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Recruiting NCT07603011

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

— Observational Urinary Retention Benign Prostate Obstruction (BPO)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP).
Who it may be relevant to
Registry conditions: Urinary Retention, Benign Prostate Obstruction (BPO). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure 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.

Primary outcome measures

  • Change in International Prostate Symptom Score (IPSS) [Time frame: Baseline and 3 months postoperatively]
  • Change in Peak Urinary Flow Rate (Qmax) [Time frame: Baseline and 3 months postoperatively.]
  • Change in Post-Void Residual Volume (PVR) [Time frame: Baseline and 3 months postoperatively.]
Secondary outcome measures (1)
  • Postoperative Complication Rate [Time frame: From the date of surgery up to 3 months postoperatively.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Eskisehir Osmangazi University, Faculty of Medicine, Department of Urology — Eskişehir

Identifiers

NCT: NCT07603011 · E-25403353-050.04-260029122

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗