Male Stress Urinary IncontinenceSMUINCT05771168
Surgery for Male Stress Urinary Incontinence
An observational study of Male Stress Urinary Incontinence, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The purpose of this observational prospective study is to evaluate the success rate (cure plus improvement) of procedures for treatment of male stress urinary incontinence (artificial urinary sphincter or male slings) at 5 years of study follow-up and to determine other outcomes of surgical treatment for each of the… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Male Stress Urinary Incontinence
- What is being tested?
- Artificial urinary sphincter and Male sling
- Type of treatment
- Medical device
- How many people
- 138 participants
- Where
- 1 siteItaly
- Study dates
- 29 Sep 2022to 29 Sep 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult male patients undergoing surgery for treatment of stress urinary incontinence (AUS or male sling)
Who may be able to join
- Male patients undergoing surgery for stress incontinence using medical devices such as AUS or sling
- Participant is willing and able to complete the questionnaires and give informed consent for participation in the study
Who cannot join
- Participant unable to complete the questionnaires and declining informed consent for participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Università Cattolica del Sacro Cuore, Fondazione Policlinico Agostino Gemelli
Roma, Rome, 00168
Emilio Sacco, Professor, emilio.sacco@policlinicogemelli.it
Filippo Marino, MD
About this study
Official title: Observational Study for Patients Undergoing Surgery for Male Stress Urinary Incontinence
The purpose of this observational prospective study is to evaluate the success rate (cure plus improvement) of procedures for treatment of male stress urinary incontinence (artificial urinary sphincter or male slings) at 5 years of study follow-up and to determine other outcomes of surgical treatment for each of the devices and, to perform a prognostic factor analysis to identify clinical and surgical variables that correlate with (in)continence or revisions for each of the device subtypes. Cure is defined as urinary continence with no need for use of pads or the use of 1 light security pad; the improvement is defined as the reduction of≥ 50% of the number of pads with use of no more than two pads.
Read the detailed description
Through the use of a prospective registry, the investigators will collect information on patient characteristics, including age (years), weight (kg), length (cm), previous urological surgeries and other surgeries in the pelvic area, radiotherapeutic treatment of the prostate, and other co-morbidities. Also, if applicable, 24h pad test and preoperative urodynamic results, presence of pre-operative urinary tract infections, and results of preoperative cystoscopy will be reported.
The surgical procedure for treatment of male stress urinary incontinence is according to standard practice. For artificial urinary sphincters, the date and time of surgery, surgeon name, time of shaving, presence of skin wounds, type of prosthesis, cuff location, cuff size, pressure regulating balloon, type of preoperative antibiotics, type of associated procedures will be reported. For slings, similar data will be reported, including type of sling and if there was a release of central tendon.
The patients will fill in the International Consultation on Incontinence Questionnaire (ICIQ) Urinary Incontinence (UI) Short Form (ICIQ-UI Questionnaire SF), the EuroQol Group Questionnaire (EQ-5D-5L) for the evaluation of the impact of incontinence on Quality of Life, and the Sexual Complaints Screener for Men (SCS-M), the Dyadic Adjustment Scale Italian version (DAS), the International Index of Erectile Function Questionnaire (IIEF-15) and the Hospital Anxiety and Depression Scale (HADS) questionnaire before the operation, at 12 weeks after surgery and at yearly intervals up to and including year 5. The results of questionnaires will be entered into the database.
- Conditions
- Male Stress Urinary Incontinence
- Being tested
- Artificial urinary sphincter, Male sling
- Keywords
- Urinary incontinence, Male incontinence, Post-prostatectomy incontinence, Radical prostatectomy, Male sling, Artificial urinary sphincter
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial urinary sphincterDevice
Implantation of peri-urethral artificial urinary sphincter
Male slingDevice
Retrourethral implantation of male sling
| Study group | Role | What they receive |
|---|---|---|
| AUS | Male patients undergoing surgery for stress urinary incontinence using artificial urinary sphincter (AUS) Receives: Device: Artificial urinary sphincter | |
| Sling | Male patients undergoing surgery for stress urinary incontinence using slings Receives: Device: Male sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate (cure plus improvement)
Will be obtained through patient 24-hour pad use. Cure rate is defined as urinary continence with no need for use of pads or the use of 1 light security pad.
Measured: 5-years after surgery
Secondary outcomes (6)
Time being continent
Interval being continent after surgery to the date of incontinence recurrence. Patients who die will be censored at time of death. Overall time of being continent will be presented using the Kaplan-Meier curve.
Measured: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Time being revision-free
Interval from the date of surgery to the date of revision.Patients who die will be censored at time of death. Overall time of being revision-free will be presented using the Kaplan-Meier curve.
Measured: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Revision-free rate
Evaluation of revision-free rate at 5 years of study follow-up
Measured: 5-years after surgery
Patient-reported quality of life
The change in the results of quality of life questionnaires (EuroQol Group EQ-5D-5L) compared with baseline over time and correlations with the primary outcome. EuroQol Group EQ-5D-5L describe health state with 5 levels (level 1 indicating no problem, level 2 indicating slight problems, level 3 indicating moderate problems, level 4 indicating severe problems, level 5 indicating unable to/extreme problems) and with a scale numbered from 0 to 100 (100 means the best health you can imagine and 0 means the worst health you can imagine)
Measured: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Post-operative general adverse events
Post-operative general adverse events related to the surgical procedure or the sling/sphincter (e.g. urinary retention, scrotal hematoma, perineal pain, hematuria, or other general problems)
Measured: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Post-operative specific adverse events
Post-operative specific adverse events related to the surgical procedure or the sling/sphincter (e.g. pump/reservoir/cuff failure, erosion of the device through the skin or urethra)
Measured: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start29 Sep 2022
- Primary completion29 Sep 2027 (estimated)
- Study completion29 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sacco Emilio, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771168
- Sponsor's protocol ID
- ID 5094
- Acronym
- SMUI
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 16 Mar 2023
- 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 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for Patients Undergoing Surgery for Male Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05771168
- Acronym / sponsor ID
- SMUI / ID 5094
- Conditions
- Male Stress Urinary Incontinence
- Keywords
- Urinary incontinence, Male incontinence, Post-prostatectomy incontinence, Radical prostatectomy, Male sling, Artificial urinary sphincter
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 29 Sep 2027 (estimated)
- Study completion
- 29 Sep 2027 (estimated)
- First posted
- 16 Mar 2023 (actual)
- 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.
The purpose of this observational prospective study is to evaluate the success rate (cure plus improvement) of procedures for treatment of male stress urinary incontinence (artificial urinary sphincter or male slings) at 5 years of study follow-up and to determine other outcomes of surgical treatment for each of the devices and, to perform a prognostic factor analysis to identify clinical and surgical variables that correlate with (in)continence or revisions for each of the device subtypes. Cure is defined as urinary continence with no need for use of pads or the use of 1 light security pad; the improvement is defined as the reduction of≥ 50% of the number of pads with use of no more than two pads.
Detailed description
Through the use of a prospective registry, the investigators will collect information on patient characteristics, including age (years), weight (kg), length (cm), previous urological surgeries and other surgeries in the pelvic area, radiotherapeutic treatment of the prostate, and other co-morbidities. Also, if applicable, 24h pad test and preoperative urodynamic results, presence of pre-operative urinary tract infections, and results of preoperative cystoscopy will be reported.
The surgical procedure for treatment of male stress urinary incontinence is according to standard practice. For artificial urinary sphincters, the date and time of surgery, surgeon name, time of shaving, presence of skin wounds, type of prosthesis, cuff location, cuff size, pressure regulating balloon, type of preoperative antibiotics, type of associated procedures will be reported. For slings, similar data will be reported, including type of sling and if there was a release of central tendon.
The patients will fill in the International Consultation on Incontinence Questionnaire (ICIQ) Urinary Incontinence (UI) Short Form (ICIQ-UI Questionnaire SF), the EuroQol Group Questionnaire (EQ-5D-5L) for the evaluation of the impact of incontinence on Quality of Life, and the Sexual Complaints Screener for Men (SCS-M), the Dyadic Adjustment Scale Italian version (DAS), the International Index of Erectile Function Questionnaire (IIEF-15) and the Hospital Anxiety and Depression Scale (HADS) questionnaire before the operation, at 12 weeks after surgery and at yearly intervals up to and including year 5. The results of questionnaires will be entered into the database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AUS | – | Device: Artificial urinary sphincterMale patients undergoing surgery for stress urinary incontinence using artificial urinary sphincter (AUS) |
| Sling | – | Device: Male slingMale patients undergoing surgery for stress urinary incontinence using slings |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male patients undergoing surgery for treatment of stress urinary incontinence (AUS or male sling)
Key inclusion criteria (2 listed)
- Male patients undergoing surgery for stress incontinence using medical devices such as AUS or sling
- Participant is willing and able to complete the questionnaires and give informed consent for participation in the study
Key exclusion criteria (1 listed)
- Participant unable to complete the questionnaires and declining informed consent for participation in the study
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 |
|---|---|---|
| Artificial urinary sphincterImplantation of peri-urethral artificial urinary sphincter | Device | AUS |
| Male slingRetrourethral implantation of male sling | Device | Sling |
Primary outcome
Success rate (cure plus improvement)
Time frame: 5-years after surgery
Will be obtained through patient 24-hour pad use. Cure rate is defined as urinary continence with no need for use of pads or the use of 1 light security pad.
6 secondary outcomes
Time being continent
Time frame: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Time being revision-free
Time frame: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Revision-free rate
Time frame: 5-years after surgery
Patient-reported quality of life
Time frame: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Post-operative general adverse events
Time frame: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Post-operative specific adverse events
Time frame: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Stress Urinary Incontinence, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 16 Mar 2023. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilio Sacco, Professor (+390630155290, emilio.sacco@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (cure plus improvement) (time frame: 5-years after surgery). 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 16 Mar 2023.