Perineal Ultrasound in Men Before and After Radical Prostatectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence, Stress
• Intervention / Treatment: Device: Perineal Sonography

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Winterthur, Switzerland, 8401
    • Kantonsspital Winterthur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Perineal Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kantonsspital Winterthur KSW
• Investigators: Study Chair: Hubert John, Prof., Head of Kantonsspital Winterthur Urology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): February 5, 2020

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: ultrasonography; perineal sonography; male sling; post prostatectomy incontinence
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: 2016-00054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No