Urinary Incontinence, StressNCT03037008
Perineal Ultrasound in Men Before and After Radical Prostatectomy
A study testing Perineal Sonography in people with Urinary Incontinence, Stress, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- Perineal Sonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2017to 5 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Male,
- Elder than 18years
- Planned RALP or history of RALP and PPSUI
Who cannot join
- Patients with history of urinary incontinence before radical prostatectomy.
- Patients with history of radiotherapy in the pelvis.
- Other diseases involving pelvic floor.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- Perineal Sonography
- Keywords
- perineal sonography, male sling, post prostatectomy incontinence, ultrasonography
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal SonographyDevice
Also called Perineal Ultrasound
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.
| Study group | Role | What they receive |
|---|---|---|
| continent men after RALP | Active comparator | perineal sonography, questionnaires, 24h pad tests Receives: Device: Perineal Sonography |
| incontinent men after RALP | Active comparator | perineal sonography, questionnaires, 24h pad tests Receives: Device: Perineal Sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 - 4 weeks before RALP
IPSS (International Prostate Symptom Score)
score Points (numeric)
Measured: 1 - 4 weeks before RALP
24h pad test
incontinence is measured by 24 pad test. pads are measured through scales.
Measured: 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.
Measured: 6 weeks after RALP
IPSS (International Prostate Symptom Score)
score Points (numeric)
Measured: 6 weeks after RALP
24h pad test
incontinence is measured by 24 pad test. pads are measured through scales.
Measured: 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.
Measured: 6 months after RALP
IPSS (International Prostate Symptom Score)
score Points (numeric)
Measured: 6 months after RALP
24h pad test
incontinence is measured by 24 pad test. pads are measured through scales.
Measured: 6 months after RALP
ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
score Points (numeric)
Measured: 1 - 4 weeks before RALP
ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
score Points (numeric)
Measured: 6 weeks after RALP
ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
score Points (numeric)
Measured: 6 months after RALP
IIEF 5 (International Index of Erectile Function)
score Points (numeric)
Measured: 1 - 4 weeks before RALP
IIEF 5 (International Index of Erectile Function)
score Points (numeric)
Measured: 6 weeks after RALP
IIEF 5 (International Index of Erectile Function)
score Points (numeric)
Measured: 6 months after RALP
VAS QoL (Visual Analogue Scale - Quality of Life)
score Points (numeric)
Measured: 1 - 4 weeks before RALP
VAS QoL (Visual Analogue Scale - Quality of Life)
score Points (numeric)
Measured: 6 weeks after RALP
VAS QoL (Visual Analogue Scale - Quality of Life)
score Points (numeric)
Measured: 6 months after RALP
PGI (Patient Generated Index)
score Points (numeric)
Measured: 1 - 4 weeks before RALP
PGI (Patient Generated Index)
score Points (numeric)
Measured: 6 weeks after RALP
PGI (Patient Generated Index)
score Points (numeric)
Measured: 6 months after RALP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion31 Oct 2019
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert John, Prof., Study chair, Head of Kantonsspital Winterthur Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037008
- Sponsor's protocol ID
- 2016-00054
- Other IDs
- 2016
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2016
- Last updated
- 27 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03037008
- Acronym / sponsor ID
- 2016-00054
- Conditions
- Urinary Incontinence, Stress
- Keywords
- perineal sonography, male sling, post prostatectomy incontinence, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continent men after RALP | Active comparator | Device: Perineal Sonographyperineal sonography, questionnaires, 24h pad tests |
| incontinent men after RALP | Active comparator | Device: Perineal Sonographyperineal sonography, questionnaires, 24h pad tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male,
- Elder than 18years
- Planned RALP or history of RALP and PPSUI
Key exclusion criteria (3 listed)
- Patients with history of urinary incontinence before radical prostatectomy.
- Patients with history of radiotherapy in the pelvis.
- Other diseases involving pelvic floor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal SonographyAlso: Perineal UltrasoundIn 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. | Device | continent men after RALP, incontinent men after RALP |
Primary outcome
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.
IPSS (International Prostate Symptom Score)
Time frame: 1 - 4 weeks before RALP
score Points (numeric)
24h pad test
Time frame: 1 - 4 weeks before RALP
incontinence is measured by 24 pad test. pads are measured through scales.
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.
IPSS (International Prostate Symptom Score)
Time frame: 6 weeks after RALP
score Points (numeric)
24h pad test
Time frame: 6 weeks after RALP
incontinence is measured by 24 pad test. pads are measured through scales.
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.
IPSS (International Prostate Symptom Score)
Time frame: 6 months after RALP
score Points (numeric)
24h pad test
Time frame: 6 months after RALP
incontinence is measured by 24 pad test. pads are measured through scales.
ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
Time frame: 1 - 4 weeks before RALP
score Points (numeric)
ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
Time frame: 6 weeks after RALP
score Points (numeric)
ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
Time frame: 6 months after RALP
score Points (numeric)
IIEF 5 (International Index of Erectile Function)
Time frame: 1 - 4 weeks before RALP
score Points (numeric)
IIEF 5 (International Index of Erectile Function)
Time frame: 6 weeks after RALP
score Points (numeric)
IIEF 5 (International Index of Erectile Function)
Time frame: 6 months after RALP
score Points (numeric)
VAS QoL (Visual Analogue Scale - Quality of Life)
Time frame: 1 - 4 weeks before RALP
score Points (numeric)
VAS QoL (Visual Analogue Scale - Quality of Life)
Time frame: 6 weeks after RALP
score Points (numeric)
VAS QoL (Visual Analogue Scale - Quality of Life)
Time frame: 6 months after RALP
score Points (numeric)
PGI (Patient Generated Index)
Time frame: 1 - 4 weeks before RALP
score Points (numeric)
PGI (Patient Generated Index)
Time frame: 6 weeks after RALP
score Points (numeric)
PGI (Patient Generated Index)
Time frame: 6 months after RALP
score Points (numeric)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert John, Prof. study chair
Head of Kantonsspital Winterthur Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal Sonography in people with Urinary Incontinence, Stress, run by Kantonsspital Winterthur KSW 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 3 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: finished, as of the sponsor's last update on 27 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perineal sonography (time frame: 1 - 4 weeks before RALP). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2020.