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NCT Number: NCT03521648

Database for the Assessment of Efficacy and Safety of BPH Treatment

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).

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Key information

Conditions

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

St. Gallen Cantonal Hospital

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location status: Recruiting

Location contact

Dominik Abt, MD

CONTACT

[email protected]

+41714941416

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

PAE

Procedure

Prostatic artery embolization

TURP

Procedure

Transurethral resection of the prostate

other

Procedure

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

Primary outcomes

  1. Reduction of Lower Urinary Tract Symptoms

    Time frame: baseline to 1 year

    Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))

  2. Changes of free urinary flow rate

    Time frame: baseline to 1 year

    Measurement of urinary stream (mL/s) by urinary flow rate measurement

  3. Changes of post void residual urine

    Time frame: baseline to 1 year

    Measurement of post void residual urine (mL) by transabdominal ultrasound

Secondary outcomes

  1. Reduction of Lower Urinary Tract Symptoms

    Time frame: baseline to 6 weeks

    Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))

  2. Reduction of Lower Urinary Tract Symptoms

    Time frame: baseline to 12 weeks

    Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))

  3. Reduction of Lower Urinary Tract Symptoms

    Time frame: baseline to 6 months

    Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))

  4. Reduction of Lower Urinary Tract Symptoms

    Time frame: baseline to 2 years

    Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))

  5. Reduction of Lower Urinary Tract Symptoms

    Time frame: baseline to 5 years

    Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))

  6. Changes of free urinary flow rate

    Time frame: baseline to 6 weeks

    Measurement of urinary stream (mL/s) by urinary flow rate measurement

  7. Changes of free urinary flow rate

    Time frame: baseline to 12 weeks

    Measurement of urinary stream (mL/s) by urinary flow rate measurement

  8. Changes of free urinary flow rate

    Time frame: baseline to 6 months

    Measurement of urinary stream (mL/s) by urinary flow rate measurement

  9. Changes of free urinary flow rate

    Time frame: baseline to 2 years

    Measurement of urinary stream (mL/s) by urinary flow rate measurement

  10. Changes of free urinary flow rate

    Time frame: baseline to 5 years

    Measurement of urinary stream (mL/s) by urinary flow rate measurement

  11. Changes of post void residual urine

    Time frame: baseline to 6 weeks

    Measurement of post void residual urine (mL) by transabdominal ultrasound

  12. Changes of post void residual urine

    Time frame: baseline to 12 weeks

    Measurement of post void residual urine (mL) by transabdominal ultrasound

  13. Changes of post void residual urine

    Time frame: baseline to 6 months

    Measurement of post void residual urine (mL) by transabdominal ultrasound

  14. Changes of post void residual urine

    Time frame: baseline to 2 years

    Measurement of post void residual urine (mL) by transabdominal ultrasound

  15. Changes of post void residual urine

    Time frame: baseline to 5 years

    Measurement of post void residual urine (mL) by transabdominal ultrasound

  16. Rate of local reinterventions

    Time frame: during 5 year study period

    Assessment of number and type of reinterventions for prostate and bladder problems

  17. Rate of local medical treatment for BPH-LUTS

    Time frame: during 5 year study period

    Assessment of number and type of medical treatments for prostate and bladder problems

  18. Adverse Events

    Time frame: 6 weeks after intervention

    Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE

  19. Adverse Events

    Time frame: 12 weeks after intervention

    Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE

  20. Adverse Events

    Time frame: 6 months after intervention

    Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE

  21. Adverse Events

    Time frame: 1 year after intervention

    Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE

  22. Adverse Events

    Time frame: 2 years after intervention

    Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE

  23. Adverse Events

    Time frame: 5 years after intervention

    Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE

  24. Urodynamic changes

    Time frame: during 5 year study period

    Results of pressure flow studies if assessed for clinical reasons during the study period

  25. Change of prostate size

    Time frame: 6 weeks after intervention

    Measurement of prostate size (using MRI or ultrasound) in mL

  26. Change of prostate size

    Time frame: 12 weeks after intervention

    Measurement of prostate size (using MRI or ultrasound) in mL

  27. Change of prostate size

    Time frame: 6 moths after intervention

    Measurement of prostate size (using MRI or ultrasound) in mL

  28. Change of prostate size

    Time frame: 1 year after intervention

    Measurement of prostate size (using MRI or ultrasound) in mL

  29. Change of prostate size

    Time frame: 2 years after intervention

    Measurement of prostate size (using MRI or ultrasound) in mL

  30. Change of prostate size

    Time frame: 5 years after intervention

    Measurement of prostate size (using MRI or ultrasound) in mL

  31. PSA

    Time frame: 6 weeks after intervention

    Changes of Prostate Specific Antigen (PSA, ng/mL)

  32. PSA

    Time frame: 12 weeks after intervention

    Changes of Prostate Specific Antigen (PSA, ng/mL)

  33. PSA

    Time frame: 6 moths after intervention

    Changes of Prostate Specific Antigen (PSA, ng/mL)

  34. PSA

    Time frame: 1 year after intervention

    Changes of Prostate Specific Antigen (PSA, ng/mL)

  35. PSA

    Time frame: 2 years after intervention

    Changes of Prostate Specific Antigen (PSA, ng/mL)

  36. PSA

    Time frame: 5 years after intervention

    Changes of Prostate Specific Antigen (PSA, ng/mL)

  37. Assessment of erectile function

    Time frame: 6 weeks after intervention

    Assessment of IIEF-5 questionnaire

  38. Assessment of erectile function

    Time frame: 12 weeks after intervention

    Assessment of IIEF-5 questionnaire

  39. Assessment of erectile function

    Time frame: 6 moths after intervention

    Assessment of IIEF-5 questionnaire

  40. Assessment of erectile function

    Time frame: 1 year after intervention

    Assessment of IIEF-5 questionnaire

  41. Assessment of erectile function

    Time frame: 2 years after intervention

    Assessment of IIEF-5 questionnaire

  42. Assessment of erectile function

    Time frame: 5 years after intervention

    Assessment of IIEF-5 questionnaire

  43. Reduction of Prostate symptoms

    Time frame: baseline to 6 weeks

    Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))

  44. Reduction of Prostate symptoms

    Time frame: baseline to 12 weeks

    Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))

  45. Reduction of Prostate symptoms

    Time frame: baseline to 6 moths

    Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))

  46. Reduction of Prostate symptoms

    Time frame: baseline to 1 year

    Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))

  47. Reduction of Prostate symptoms

    Time frame: baseline to 2 years

    Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))

  48. Reduction of Prostate symptoms

    Time frame: baseline to 5 years

    Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))

  49. Ejaculatory function

    Time frame: 6 weeks after intervention

    Assessment of ejaculatory function according to CTCAE

  50. Ejaculatory function

    Time frame: 12 weeks after intervention

    Assessment of ejaculatory function according to CTCAE

  51. Ejaculatory function

    Time frame: 6 moths after intervention

    Assessment of ejaculatory function according to CTCAE

  52. Ejaculatory function

    Time frame: 1 year after intervention

    Assessment of ejaculatory function according to CTCAE

  53. Ejaculatory function

    Time frame: 2 years after intervention

    Assessment of ejaculatory function according to CTCAE

  54. Ejaculatory function

    Time frame: 5 years after intervention

    Assessment of ejaculatory function according to CTCAE

Study contacts

Contact information is provided by the study sponsor or research team.

Dominik Abt, MD

CONTACT

[email protected]

+41 71 494 14 16

Gautier Müllhaupt, MD

CONTACT

[email protected]

+41 71 494 14 16

Sponsors and collaborators

Lead sponsor

Dominik Abt

Other

Registry information

Acronym: KSSG-BPH-REG

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
May 11, 2018
Registry last updated
Jan 26, 2021

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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