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Perineal Ultrasound in Men Before and After Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT03037008
Recruitment Status : Not yet recruiting
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Winterthur KSW

Brief Summary:

Prospective study to evaluate a new technique. Comparison of perineal sonography in men before and after radical prostatectomy and in incontinent men after radical prostatectomy before and after operative treatment with male sling and comparison with pre- and postoperative functional MRI

Inclusion / Exclusion criteria: Inclusion: male, elder than 18years, planned RALP or history of RALP and PPSUI (Post Prostatectomy Stress Urinary Incontinence).

Exclusion: Patients with history of urinary incontinence before radical prostatectomy. Patients with history of radiotherapy in the pelvis. Other diseases involving pelvic floor.


Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Device: Perineal Sonography Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Perineal Ultrasound in Men Before and After Radical Prostatectomy and in Incontinent Men After Radical Prostatectomy Before and After Operative Treatment With Male Sling
Estimated Study Start Date : February 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: continent men after RALP
perineal sonography, questionnaires, 24h pad tests
Device: Perineal Sonography
In a modified lithotomy position (supine position with elevated legs), probands will get an examination of their pelvic floor by using a common ultrasound probe head on the perineum. During the examination, the bladder should be filled with around 300ml. If patient appear with empty bladder, the examination can be repeated on an other date. During the examination, the pelvic floor will be observed during rest, coughing and valsalva-maneuver. One examination takes around 30minutes. During ultrasound, we want to illustrate the urethral mobility, the bladder neck opening and the urethral angle as well as the distance from the urethra to the symphysis.
Other Name: Perineal Ultrasound

Active Comparator: incontinent men after RALP
perineal sonography, questionnaires, 24h pad tests
Device: Perineal Sonography
In a modified lithotomy position (supine position with elevated legs), probands will get an examination of their pelvic floor by using a common ultrasound probe head on the perineum. During the examination, the bladder should be filled with around 300ml. If patient appear with empty bladder, the examination can be repeated on an other date. During the examination, the pelvic floor will be observed during rest, coughing and valsalva-maneuver. One examination takes around 30minutes. During ultrasound, we want to illustrate the urethral mobility, the bladder neck opening and the urethral angle as well as the distance from the urethra to the symphysis.
Other Name: Perineal Ultrasound




Primary Outcome Measures :
  1. perineal sonography [ Time Frame: 1 - 4 weeks before RALP ]
    In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.

  2. IPSS (International Prostate Symptom Score) [ Time Frame: 1 - 4 weeks before RALP ]
    score Points (numeric)

  3. 24h pad test [ Time Frame: 1 - 4 weeks before RALP ]
    incontinence is measured by 24 pad test. pads are measured through scales.

  4. perineal sonography [ Time Frame: 6 weeks after RALP ]
    In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.

  5. IPSS (International Prostate Symptom Score) [ Time Frame: 6 weeks after RALP ]
    score Points (numeric)

  6. 24h pad test [ Time Frame: 6 weeks after RALP ]
    incontinence is measured by 24 pad test. pads are measured through scales.

  7. perineal sonography [ Time Frame: 6 months after RALP ]
    In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.

  8. IPSS (International Prostate Symptom Score) [ Time Frame: 6 months after RALP ]
    score Points (numeric)

  9. 24h pad test [ Time Frame: 6 months after RALP ]
    incontinence is measured by 24 pad test. pads are measured through scales.

  10. ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form) [ Time Frame: 1 - 4 weeks before RALP ]
    score Points (numeric)

  11. ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form) [ Time Frame: 6 weeks after RALP ]
    score Points (numeric)

  12. ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form) [ Time Frame: 6 months after RALP ]
    score Points (numeric)

  13. IIEF 5 (International Index of Erectile Function) [ Time Frame: 1 - 4 weeks before RALP ]
    score Points (numeric)

  14. IIEF 5 (International Index of Erectile Function) [ Time Frame: 6 weeks after RALP ]
    score Points (numeric)

  15. IIEF 5 (International Index of Erectile Function) [ Time Frame: 6 months after RALP ]
    score Points (numeric)

  16. VAS QoL (Visual Analogue Scale - Quality of Life) [ Time Frame: 1 - 4 weeks before RALP ]
    score Points (numeric)

  17. VAS QoL (Visual Analogue Scale - Quality of Life) [ Time Frame: 6 weeks after RALP ]
    score Points (numeric)

  18. VAS QoL (Visual Analogue Scale - Quality of Life) [ Time Frame: 6 months after RALP ]
    score Points (numeric)

  19. PGI (Patient Generated Index) [ Time Frame: 1 - 4 weeks before RALP ]
    score Points (numeric)

  20. PGI (Patient Generated Index) [ Time Frame: 6 weeks after RALP ]
    score Points (numeric)

  21. PGI (Patient Generated Index) [ Time Frame: 6 months after RALP ]
    score Points (numeric)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male,
  • Elder than 18years
  • Planned RALP or history of RALP and PPSUI

Exclusion Criteria:

  • Patients with history of urinary incontinence before radical prostatectomy.
  • Patients with history of radiotherapy in the pelvis.
  • Other diseases involving pelvic floor.

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): NCT03037008


Contacts
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Contact: Hubert John, Prof. +41522662981 hubert.john@ksw.ch

Locations
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Switzerland
Kantonsspital Winterthur Not yet recruiting
Winterthur, Switzerland, 8401
Contact: Pascal Baier, pract. med.    +41522662998    pascal.viktorin@ksw.ch   
Contact: Hubert John, Prof.    +41522662992    hubert.john@ksw.ch   
Sponsors and Collaborators
Kantonsspital Winterthur KSW
Investigators
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Study Chair: Hubert John, Prof. Head of Kantonsspital Winterthur Urology

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Responsible Party: Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT03037008     History of Changes
Other Study ID Numbers: 2016-00054
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Kantonsspital Winterthur KSW:
perineal sonography
male sling
post prostatectomy incontinence
ultrasonography

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders