SteamOne

Benign prostate enlargement is one of the most common diseases in ageing men. However, the glandular tissue of the prostate in the transition zone can begin to grow from the age of 30. Statistically speaking, half of all men between the ages of 50 and 60 already have benign prostatic hyperplasia (BPH) (1). The excess tissue can lead to a narrowing of the prostatic urethra, which is referred to as benign prostatic obstruction (BPO), which can lead to an increase in bladder outlet resistance. BPO can lead to stressful symptoms of the lower urinary tract, so-called "lower urinary tract symptoms" (LUTS).

The incidence of LUTS due to BPO is 3/100,000 men per year in the 45-49 age group and rises to a maximum of 38/100,000 men per year in the 75-79 age group. For a symptom-free man aged 46, the risk of developing BPO-related LUTS in the next 30 years is therefore 45% (2).

There is a demonstrable need for patient-centered treatment decisions that focus on the patient's needs. Accordingly, a large number of minimally invasive treatment techniques have been developed in recent years (3).

Rezum water vapor therapy of the prostate is understandably arousing the interest of treating physicians and men suffering from BPO-induced LUTS, as Rezum has been shown to be able to significantly improve urination (4,5) as well as protect sexual function (6,7). In addition, Rezum can be performed under local anesthesia and without general or spinal anesthesia, which means that older or multimorbid patients can also be treated with Rezum. However, further studies, such as SteamOne, are needed to validate the promising data from the aforementioned pivotal studies, which will hopefully lead to evidence- and guideline-based recommendations for Rezum in the future in order to better advise and treat patients.

The aim of the SteamOne study is to further improve the data available on Rezum treatment. Around 1000 patients will be observed and data collected over a period of 5 years as part of routine treatment with Rezum.

Inclusion criteria:

• Basically all patients who are treated for BPO/LUTS in the participating study centers
• Age ≥ 18
• The indication for Rezum must be made independently of the study
• The decision to perform Rezum is the responsibility of the patient and the treating medical staff
• Operated or supervised by a certified urologist/urologist
• Subgroups of particular interest are e.g. catheter-dependent patients, patients on oral anticoagulation, patients with preoperative urodynamic pressure-flow examination (not older than 6 months) or patients with a prostate of more than 80 ml

Exclusion criteria:

• Lack of informed consent
• Inability to answer questionnaires independently in German (e.g. dementia, mental disability)
• The patient does not have a personal e-mail address and cannot complete the survey using a relative's e-mail address and is not willing to complete the survey on the tablet in the clinic
• Known or suspected neurogenic bladder dysfunction (e.g. Parkinson's disease, multiple sclerosis or other neurogenic diseases with possible bladder dysfunction)
• History of bladder tumor in the last two years (incl. CIS) or bladder tumor at the time of recurrence treatment (incl. CIS)
• Previous prostate procedures, except prostate biopsies, if these were performed more than 4 weeks prior to the recurrence procedure
• Previous bladder neck surgery
• Bladder neck stenosis requiring treatment at the time of recum treatment
• Planned combination of a simultaneous Rezum treatment with another urological* or medical procedure

* Combination with a planned transurethral procedure is also an exclusion criterion, except in the case of bladder stone removal

As a study patient, you will be asked to answer various questionnaires at certain survey times. These will be sent to you by email link via the study database and can be completed conveniently at home. Study patients will also receive a urine flow meter for use at home free of charge. The data collected in this way is automatically transferred to the study database of the University Hospital Basel via app and smartphone. The time required and the survey and measurement times can be found in the table below.

No health risks are to be expected.

• All data will be treated confidentially.
• Participation in the study is free of charge for patients.
• Study patients receive their own urine flow meter to use at home.
• Some of the questionnaires will also be used for follow-up visits. These can be completed easily and efficiently at home, which means less time in the clinic for study patients.
• Urinary stream measurements do not have to be carried out "on command" in the clinic, but at home at the appropriate time, which should increase the measurement quality.
• The data is automatically and easily transmitted to the study database via an app or email link.
• Last but not least, your own state of health is documented, which is valuable both for you and for the clinic treating you.

The Rezum procedure is attracting increasing attention from both patients and specialists. Unfortunately, the current data situation is limited. So far, mainly cohort studies with relatively small numbers of cases have been conducted. These studies are often retrospective, and subgroup analyses are lacking. These study limitations mean that there are currently still no recommendations on the Rezum procedure in urological guidelines (for example, the guideline of the European Association of Urology (EAU): Management of Non-neurogenic Male LUTS).

SteamOne is intended to help remedy this deficit.

Study centers

Clinics qualify as study centers if they have already performed more than 50 Rezum treatments and see potential to recruit 50 patients within 12-18 months.

The Rezum procedure must be performed by a certified urologist who has successfully completed a Rezum training course.

Inclusion criteria:

• Basically all patients who are treated for BPO/LUTS in the participating study centers
• Age ≥ 18
• The indication for Rezum must be made independently of the study
• The decision to perform Rezum is the responsibility of the patient and the treating medical staff
• Operated or supervised by a certified urologist/urologist
• Subgroups of particular interest are e.g. catheter-dependent patients, patients on oral anticoagulation, patients with preoperative urodynamic pressure-flow examination (not older than 6 months) or patients with a prostate of more than 80

Exclusion criteria:

• Lack of informed consent
• Inability to independently answer questionnaires in German (e.g. dementia, mental disability)
• The patient does not have a personal e-mail address and cannot complete the survey using a relative's e-mail address and is not willing to complete the survey on the tablet in the clinic
• Known or suspected neurogenic bladder dysfunction (e.g. Parkinson's disease, multiple sclerosis or other neurogenic diseases with possible bladder dysfunction)
• History of bladder tumor in the last two years (incl. CIS) or bladder tumor at the time of recurrence treatment (incl. CIS)
• Previous prostate procedures, except prostate biopsies, if these were performed more than 4 weeks prior to the recurrence procedure
• Previous bladder neck surgery
• Bladder neck stenosis requiring treatment at the time of recum treatment
• Planned combination of a simultaneous Rezum treatment with another urological* or medical procedure

* Combination with a planned transurethral procedure is also an exclusion criterion, except in the case of bladder stone removal

SteamOne is designed as a prospective, multicenter observational study. The aim is to recruit 1000 patients in Switzerland, Germany and Austria at a maximum of 20 study centers over a period of 18-24 months as part of routine treatment with Rezum. PROMs (Patient Reported Outcome Measures) and CROMs (Clincal Reported Outcome Measures) will be collected over a follow-up period of 5 years. The web-based platform "Heartbeat ONE" serves as the survey portal and study database. Patients receive questionnaires on the various focal points via an uncomplicated email link and complete them electronically themselves. As part of the study, each participating center receives its own licensed version of the Heartbeat ONE software with an associated local database for entering clinical parameters. The data is automatically transmitted electronically via a secure connection to the main study center at the University Hospital Basel. In addition, each participating patient receives an approved and certified home uroflowmetry device (Kesem Health iUFlow). This enables patients to take uroflowmetry measurements from home. Here too, data transmission is electronically encrypted and automated via a smartphone app.

Participating study centers receive an expense allowance of 500 euros per patient.