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RecruitingNCT07603011Updated Sep 11, 2026

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

An observational study in Urinary Retention and Benign Prostate Obstruction (BPO), sponsored by Eskişehir Osmangazi University Medicine Faculty Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Eskişehir Osmangazi University Medicine Faculty Hospital · Observational

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
54
Ages
18 Years and older
Sex
Male
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Study summary

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.

Read the 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.

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Conditions studied

  • Urinary Retention
  • Benign Prostate Obstruction (BPO)

Keywords

  • Benign Prostatic Obstruction
  • BPO
  • BPH
  • Benign Prostatic Hyperplasia
  • Bladder Outlet Obstruction
  • Lower Urinary Tract Symptoms
  • Acute Urinary Retention
  • Urinary Catheterization
  • Catheter Duration
  • Holmium Laser Enucleation of the Prostate
  • Thulium Laser Enucleation of the Prostate
  • HoLEP
  • ThuLEP
  • Urology
  • Prospective Registry
  • Multicenter Study
  • ThuFLEP
  • Thulium Fiber Laser Enucleation of the Prostate
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In context

Urinary Retention

241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.

This study's planned enrollment of 54 is below the median of 116 across 45 observational studies indexed under Urinary Retention.

Browse Urinary Retention studies →

Lead sponsor

This is the only study on the registry with Eskişehir Osmangazi University Medicine Faculty Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

The study population consists of adult male patients presenting to the urology departments of multiple tertiary care hospitals (university and research centers) across Turkey. These patients are characterized by symptomatic benign prostatic obstruction (BPO) and require surgical intervention. Specifically, the population includes individuals who are managed with an indwelling urinary catheter due to urinary retention while awaiting laser enucleation of the prostate (HoLEP, ThuLEP or ThuFLEP).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
54 participants (estimated)
Patient registry
No

Groups and cohorts

  • Short-term Catheterization Group

    Patients who have been using an indwelling urinary catheter for less than the average of groups prior to the laser enucleation surgery (HoLEP, ThuLEP, ThuFLEP)

    Procedure: Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP)

  • Long-term Catheterization Group

    Patients who have been using an indwelling urinary catheter for more than the average of groups prior to the laser enucleation surgery (HoLEP, ThuLEP, ThuFLEP)

    Procedure: Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP)

Interventions

  • ProcedureLaser 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.

    Also known as: HoLEP, ThuLEP, Holmium Laser Enucleation of the Prostate, Thulium Laser Enucleation of the Prostate, Laser Prostatectomy, ThuFLEP, Thulium Fiber Laser Enucleation of the Prostate

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What researchers measure

Primary outcomes

  1. Change in International Prostate Symptom Score (IPSS)

    Evaluation of the improvement in urinary functions after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP): The International Prostate Symptom Score (IPSS) is a validated questionnaire used to assess the severity of urinary symptoms. It consists of 7 questions, each scored from 0 to 5. Total score ranges from 0 to 35. Higher scores indicate more severe urinary symptoms (0-7: mild, 8-19: moderate, 20-35: severe).

    Time frame: Baseline and 3 months postoperatively

  2. Change in Peak Urinary Flow Rate (Qmax)

    Evaluation of the improvement in urinary functions after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP): Peak urinary flow rate is measured in milliliters per second (mL/s) using uroflowmetry to assess the improvement in urinary flow after the surgical procedure.

    Time frame: Baseline and 3 months postoperatively.

  3. Change in Post-Void Residual Volume (PVR)

    Evaluation of the improvement in urinary functions after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP): Post-void residual volume is the amount of urine remaining in the bladder after voiding, measured in milliliters (mL) via transabdominal ultrasound or catheterization.

    Time frame: Baseline and 3 months postoperatively.

Secondary outcomes

  1. Postoperative Complication Rate

    The frequency and severity of surgical complications occurring after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP). Complications will be categorized and graded using the Clavien-Dindo Classification of Surgical Complications. This scale ranges from Grade I (minor deviations from the normal postoperative course) to Grade V (death of the patient). Higher grades indicate a worse outcome (more severe complications). Grade I: Any deviation from the normal postoperative course without the need for treatment. Grade II: Complications requiring pharmacological treatment Grade III: Complications requiring surgical, endoscopic, or radiological intervention Grade IV: Life-threatening complications requiring intensive care unit (ICU) management Grade V: Death of the patient.

    Time frame: From the date of surgery up to 3 months postoperatively.

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Study locations

1 of 1 sites recruiting
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared due to privacy concerns and data protection regulations, including the Turkish Personal Data Protection Law (KVKK). Only aggregated, de-identified results will be reported in publications and presentations.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Feb 2028, 24 months after the start.

Of 17 observational studies under Urinary Retention, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 50. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2026
First posted
May 22, 2026
StartActual
Feb 4, 2026
Primary completionEst.
Feb 4, 2028
CompletionEst.
Feb 4, 2029
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07603011
Lead sponsor
Eskişehir Osmangazi University Medicine Faculty Hospital
Collaborators
Ankara University, Dokuz Eylul University, Erol Olcok Corum Training and Research Hospital, Gazi University, Marmara University, Samsun Education and Research Hospital, Ondokuz Mayıs University, Cukurova University, Izmir Metropolitan Municipality Esrefpasa Hospital, Tepecik Training and Research Hospital
Responsible party
Süleyman Öner (Assistant Professor, Eskişehir Osmangazi University Medicine Faculty Hospital) — Principal investigator
First posted
May 22, 2026
Start date
Feb 4, 2026
Primary completion
Feb 4, 2028 (estimated)
Completion
Feb 4, 2029 (estimated)
Last update
Sep 11, 2026

Study contacts

Suleyman Oner, MD
Contact
dr.suleymanoner@gmail.com
+905544064491
Cemil Aydin, Professor
Contact
cemilaydin78@yahoo.com.tr
+905326960378
Suleyman Oner, MD
study chair · Eskisehir Osmangazi University Faculty of Medicine Hospital
View the source record on ClinicalTrials.gov ↗

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