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Lower Urinary Tract SymptomsKSSG-BPH-REGNCT03521648

Database for the Assessment of Efficacy and Safety of BPH Treatment

An observational study of Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by Dominik Abt at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
PAE, TURP and Other
Type of treatment
Surgery or procedure
How many people
500 participants
Where
1 siteSwitzerland
Study dates
7 Jul 2017to 1 Dec 2027
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients treated for BPH / LUTS / prostatic obstruction at the urological department of KSSG

Who may be able to join

  • All patients treated for BPH / LUTS / prostatic obstruction at the urological department of KSSG
  • Patient age ≥ 18 years
  • Informed consent provided

Who cannot join

  • -Cognitive impairment not allowing Informed Consent or adequate data assessment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dominik Abt, MD contact

+41 71 494 14 16

dominik.abt@kssg.ch

Gautier Müllhaupt, MD contact

+41 71 494 14 16

Gautier.muellhaupt@kssg.ch

Switzerland1 site, 1 recruiting

  • St. Gallen Cantonal Hospital

    Sankt Gallen, Canton of St. Gallen, 9007

    Dominik Abt, MD, +41714941416, dominik.abt@kssg.ch

    Recruiting

Other trials in Switzerland

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).

Read the 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.

Being tested
PAE, TURP, Other
Keywords
Prostatic Artery Embolization, Transurethral Prostate Resection, Transurethral Electroresection of Prostate, Contact Laser Ablation of Prostate, Laser Enucleation of Prostate, Open prostatectomy
Medical subject headings
Lower Urinary Tract Symptoms, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PAEProcedure or surgery

    Prostatic artery embolization

  • TURPProcedure or surgery

    Transurethral resection of the prostate

  • OtherProcedure or surgery

    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

Study groups in NCT03521648
Study groupRoleWhat they receive
PAEMen with BPH - LUTS BPE who have opted for PAE and have consented to take part in the Register Study.
Receives: Procedure: PAE
TURPMen with BPH - LUTS BPE who have opted for TURP and have consented to take part in the Register Study.
Receives: Procedure: TURP
OtherMen 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.
Receives: Procedure: Other

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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))

    Measured: baseline to 1 year

  2. Changes of free urinary flow rate

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

    Measured: baseline to 1 year

  3. Changes of post void residual urine

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

    Measured: baseline to 1 year

Secondary outcomes (54)

  1. 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))

    Measured: baseline to 6 weeks

  2. 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))

    Measured: baseline to 12 weeks

  3. 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))

    Measured: baseline to 6 months

  4. 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))

    Measured: baseline to 2 years

  5. 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))

    Measured: baseline to 5 years

  6. Changes of free urinary flow rate

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

    Measured: baseline to 6 weeks

  7. Changes of free urinary flow rate

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

    Measured: baseline to 12 weeks

  8. Changes of free urinary flow rate

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

    Measured: baseline to 6 months

  9. Changes of free urinary flow rate

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

    Measured: baseline to 2 years

  10. Changes of free urinary flow rate

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

    Measured: baseline to 5 years

  11. Changes of post void residual urine

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

    Measured: baseline to 6 weeks

  12. Changes of post void residual urine

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

    Measured: baseline to 12 weeks

  13. Changes of post void residual urine

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

    Measured: baseline to 6 months

  14. Changes of post void residual urine

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

    Measured: baseline to 2 years

  15. Changes of post void residual urine

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

    Measured: baseline to 5 years

  16. Rate of local reinterventions

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

    Measured: during 5 year study period

  17. Rate of local medical treatment for BPH-LUTS

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

    Measured: during 5 year study period

  18. Adverse Events

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

    Measured: 6 weeks after intervention

  19. Adverse Events

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

    Measured: 12 weeks after intervention

  20. Adverse Events

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

    Measured: 6 months after intervention

  21. Adverse Events

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

    Measured: 1 year after intervention

  22. Adverse Events

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

    Measured: 2 years after intervention

  23. Adverse Events

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

    Measured: 5 years after intervention

  24. Urodynamic changes

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

    Measured: during 5 year study period

  25. Change of prostate size

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

    Measured: 6 weeks after intervention

  26. Change of prostate size

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

    Measured: 12 weeks after intervention

  27. Change of prostate size

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

    Measured: 6 moths after intervention

  28. Change of prostate size

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

    Measured: 1 year after intervention

  29. Change of prostate size

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

    Measured: 2 years after intervention

  30. Change of prostate size

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

    Measured: 5 years after intervention

  31. PSA

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

    Measured: 6 weeks after intervention

  32. PSA

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

    Measured: 12 weeks after intervention

  33. PSA

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

    Measured: 6 moths after intervention

  34. PSA

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

    Measured: 1 year after intervention

  35. PSA

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

    Measured: 2 years after intervention

  36. PSA

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

    Measured: 5 years after intervention

  37. Assessment of erectile function

    Assessment of IIEF-5 questionnaire

    Measured: 6 weeks after intervention

  38. Assessment of erectile function

    Assessment of IIEF-5 questionnaire

    Measured: 12 weeks after intervention

  39. Assessment of erectile function

    Assessment of IIEF-5 questionnaire

    Measured: 6 moths after intervention

  40. Assessment of erectile function

    Assessment of IIEF-5 questionnaire

    Measured: 1 year after intervention

  41. Assessment of erectile function

    Assessment of IIEF-5 questionnaire

    Measured: 2 years after intervention

  42. Assessment of erectile function

    Assessment of IIEF-5 questionnaire

    Measured: 5 years after intervention

  43. Reduction of Prostate symptoms

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

    Measured: baseline to 6 weeks

  44. Reduction of Prostate symptoms

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

    Measured: baseline to 12 weeks

  45. Reduction of Prostate symptoms

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

    Measured: baseline to 6 moths

  46. Reduction of Prostate symptoms

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

    Measured: baseline to 1 year

  47. Reduction of Prostate symptoms

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

    Measured: baseline to 2 years

  48. Reduction of Prostate symptoms

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

    Measured: baseline to 5 years

  49. Ejaculatory function

    Assessment of ejaculatory function according to CTCAE

    Measured: 6 weeks after intervention

  50. Ejaculatory function

    Assessment of ejaculatory function according to CTCAE

    Measured: 12 weeks after intervention

  51. Ejaculatory function

    Assessment of ejaculatory function according to CTCAE

    Measured: 6 moths after intervention

  52. Ejaculatory function

    Assessment of ejaculatory function according to CTCAE

    Measured: 1 year after intervention

  53. Ejaculatory function

    Assessment of ejaculatory function according to CTCAE

    Measured: 2 years after intervention

  54. Ejaculatory function

    Assessment of ejaculatory function according to CTCAE

    Measured: 5 years after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2018
  2. Study start7 Jul 2017
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03521648
Sponsor's protocol ID
CTU P-17/006
Acronym
KSSG-BPH-REG
Status last verified
Jan 2021
First submitted
29 Apr 2018
Last updated
26 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by Dominik Abt at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dominik Abt, MD (+41 71 494 14 16, dominik.abt@kssg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of Lower Urinary Tract Symptoms (time frame: baseline to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03521648.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.

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