Stress Urinary IncontinenceNCT06559423
Combined Non-ablative Er:YAG Laser and Magnetic Stimulation for Treatment of Female Urinary Incontinence
A study testing non-ablative Er:YAG laser and high intensity Tesla magnetic stimulation (HITS) in people with Stress Urinary Incontinence and Urinary Incontinence, run by Zdravstveni Zavod Štrumbelj at 1 site in Slovenia.
Trial summary
This single-arm pilot study aims to investigate the efficacy and safety of a combined non-ablative Erbium:Yttrium-Aluminium-Garnet (Er:YAG) laser and High Intensity Tesla magnetic Stimulation (HITS) treatment for female urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Urinary Incontinence
- What is being tested?
- non-ablative Er:YAG laser and high intensity Tesla magnetic stimulation (HITS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSlovenia
- Study dates
- 23 Apr 2021to 21 Oct 2022
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female, 18 years of age or older
- Clinical diagnosis of stress or mixed urinary incontinence, with stress incontinence as the predominant symptom
Who cannot join
- Very severe urinary incontinence (ICIQ-UI SF score at baseline >18)
- Pregnancy
- BMI>35
- Not willing to abstain from vaginal intercourse for one week following the laser-therapy
- Acute urinary tract infections (UTIs)
- History of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during screening physical exam (e.g., perineal body)
Show all 12Show fewer
- Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection
- Prolapse grade 2 or higher
- History of radiotherapy for cervical or uterine cancer
- Medical condition that may interfere with participants' compliance to the protocol
- Medical condition for which the HITS and laser therapy are contraindicated
- Previous laser or HITS treatment for UI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Non-ablative Er:YAG Laser and High Intensity Tesla Magnetic Stimulation (HITS) for Treatment of Female Urinary Incontinence: A Single-centre, Single-arm Pilot Study
This single-arm pilot study aims to investigate the efficacy and safety of a combined non-ablative Erbium:Yttrium-Aluminium-Garnet (Er:YAG) laser and High Intensity Tesla magnetic Stimulation (HITS) treatment for female urinary incontinence. The study involves 25 women diagnosed with mild to moderate stress or mixed urinary incontinence. Participants will receive three vaginal Er:YAG laser treatments and six HITS sessions. The primary objective is to improve symptoms of urinary incontinence, as measured by changes in scores on two questionnaires compared to baseline. Secondary objectives include improvement in sexual function, durability of improvement in urinary incontinence symptoms at 3- and 6- month follow-up, patient-reported improvement, and discomfort during treatment.
Read the detailed description
The aim of this single-centre, single-arm pilot study is to investigate the combined effects of vaginal Er:YAG laser and HITS treatment on urinary incontinence (UI) in women. The study will involve 25 women suffering from mild to moderate stress urinary incontinence or mixed urinary incontinence. The aim of the study is to investigate whether the combination of non-ablative Er:YAG laser therapy and HITS can have a synergistic effect in relieving UI symptoms. Participants will undergo three sessions of intravaginal laser treatment according to the IncontiLase® Er:YAG laser protocol and six HITS sessions. The laser treatments will take place one month apart, while the HITS sessions will take place twice a week for three weeks after the last laser treatment.
Primary endpoints include improvement in UI symptoms as measured by changes in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and Questionnaire for Urinary Incontinence Diagnosis (QUID) scores from baseline to post-treatment. Secondary endpoints include improvement in sexual function as measured by the Female Sexual Function Index (FSFI), durability of improvement in UI symptoms 3 and 6 months after treatment, patient-reported global impression of improvement (Patient Global Impression of Improvement, PGI-I), and treatment-related discomfort as measured by the Visual Analog Scale (VAS) for pain.
The study also includes rigorous safety assessments and monitoring of adverse events or complaints during and after the treatments. Recruitment of participants will ensure that they meet certain inclusion criteria, such as adult women with a clinical diagnosis of stress or mixed UI, as well as exclusion criteria to minimize risks and improve compliance.
Statistical analysis will be performed using various tests to check the data for normality and distribution. The results of the study should provide valuable insight into the efficacy and safety of combining laser and HITS treatments for female urinary incontinence and potentially provide a new non-invasive treatment option for this condition.
- Conditions
- Stress Urinary Incontinence, Urinary Incontinence
- Being tested
- non-ablative Er:YAG laser and high intensity Tesla magnetic stimulation (HITS)
- Keywords
- stress urinary incontinence, urinary incontinence, non-ablative erbium laser, magnetic stimulation, High Intensity Tesla magnetic Stimulation (HITS), combined therapy, Er:YAG laser
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-ablative Er:YAG laser and high intensity Tesla magnetic stimulation (HITS)Device
Patients will initially undergo three monthly intravaginal treatments with the Er:YAG laser. Six weeks after the final laser treatment, patients will receive six sessions of magnetic stimulation. During these sessions, patients will sit on a specialized chair that generates a therapeutic magnetic field.
| Study group | Role | What they receive |
|---|---|---|
| Laser + HITS | Experimental | The treatment involved three consecutive Er:YAG laser sessions (TimeWalker® Intima Laser™, Fotona) followed by six HITS treatments (StarFormer® IntimaWave®, Fotona).
The laser sessions were spaced one month apart, following the IncontiLase® protocol using the G-Runner robotic handpiece. The protocol included three steps: (i) intravaginal laser treatment of the anterior vaginal wall, (ii) treatment of the entire vaginal canal, and (iii) treatment of the vestibule and introitus. Each session lasted 20 minutes.
Six weeks after the final laser treatment, patients received six HITS treatments, with two sessions per week. The HITS protocol involved increasing stimulation frequencies, each for 10 minutes, with the total session lasting 30 minutes. Receives: Device: non-ablative Er:YAG laser and high intensity Tesla magnetic stimulation (HITS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the combined laser and HITS treatment
Improvement of symptoms of stress and/or mixed urinary incontinence as measured by change in ICIQ-UI SF and QUID scores from the baseline.
Measured: up to 6 months after treatment
Safety of the combined laser and HITS treatment
Incidence and severity of treatment-related Adverse Events
Measured: up to 6 months after treatment
Secondary outcomes (4)
Improvement of sexual function
Improvement of sexual function as measured by FSFI scores change from baseline
Measured: up to 6 months after treatment
Durability of the effect
Improvement of the urinary incontinence symptoms measured at 3 and 6 months follow-up
Measured: up to 6 months after treatment
Patient reported assessment of improvement
Assessed by PGI-I questionnaire
Measured: up to 6 months after treatment
Patient reported assessment of discomfort during treatment
Measured by visual analog scale pain score
Measured: up to 24 hours after each laser and HITS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start23 Apr 2021
- Primary completion21 Oct 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zdravstveni Zavod Štrumbelj
- Sponsor type
- University, hospital or other
- Collaborators
- Fotona d.o.o.
- Responsible party
- Sponsor
- Investigators
- Tadeja Štrumbelj, MD, Principal investigator, Zdravstveni Zavod Štrumbelj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559423
- Sponsor's protocol ID
- Study Laser + HITS
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Non-ablative Er:YAG Laser and High Intensity Tesla Magnetic Stimulation (HITS) for Treatment of Female Urinary Incontinence: A Single-centre, Single-arm Pilot Study
- ClinicalTrials.gov ID
- NCT06559423
- Acronym / sponsor ID
- Study Laser + HITS
- Conditions
- Stress Urinary Incontinence, Urinary Incontinence
- Keywords
- stress urinary incontinence, urinary incontinence, non-ablative erbium laser, magnetic stimulation, High Intensity Tesla magnetic Stimulation (HITS), combined therapy, Er:YAG laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Zdravstveni Zavod ŠtrumbeljUniversity, hospital or other
- Collaborators
- Fotona d.o.o.
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 19 Aug 2024 (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.
This single-arm pilot study aims to investigate the efficacy and safety of a combined non-ablative Erbium:Yttrium-Aluminium-Garnet (Er:YAG) laser and High Intensity Tesla magnetic Stimulation (HITS) treatment for female urinary incontinence. The study involves 25 women diagnosed with mild to moderate stress or mixed urinary incontinence. Participants will receive three vaginal Er:YAG laser treatments and six HITS sessions. The primary objective is to improve symptoms of urinary incontinence, as measured by changes in scores on two questionnaires compared to baseline. Secondary objectives include improvement in sexual function, durability of improvement in urinary incontinence symptoms at 3- and 6- month follow-up, patient-reported improvement, and discomfort during treatment.
Detailed description
The aim of this single-centre, single-arm pilot study is to investigate the combined effects of vaginal Er:YAG laser and HITS treatment on urinary incontinence (UI) in women. The study will involve 25 women suffering from mild to moderate stress urinary incontinence or mixed urinary incontinence. The aim of the study is to investigate whether the combination of non-ablative Er:YAG laser therapy and HITS can have a synergistic effect in relieving UI symptoms. Participants will undergo three sessions of intravaginal laser treatment according to the IncontiLase® Er:YAG laser protocol and six HITS sessions. The laser treatments will take place one month apart, while the HITS sessions will take place twice a week for three weeks after the last laser treatment.
Primary endpoints include improvement in UI symptoms as measured by changes in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and Questionnaire for Urinary Incontinence Diagnosis (QUID) scores from baseline to post-treatment. Secondary endpoints include improvement in sexual function as measured by the Female Sexual Function Index (FSFI), durability of improvement in UI symptoms 3 and 6 months after treatment, patient-reported global impression of improvement (Patient Global Impression of Improvement, PGI-I), and treatment-related discomfort as measured by the Visual Analog Scale (VAS) for pain.
The study also includes rigorous safety assessments and monitoring of adverse events or complaints during and after the treatments. Recruitment of participants will ensure that they meet certain inclusion criteria, such as adult women with a clinical diagnosis of stress or mixed UI, as well as exclusion criteria to minimize risks and improve compliance.
Statistical analysis will be performed using various tests to check the data for normality and distribution. The results of the study should provide valuable insight into the efficacy and safety of combining laser and HITS treatments for female urinary incontinence and potentially provide a new non-invasive treatment option for this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser + HITS | Experimental | Device: non-ablative Er:YAG laser and high intensity Tesla magnetic stimulation (HITS)The treatment involved three consecutive Er:YAG laser sessions (TimeWalker® Intima Laser™, Fotona) followed by six HITS treatments (StarFormer® IntimaWave®, Fotona). The laser sessions were spaced one month apart, following the IncontiLase® protocol using the G-Runner robotic handpiece. The protocol included three steps: (i) intravaginal laser treatment of the anterior vaginal wall, (ii) treatment of the entire vaginal canal, and (iii) treatment of the vestibule and introitus. Each session lasted 20 minutes. Six weeks after the final laser treatment, patients received six HITS treatments, with two sessions per week. The HITS protocol involved increasing stimulation frequencies, each for 10 minutes, with the total session lasting 30 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult female, 18 years of age or older
- Clinical diagnosis of stress or mixed urinary incontinence, with stress incontinence as the predominant symptom
Key exclusion criteria (12 listed)
- Very severe urinary incontinence (ICIQ-UI SF score at baseline >18)
- Pregnancy
- BMI>35
- Not willing to abstain from vaginal intercourse for one week following the laser-therapy
- Acute urinary tract infections (UTIs)
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 |
|---|---|---|
| non-ablative Er:YAG laser and high intensity Tesla magnetic stimulation (HITS)Patients will initially undergo three monthly intravaginal treatments with the Er:YAG laser. Six weeks after the final laser treatment, patients will receive six sessions of magnetic stimulation. During these sessions, patients will sit on a specialized chair that generates a therapeutic magnetic field. | Device | Laser + HITS |
Primary outcome
Efficacy of the combined laser and HITS treatment
Time frame: up to 6 months after treatment
Improvement of symptoms of stress and/or mixed urinary incontinence as measured by change in ICIQ-UI SF and QUID scores from the baseline.
Safety of the combined laser and HITS treatment
Time frame: up to 6 months after treatment
Incidence and severity of treatment-related Adverse Events
4 secondary outcomes
Improvement of sexual function
Time frame: up to 6 months after treatment
Durability of the effect
Time frame: up to 6 months after treatment
Patient reported assessment of improvement
Time frame: up to 6 months after treatment
Patient reported assessment of discomfort during treatment
Time frame: up to 24 hours after each laser and HITS session
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 19 Aug 2024.
- 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.
Tadeja Štrumbelj, MD principal investigator
Zdravstveni Zavod Štrumbelj
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-ablative Er:YAG laser and high intensity Tesla magnetic stimulation (HITS) in people with Stress Urinary Incontinence and Urinary Incontinence, run by Zdravstveni Zavod Štrumbelj at 1 site in Slovenia.
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 12 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 19 Aug 2024. 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 Slovenia. 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?
Efficacy of the combined laser and HITS treatment (time frame: up to 6 months after 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?
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 19 Aug 2024.