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

Not Applicable

Not yet recruiting

• Conditions: Stress Urinary Incontinence
• Interventions: Device: laser (without HITS treatment); Device: laser and High intensity Tesla magnetic stimulation

• Registration Number: NCT05670392
• Lead Sponsor: Cork University Maternity Hospital

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.

Study Timeline

• Study First Submitted: 2022-12-20
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-01
• Last Update Submitted: 2023-01-01
• Study First Posted: 2023-01-04
• Last Update Posted: 2023-01-04
• Study Start: 2023-02-01
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: laser (without HITS treatment)	laser (without HITS treatment)	Laser treatment
Arm 1: laser and HITS treatment	laser and High intensity Tesla magnetic stimulation	Laser and magnetic chair Treatment

Primary Outcome Measures

Name	Time	Method
Adverse events	up to 6 month post procedure	The number and severity of treatment-related Adverse Events.
Symptoms of stress urinary incontinence	measured at 3 and 6 months	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.

Secondary Outcome Measures

Name	Time	Method
PGI-I - Patient Global Impression of Improvement	measured at 3 and 6 months	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.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)	measured at 3 and 6 months	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 )
QUID - Questionnaire for Urinary Incontinence Diagnosis	measured at 3 and 6 months	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	measured at 3 and 6 months	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).
One-hour pad test.	measured at 3 and 6 months	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.