- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05495633
SteamOne - Prospective Registry Database for Rezum Water Vapor Therapy of the Prostate (SteamOne)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Michel Schrutt, study nurse
- Phone Number: +41 61 328 56 59
- Email: SteamOne.urologie@usb.ch
Study Contact Backup
- Name: Heike Püschel, study nurse
- Phone Number: +41 61 556 54 77
- Email: SteamOne.urologie@usb.ch
Study Locations
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-
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Aarau, Switzerland, 5001
- Not yet recruiting
- Kantonsspital Aarau
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Contact:
- Lukas Prause, Dr.med.univ.
- Phone Number: +41 62 838 47 59
- Email: lukas.prause@ksa.ch
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Principal Investigator:
- Lukas Prause, Dr.med.univ.
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Basel, Switzerland, 4031
- Recruiting
- University Hospital Basel, Department of Urology
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Principal Investigator:
- Jan Ebbing, PD Dr. med.
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Contact:
- Jan Ebbing, PD Dr. med.
- Phone Number: +41 61 328 56 59
- Email: SteamOne.urologie@usb.ch
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Luzern, Switzerland, 6006
- Not yet recruiting
- Hirslanden Klinik St. Anna
-
Contact:
- Felix Moltzahn, Dr. med.
- Phone Number: +41 41 410 4170
- Email: felix.moltzahn@hin.ch
-
Principal Investigator:
- Felix Moltzahn, Dr. med.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All male patients who are treated with Rezum due to prostate obstruction and LUTS in the participating study centers can be included if certain inclusion criteria are met and some exclusion criteria are not present.
- The indication to perform Rezum needs to be made independently from the study. The decision for Rezum treatment is the responsibility of each individual practitioner and patient.
- Age ≥ 18 years
- Operated or supervision of surgery by a certified urologist
- Subgroups of special interest are e.g. catheter-dependent patients, patients with oral anticoagulation, patients with preoperative urodynamic pressure-flow investigation (not older than 6 months) or patients with prostates bigger than 80 ml
Exclusion Criteria:
- Missing informed consent
- Lack of ability to answer questionnaires in German language or mentally by oneself (e.g. in dementia, mental disability).
- Patient does not have a personal email address available and the survey cannot be completed via a relative's email address and the patient is not willing to complete the survey on the tablet at the clinic
- Known or suspected neurogenic bladder dysfunction in e.g. Parkinson's disease, multiple sclerosis or other neurological diseases with possible effects on bladder function
- History of malignant bladder tumor in the last two years (including CIS) or currently present malignant bladder tumor at time of Rezum treatment (including CIS)
- Previous operation(s) on the prostate, except prostate biopsy, if this was performed more than 4 weeks ago at time of Rezum treatment
- Previous operation(s) on the bladder neck
- Presence of bladder neck stenosis requiring treatment at time of Rezum treatment
- Planned combination of Rezum treatment concurrently with another urologic (*) or non-urologic procedure
(*) also the combination with a planned transurethral procedure is not allowed except for bladder stone removal
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in International Prostate Symptom Score/ Quality of Life (IPSS/ QoL)
Time Frame: At baseline, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum
|
The IPSS is an eight-item validated questionnaire, consisting of seven symptom questions and one QoL question.
The IPSS score is categorised as 'asymptomatic' (0 points), 'mildly symptomatic' (1-7 points), 'moderately symptomatic' (8-19 points), and 'severely symptomatic' (20-35 points).
|
At baseline, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of maximum urinary flow rate (Qmax) measured by uroflowmetry
Time Frame: At baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum
|
Self-measured by patients at home using the iUFlow device (Kesem Health).
|
At baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum
|
Change of International Consultation on Incontinence Questionnaire for male lower urinary tract symptoms (ICIQ-MLUTS)
Time Frame: At baseline, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum
|
The ICIQ-MLUTS is a widely used and validated patient-completed questionnaire including incontinence questions and bother for each symptom.
It contains thirteen items (including incontinence questions and bother for each symptom), with subscales for nocturia and overactive bladder (OAB).
|
At baseline, 6 weeks, 3 months, 6 months, 12 months and annually until the 5th follow-up year after treatment with Rezum
|
Change of Male Sexual Health Questionnaire (MSHQ)
Time Frame: At baseline, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
|
The MSHQ long form includes 3 domains: Erection scale (3 items), Ejaculation scale (7 items), Sexual satisfaction scale (6 items) (additional 2 items measuring bothersome linked to erection and ejaculation).
Additional Items (Sexual Activity and Desire) are not to be collected.
|
At baseline, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
|
Change of International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ-MLUTSsex)
Time Frame: At baseline, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
|
The ICIQ-MLUTSsex is a patient-completed questionnaire for detailed evaluation of male sexual matters associated with their lower urinary tract symptoms and impact on quality of life (QoL).
It is composed of 4 sections (erection, ejaculation, pain/discomfort during ejaculation, impact of urinary symptoms).
|
At baseline, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
|
Patient's postoperative recovery by QoR-15
Time Frame: At baseline, at the first postoperative day and 2 weeks after treatment with Rezum
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Investigation of type of anesthesia (general anesthesia, spinal anesthesia, local anesthesia, analgosedation) incl.
reason for type of anesthesia and postoperative recovery using the validated German version of the Quality-of-Recovery-Score (QoR-15GE).
|
At baseline, at the first postoperative day and 2 weeks after treatment with Rezum
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Change in PROMIS Global Health 10 questionnaire
Time Frame: At baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
|
Changes in Quality of Life associated with Rezum treatment using the PROMIS Global Health 10 questionnaire.
It is a measure of overall health-related quality of life.
The questionnaire consists of a combination of 10 questions that assess both the physical and mental health status of adult patients independent of their individual medical situation.
The items are measured using a five-point response matrix that includes physical function, fatigue, pain, emotional distress and social health.
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At baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
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Change in ICIQ-S (International Consultation on Incontinence - Satisfaction)
Time Frame: At 2 weeks, 6 weeks, 3 months, 6 months, 12 months and annually after treatment with Rezum
|
The ICIQ-S (International Consultation on Incontinence - Satisfaction) will be used to evaluate patient satisfaction after urological surgery.
Question items consist of: outcome success, comparison of symptoms, return to "normal life", same situation, same choice, recommend, current symptoms, preparation for surgery, satisfaction of explanation, pain after surgery, satisfaction of pain relief, current pain, complications/side effects, result of surgery and satisfaction with surgery.
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At 2 weeks, 6 weeks, 3 months, 6 months, 12 months and annually after treatment with Rezum
|
Numeric pain Rating Scale (NRS)
Time Frame: At the first postoperative day
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Investigation of patients' perception of pain during Rezum procedure in case of local anesthesia and/or analgosedation and after Rezum treatment using NRS.
The NRS has the following scale: from 0 - 10 (no pain - worst pain imaginable).
|
At the first postoperative day
|
Rezum side effects and Pain medication
Time Frame: At baseline, 2 weeks, 6 weeks and 3 months
|
This questionnaire is self-designed.
Typical side effects must be seen and investigated independently of treatment complications in order to provide patients with the best possible advice and information.
The need for pain medication will be evaluated in a time context as well.
|
At baseline, 2 weeks, 6 weeks and 3 months
|
Patients' preferences and expectations of Rezum Treatment
Time Frame: At baseline, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
|
This self-designed questionnaire considers measurement tools related to BPO/male LUTS treatment and aims to investigate patients' motivations, expectations and preferences for surgical desobstruction of the prostate due to BPO in general but also in particular concerning the Rezum treatment.
This will attempt to better understand patient attitudes in order to improve future counseling of patients regarding minimally invasive procedures for the treatment of BPO-related male LUTS.
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At baseline, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
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Questionnaire: BPO (BPH)/LUTS medication
Time Frame: At 2 weeks, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
|
This self-designed questionnaire aims to evaluate the need for BPO (BPH)/LUTS medication.
|
At 2 weeks, 6 weeks, 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
|
Questionnaire: Reoperation
Time Frame: At 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
|
This self-designed questionnaire aims to evaluate the need for urological reoperation.
|
At 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
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Questionnaire: Bladder catheter
Time Frame: At 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
|
This self-designed questionnaire aims to evaluate the need for bladder catheterization.
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At 3 months, 6 months, 12 months and then annually until the 5th follow-up year after treatment with Rezum
|
Number of steam injections and injection points during Rezum treatment
Time Frame: At Baseline (on day of treatment with Rezum)
|
Investigation of the influence of the number of steam injections and Injection points on outcome parameters, micturition parameters, sexual function, prostate size, side effects and complications.
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At Baseline (on day of treatment with Rezum)
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Retreatment rate
Time Frame: Up to 5 years after treatment with Rezum
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Number of retreatments (medical (drugs), bladder catheter and surgical) after Rezum treatment.
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Up to 5 years after treatment with Rezum
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Surgical safety by classification of intraoperative adverse events (ClassIntra®)
Time Frame: On day of treatment with Rezum
|
The classification defines intraoperative adverse events as any surgery or anesthesia-related deviation from the ideal intraoperative course occurring between begin of anesthesia and end of anesthesia. Surgical safety is investigated by analyzing intraoperative complications classified by ClassIntra (from Grade 0: No deviation from the ideal intraoperative course to Grade 5: Any deviation from the ideal intraoperative course with intraoperative death of the patient). |
On day of treatment with Rezum
|
30-days postoperative complications by the Clavien-Dindo classification
Time Frame: Within 30-days after treatment with Rezum
|
The classification defines postoperative adverse events occurring after the patient has left the recovery room until 30 days after surgery (from Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological intervention to Grade V: Death of a patient).
|
Within 30-days after treatment with Rezum
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Antimicrobial prophylaxis
Time Frame: Within the first 30 days after treatment with Rezum
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Investigation of the effectiveness of the chosen antimicrobial prophylaxis by analyzing the rate of postoperative symptomatic urinary tract infections (UTI) within the first 30 days after surgery as part of the Clavien-Dindo classification.
Definition of symptomatic UTI is based on clinical diagnosis supported by measured bacteriuria of ≥105 cfu/ml treated with antimicrobial agents.
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Within the first 30 days after treatment with Rezum
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Post voiding residual volume (PVR) measured by ultrasound
Time Frame: Baseline and up to 5 years after treatment with Rezum
|
Change of post voiding residual volume (PVR) measured by ultrasound is a simple test that can raise or lower the suspicion of bladder outlet obstruction (BOO).
|
Baseline and up to 5 years after treatment with Rezum
|
Change of prostate size
Time Frame: Baseline and up to 5 years after treatment with Rezum
|
Measured by ultrasound or magnetic resonance imaging (MRI).
|
Baseline and up to 5 years after treatment with Rezum
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Change in bladder outlet obstruction index (BOOI)
Time Frame: Max. 6 months before Rezum and/or 3-6 months after Rezum treatment
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BOOI is represented by the equation: BOOI = Pdet @ Qmax - 2 x Qmax (Pdet = detrusor pressure; Qmax = maximum flow rate).
BOOI > 40 = obstructed; BOOI 20-40 = equivocal; and BOOI < 20 = unobstructed.
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Max. 6 months before Rezum and/or 3-6 months after Rezum treatment
|
Change in bladder contractility index (BCI)
Time Frame: Max. 6 months before Rezum and/or 3-6 months after Rezum treatment
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The BCI is represented by the following formula: BCI = Pdet @ Qmax + 5 x Qmax.
Using this formula, contractility can be divided into strong > 150, normal 100-150, and weak < 100.
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Max. 6 months before Rezum and/or 3-6 months after Rezum treatment
|
Change in International Prostate Symptom Score (IPSS) for detrusor (bladder muscle) overactivity (DO)
Time Frame: Max. 6 months before Rezum and/or 3-6 months after Rezum treatment
|
Urodynamic analysis of detrusor overactivity (DO) during storage phase and correlation of pre- and postoperative DO with PROMs (IPSS).
The IPSS is made up of 7 questions related to voiding symptoms.
A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
|
Max. 6 months before Rezum and/or 3-6 months after Rezum treatment
|
MRI (magnetic resonance imaging) data
Time Frame: Max. 12 months before Rezum and up to 5 years after treatment with Rezum
|
MRI data not older than 12 months at time of Rezum treatment and MRI data in the follow-up period of 5 years are investigated in terms of prostate size, ablative lesions (lesions caused by Rezum) and PI-RADS (prostate imaging-reporting and data system) lesions.
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Max. 12 months before Rezum and up to 5 years after treatment with Rezum
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Prostate cancer (PCa) detected by positive prostate biopsy
Time Frame: Max 12 months and up to 5 years after treatment with Rezum
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The proportion of patients who receive Rezum treatment with a history of prostate cancer or who develop histologically confirmed prostate cancer during the post-treatment course.
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Max 12 months and up to 5 years after treatment with Rezum
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Doctors' preferences, motivations and reasons to use Rezum
Time Frame: Before treatment with Rezum
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Investigation of doctors' reasons for preference/choice of using Rezum in a patient using a self-designed questionnaire.
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Before treatment with Rezum
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Change in ICIQ-Lower Urinary Tract Symptoms Quality of Life (ICIQ-MLUTS) score for detrusor (bladder muscle) overactivity (DO)
Time Frame: Max. 6 months before Rezum and/or 3-6 months after Rezum treatment
|
Urodynamic analysis of detrusor overactivity (DO) during storage phase and correlation of pre- and postoperative DO with PROMs (ICIQ-MLUTS).
The ICIQ-MLUTS is a questionnaire for evaluating male lower urinary tract symptoms and impact on quality of life (QoL).
1-84 overall score with greater values indicating increased symptom severity.
|
Max. 6 months before Rezum and/or 3-6 months after Rezum treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jan Ebbing, PD Dr. med., University Hospital Basel, Department of Urology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022-00544; bb21Ebbing
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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