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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Egypt1 site
  • Ain shams university _faculty of medicine

    Cairo

Other trials in Egypt

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.

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.

  1. 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)
  1. 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

  2. Operative time (minutes)

    Duration of surgery measured in minutes from initial cystoscope insertion to removal.

    Measured: 1 year

  3. Length of hospital stay (days)

    Number of days from admission to discharge following surgery.

    Measured: Postoperative hospital stay

  4. Duration of catheterization (days)

    Total number of days patient remained catheterized postoperatively.

    Measured: Postoperative period until catheter removal

  5. 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

  6. Serum prostate-specific antigen (PSA) at 12 months

    Mean change in serum PSA level (ng/mL) compared to baseline.

    Measured: Baseline and 12 months

  7. 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

  8. 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.

  1. First posted29 Sep 2025
  2. Study start1 Jun 2021
  3. Primary completion1 Jun 2023
  4. Study completion1 Jun 2023

Resources

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)
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

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.

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