An observational study in Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, sponsored by Dominik Abt. Recruiting at 1 site in Switzerland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-26.
Sponsored by Dominik Abt · Observational
This registry study aims to collect data on efficacy and safety of different treatments of benign prostatic enlargement (BPE) and lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH-LUTS).
This registry study aims to collect data on efficacy and safety of different treatments of benign prostatic enlargement (BPE) and lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH-LUTS).
Clinical, patient reported and imaging data that are assessed in clinical routine will be prospectively collected. All patients that are treated for BPE / BPH-LUTS at our institution will be included if they provide written informed consent.
This registry enables us to compare novel treatment option (e.g. prostatic artery embolization; PAE) to established interventions (e.g., TURP, HoLEP, open prostatectomy, ThuLEP, Thulium laser vaporization, TUIP) regarding safety and efficacy.
416 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's planned enrollment of 500 is above the median of 153 across 131 observational studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →Dominik Abt is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients treated for BPH / LUTS / prostatic obstruction at the urological department of KSSG
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-Cognitive impairment not allowing or adequate data assessment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Men with BPH - LUTS BPE who have opted for PAE and have consented to take part in the Register Study.
Procedure: PAE
Men with BPH - LUTS BPE who have opted for TURP and have consented to take part in the Register Study.
Procedure: TURP
Men with BPH - LUTS BPE who have opted for other treatment options (e.g., holmium laser enucleation of the prostate, open prostatectomy, thulium laser vaporization, resection or enucleation, transurethral incision of the prostate) and have consented to take part in the Register Study.
Procedure: Other
Prostatic artery embolization
Transurethral resection of the prostate
Other surgical procedures for BPH treatment including holmium laser enucleation of the prostate, open prostatectomy, thulium laser vaporization, resection or enucleation, transurethral incision of the prostate
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: baseline to 1 year
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: baseline to 1 year
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: baseline to 1 year
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: baseline to 6 weeks
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: baseline to 12 weeks
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: baseline to 6 months
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: baseline to 2 years
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: baseline to 5 years
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: baseline to 6 weeks
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: baseline to 12 weeks
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: baseline to 6 months
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: baseline to 2 years
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: baseline to 5 years
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: baseline to 6 weeks
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: baseline to 12 weeks
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: baseline to 6 months
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: baseline to 2 years
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: baseline to 5 years
Rate of local reinterventions
Assessment of number and type of reinterventions for prostate and bladder problems
Time frame: during 5 year study period
Rate of local medical treatment for BPH-LUTS
Assessment of number and type of medical treatments for prostate and bladder problems
Time frame: during 5 year study period
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 6 weeks after intervention
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 12 weeks after intervention
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 6 months after intervention
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 1 year after intervention
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 2 years after intervention
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 5 years after intervention
Urodynamic changes
Results of pressure flow studies if assessed for clinical reasons during the study period
Time frame: during 5 year study period
Change of prostate size
Measurement of prostate size (using MRI or ultrasound) in mL
Time frame: 6 weeks after intervention
Change of prostate size
Measurement of prostate size (using MRI or ultrasound) in mL
Time frame: 12 weeks after intervention
Change of prostate size
Measurement of prostate size (using MRI or ultrasound) in mL
Time frame: 6 moths after intervention
Change of prostate size
Measurement of prostate size (using MRI or ultrasound) in mL
Time frame: 1 year after intervention
Change of prostate size
Measurement of prostate size (using MRI or ultrasound) in mL
Time frame: 2 years after intervention
Change of prostate size
Measurement of prostate size (using MRI or ultrasound) in mL
Time frame: 5 years after intervention
PSA
Changes of Prostate Specific Antigen (PSA, ng/mL)
Time frame: 6 weeks after intervention
PSA
Changes of Prostate Specific Antigen (PSA, ng/mL)
Time frame: 12 weeks after intervention
PSA
Changes of Prostate Specific Antigen (PSA, ng/mL)
Time frame: 6 moths after intervention
PSA
Changes of Prostate Specific Antigen (PSA, ng/mL)
Time frame: 1 year after intervention
PSA
Changes of Prostate Specific Antigen (PSA, ng/mL)
Time frame: 2 years after intervention
PSA
Changes of Prostate Specific Antigen (PSA, ng/mL)
Time frame: 5 years after intervention
Assessment of erectile function
Assessment of IIEF-5 questionnaire
Time frame: 6 weeks after intervention
Assessment of erectile function
Assessment of IIEF-5 questionnaire
Time frame: 12 weeks after intervention
Assessment of erectile function
Assessment of IIEF-5 questionnaire
Time frame: 6 moths after intervention
Assessment of erectile function
Assessment of IIEF-5 questionnaire
Time frame: 1 year after intervention
Assessment of erectile function
Assessment of IIEF-5 questionnaire
Time frame: 2 years after intervention
Assessment of erectile function
Assessment of IIEF-5 questionnaire
Time frame: 5 years after intervention
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline to 6 weeks
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline to 12 weeks
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline to 6 moths
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline to 1 year
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline to 2 years
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline to 5 years
Ejaculatory function
Assessment of ejaculatory function according to CTCAE
Time frame: 6 weeks after intervention
Ejaculatory function
Assessment of ejaculatory function according to CTCAE
Time frame: 12 weeks after intervention
Ejaculatory function
Assessment of ejaculatory function according to CTCAE
Time frame: 6 moths after intervention
Ejaculatory function
Assessment of ejaculatory function according to CTCAE
Time frame: 1 year after intervention
Ejaculatory function
Assessment of ejaculatory function according to CTCAE
Time frame: 2 years after intervention
Ejaculatory function
Assessment of ejaculatory function according to CTCAE
Time frame: 5 years after intervention
Plan to share: Undecided — Requests for an anonymized, full data set of physician-level data and statistical code will be considered if the proposed use aligns with public good purposes, does not conflict with other requests, or planned use by the trial steering committee and is contingent on approval from the local ethics committee (EKOS). Requests can be addressed to the corresponding author.
No publications or documents are linked to this record.
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Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Lower Urinary Tract Symptoms →
Dominik Abt