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Completed

NCT Number: NCT03037008

Perineal Ultrasound in Men Before and After Radical Prostatectomy

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.

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Key information

Conditions

Urinary Incontinence, Stress Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

About this study

After radical prostatectomy, a part of all patients suffer from urinary incontinence. Until now, only few information exists about the functional anatomy of the male pelvic floor, especially in incontinent men. Transperineal ultrasound is non-hazardous, cheap and easy available method to visualize the pelvic floor and is well established in gynecological examination. literature described the technique of transperineal ultrasound but there are no well established reference lines measured and the number of examined men in the series are small. The investigators want to confirm the published data and probably find new reference lines/parameters, e.g. the distance between the posterior wall of the symphysis to the posterior wall of the urethra in a direct, horizontal line. At the moment, the authors published data about urethral mobility, bladder neck opening and urethral angle. The investigators estimate that there is also a possible significant difference in the distance from the urethra to the symphysis in incontinent men compare to continent men after radical prostatectomy.

Incontinent men can be treated by pelvic floor exercises or, in case of persisting incontinence, with operative treatment. There exists several techniques of implanted slings and meshes, similar to the better known TVT (tension free vaginal tape) in female urinary incontinence, besides the gold standard - the implantation of an artificial sphincter prosthesis. The sling-operations are less invasive, cheaper and preferred by patients du to the fact, that normal micturition is still possible. Nevertheless, around 20% of patients stay incontinent after sling operation. At the moment, it is unknown why they do not profit from the sling. In a previous study functional pelvic cine-MRI in patients with post-prostatectomy incontinence before and after implantation of a bulbourethral composite Suspension were compared. The investigators could find significant differences in the membranous urethral length and could show an elevation oft he bladder neck postoperatively but no significant MRI differences were found between patients showing clinical success or failure. With perineal sonography, the investigators want to establish a prediction tool for sling-operations in patients with urinary stress incontinence after radical prostatectomy.

The purpose of this study is to evaluate whether perineal ultrasound in men is an adequate possibility to evaluate the pelvic floor and its function in the regard of urinary incontinence. The study is trying to find a prediction tool for bulbourethral composite suspension (sling-operation) using transperineal sonography. The investigators further want to establish and confirm parameters/standards to measure the male pelvic floor with the new technique of perineal sonography in men. Further the investigators want to to compare findings from perineal sonography with data from functional MRI in men with urinary incontinence following radical prostatectomy before and after bulbourethral composite suspension. Findings from perineal sonography with results from questionnaires concerning quality of life will be compared.

There is a comparison study with two arms to compare the anatomy and function of the pelvic floor with perineal ultrasound from men prior to RALP due to prostate cancer, without prior history of diseases involving the pelvic floor.

Participants will be asked to participate the study during routine consultations in the department of Kantonsspital Winterthur or selected in our database of the clinical information system searching for radical prostatectomies in the past and recruit these participants by telephone.

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 is observed during rest, coughing and valsalva-maneuver. One examination takes around 30minutes. During ultrasound, the investigators 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.

Urinary incontinence is measured by 24h pad test: Probands have to collect their pads, and scale them before and after using it during 24 hours, to measure the difference. The difference (after-before) shows the amount of lost urine. The results don't have to be exact and a result with a precision of approximately 50ml (= 50g) is acceptable.

Results from urinary analysis (culture) are taken out of medical history from the hospitals database during the period of incontinence to exclude urinary tract infection. If no data is available, urinary analysis will be collected.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Perineal Sonography

Device

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 names: Perineal Ultrasound

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Kantonsspital Winterthur KSW

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 31, 2017
Registry last updated
Apr 27, 2020

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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