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Completed

NCT Number: NCT06818383

Comparative Study Between Rezum Therapy in Small and Large Prostates

The investigators aimed to compare the efficacy and safety of Rezūm therapy for the management of benign prostatic hyperplasia (BPH) in small and large prostates.

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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

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Armed Forces College of Medicine (AFCM)

Cairo, Nozha, 4470351, Egypt

About this study

For decades, Transurethral resection of the prostate (TURP) was the gold standard surgical intervention for small and moderate prostates, however it has high morbidity and prolonged hospital stay Rezūm is a radiofrequency made water vapour thermal treatment. It has recently been added to the international guidelines as a choice for medical treatment resistant lower urinary tract symptoms (LUTS). The AUA and Canadian Urological Association (CUA) guidelines now add water vapour therapy as a treatment option for BPH patients with small prostate size <80 gm and for those wishing to maintain antegrade ejaculation. While investigators still offer no clear recommendation to Rezūm use for those with large prostates.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • prostate size 45-75 gm
  • sexually active
  • mod - sever LUTS
  • Q max < 15
  • IPSS > 15
  • failed medical treatment with alpha blockers

Exclusion criteria

  • neurogenic bladder
  • urethral stricture
  • UB stones
  • cancer prostate

Treatment and study plan

Rezum therapy

Device

minimal invasive technique for treating BPH

Primary outcomes

  1. The Maximum Urinary flow rate (Qmax)

    Time frame: for each case in both groups the investigator assess Qmax at 3, 12, 24, 36 and 48 months after procedures through study completion, an average of 4 years]

    Measurement of The Maximum Urinary flow rate (Qmax) in both groups After 3, 12, 24, 36 and 48 months of operation, the procedure is performed. Qmax is measured by (ml/sec) Normal values are described as a Qmax above 15 ml/sec and below 10 ml/sec is considered abnormal

  2. The Quality of Life (QoL)

    Time frame: for each case in both groups the investigator assess QoLat 3, 12, 24, 36 and 48 months after procedures through study completion, an average of 4 years]

    Measurement of The Quality of Life (QoL) in both groups After 3, 12, 24, 36 and 48 months of operation, the questioner is performed. Minimum :0 means delighted / Maximum : 5 means unhappy

  3. The Prostatic specific antigen (PSA)

    Time frame: for each case in both groups the investigator measures PSA at 3, 12, and 24, 36 and 48 months after procedures through study completion, an average of 4 years

    Concentration of The Prostatic specific antigen (PSA) in both groups after 3, 12, 24, 36 and 48 months of operation, the procedure is performed. PSA is measured by ng/ml PSA levels of 4.0 ng/ mL and lower were considered

  4. The International Prostate Symptom score (IPSS)

    Time frame: for each case in both groups the investigator assess IPSS at 3, 12, 24, 36 and 48 months after procedures through study completion, an average of 4 years

    Measurement of The International Prostate Symptom score (IPSS) in both groups After 3, 12, 24, 36 and 48 months of operation, the questioner is performed. Minimum :0 / Maximum : 35 Total score: 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic

  5. The International Index of Erectile Function (IIEF)

    Time frame: for each case in both groups the investigator assess IIEF at 3, 12, 24, 36 and 48 months after procedures through study completion, an average of 4 years

    Measurement of The International Index of Erectile Function (IIEF) in both groups After 3, 12, 24, 36 and 48 months of operation, the questioner is performed. The IIEF-5 score is the sum of the ordinal responses to the 5 items.

  6. The Prostate size

    Time frame: for each case in both groups the investigator assess prostate size at 12, 24, 36 and 48 months after procedures through study completion, an average of 4 years

    the prostate size was measured by grams by Trans-rectal ultra sound

  7. The operative time

    Time frame: for each case in both groups the investigator assess the time of operation from induction of anaesthesia till the end of the operation through study completion, an average of 4 years

    the operative time was measured by minutes in both groups.

  8. Incidence of The catheter duration post operative

    Time frame: for each case in both groups the investigator assess the catheter duration from the end of the operation till removal through study completion, an average of 4 years

    The catheter duration was measured by days in both groups

  9. Post operative hospital stay time

    Time frame: for each case in both groups the investigator assess the hospital time from the day of admission of the patient in hospital to do intervention till discharge from hospital through study completion, an average of 4 years

    the Post operative hospital stay time was measured by hours in both groups.

  10. Post operative residual urine (PVR)

    Time frame: for each case in both groups the investigator assess prostate size at 3, 12, 24, 36 and 48 months after procedures through study completion, an average of 4 years

    PVR was measured by ml by pelvi abdominal ultra sound in both groups. Normal ranges are below 150 ml of urine.

Secondary outcomes

  1. Incidence of complications

    Time frame: through four years

    For each case in both groups the investigator assess the safety using incidence of complications by The Clavien-Dindo system

Sponsors and collaborators

Lead sponsor

khaled Abdelsattar Gad Ibrahim

Other

Registry information

Official study title

Four-year Follow-up in Rezum Therapy of Small Prostates in Comparison with Large Prostates. a Prospective Trial

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Feb 12, 2025

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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