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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: laser and High intensity Tesla magnetic stimulation; Device: laser (without HITS treatment)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yair Daykan, M.D; Phone Number: +353216013387; Email: yair.dykan@gmail.com
• Study Contact Backup: Name: Suzan Wilson, M.D; Phone Number: +353858887814; Email: suzi_f_wilson@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Adult female, 18 years of age or older
2. Clinical diagnosis of stress or mixed urinary incontinence, with stress incontinence as the predominant symptom (SUI or MUI)

Exclusion Criteria:

1. 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)
2. Pregnancy
3. BMI>35
4. Acute urinary tract infections (UTIs)
5. 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)
6. Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection
7. Prolapse grade 2 or higher
8. History of radiotherapy for cervical or uterine cancer
9. Medical condition that may interfere with participants' compliance to the protocol
10. Medical condition for which the HITS and laser therapy are contraindicated
11. Previous laser or HITS treatment for SUI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: laser and HITS treatment; Laser and magnetic chair Treatment	Device: laser and High intensity Tesla magnetic stimulation; 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(.
Other: Arm 2: laser (without HITS treatment); Laser treatment	Device: laser (without HITS treatment); Three (3) non-ablative Er:YAG laser treatments will be applied at monthly intervals as described above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 at 3 and 6 months
Adverse events	The number and severity of treatment-related Adverse Events.	up to 6 month post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 at 3 and 6 months
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 at 3 and 6 months
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 at 3 and 6 months
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 at 3 and 6 months
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 at 3 and 6 months

Collaborators and Investigators

• Sponsor: Cork University Maternity Hospital
• Collaborators: Fotona d.o.o.
• Investigators: Principal Investigator: Barry O'Reilly, Prof., Cork University Maternity Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): January 31, 2025
• Study Completion (Anticipated): January 31, 2025

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: January 1, 2023
• First Posted (Estimate): January 4, 2023

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Incontinence; SUI; Laser; High Intensity Tesla Magnetic Stimulation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: LASERHITS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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