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Database for the Assessment of Efficacy and Safety of BPH Treatment (KSSG-BPH-REG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03521648
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Dominik Abt, Cantonal Hospital of St. Gallen

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment
Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Procedure: PAE Procedure: TURP Procedure: Other

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Database for the Assessment of Efficacy and Safety of BPH Treatment
Actual Study Start Date : July 7, 2017
Estimated Primary Completion Date : December 1, 2027
Estimated Study Completion Date : December 1, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
PAE
Men with BPH - LUTS BPE who have opted for PAE and have consented to take part in the Register Study.
 Procedure: PAE
Prostatic artery embolization
TURP
Men with BPH - LUTS BPE who have opted for TURP and have consented to take part in the Register Study.
 Procedure: TURP
Transurethral resection of the prostate
Other
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
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients treated for BPH / LUTS / prostatic obstruction at the urological department of KSSG
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521648


Contacts
Layout table for location contacts
Contact: Dominik Abt, MD +41 71 494 14 16 dominik.abt@kssg.ch
Contact: Gautier Müllhaupt, MD +41 71 494 14 16 Gautier.muellhaupt@kssg.ch

Locations
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Switzerland
St. Gallen Cantonal Hospital Recruiting
St. Gallen, Saint Gallen, Switzerland, 9007
Contact: Dominik Abt, MD    +41714941416    dominik.abt@kssg.ch   
Sponsors and Collaborators
Dominik Abt
More Information
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Additional Information:

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Responsible Party: Dominik Abt, Dr. med. Dominik Abt, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT03521648    
Other Study ID Numbers: CTU P-17/006
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dominik Abt, Cantonal Hospital of St. Gallen:
Prostatic Artery Embolization
Transurethral Prostate Resection
Transurethral Electroresection of Prostate
 Contact Laser Ablation of Prostate
Laser Enucleation of Prostate
Open prostatectomy
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Lower Urinary Tract Symptoms
 Pathologic Processes
Prostatic Diseases
Urological Manifestations