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NCT Number: NCT06116370

The Clinical Efficacy of Rezūm Therapy Versus Bipolar Trans-urethral Resection of the Prostate for Treatment Benign Prostatic Hyperplasia

We aimed to compare the efficacy and safety of Rezūm therapy and bipolar transurethral resection of prostate (B-TURP) for the management of benign prostatic hyperplasia (BPH) of 50-120gm size.

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Key information

Conditions

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

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Abbassia, 11566, 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. In contrast to monopolar TURP (M-TURP), where prolonged resection carries the risk of transurethral resection (TUR) syndrome, bipolar transurethral resection of prostate (B-TURP), especially in large prostates was a promising procedure for urologists, but unfortunately, the morbidity rate of B-TURP remains high [4]. Therefore, newer minimally invasive procedures have been introduced to provide alternative surgical options to TURP.

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 they still offer no clear recommendation to Rezūm use for those with large prostates. Early studies on this topic have found out promising results.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 50-80 years
  • prostate volumes of 50-120 ml
  • sexually active
  • severe LUTS
  • [Q max] of <10 ml/s
  • [IPSS] of >20)
  • failed medical treatment with alpha blockers

Exclusion criteria

  • prostate cancer
  • Neurogenic bladder
  • urethral stricture
  • urinary bladder stone
  • previous prostatic surgery.

Treatment and study plan

Rezum procedure

Procedure

In Rezūm procedure, the Rezūm System (NxThera Inc., Maple Grove, MN, USA) consists of a radiofrequency (RF) power supply generator and single-use transurethral delivery device. Starting 1 cm distal to the bladder neck, injection was done at 3 and 9 o'clock sites. The needle was inserted for 9 s duration, retracted, and then delivered to another treatment site in 1 cm distance distal to the previous one.

B-TURP procedure

Procedure

In B-TURP, Olympus SurgMaster™ UES-40 bipolar generator (Olympus Europe, Hamburg, Germany) was used. Current's settings used were cut/coag 200/120. Using continuous flow 26Fr resectoscope first resection of the median lobe from the level of the bladder neck to the apex of the prostate was done followed by resection of the lateral lobes. Using Ellic evacuator, Prostatic chips were extracted from the field. A 22 fr three-way silicon Foley catheter was placed with traction applied and the balloon inflated by normal saline of 30-80 cc according to the size of the prostate.

Primary outcomes

  1. Measurement of The International Prostate Symptom score (IPSS) in both groups

    Time frame: for each case in both groups the investigator assess IPSS at 6, 12, and 24 months after procedures through study completion, an average of 2 years

    After 6, 12, and 24 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

  2. Measurement of The Quality of Life (QoL) in both groups

    Time frame: for each case in both groups the investigator assess QoLat 6, 12, and 24 months after procedures through study completion, an average of 2 years

    After 6, 12, and 24 months of operation, the questioner is performed. Minimum :0 means delighted / Maximum : 5 means unhappy

  3. Measurement of The Maximum Urinary flow rate (Qmax) in both groups

    Time frame: for each case in both groups the investigator assess Qmax at 6, 12, and 24 months after procedures through study completion, an average of 2 years

    After 6, 12, and 24 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

  4. Concentration of The Prostatic specific antigen (PSA) in both groups

    Time frame: for each case in both groups the investigator measures PSA at 6, 12, and 24 months after procedures through study completion, an average of 2 years

    After 6, 12, and 24 months of operation, the procedure is performed. PSA is measured by ng/ml PSA levels of 4.0 ng/mL and lower were considered

  5. Measurement of The International Index of Erectile Function (IIEF) in both groups

    Time frame: for each case in both groups the investigator assess IIEF at 6, 12, and 24 months after procedures through study completion, an average of 2 years

    After 6, 12, and 24 months of operation, the questioner is performed. The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction

  6. Measurement of The Prostate size

    Time frame: for each case in both groups the investigator assess prostate size at 24 months after procedures through study completion, an average of 2 years

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

  7. The operative time of both groups

    Time frame: for each case in both groups the investigator assess the time of operation from induction of anaesthesiatill the end of the operation through study completion, an average of 2 years

    the operative time was measured by minutes in both groups.

  8. Post operative hospital stay time in both groups

    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 2 years

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

  9. Incidence of The catheter duration post operative in both groups

    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 2 years

    The catheter duration was measured by days in both groups.

  10. Measurement of Post operative residual urine (PVR)

    Time frame: for each case in both groups the investigator assess prostate size at 6, 12 and 24 months after procedures through study completion, an average of 2 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 two 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

Ain Shams University

Other

Registry information

Official study title

Two-Year Follow-Up Comparing Rezūm Therapy Versus Bipolar Transurethral Resection of the Prostate for Treating Benign Prostatic Hyperplasia. A Prospective Randomized Study.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 3, 2023
Registry last updated
Nov 7, 2023

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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