Urinary RetentionNCT07603011
Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Urinary Retention
An observational study of Urinary Retention and Benign Prostate Obstruction (BPO), run by Eskişehir Osmangazi University Medicine Faculty Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Retention, Benign Prostate Obstruction (BPO)
- What is being tested?
- Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Feb 2026to 4 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Patients with a diagnosis of neurogenic bladder or prostate cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Eskisehir Osmangazi University, Faculty of Medicine, Department of Urology
Eskişehir, Eskişehir, 26040
Suleyman Oner, MD, +905544064491, dr.suleymanoner@gmail.com
About this study
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
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.
- Being tested
- Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP)
- 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
- Medical subject headings
- Urinary Retention, Prostatic Hyperplasia, Urinary Bladder Neck Obstruction, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP)Procedure or surgery
Also called HoLEP, ThuLEP, Holmium Laser Enucleation of the Prostate, Thulium Laser Enucleation of the Prostate
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 3 months postoperatively
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.
Measured: Baseline and 3 months postoperatively.
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.
Measured: 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.
Measured: From the date of surgery up to 3 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start4 Feb 2026
- Primary completion4 Feb 2028 (estimated)
- Study completion4 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskişehir Osmangazi University Medicine Faculty Hospital
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Süleyman Öner, Eskişehir Osmangazi University Medicine Faculty Hospital
- Investigators
- Suleyman Oner, MD, Study chair, Eskisehir Osmangazi University Faculty of Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603011
- Sponsor's protocol ID
- E-25403353-050.04-260029122
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07603011
- Acronym / sponsor ID
- E-25403353-050.04-260029122
- Keywords
- Benign Prostatic Obstruction, BPO, BPH, Benign Prostatic Hyperplasia, Bladder Outlet Obstruction, Lower Urinary Tract Symptoms, Acute Urinary Retention, Urinary Catheterization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Eskişehir Osmangazi University Medicine Faculty HospitalUniversity, hospital or other
- 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
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 4 Feb 2028 (estimated)
- Study completion
- 4 Feb 2029 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-term Catheterization Group | – | Procedure: Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP)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) |
| Long-term Catheterization Group | – | Procedure: Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with a diagnosis of neurogenic bladder or prostate cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP)Also: HoLEP, ThuLEP, Holmium Laser Enucleation of the Prostate, Thulium Laser Enucleation of the ProstatePatients 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. | Procedure or surgery | Long-term Catheterization Group, Short-term Catheterization Group |
Primary outcome
Change in International Prostate Symptom Score (IPSS)
Time frame: Baseline and 3 months postoperatively
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).
Change in Peak Urinary Flow Rate (Qmax)
Time frame: Baseline and 3 months postoperatively.
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.
Change in Post-Void Residual Volume (PVR)
Time frame: Baseline and 3 months postoperatively.
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.
1 secondary outcome
Postoperative Complication Rate
Time frame: From the date of surgery up to 3 months postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suleyman Oner, MD study chair
Eskisehir Osmangazi University Faculty of Medicine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Retention and Benign Prostate Obstruction (BPO), run by Eskişehir Osmangazi University Medicine Faculty Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suleyman Oner, MD (+905544064491, dr.suleymanoner@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (IPSS) (time frame: Baseline and 3 months postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.