Urinary Incontinence , StressCIP-003NCT07327528
Monocentric Pilot Study for the Application of an Endourethral Device for the Treatment of Stress Urinary Incontinence
A study testing UroRelief, a sterile, single-use, endourethral medical device suitable for both men and women, which is positioned at the bladder neck for the treatment of stress incontinence. in people with Urinary Incontinence , Stress, run by Relief srl at 1 site in Italy.
Trial summary
Stress urinary incontinence is defined as the involuntary loss of urine during exertion or physical activity (i.e., sports) or during sneezing or coughing. Approximately 127 million women and 10 million men reported suffering from stress urinary incontinence in 2008, and current estimates are on the rise. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Urinary Incontinence , Stress
- What is being tested?
- UroRelief, a sterile, single-use, endourethral medical device suitable for both men and women, which is positioned at the bladder neck for the treatment of stress incontinence.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (both women and men) aged between 21 and 85 years
- Documented stress urinary incontinence (urethral hypermobility or intrinsic sphincter deficiency) in which urgency symptoms are a minor component of the incontinence symptoms
- Stress urinary incontinence present and physiologically stable over the last 6 months.
- Urinary leakage >150 ml in the 24-hour PAD test performed during the pre-implantation screening phasefor male patients.- Urinary leakage >150 ml in the 24-hour PAD test performed during the pre-implantation screening phase
- Cognitive/manual ability to use the device.
- The patient is willing and able to meet the requirements of the protocol.
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- The patient has decided to be implanted with the device for the treatment of urinary incontinence
- Willingness to sign the informed consent form.
- Willingness to return for follow-up evaluations and complete questionnaires.
- The patient has been informed about alternative therapies available for the treatment or management of urinary incontinence and about all possible risks associated with the implantation of the device.
- Any pre-existing urological conditions have been treated and resolved or are under control.
- Urinalysis and urine culture negative for infections and (micro)hematuria.
- Flexible cystoscopy with evidence of sphincter incompetence.
Who cannot join
- Primary urge incontinence or mixed stress and urge incontinence in which urge symptoms are a major component of the incontinence symptoms.
- Detrusor overactivity.
- History of recurrent bladder stones.
- Atonic neurogenic bladder or detrusor sphincter dyssynergia.
- Patients taking specific medications for bladder dysfunction or currently undergoing treatment for incontinence.
- Post-void residual urine >200 ml.
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- Maximum cystometric capacity <150 ml.
- Detrusor pressure >20 cmH2O.
- Flexible cystoscopy showing stenosis that prevents device implantation.
- History of previously undiagnosed and unidentified microhematuria.
- Unexplained cystoscopic abnormalities and any suspected ongoing urological pathology.
- Asymptomatic bacteriuria during the screening period.
- History of bladder or upper urinary tract infections more than twice in the last 12 months.
- Patients requiring frequent catheterization or intermittent cystoscopy due to previous conditions.
- Female patients who are pregnant or planning to become pregnant within the next year.
- Stage II uterine prolapse in female patients.
- Previous pelvic surgery or radiotherapy in female patients.
- Any previous implantation of medical devices for urinary incontinence.
- History of sensitivity to silicone, titanium, nickel, and all materials listed in the technical data sheet.
- Vulnerable patients or those in emergency circumstances.
- The patient's health status precludes completion of follow-up, including terminal illnesses.
- Not willing/able to comply with the study requirements.
- Participation in any clinical study in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Stress urinary incontinence is defined as the involuntary loss of urine during exertion or physical activity (i.e., sports) or during sneezing or coughing. Approximately 127 million women and 10 million men reported suffering from stress urinary incontinence in 2008, and current estimates are on the rise.
The prevalence of stress urinary incontinence is higher in older age groups, with 10% of women and 5% of men over the age of 65 suffering from this condition. The initial management of urinary incontinence consists of basic diagnostic investigations to rule out any reversible conditions (i.e., bacterial urinary tract infections, UTIs), while conservative and non-invasive treatment options include lifestyle changes, (PFMT) with or without biofeedback, and bladder retraining.
Read the detailed description
Stress urinary incontinence is defined as the involuntary loss of urine during exertion or physical activity (i.e., sports) or during sneezing or coughing.
It is estimated to be the most common type of urinary incontinence worldwide due to its high prevalence in women. Approximately 127 million women and 10 million men reported suffering from stress urinary incontinence in 2008, and current estimates are on the rise. It can be primary or secondary and is caused by damage to either the sphincter innervation or the anatomical structures that make up the urethral sphincter. It is usually classified according to its severity and, consequently, according to the impairment of the patient's quality of life. It can seriously affect patients' quality of life in severalareas, leading to conditions such as sexual dysfunction, social isolation, withdrawal from physical activity, and major depression. The initial management of urinary incontinence consists of basic diagnostic investigations to rule out any reversible conditions (i.e., bacterial urinary tract infections, UTIs), while conservative and non-invasive treatment options include lifestyle changes, pelvic floor muscle training (PFMT) with or without biofeedback and bladder retraining, as well as the chronic and daily use of external aids (diapers).
The goal of treatment is to achieve complete or partial continence, with the aim of restoring normal sexual function. (PFMT) with or without biofeedback and bladder retraining, as well as the chronic and daily use of external aids (diapers, collection systems, prophylactics, etc.). However, this does not guarantee the restoration of a good quality of life. The current guidelines of the European Association of Urology (EAU) recommend surgical treatment when conservative and pharmacological therapies fail. In men, the most common surgical treatment for stress urinary incontinence that does not respond to therapy is the implantation of an artificial urethral sphincter, while in women, the indication is for complicated stress urinary incontinence (failure of other treatments such as retropubic or transobturator mid-retral slings). Currently, the most widely used device is a three-chamber device (consisting of a cuff, a balloon, and a pump) placed extraurethrally, whose application requires general and/or spinal anesthesia. The system proposed in the study, on the other hand, is an endourethral device to be applied endoscopically after anesthesia. The device is applied through a simple endoscopic maneuver without the need for other devices implanted in other anatomical sites and can be activated by slight abdominal pressure exerted by the patient.
- Conditions
- Urinary Incontinence , Stress
- Being tested
- UroRelief, a sterile, single-use, endourethral medical device suitable for both men and women, which is positioned at the bladder neck for the treatment of stress incontinence.
- Keywords
- Urinary incontinence, Stress
- 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.
UroRelief, a sterile, single-use, endourethral medical device suitable for both men and women, which is positioned at the bladder neck for the treatment of stress incontinence.Device
UroRelief is a sterile, single-use, endourethral medical device suitable for both men and women, which is positioned at the bladder neck for the treatment of stress incontinence. The device is designed to be inserted through the urethra using a routine endoscopic procedure with a resectoscope. Once in place, the device is completely inside the body with no visible parts outside and can restore urinary continence control.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic surgery for device installation | Experimental | Endoscopic surgery for device installation Receives: Device: UroRelief, a sterile, single-use, endourethral medical device suitable for both men and women, which is positioned at the bladder neck for the treatment of stress incontinence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of UroRelief
- Complete characterization of all serious and unrecorded adverse events, including frequency and severity, reported throughout the study, according to the Clavien Dindo classification (I, II, 111°, IIIb, IVa, IVb, V).
Measured: 18 months
The safety of UroRelief
- Pain assessed using the Visual Analog Scale (VAS) 1-10 for pain [Observation period:Baseline, 10, 30, 60, 90, and 120 days].
Measured: 18 months
The safety of UroRelief
- Quality of sexual life assessed using the Female Sexual Function Index (FSFI) for women [Observation period: Baseline, 10, 30, 60, 90, and 120 days].
Measured: 18 months
The safety of UroRelief
- Quality of sexual life assessed using the International Index of Erectile Function (IIEF) questionnaire for men [Observation period: Baseline, 10, 30, 60, 90, and 120 days].
Measured: 18 months
Secondary outcomes (1)
Assess incontinence at 30 days, measured using the 24-hour pad weight test.
Percentage of patients with a significant reduction in incontinence at 60 days. A subject is considered a success if they experience a reduction in the weight of the diaper over 24 hours of at least 50% at 30 days compared to the baseline value.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start9 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Relief srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327528
- Sponsor's protocol ID
- CIP-003
- Acronym
- CIP-003
- Status last verified
- Jan 2026
- First submitted
- 5 Aug 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Pilot Study for the Application of an Endourethral Device for the Treatment of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07327528
- Acronym / sponsor ID
- CIP-003 / CIP-003
- Conditions
- Urinary Incontinence , Stress
- Keywords
- Urinary incontinence, Stress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Relief srlIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jan 2026 (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.
Stress urinary incontinence is defined as the involuntary loss of urine during exertion or physical activity (i.e., sports) or during sneezing or coughing. Approximately 127 million women and 10 million men reported suffering from stress urinary incontinence in 2008, and current estimates are on the rise.
The prevalence of stress urinary incontinence is higher in older age groups, with 10% of women and 5% of men over the age of 65 suffering from this condition. The initial management of urinary incontinence consists of basic diagnostic investigations to rule out any reversible conditions (i.e., bacterial urinary tract infections, UTIs), while conservative and non-invasive treatment options include lifestyle changes, (PFMT) with or without biofeedback, and bladder retraining.
Detailed description
Stress urinary incontinence is defined as the involuntary loss of urine during exertion or physical activity (i.e., sports) or during sneezing or coughing.
It is estimated to be the most common type of urinary incontinence worldwide due to its high prevalence in women. Approximately 127 million women and 10 million men reported suffering from stress urinary incontinence in 2008, and current estimates are on the rise. It can be primary or secondary and is caused by damage to either the sphincter innervation or the anatomical structures that make up the urethral sphincter. It is usually classified according to its severity and, consequently, according to the impairment of the patient's quality of life. It can seriously affect patients' quality of life in severalareas, leading to conditions such as sexual dysfunction, social isolation, withdrawal from physical activity, and major depression. The initial management of urinary incontinence consists of basic diagnostic investigations to rule out any reversible conditions (i.e., bacterial urinary tract infections, UTIs), while conservative and non-invasive treatment options include lifestyle changes, pelvic floor muscle training (PFMT) with or without biofeedback and bladder retraining, as well as the chronic and daily use of external aids (diapers).
The goal of treatment is to achieve complete or partial continence, with the aim of restoring normal sexual function. (PFMT) with or without biofeedback and bladder retraining, as well as the chronic and daily use of external aids (diapers, collection systems, prophylactics, etc.). However, this does not guarantee the restoration of a good quality of life. The current guidelines of the European Association of Urology (EAU) recommend surgical treatment when conservative and pharmacological therapies fail. In men, the most common surgical treatment for stress urinary incontinence that does not respond to therapy is the implantation of an artificial urethral sphincter, while in women, the indication is for complicated stress urinary incontinence (failure of other treatments such as retropubic or transobturator mid-retral slings). Currently, the most widely used device is a three-chamber device (consisting of a cuff, a balloon, and a pump) placed extraurethrally, whose application requires general and/or spinal anesthesia. The system proposed in the study, on the other hand, is an endourethral device to be applied endoscopically after anesthesia. The device is applied through a simple endoscopic maneuver without the need for other devices implanted in other anatomical sites and can be activated by slight abdominal pressure exerted by the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic surgery for device installation | Experimental | Device: UroRelief, a sterile, single-use, endourethral medical device suitable for both men and women, which is positioned at the bladder neck for the treatment of stress incontinence.Endoscopic surgery for device installation |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult patients (both women and men) aged between 21 and 85 years
- Documented stress urinary incontinence (urethral hypermobility or intrinsic sphincter deficiency) in which urgency symptoms are a minor component of the incontinence symptoms
- Stress urinary incontinence present and physiologically stable over the last 6 months.
- Urinary leakage >150 ml in the 24-hour PAD test performed during the pre-implantation screening phasefor male patients.- Urinary leakage >150 ml in the 24-hour PAD test performed during the pre-implantation screening phase
- Cognitive/manual ability to use the device.
Key exclusion criteria (23 listed)
- Primary urge incontinence or mixed stress and urge incontinence in which urge symptoms are a major component of the incontinence symptoms.
- Detrusor overactivity.
- History of recurrent bladder stones.
- Atonic neurogenic bladder or detrusor sphincter dyssynergia.
- Patients taking specific medications for bladder dysfunction or currently undergoing treatment for incontinence.
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 |
|---|---|---|
| UroRelief, a sterile, single-use, endourethral medical device suitable for both men and women, which is positioned at the bladder neck for the treatment of stress incontinence.UroRelief is a sterile, single-use, endourethral medical device suitable for both men and women, which is positioned at the bladder neck for the treatment of stress incontinence. The device is designed to be inserted through the urethra using a routine endoscopic procedure with a resectoscope. Once in place, the device is completely inside the body with no visible parts outside and can restore urinary continence control. | Device | Endoscopic surgery for device installation |
Primary outcome
The safety of UroRelief
Time frame: 18 months
- Complete characterization of all serious and unrecorded adverse events, including frequency and severity, reported throughout the study, according to the Clavien Dindo classification (I, II, 111°, IIIb, IVa, IVb, V).
The safety of UroRelief
Time frame: 18 months
- Pain assessed using the Visual Analog Scale (VAS) 1-10 for pain [Observation period:Baseline, 10, 30, 60, 90, and 120 days].
The safety of UroRelief
Time frame: 18 months
- Quality of sexual life assessed using the Female Sexual Function Index (FSFI) for women [Observation period: Baseline, 10, 30, 60, 90, and 120 days].
The safety of UroRelief
Time frame: 18 months
- Quality of sexual life assessed using the International Index of Erectile Function (IIEF) questionnaire for men [Observation period: Baseline, 10, 30, 60, 90, and 120 days].
1 secondary outcome
Assess incontinence at 30 days, measured using the 24-hour pad weight test.
Time frame: 18 months
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 8 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UroRelief, a sterile, single-use, endourethral medical device suitable for both men and women, which is positioned at the bladder neck for the treatment of stress incontinence. in people with Urinary Incontinence , Stress, run by Relief srl 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 13 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. 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?
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?
The safety of UroRelief (time frame: 18 months). The study lists 4 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 8 Jan 2026.