NCT03037008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
Last Updated

April 27, 2020

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

August 2, 2016

Last Update Submit

April 23, 2020

Conditions

Urinary Incontinence, Stress

Keywords

perineal sonographymale slingpost prostatectomy incontinenceultrasonography

Outcome Measures

Primary Outcomes (21)

  • perineal sonography

    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.

    1 - 4 weeks before RALP

  • IPSS (International Prostate Symptom Score)

    score Points (numeric)

    1 - 4 weeks before RALP

  • 24h pad test

    incontinence is measured by 24 pad test. pads are measured through scales.

    1 - 4 weeks before RALP

  • perineal sonography

    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.

    6 weeks after RALP

  • IPSS (International Prostate Symptom Score)

    score Points (numeric)

    6 weeks after RALP

  • 24h pad test

    incontinence is measured by 24 pad test. pads are measured through scales.

    6 weeks after RALP

  • perineal sonography

    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.

    6 months after RALP

  • IPSS (International Prostate Symptom Score)

    score Points (numeric)

    6 months after RALP

  • 24h pad test

    incontinence is measured by 24 pad test. pads are measured through scales.

    6 months after RALP

  • ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)

    score Points (numeric)

    1 - 4 weeks before RALP

  • ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)

    score Points (numeric)

    6 weeks after RALP

  • ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)

    score Points (numeric)

    6 months after RALP

  • IIEF 5 (International Index of Erectile Function)

    score Points (numeric)

    1 - 4 weeks before RALP

  • IIEF 5 (International Index of Erectile Function)

    score Points (numeric)

    6 weeks after RALP

  • IIEF 5 (International Index of Erectile Function)

    score Points (numeric)

    6 months after RALP

  • VAS QoL (Visual Analogue Scale - Quality of Life)

    score Points (numeric)

    1 - 4 weeks before RALP

  • VAS QoL (Visual Analogue Scale - Quality of Life)

    score Points (numeric)

    6 weeks after RALP

  • VAS QoL (Visual Analogue Scale - Quality of Life)

    score Points (numeric)

    6 months after RALP

  • PGI (Patient Generated Index)

    score Points (numeric)

    1 - 4 weeks before RALP

  • PGI (Patient Generated Index)

    score Points (numeric)

    6 weeks after RALP

  • PGI (Patient Generated Index)

    score Points (numeric)

    6 months after RALP

Study Arms (2)

continent men after RALP

ACTIVE COMPARATOR

perineal sonography, questionnaires, 24h pad tests

Device: Perineal Sonography

incontinent men after RALP

ACTIVE COMPARATOR

perineal sonography, questionnaires, 24h pad tests

Device: Perineal Sonography

Interventions

Perineal SonographyDEVICE

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.

Also known as: Perineal Ultrasound
continent men after RALPincontinent men after RALP

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hubert John, Prof.

    Head of Kantonsspital Winterthur Urology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

January 31, 2017

Study Start

February 1, 2017

Primary Completion

October 31, 2019

Study Completion

February 5, 2020

Last Updated

April 27, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)