Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
Conditions
Keywords
Prostatic Artery Embolization, Transurethral Prostate Resection, Transurethral Electroresection of Prostate, Contact Laser Ablation of Prostate, Laser Enucleation of Prostate, Open prostatectomy
Brief summary
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).
Detailed description
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.
Interventions
PROCEDUREPAE
Prostatic artery embolization
PROCEDURETURP
Transurethral resection of the prostate
PROCEDUREOther
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
Sponsors
Dominik Abt
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients treated for BPH / LUTS / prostatic obstruction at the urological department of KSSG * Patient age ≥ 18 years * Informed consent provided
Exclusion criteria
-Cognitive impairment not allowing Informed Consent or adequate data assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Lower Urinary Tract Symptoms | baseline to 1 year | Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms)) |
| Changes of free urinary flow rate | baseline to 1 year | Measurement of urinary stream (mL/s) by urinary flow rate measurement |
| Changes of post void residual urine | baseline to 1 year | Measurement of post void residual urine (mL) by transabdominal ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of local reinterventions | during 5 year study period | Assessment of number and type of reinterventions for prostate and bladder problems |
| Rate of local medical treatment for BPH-LUTS | during 5 year study period | Assessment of number and type of medical treatments for prostate and bladder problems |
| Adverse Events | 6 weeks after intervention | Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE |
| Urodynamic changes | during 5 year study period | Results of pressure flow studies if assessed for clinical reasons during the study period |
| Reduction of Lower Urinary Tract Symptoms | baseline to 6 weeks | Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms)) |
| PSA | 6 weeks after intervention | Changes of Prostate Specific Antigen (PSA, ng/mL) |
| Assessment of erectile function | 6 weeks after intervention | Assessment of IIEF-5 questionnaire |
| Reduction of Prostate symptoms | baseline to 6 weeks | Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms)) |
| Ejaculatory function | 6 weeks after intervention | Assessment of ejaculatory function according to CTCAE |
| Change of prostate size | 6 weeks after intervention | Measurement of prostate size (using MRI or ultrasound) in mL |
| Changes of free urinary flow rate | baseline to 6 weeks | Measurement of urinary stream (mL/s) by urinary flow rate measurement |
| Changes of post void residual urine | baseline to 6 weeks | Measurement of post void residual urine (mL) by transabdominal ultrasound |
Countries
Switzerland
Contacts
Primary ContactDominik Abt, MD
Backup ContactGautier Müllhaupt, MD
Outcome results
None listed