Back to resultsLaser and High Intensity Tesla Magnetic Stimulation (HITS) for Stress Urinary Incontinence (SUI)
Primary Purpose
Stress Urinary Incontinence
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laser and High intensity Tesla magnetic stimulation
laser (without HITS treatment)
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring SUI, Incontinence, Laser, High Intensity Tesla Magnetic Stimulation
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Arm 1: laser and HITS treatment
Arm 2: laser (without HITS treatment)
Arm Description
Laser and magnetic chair Treatment
Laser treatment
Outcomes
Primary Outcome Measures
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.
Adverse events
The number and severity of treatment-related Adverse Events.
Secondary Outcome Measures
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.
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).
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.
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.
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 )
Full Information
NCT ID
NCT05670392
First Posted
December 20, 2022
Last Updated
January 1, 2023
Sponsor
Cork University Maternity Hospital
Collaborators
Fotona d.o.o.
1. Study Identification
Unique Protocol Identification Number
NCT05670392
Brief Title
Laser and High Intensity Tesla Magnetic Stimulation (HITS) for Stress Urinary Incontinence (SUI)
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cork University Maternity Hospital
Collaborators
Fotona d.o.o.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the efficacy of combined laser and HITS treatment for female stress urinary incontinence (SUI)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
SUI, Incontinence, Laser, High Intensity Tesla Magnetic Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a two-arm parallel assignment, randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: laser and HITS treatment
Arm Type
Active Comparator
Arm Description
Laser and magnetic chair Treatment
Arm Title
Arm 2: laser (without HITS treatment)
Arm Type
Other
Arm Description
Laser treatment
Intervention Type
Device
Intervention Name(s)
laser and High intensity Tesla magnetic stimulation
Intervention Description
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(.
Intervention Type
Device
Intervention Name(s)
laser (without HITS treatment)
Intervention Description
Three (3) non-ablative Er:YAG laser treatments will be applied at monthly intervals as described above.
Primary Outcome Measure Information:
Title
Symptoms of stress urinary incontinence
Description
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.
Time Frame
measured at 3 and 6 months
Title
Adverse events
Description
The number and severity of treatment-related Adverse Events.
Time Frame
up to 6 month post procedure
Secondary Outcome Measure Information:
Title
QUID - Questionnaire for Urinary Incontinence Diagnosis
Description
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.
Time Frame
measured at 3 and 6 months
Title
FSFI - The Female Sexual Function Index
Description
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).
Time Frame
measured at 3 and 6 months
Title
PGI-I - Patient Global Impression of Improvement
Description
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.
Time Frame
measured at 3 and 6 months
Title
One-hour pad test.
Description
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.
Time Frame
measured at 3 and 6 months
Title
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Description
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 )
Time Frame
measured at 3 and 6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female genitalia
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yair Daykan, M.D
Phone
+353216013387
Email
yair.dykan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suzan Wilson, M.D
Phone
+353858887814
Email
suzi_f_wilson@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry O'Reilly, Prof.
Organizational Affiliation
Cork University Maternity Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31828400
Citation
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.
Results Reference
background
PubMed Identifier
15008725
Citation
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.
Results Reference
background
PubMed Identifier
30288727
Citation
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.
Results Reference
result
PubMed Identifier
31235706
Citation
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.
Results Reference
result
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Laser and High Intensity Tesla Magnetic Stimulation (HITS) for Stress Urinary Incontinence (SUI)
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