Stress Urinary IncontinenceNCT03098992
The Efficacy and Safety of Fotona Smooth® Device for the Treatment of Stress Urinary Incontinence
A study testing Fotona Dynamis Er:YAG Laser System in people with Stress Urinary Incontinence, run by Cork University Hospital at 9 sites in 6 countries.
Trial summary
There are many existing treatments of female stress urinary incontinence such as the use of adult absorbent pads and diapers, behavioral training, including bladder training, pelvic muscle exercises, biofeedback, urethral plugs, intravaginal prosthesis, electrical stimulation, periurethral injections, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Fotona Dynamis Er:YAG Laser System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 1 Jun 2017to 30 Jun 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Female, 18 years of age or older,
- Clinical and UDS diagnosis of Stress Urinary Incontinence,
- No significant improvement in urinary incontinence from at least one previous conservative treatments, such as behavioral measures, pelvic floor muscle training or the use of absorbent pads
Who cannot join
- Pre-existing bladder pathology including prior radiation treatment
- Pregnancy
- BMI>35
- Radical pelvic surgery or previous incontinence surgery
- Urinary tract infection or other active infections of urinary tract or bladder
- Endometriosis
Show all 15Show fewer
- Any form of pelvic organ prolapse greater than stage 2, according to POP-Q
- Diagnosis of urge incontinence
- Diagnosis of collagen disorders e.g. benign joint hypermobility / Elhers-Danlos / Marfans etc.
- Incomplete bladder emptying
- Vesicovaginal fistula
- Fecal incontinence
- Unwillingness or inability to complete follow-up schedule
- Unwillingness or inability to give Informed Consent
- Failure to comply with diary requirements during extended baseline period
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
United Kingdom3 sites
Basingstoke and North Hampshire Hospital
Basingstoke
Birmingham Women's Hospital NHS foundation trust
Birmingham
King's College Hospital
London
Switzerland2 sites
Inselspital Bern, University Hospital
Bern
Cantonal Hospital Frauenfeld
Frauenfeld
About this study
Official title: Post-market, Prospective, Randomised, Sham-controlled Clinical Trial Designed to Confirm the Efficacy and Safety of the Fotona Smooth® Device to Treat Female Stress Urinary Incontinence
There are many existing treatments of female stress urinary incontinence such as the use of adult absorbent pads and diapers, behavioral training, including bladder training, pelvic muscle exercises, biofeedback, urethral plugs, intravaginal prosthesis, electrical stimulation, periurethral injections, and reconstructive surgery. However, there is still a lack of effective minimally invasive treatment options that are independent of patient compliance.
One emerging approach of minimally invasive SUI therapy is pelvic floor reinforcement using laser therapy.
Read more
The primary objective of this post-marketing study is to confirm the effectiveness and safety of the FotonaSmooth® device in the treatment of stress urinary incontinence (SUI) in a large number of females using objective and subjective methods.
Patients with stress incontinence will be assigned to two groups, an active group, where the Fotona Dynamis Er:YAG Laser System will be used, and a sham group where a very low laser setting will be used, and parameter presentations will be masked.
Participants will be adult females, 18 years old and older with clinical and urodynamic diagnosis of Stress Urinary Incontinence,who have had no significant improvement in urinary incontinence from at least one previous conservative treatment, such as behavioral measures, pelvic floor muscle training or the use of absorbent pads
Read the detailed description
Prospective, randomized, 2-treatment, sham-controlled, single (patient only) blinded, study design using convenience sampling to enroll subjects as they present and are found to be eligible per the inclusion/exclusion criteria. This multicenter clinical trial utilizes a randomized assignment allocation schedule stratified by clinical site. Allocation rule pertains to the ratio of subjects in each treatment arm. Sampling rules pertain to the number of subjects in each active treatment arm.
Two treatment arms enrolled on a 2:1 ratio: Active arm is the Fotona Dynamis Er:YAG Laser System and the control arm is a sham treatment with a very low laser setting and parameter presentations masked. The active arm subjects will be followed out to 12 months post-treatment. The sham arm subjects will be followed out to 6 months and then offered the active treatment.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Fotona Dynamis Er:YAG Laser System, Fotona Dynamis Er:YAG Laser System with sham handpience
- 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.
Fotona Dynamis Er:YAG Laser SystemDevice
Treatment of urodynamic proven stress urinary incontinence using the Fotona Dynamis Er:YAG Laser System in the active arm
Fotona Dynamis Er:YAG Laser System with sham handpienceDevice
Sham treatment with a sham handpiece and parameter presentations masked
| Study group | Role | What they receive |
|---|---|---|
| Fotona Dynamis Er:YAG Laser System | Active comparator | Active treatment with Fotona Dynamis Er:YAG Laser System Receives: Device: Fotona Dynamis Er:YAG Laser System |
| Fotona Dynamis Er:YAG Laser System with Sham handpience | Sham comparator | Sham treatment with a sham handpiece and parameter presentations masked Receives: Device: Fotona Dynamis Er:YAG Laser System with sham handpience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Reduction in 1-hour pad weight between active and sham groups
Reduction in 1-hour pad weight at 6 months post-treatment in active group vs the sham treated group at 6 months post treatment
Measured: 6 months post-treatment
Safety: Incidence and severity of device related Adverse Events
Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, increased vaginal discharge, de novo urge incontinence).
Measured: 6 months post-treatment
Secondary outcomes (6)
Durability of the effect
Reduction in 1hr pad test weight in the treated group at 12 month follow-up vs. pad weight in the same group at baseline
Measured: 12 months post-treatment
Improvement
Change in mean Cough Stress test score at 6 and 12 months post-treatment
Measured: 6 and 12 months post-treatment
Change in King's Health Questionnaire (KHQ)
Change in mean KHQ from baseline to 6 and 12 months post-treatment
Measured: from baseline to 6 and 12 months post-treatment.
Change in mean PISQ-12 test scores
Change in mean PISQ-12 test scores from baseline to 6 and 12 months post-treatment.
Measured: from baseline to 6 and 12 months post-treatment.
Subjective assessment of pain
Patient reported assessment of pain during treatment
Measured: 6 months
Change in International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) score
Change in mean ICIQ-SF from baseline to 6 and 12 months post-treatment
Measured: from baseline to 6 and 12 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Jun 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cork University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fotona d.o.o.
- Responsible party
- Principal investigator, Barry O'Reilly, Cork University Hospital
- Investigators
- Barry O'Reilly, Professor, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098992
- Sponsor's protocol ID
- FOTONA-Incontilase
- Status last verified
- Jun 2019
- First submitted
- 20 Mar 2017
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
PubMed 40709601
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market, Prospective, Randomised, Sham-controlled Clinical Trial Designed to Confirm the Efficacy and Safety of the Fotona Smooth® Device to Treat Female Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03098992
- Acronym / sponsor ID
- FOTONA-Incontilase
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Cork University HospitalUniversity, hospital or other
- Collaborators
- Fotona d.o.o.
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 4 Apr 2017 (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.
There are many existing treatments of female stress urinary incontinence such as the use of adult absorbent pads and diapers, behavioral training, including bladder training, pelvic muscle exercises, biofeedback, urethral plugs, intravaginal prosthesis, electrical stimulation, periurethral injections, and reconstructive surgery. However, there is still a lack of effective minimally invasive treatment options that are independent of patient compliance.
One emerging approach of minimally invasive SUI therapy is pelvic floor reinforcement using laser therapy.
The primary objective of this post-marketing study is to confirm the effectiveness and safety of the FotonaSmooth® device in the treatment of stress urinary incontinence (SUI) in a large number of females using objective and subjective methods.
Patients with stress incontinence will be assigned to two groups, an active group, where the Fotona Dynamis Er:YAG Laser System will be used, and a sham group where a very low laser setting will be used, and parameter presentations will be masked.
Participants will be adult females, 18 years old and older with clinical and urodynamic diagnosis of Stress Urinary Incontinence,who have had no significant improvement in urinary incontinence from at least one previous conservative treatment, such as behavioral measures, pelvic floor muscle training or the use of absorbent pads
Detailed description
Prospective, randomized, 2-treatment, sham-controlled, single (patient only) blinded, study design using convenience sampling to enroll subjects as they present and are found to be eligible per the inclusion/exclusion criteria. This multicenter clinical trial utilizes a randomized assignment allocation schedule stratified by clinical site. Allocation rule pertains to the ratio of subjects in each treatment arm. Sampling rules pertain to the number of subjects in each active treatment arm.
Two treatment arms enrolled on a 2:1 ratio: Active arm is the Fotona Dynamis Er:YAG Laser System and the control arm is a sham treatment with a very low laser setting and parameter presentations masked. The active arm subjects will be followed out to 12 months post-treatment. The sham arm subjects will be followed out to 6 months and then offered the active treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fotona Dynamis Er:YAG Laser System | Active comparator | Device: Fotona Dynamis Er:YAG Laser SystemActive treatment with Fotona Dynamis Er:YAG Laser System |
| Fotona Dynamis Er:YAG Laser System with Sham handpience | Sham comparator | Device: Fotona Dynamis Er:YAG Laser System with sham handpienceSham treatment with a sham handpiece and parameter presentations masked |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Female, 18 years of age or older,
- Clinical and UDS diagnosis of Stress Urinary Incontinence,
- No significant improvement in urinary incontinence from at least one previous conservative treatments, such as behavioral measures, pelvic floor muscle training or the use of absorbent pads
Key exclusion criteria (15 listed)
- Pre-existing bladder pathology including prior radiation treatment
- Pregnancy
- BMI>35
- Radical pelvic surgery or previous incontinence surgery
- Urinary tract infection or other active infections of urinary tract or bladder
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 |
|---|---|---|
| Fotona Dynamis Er:YAG Laser SystemTreatment of urodynamic proven stress urinary incontinence using the Fotona Dynamis Er:YAG Laser System in the active arm | Device | Fotona Dynamis Er:YAG Laser System |
| Fotona Dynamis Er:YAG Laser System with sham handpienceSham treatment with a sham handpiece and parameter presentations masked | Device | Fotona Dynamis Er:YAG Laser System with Sham handpience |
Primary outcome
Efficacy: Reduction in 1-hour pad weight between active and sham groups
Time frame: 6 months post-treatment
Reduction in 1-hour pad weight at 6 months post-treatment in active group vs the sham treated group at 6 months post treatment
Safety: Incidence and severity of device related Adverse Events
Time frame: 6 months post-treatment
Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, increased vaginal discharge, de novo urge incontinence).
6 secondary outcomes
Durability of the effect
Time frame: 12 months post-treatment
Improvement
Time frame: 6 and 12 months post-treatment
Change in King's Health Questionnaire (KHQ)
Time frame: from baseline to 6 and 12 months post-treatment.
Change in mean PISQ-12 test scores
Time frame: from baseline to 6 and 12 months post-treatment.
Subjective assessment of pain
Time frame: 6 months
Change in International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) score
Time frame: from baseline to 6 and 12 months post-treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Derived from this study: PubMed 40709601Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
- 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.
Barry O'Reilly, Professor principal investigator
University College Cork
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fotona Dynamis Er:YAG Laser System in people with Stress Urinary Incontinence, run by Cork University Hospital at 9 sites in 6 countries.
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 15 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: status not confirmed, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, Switzerland, Germany, Greece, Ireland and 1 more country. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Efficacy: Reduction in 1-hour pad weight between active and sham groups (time frame: 6 months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03098992, which also lists 1 linked publication.
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 12 Jun 2019.