuLEP or ThuFLEP) is a safe and effective surgical treatment, it is not well understood how the length of time a patient spent with a urethral catheter before surgery affects the final surgical outcomes. By analyzing patient data from multiple centers of the Minimally Invasive Urology Society, this study aims to evaluate the impact of preoperative catheterization duration on functional outcomes.

Подробное описание

This study is designed as a prospective, observational, multicenter, cohort study conducted under the academic coordination of the Minimally Invasive Urology Society. The study will analyze data from multiple participating centers across Turkey. All clinical parameters will be standardized and recorded in a secure, electronic environment. Preoperative data include patient demographics, catheter duration and baseline urinary scores. Intraoperative data focus on surgical duration and energy parameters. Postoperative data track recovery, complication rates according to the Clavien-Dindo classifications and functional outcomes like flow rates (Qmax), International Prostate Symptom Score (IPSS), post-void residual volume (PVR) at 3 months.

By integrating data from diverse clinical settings, this multicenter study aims to establish a clearer understanding of the optimal timing of surgery, ultimately improving clinical decision-making for patients with urinary retention.

Вмешательства

• Процедура Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP)
  Patients undergo endoscopic laser enucleation of the prostate using either Holmium or Thulium laser platforms, depending on the standard equipment and clinical preference of the participating center. The procedure involves the anatomical enucleation of the prostatic adenoma from the surgical capsule, followed by intravesical morcellation of the enucleated tissue. All surgeries are performed by urologists according to established surgical protocols.

Первичные конечные точки

• Change in International Prostate Symptom Score (IPSS) [Срок оценки: Baseline and 3 months postoperatively]
• Change in Peak Urinary Flow Rate (Qmax) [Срок оценки: Baseline and 3 months postoperatively.]
• Change in Post-Void Residual Volume (PVR) [Срок оценки: Baseline and 3 months postoperatively.]

Вторичные конечные точки (1)

• Postoperative Complication Rate [Срок оценки: From the date of surgery up to 3 months postoperatively.]

Критерии участия

Критерии включения

• Patients undergoing laser enucleation of the prostate, including HoLEP, ThuLEP or ThuFLEP procedures, who have an indwelling urinary catheter due to pre-operative urinary retention.

Критерии исключения

• Patients with a diagnosis of neurogenic bladder or prostate cancer.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Eskisehir Osmangazi University, Faculty of Medicine, Department of Urology — Eskişehir

Идентификаторы

NCT: NCT07603011 · E-25403353-050.04-260029122

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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