Benign Prostate Hypertrophy(BPH)NCT07196475
Transurethral Focal Laser Ablation Versus Transurethral Prostatectomy For Management Of Benign Prostatic Obstruction
A study testing FOCAL LASER ABLATION OF PROSTATE in people with Benign Prostate Hypertrophy(BPH), run by Ain Shams University at 1 site in Egypt.
Trial summary
Introduction and objectives: Laser prostatectomy has become an increasingly popular and effective alternative to transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH).-. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH)
- What is being tested?
- FOCAL LASER ABLATION OF PROSTATE
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with lower urinary tract symptoms (voiding ± storage) refractory to medical treatment with IPSS > 20 (International Prostate Symptom Score) and Qmax < 15 mL/sec
- Refractory acute urinary retention
- Hematuria or recurrent urinary tract infections secondary to BPH
- Renal impairment secondary to prostatic obstruction
Who cannot join
- Proven malignancy by biopsy
- Urethral strictures
- Urinary bladder stones
- Previous prostate surgery
- Urodynamically proven neurogenic bladder
- Bladder cancer
- Unfit for anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety And Efficacy Of Transurethral Focal Laser Ablation of Prostatic Adenoma In Comparison With Transurethral Prostatectomy For Management Of Benign Prostatic Adenoma Comparative Randomized Prospective Study
Introduction and objectives: Laser prostatectomy has become an increasingly popular and effective alternative to transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH).-. This study focuses on assessing the safety, efficacy, and postoperative complications of Transurethral Focal Laser Ablation of Prostatic Adenoma (TU-FLAP) versus M-TURP in managing BPH, with a 12-month monitoring.
Patients and Methods: 60 BPH cases meeting the inclusion criteria have randomly been assigned into 2 equal groups to undergo either TU-FLAP or M-TURP. Outcomes have been assessed using IPSS, QoL, Qmax, operative time, catheterization ,duration of hospital stay, PVR, PSA, and residual prostate volume. Safety was evaluated based on perioperative and postoperative complications.
Read the detailed description
INTRODUCTION Benign prostatic hyperplasia is a frequent condition between aging men, often leading to lower urinary tract symptoms (LUTS) that significantly impair quality of life. TURP was long considered the gold standard surgical intervention for prostates ranging from 30 to 80 grams [1]. Despite its efficacy, TURP is associated with notable risks, including intraoperative bleeding and the potential for fluid absorption leading to dilutional hyponatremia, commonly referred to as TUR syndrome. These risks are particularly pronounced in patients with larger prostates or those on anticoagulant therapy. Additionally, TURP requires considerable surgical expertise and is associated with a steep learning curve [2].
Transperineal focal laser ablation (TPLA) has emerged as a novel approach, targeting obstructive transitional zone tissue while sparing adjacent structures. This technique achieves debulking by inducing strategic coagulative necrosis, which is subsequently reabsorbed by the body, resulting in reduced prostate volume with minimal impact on urinary continence and sexual function [3]. Similarly, Rezūm therapy utilizes convective water vapor energy to ablate prostatic tissue. It is an office-based procedure that requires no general anesthesia and has demonstrated durable improvement in LUTS while preserving sexual function [4]. Despite these advancements, both TPLA and Rezūm are constrained by limited availability and relatively narrow indications. In this context, TU-FLAP represents a new approach. Unlike existing laser therapies, TU-FLAP is designed to ablate obstructive prostatic adenoma via a transurethral route, without disturbing the urethral mucosa or the ejaculatory ducts. This distinction provides a significant advantage in preserving antegrade ejaculation and reducing the risk of urethral trauma-outcomes often compromised in TURP, HoLEP (Holmium laser Enucleation of the prostate), and other enucleative procedures.
To the best of our knowledge, this is the 1st research to evaluate TU-FLAP using diode laser energy under local anesthesia. The technique leverages real-time endoscopic visualization to deliver precise, targeted energy into the prostatic adenoma, while avoiding direct contact with critical structures such as the urethral sphincter.
This randomized controlled trial was designed to compare TU-FLAP with monopolar TURP in terms of operative metrics, postoperative complications, and patient-reported symptom scores over a one year follow-up duration.
Preoperative workup All cases had a standardized preoperative evaluation, including the International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF), and quality of life (QoL) assessment. Physical examination included a digital rectal examination (DRE). Additional assessments included uroflowmetry, urinalysis, and urine culture when indicated, as well as measurement of serum prostate-specific antigen (PSA). Pelvic ultrasound was performed to determine post-void residual urine (PVR), and transrectal ultrasound (TRUS) was used to estimate prostate volume.
Technique:
All monopolar TURP procedures were performed under spinal anaesthesia, whereas all TU-FLAP procedures were conducted under local anaesthesia with intravenous sedation. A single experienced surgical team performed all operations, with each surgeon having completed over 100 similar procedures prior to the study's initiation. Prophylactic antibiotic coverage with a third-generation cephalosporin has been administered at the time of anaesthesia induction. Cases were placed in the lithotomy position, followed by diagnostic urethrocystoscopy. In the TU-FLAP group, a 980 nm diode laser fig(1) by applying end-firing fiber fig (2) was introduced via the side working channel of a 22 Fr cystoscope under local anesthesia. Laser energy was applied at 15 watts for two minutes at multiple sites within the right and left prostatic lobes, approximately 1.5 cm distal to the bladder neck, with 1 cm spacing between punctures. In cases with an enlarged median lobe, one or two additional laser punctures were applied. Postoperative urethral catheterization has been maintained for three to seven days, depending on the volume of treated prostatic tissue and the period of preoperative urinary retention.
Postoperative Follow-up Protocol:
Efficacy was evaluated using the following parameters: International Prostate Symptom Score (IPSS), quality of life (QoL) score, operative time, maximum urinary flow rate (Qmax), , length of hospital stay, duration of catheterization, post-void residual urine volume (PVR), serum prostate-specific antigen (PSA), and residual prostate volume measured via transrectal ultrasound. The safety profile of each procedure, which was determined by recording the incidence and nature of intraoperative and postoperative complications
Ethics statement:
The research protocol has been approved and reviewed by the Research Ethics Committee of the Faculty of Medicine, Ain Shams University. Written informed consent has been attained from all participants prior to enrolment, following a detailed explanation of the research's objectives, potential risks, procedures, and benefits. Participant confidentiality and data privacy were strictly maintained throughout all phases of the study. Participation was entirely voluntary, and individuals were informed of their right to withdraw from the study at any time without any consequences to their medical care
Statistical Analysis:
Statistical analysis was performed using IBM SPSS (Statistical Package for the social sciences) Statistics for Windows, Version 27.0 (IBM Corp., Armonk, USA). Continuous variables were expressed as mean ± standard deviation, and categorical variables as frequencies and percentages. Between-group comparisons were conducted using the Student's t-test for normally distributed continuous variables. The Chi-square (χ²) test or Fisher's exact test was applied for categorical variables, depending on expected cell counts. A two-tailed p-value < 0.05 was considered statistically significant.
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Being tested
- FOCAL LASER ABLATION OF PROSTATE
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOCAL LASER ABLATION OF PROSTATEProcedure or surgery
All monopolar TURP procedures were performed under spinal anaesthesia, whereas all TU-FLAP procedures were conducted under local anaesthesia with intravenous sedation. A single experienced surgical team performed all operations, with each surgeon having completed over 100 similar procedures prior to the study's initiation. Prophylactic antibiotic coverage with a third-generation cephalosporin has been administered at the time of anaesthesia induction. Cases were placed in the lithotomy position, followed by diagnostic urethrocystoscopy. In the TU-FLAP group, a 980 nm diode laser fig(1) by applying end-firing fiber fig(2) was introduced via the side working channel of a 22 Fr cystoscope under local anesthesia. Laser energy was applied at 15 watts for two minutes at multiple sites within the right and left prostatic lobes, approximately 1.5 cm distal to the bladder neck, with 1 cm spacing between punctures. In cases with an enlarged median lobe, one or two additional laser punctures were
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum urinary flow rate (Qmax) at 12 months
Mean change in maximum urinary flow rate (mL/sec) measured by uroflowmetry compared to baseline.
Measured: Baseline and 12 months
Secondary outcomes (8)
Change in International Prostate Symptom Score (IPSS) from baseline to 12 months
Mean change in patient-reported IPSS questionnaire score compared to baseline, reflecting severity of lower urinary tract symptoms.
Measured: 1 year
Operative time (minutes)
Duration of surgery measured in minutes from initial cystoscope insertion to removal.
Measured: 1 year
Length of hospital stay (days)
Number of days from admission to discharge following surgery.
Measured: Postoperative hospital stay
Duration of catheterization (days)
Total number of days patient remained catheterized postoperatively.
Measured: Postoperative period until catheter removal
Post-void residual urine volume (PVR) at 12 months
Mean post-void residual urine volume (mL) measured by ultrasound compared to baseline.
Measured: Baseline and 12 months
Serum prostate-specific antigen (PSA) at 12 months
Mean change in serum PSA level (ng/mL) compared to baseline.
Measured: Baseline and 12 months
Residual prostate volume by transrectal ultrasound (TRUS) at 12 months
Mean residual prostate volume (mL) measured by TRUS compared to baseline.
Measured: Baseline and 12 months
Number of participants with intraoperative and postoperative complications
Frequency and type of complications recorded up to 12 months postoperatively, classified according to Clavien-Dindo system.
Measured: ntraoperative and up to 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Jun 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196475
- Sponsor's protocol ID
- FMASU MD 19/2022
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And Efficacy Of Transurethral Focal Laser Ablation of Prostatic Adenoma In Comparison With Transurethral Prostatectomy For Management Of Benign Prostatic Adenoma Comparative Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT07196475
- Acronym / sponsor ID
- FMASU MD 19/2022
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 29 Sep 2025 (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.
Introduction and objectives: Laser prostatectomy has become an increasingly popular and effective alternative to transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH).-. This study focuses on assessing the safety, efficacy, and postoperative complications of Transurethral Focal Laser Ablation of Prostatic Adenoma (TU-FLAP) versus M-TURP in managing BPH, with a 12-month monitoring.
Patients and Methods: 60 BPH cases meeting the inclusion criteria have randomly been assigned into 2 equal groups to undergo either TU-FLAP or M-TURP. Outcomes have been assessed using IPSS, QoL, Qmax, operative time, catheterization ,duration of hospital stay, PVR, PSA, and residual prostate volume. Safety was evaluated based on perioperative and postoperative complications.
Detailed description
INTRODUCTION Benign prostatic hyperplasia is a frequent condition between aging men, often leading to lower urinary tract symptoms (LUTS) that significantly impair quality of life. TURP was long considered the gold standard surgical intervention for prostates ranging from 30 to 80 grams [1]. Despite its efficacy, TURP is associated with notable risks, including intraoperative bleeding and the potential for fluid absorption leading to dilutional hyponatremia, commonly referred to as TUR syndrome. These risks are particularly pronounced in patients with larger prostates or those on anticoagulant therapy. Additionally, TURP requires considerable surgical expertise and is associated with a steep learning curve [2].
Transperineal focal laser ablation (TPLA) has emerged as a novel approach, targeting obstructive transitional zone tissue while sparing adjacent structures. This technique achieves debulking by inducing strategic coagulative necrosis, which is subsequently reabsorbed by the body, resulting in reduced prostate volume with minimal impact on urinary continence and sexual function [3]. Similarly, Rezūm therapy utilizes convective water vapor energy to ablate prostatic tissue. It is an office-based procedure that requires no general anesthesia and has demonstrated durable improvement in LUTS while preserving sexual function [4]. Despite these advancements, both TPLA and Rezūm are constrained by limited availability and relatively narrow indications. In this context, TU-FLAP represents a new approach. Unlike existing laser therapies, TU-FLAP is designed to ablate obstructive prostatic adenoma via a transurethral route, without disturbing the urethral mucosa or the ejaculatory ducts. This distinction provides a significant advantage in preserving antegrade ejaculation and reducing the risk of urethral trauma-outcomes often compromised in TURP, HoLEP (Holmium laser Enucleation of the prostate), and other enucleative procedures.
To the best of our knowledge, this is the 1st research to evaluate TU-FLAP using diode laser energy under local anesthesia. The technique leverages real-time endoscopic visualization to deliver precise, targeted energy into the prostatic adenoma, while avoiding direct contact with critical structures such as the urethral sphincter.
This randomized controlled trial was designed to compare TU-FLAP with monopolar TURP in terms of operative metrics, postoperative complications, and patient-reported symptom scores over a one year follow-up duration.
Preoperative workup All cases had a standardized preoperative evaluation, including the International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF), and quality of life (QoL) assessment. Physical examination included a digital rectal examination (DRE). Additional assessments included uroflowmetry, urinalysis, and urine culture when indicated, as well as measurement of serum prostate-specific antigen (PSA). Pelvic ultrasound was performed to determine post-void residual urine (PVR), and transrectal ultrasound (TRUS) was used to estimate prostate volume.
Technique:
All monopolar TURP procedures were performed under spinal anaesthesia, whereas all TU-FLAP procedures were conducted under local anaesthesia with intravenous sedation. A single experienced surgical team performed all operations, with each surgeon having completed over 100 similar procedures prior to the study's initiation. Prophylactic antibiotic coverage with a third-generation cephalosporin has been administered at the time of anaesthesia induction. Cases were placed in the lithotomy position, followed by diagnostic urethrocystoscopy. In the TU-FLAP group, a 980 nm diode laser fig(1) by applying end-firing fiber fig (2) was introduced via the side working channel of a 22 Fr cystoscope under local anesthesia. Laser energy was applied at 15 watts for two minutes at multiple sites within the right and left prostatic lobes, approximately 1.5 cm distal to the bladder neck, with 1 cm spacing between punctures. In cases with an enlarged median lobe, one or two additional laser punctures were applied. Postoperative urethral catheterization has been maintained for three to seven days, depending on the volume of treated prostatic tissue and the period of preoperative urinary retention.
Postoperative Follow-up Protocol:
Efficacy was evaluated using the following parameters: International Prostate Symptom Score (IPSS), quality of life (QoL) score, operative time, maximum urinary flow rate (Qmax), , length of hospital stay, duration of catheterization, post-void residual urine volume (PVR), serum prostate-specific antigen (PSA), and residual prostate volume measured via transrectal ultrasound. The safety profile of each procedure, which was determined by recording the incidence and nature of intraoperative and postoperative complications
Ethics statement:
The research protocol has been approved and reviewed by the Research Ethics Committee of the Faculty of Medicine, Ain Shams University. Written informed consent has been attained from all participants prior to enrolment, following a detailed explanation of the research's objectives, potential risks, procedures, and benefits. Participant confidentiality and data privacy were strictly maintained throughout all phases of the study. Participation was entirely voluntary, and individuals were informed of their right to withdraw from the study at any time without any consequences to their medical care
Statistical Analysis:
Statistical analysis was performed using IBM SPSS (Statistical Package for the social sciences) Statistics for Windows, Version 27.0 (IBM Corp., Armonk, USA). Continuous variables were expressed as mean ± standard deviation, and categorical variables as frequencies and percentages. Between-group comparisons were conducted using the Student's t-test for normally distributed continuous variables. The Chi-square (χ²) test or Fisher's exact test was applied for categorical variables, depending on expected cell counts. A two-tailed p-value < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with lower urinary tract symptoms (voiding ± storage) refractory to medical treatment with IPSS > 20 (International Prostate Symptom Score) and Qmax < 15 mL/sec
- Refractory acute urinary retention
- Hematuria or recurrent urinary tract infections secondary to BPH
- Renal impairment secondary to prostatic obstruction
Key exclusion criteria (7 listed)
- Proven malignancy by biopsy
- Urethral strictures
- Urinary bladder stones
- Previous prostate surgery
- Urodynamically proven neurogenic bladder
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 |
|---|---|---|
| FOCAL LASER ABLATION OF PROSTATEAll monopolar TURP procedures were performed under spinal anaesthesia, whereas all TU-FLAP procedures were conducted under local anaesthesia with intravenous sedation. A single experienced surgical team performed all operations, with each surgeon having completed over 100 similar procedures prior to the study's initiation. Prophylactic antibiotic coverage with a third-generation cephalosporin has been administered at the time of anaesthesia induction. Cases were placed in the lithotomy position, followed by diagnostic urethrocystoscopy. In the TU-FLAP group, a 980 nm diode laser fig(1) by applying end-firing fiber fig(2) was introduced via the side working channel of a 22 Fr cystoscope under local anesthesia. Laser energy was applied at 15 watts for two minutes at multiple sites within the right and left prostatic lobes, approximately 1.5 cm distal to the bladder neck, with 1 cm spacing between punctures. In cases with an enlarged median lobe, one or two additional laser punctures were | Procedure or surgery | – |
Primary outcome
Maximum urinary flow rate (Qmax) at 12 months
Time frame: Baseline and 12 months
Mean change in maximum urinary flow rate (mL/sec) measured by uroflowmetry compared to baseline.
8 secondary outcomes
Change in International Prostate Symptom Score (IPSS) from baseline to 12 months
Time frame: 1 year
Operative time (minutes)
Time frame: 1 year
Length of hospital stay (days)
Time frame: Postoperative hospital stay
Duration of catheterization (days)
Time frame: Postoperative period until catheter removal
Post-void residual urine volume (PVR) at 12 months
Time frame: Baseline and 12 months
Serum prostate-specific antigen (PSA) at 12 months
Time frame: Baseline and 12 months
Residual prostate volume by transrectal ultrasound (TRUS) at 12 months
Time frame: Baseline and 12 months
Number of participants with intraoperative and postoperative complications
Time frame: ntraoperative and up to 12 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- https://sperlingprostatecenter.com/focal-laser-treatment-benign-prostatic-hyperplasia-bph/\>Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOCAL LASER ABLATION OF PROSTATE in people with Benign Prostate Hypertrophy(BPH), run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 29 Sep 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum urinary flow rate (Qmax) at 12 months (time frame: Baseline and 12 months). 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 29 Sep 2025.