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

NCT05670392 | Unknown DMC

• 1 other identifier: LASERHITS
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Stress Urinary Incontinence

Keywords

SUI; Incontinence; Laser; High Intensity Tesla Magnetic Stimulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• QUID - Questionnaire for Urinary Incontinence Diagnosis

  measured at 3 and 6 months

• FSFI - The Female Sexual Function Index

  measured at 3 and 6 months

• PGI-I - Patient Global Impression of Improvement

  measured at 3 and 6 months

• One-hour pad test.

  measured at 3 and 6 months

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

  measured at 3 and 6 months

Study Arms (2)

Arm 1: laser and HITS treatment

ACTIVE COMPARATOR

Laser and magnetic chair Treatment

Device: laser and High intensity Tesla magnetic stimulation

Arm 2: laser (without HITS treatment)

OTHER

Laser treatment

Device: laser (without HITS treatment)

Interventions

laser and High intensity Tesla magnetic stimulation DEVICE

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(.

Arm 1: laser and HITS treatment

laser (without HITS treatment) DEVICE

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

Arm 2: laser (without HITS treatment)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female genitalia
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cork University Maternity Hospital: lead
• Fotona d.o.o.: collaborator

Related Publications (4)

• 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.

  PMID: 31828400 BACKGROUND

• 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.

  PMID: 15008725 BACKGROUND

• 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.

  PMID: 30288727 RESULT

• 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.

  PMID: 31235706 RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Lasers

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Barry O'Reilly, Prof.

  Cork University Maternity Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yair Daykan, M.D

CONTACT

+353216013387; yair.dykan@gmail.com

Suzan Wilson, M.D

CONTACT

+353858887814; suzi_f_wilson@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Urogynecology department

Model Details: a two-arm parallel assignment, randomized control trial

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 4, 2023
• Study Start: February 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share