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Completed

NCT Number: NCT04580628

Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)

Thuflep TLF: initial experience and results of prostate laser enucleation with fibrous thulium laser (TLF)

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Key information

Conditions

Prostate Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Clinique Saint Hilaire

Rouen, 76000, France

About this study

While prostate laser enucleation is being confirmed as the new gold standard for surgical management of benign prostate hypertrophy, the holmium:Yag laser is currently the most widely used. A new laser technology, the fibrous thulium laser (TFL), has recently appeared with clearly superior results for lithotripsy. The question therefore arises of the surgical and functional results of the use of fibrous thulium for prostate enucleation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients superior or equal to 18 years old
  • Benign Prostate Hypertrophy ( more than 30cc.)
  • Indication to surgical treatment
  • No contraindication for surgery
  • No opposition to participating in the study

Exclusion criteria

  • Evidence of urethral stenosis
  • Evidence of a bladder tumour
  • Evidence of prostate cancer known or confirmed by prostate biopsies if suspected
  • Known neurological bladder
  • Refusal to participate

Treatment and study plan

Primary outcomes

  1. Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL

    Time frame: MONTH 12

    self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)

Secondary outcomes

  1. Rate of post-operative complications

    Time frame: MONTH 6

    post operative complications : urethral stenosis, prostate bed sclerosis, overactive bladder, urinary incontinence, erectile dysfunction

  2. duration of intervention

    Time frame: POST SURGERY HOUR 24

    in minutes

  3. bloodloss assessment

    Time frame: Day 1

    measurement of haemoglobinemia

  4. max flow assessment

    Time frame: MONTH 12

    measured with urinary flowmeter in ml/sec

  5. max flow assessment

    Time frame: MONTH 6

    measured with urinary flowmeter

  6. max flow assessment

    Time frame: MONTH 3

    measured with urinary flowmeter

  7. max flow assessment

    Time frame: MONTH 1

    measured with urinary flowmeter

  8. post-void residual (PVR) urine test

    Time frame: MONTH 12

    ml

  9. post-void residual (PVR) urine test

    Time frame: MONTH 6

    ml

  10. post-void residual (PVR) urine test

    Time frame: MONTH 3

    ml

  11. post-void residual (PVR) urine test

    Time frame: MONTH 1

    ml

  12. erectile dysfunction assessment

    Time frame: MONTH 12

    self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction

  13. erectile dysfunction assessment

    Time frame: MONTH 6

    self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction

  14. erectile dysfunction assessment

    Time frame: MONTH 3

    self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction

  15. erectile dysfunction assessment

    Time frame: MONTH 1

    self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction

  16. quality of life assessment

    Time frame: MONTH 12

    self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)

  17. quality of life assessment

    Time frame: MONTH 6

    self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)

  18. quality of life assessment

    Time frame: MONTH 3

    self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)

  19. quality of life assessment

    Time frame: MONTH 1

    self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)

  20. urinary incontinence Assessment

    Time frame: MONTH 12

    self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks

  21. urinary incontinence Assessment

    Time frame: MONTH 6

    self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks

  22. urinary incontinence Assessment

    Time frame: MONTH 3

    self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks

  23. urinary incontinence Assessment

    Time frame: MONTH 1

    self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks

  24. prostatic specific antigen in ng/mL level evolution

    Time frame: MONTH 1

    ng/ml

  25. Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL

    Time frame: MONTH 1

    self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)

  26. Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL

    Time frame: MONTH 3

    self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)

  27. Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL

    Time frame: MONTH 6

    self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)

  28. PATIENT GLOBAL IMPRESSION OF IMPROVEMENT

    Time frame: MONTH 1

    SELF REPORT SATISFACTION QUESTIONARY FROM 1 (better condition ) to 7 ( worse condition)

  29. PATIENT GLOBAL IMPRESSION OF SEVERITY

    Time frame: MONTH 1

    SELF REPORT SATISFACTION QUESTIONARY FROM 1( normal )to 4 (severe )

Sponsors and collaborators

Lead sponsor

Clinique Saint-Hilaire

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2020
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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