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

Sponsor
Clinique Saint-Hilaire (Other)
Overall Status
Completed
CT.gov ID
NCT04580628
Collaborator
(none)
50
Enrollment
1
Location
6
Actual Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)
    Actual Study Start Date :
    Jul 1, 2020
    Actual Primary Completion Date :
    Dec 31, 2020
    Actual Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL [MONTH 12]

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

    Secondary Outcome Measures

    1. Rate of post-operative complications [MONTH 6]

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

    2. duration of intervention [POST SURGERY HOUR 24]

      in minutes

    3. bloodloss assessment [Day 1]

      measurement of haemoglobinemia

    4. max flow assessment [MONTH 12]

      measured with urinary flowmeter in ml/sec

    5. max flow assessment [MONTH 6]

      measured with urinary flowmeter

    6. max flow assessment [MONTH 3]

      measured with urinary flowmeter

    7. max flow assessment [MONTH 1]

      measured with urinary flowmeter

    8. post-void residual (PVR) urine test [MONTH 12]

      ml

    9. post-void residual (PVR) urine test [MONTH 6]

      ml

    10. post-void residual (PVR) urine test [MONTH 3]

      ml

    11. post-void residual (PVR) urine test [MONTH 1]

      ml

    12. erectile dysfunction assessment [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 [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 [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 [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 [MONTH 12]

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

    17. quality of life assessment [MONTH 6]

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

    18. quality of life assessment [MONTH 3]

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

    19. quality of life assessment [MONTH 1]

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

    20. urinary incontinence Assessment [MONTH 12]

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

    21. urinary incontinence Assessment [MONTH 6]

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

    22. urinary incontinence Assessment [MONTH 3]

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

    23. urinary incontinence Assessment [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 [MONTH 1]

      ng/ml

    25. Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL [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 [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 [MONTH 6]

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

    28. PATIENT GLOBAL IMPRESSION OF IMPROVEMENT [MONTH 1]

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

    29. PATIENT GLOBAL IMPRESSION OF SEVERITY [MONTH 1]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinique Saint Hilaire Rouen France 76000

    Sponsors and Collaborators

    • Clinique Saint-Hilaire

    Investigators

    • Principal Investigator: BENOIT MALVAL, Clinique Saint-Hilaire

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MALVAL Benoit, Principal Investigator, Doctor in urology department, Clinique Saint-Hilaire
    ClinicalTrials.gov Identifier:
    NCT04580628
    Other Study ID Numbers:
    • 202000549
    First Posted:
    Oct 8, 2020
    Last Update Posted:
    Mar 22, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hyperplasia

    Study Results

    No Results Posted as of Mar 22, 2022