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Stress Urinary IncontinenceNCT05670392

Laser and High Intensity Tesla Magnetic Stimulation (HITS) for Stress Urinary Incontinence (SUI)

A study testing laser and High intensity Tesla magnetic stimulation and laser (without HITS treatment) in people with Stress Urinary Incontinence, run by Cork University Maternity Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To investigate the efficacy of combined laser and HITS treatment for female stress urinary incontinence (SUI) Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Stress Urinary Incontinence
What is being tested?
laser and High intensity Tesla magnetic stimulation and laser (without HITS treatment)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
1 Feb 2023to 31 Jan 2025
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
  • Healthy volunteers accepted
  • 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 (SUI or MUI)

Who cannot join

  • Very severe urinary incontinence (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) ICIQ-UI )score at baseline >18 or Pad test > 50 gr)
  • Pregnancy
  • BMI>35
  • 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)
  • Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection
Show all 11Show fewer
  • 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 SUI

Trial locations and contacts

No sites are listed yet.

Yair Daykan, M.D contact

+353216013387

yair.dykan@gmail.com

Suzan Wilson, M.D contact

+353858887814

suzi_f_wilson@hotmail.com

About this study

Official title: The Advantage of Combined Non-ablative Erbium Yttrium Aluminum Garnet Laser and High Intensity Tesla Magnetic Stimulation for Treatment of Female Stress Urinary Incontinence

To investigate the efficacy of combined laser and HITS treatment for female stress urinary incontinence (SUI)

Read the detailed description

This study is a single-centre, two-arm randomized control trial study conducted according to Helsinki Declaration. Women with symptoms of stress urinary incontinence (SUI) (stress or mixed with stress incontinence as the predominant symptom) will be enrolled.

The efficacy and safety of combined treatment with non-ablative intravaginal Er:YAG laser procedure and high intensity Tesla magnetic stimulation will be compared to the treatment of non-ablative intravaginal Er:YAG laser alone.

Being tested
laser and High intensity Tesla magnetic stimulation, laser (without HITS treatment)
Keywords
SUI, Incontinence, Laser, High Intensity Tesla Magnetic Stimulation
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.

  • laser and High intensity Tesla magnetic stimulationDevice

    Three (3) non-ablative Er:YAG laser treatments will be applied at monthly intervals followed by Eight (8) HITS therapies) Patients will receive two (2) HITS treatments per week for four (4) weeks(.

  • laser (without HITS treatment)Device

    Three (3) non-ablative Er:YAG laser treatments will be applied at monthly intervals as described above.

Study groups in NCT05670392
Study groupRoleWhat they receive
Arm 1: laser and HITS treatmentActive comparatorLaser and magnetic chair Treatment
Receives: Device: laser and High intensity Tesla magnetic stimulation
Arm 2: laser (without HITS treatment)OtherLaser treatment
Receives: Device: laser (without HITS treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptoms of stress urinary incontinence

    Change of symptoms of stress and/or mixed urinary incontinence as measured by change in one hour pad test (gr/h) results at the end of treatment period from the baseline results.

    Measured: measured at 3 and 6 months

  2. Adverse events

    The number and severity of treatment-related Adverse Events.

    Measured: up to 6 month post procedure

Secondary outcomes (5)

  1. QUID - Questionnaire for Urinary Incontinence Diagnosis

    The Questionnaire for Urinary Incontinence Diagnosis (QUID) identifies the presence and frequency of stress and urge incontinence symptoms. Three items focus on stress incontinence symptoms and three on urge incontinence symptoms. Each item includes 6 frequency-based response options, ranging from "none of the time" to "all of the time", which are scored from 0 to 5 points. Scores are calculated in an additive fashion, resulting in separate Stress and Urge scores, each ranging from 0 to 15 points.

    Measured: measured at 3 and 6 months

  2. FSFI - The Female Sexual Function Index

    FSFI - The Female Sexual Function Index is a generalized questionnaire utilized to assess sexual function in women in a general population. It has been validated on clinically diagnosed samples of women with female sexual arousal disorder, female orgasmic disorder, and hypoactive sexual desire disorder.

    Scoring is between 2 (low sexual function)-36 (high sexual function).

    Measured: measured at 3 and 6 months

  3. PGI-I - Patient Global Impression of Improvement

    The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians.

    1-7: Very much better- 1, Much better -2, A little better-3, No change-4, A little worse-5, Much worse-6, Very much worse-7.

    Measured: measured at 3 and 6 months

  4. One-hour pad test.

    he testing protocol has been standardized by International Continence Society (ICS-pad test):

    • the test is started by putting one pre-weighted pad without patient voiding,
    • patient drinks 500 ml of sodium-free liquid in <15 min- then sits or rests,
    • patient walks for 30 min, including climbing one flight of stairs (up and down),
    • patient performs the following activities: standing up from sitting (10x), coughing vigorously (10x), running on the spot for 1 min, bending to pick up an object from the floor (5x), and washing hands in running water for 1min (this activity program may be modified according to the patient's physical fitness),
    • the total amount of urine leaked is determined by weighing the pad. If a moderately full bladder cannot be maintained through the hour (if the patient must void), the test has to be started again.

    Measured: measured at 3 and 6 months

  5. International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

    The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. This short and simple questionnaire is also of use to general practitioners and clinicians in both primary and secondary care institutions to screen for incontinence, to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence and to facilitate patient-clinician discussions. Scoring is between 0 to 21 (worse symptoms )

    Measured: measured at 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2023
  2. Study start1 Feb 2023 (estimated)
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Resources

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
Model description
a two-arm parallel assignment, randomized control trial
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05670392
Sponsor's protocol ID
LASERHITS
Status last verified
Jan 2023
First submitted
20 Dec 2022
Last updated
4 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kuszka A, Gamper M, Walser C, Kociszewski J, Viereck V. Erbium:YAG laser treatment of female stress urinary incontinence: midterm data. Int Urogynecol J. 2020 Sep;31(9):1859-1866. doi: 10.1007/s00192-019-04148-9. Epub 2019 Dec 11.

    PubMed 31828400

  • Chandi DD, Groenendijk PM, Venema PL. Functional extracorporeal magnetic stimulation as a treatment for female urinary incontinence: 'the chair'. BJU Int. 2004 Mar;93(4):539-42. doi: 10.1111/j.1464-410x.2003.04659.x.

    PubMed 15008725

  • Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005654. doi: 10.1002/14651858.CD005654.pub4.

    PubMed 30288727

  • He Q, Xiao K, Peng L, Lai J, Li H, Luo D, Wang K. An Effective Meta-analysis of Magnetic Stimulation Therapy for Urinary Incontinence. Sci Rep. 2019 Jun 24;9(1):9077. doi: 10.1038/s41598-019-45330-9.

    PubMed 31235706

Questions about this trial

What is this clinical trial studying?

A study testing laser and High intensity Tesla magnetic stimulation and laser (without HITS treatment) in people with Stress Urinary Incontinence, run by Cork University Maternity Hospital.

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 11 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 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yair Daykan, M.D (+353216013387, yair.dykan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptoms of stress urinary incontinence (time frame: measured at 3 and 6 months). 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 NCT05670392, which also lists 4 linked publications.

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 4 Jan 2023.

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