Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000458538p
Ethics application status
Submitted, not yet approved
Date submitted
20/11/2023
Date registered
15/04/2024
Date last updated
15/04/2024
Date data sharing statement initially provided
15/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Vaginal Laser therapy for Treatment of Stress Urinary Incontinence
Scientific title
Investigating the effect of Er-YAG Surgical Laser on Stress Urinary Incontinence symptoms in adult women – a randomised control trial.
Secondary ID [1] 310997 0
None
Universal Trial Number (UTN)
Trial acronym
LATSI study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress urinary incontinence 332102 0
Condition category
Condition code
Renal and Urogenital 328823 328823 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
If happy to participate, they will have their urine tested for infection (dipstick urinalysis) and pregnancy. If urinalysis is negative, they will be receiving laser or sham treatment as outlined. The whole appointment lasts approximately 30 minutes. The patient can return to most normal activities immediately but should refrain from intercourse for 2 weeks and vigorous exercise for 1 week. They will be given a leaflet outlining what to expect and a contact number if they have any concerns or questions. They will be asked about any deleterious effects since their last appointment and asked to complete an ICIQ-UI-SF; UDI-6; PGI-I and PASS questionnaire (treatment 2 onwards). Patients will routinely receive 3 treatments. Each treatment can be 6 weeks apart (+/- 14 days) (ie. from 1 -2 months apart).

The treatment protocol using the three phase IntimaLase protocol with glass speculum will be following the standard parameters by the manufacturer:

Three non-ablative Er:YAG IncontiLase® treatments applied by a doctor of the research team at monthly intervals.
The IncontiLase® protocol consists of three steps:
1. Intravaginal laser pulses with a directed angular, patterned laser beam (PS03-GAc, 7 mm, 6 J/cm2, 2.0 Hz, seven pulses, six positions, one pass per position)
2. Intravaginal laser pulses with a circular full laser beam (R11-GCc, 7 mm, 3 J/cm2, 2.0 Hz, seven pulses, two passes)
3. Laser pulses of vestibule and introitus with a straight, patterned laser (PS03, 7 mm, 10 J/cm2, 1.6 Hz, two to three pulses, two to three passes, 10% overlapping)
The total duration of the treatment: 20 min/session.

Treatment complication and discomfort evaluation will be performed after each treatment. Participants will be asked if they would recommend this treatment to a friend as a proxy for treatment acceptability.

Patients will be invited to attend a follow up visit 3, 6 and 12 months after the 3rd treatment. They will be asked if they are happy to continue to participate in the trial and if happy, asked to complete Severity Index, ICIQ-SF, UDI-6, PGI-I and PASS symptom questionnaires and undergo a clinical examination to ensure the tissues are healthy. At 6 months after treatment, the patients will be asked if they reconsider retreatment and what treatment they got in their opinion.
They will receive a transperineal ultrasound and will be asked to perform a 1 hour pad test at 3, 6 and 12 months. perform Patients randomised to the Sham arm will be un-blinded at 6 months and offered the three treatments if they wish.
Intervention code [1] 327439 0
Treatment: Devices
Comparator / control treatment
The treatment protocol using the three phase IntimaLase protocol with glass speculum will be following the standard parameters by the manufacturer:

Three non-ablative Er:YAG IncontiLase® treatments applied at monthly intervals.
The IncontiLase® protocol consists of three steps:
1. Intravaginal laser pulses with a directed angular, patterned laser beam (PS03-GAc, 7 mm, 6J/cm2, 2.0 Hz, seven pulses, six positions, one pass per position)
2. Intravaginal laser pulses with a circular full laser beam (R11-GCc, 7 mm, 3 J/cm2, 2.0 Hz, seven pulses, two passes)
3. Laser pulses of vestibule and introitus with a straight, patterned laser (PS03, 7 mm, 10J/cm2, 1.6 Hz, two to three pulses, two to three passes, 10% overlapping) The total duration of the treatment: 20 min/session.

For the sham group, the laser shutter (which blocks the beam) will be used. 9 whole vagina passes.

Treatment complication and discomfort evaluation will be performed after each treatment. Participants will be asked if they would recommend this treatment to a friend as a proxy for treatment acceptability.

Patients will be invited to attend a follow up visit 3, 6 and 12 months after the 3rd treatment. They will be asked if they are happy to continue to participate in the trial and if happy, asked to complete Severity Index, ICIQ-SF, UDI-6, PGI-I and PASS symptom questionnaires and undergo a clinical examination to ensure the tissues are healthy. At 6 months after treatment, the patients will be asked if they reconsider retreatment and what treatment they got in their opinion.
They will receive a transperineal ultrasound and will be asked to perform a 1 hour pad test at 3, 6 and 12 months. perform Patients randomised to the Sham arm will be un-blinded at 6 months and offered the three treatments if they wish.
Control group
Placebo

Outcomes
Primary outcome [1] 336628 0
Change in stress urinary incontinence symptoms.
Timepoint [1] 336628 0
Baseline and 6 months after last treatment (primary endpoint). And 12 months post last treatment.
Secondary outcome [1] 429054 0
Urinary distress
Timepoint [1] 429054 0
baseline and 6 months after last treatment. Patients will be followed-up until 12 months post last treatment.
Secondary outcome [2] 433288 0
To assess the subjective change in stress urinary incontinence after laser treatment against sham

Timepoint [2] 433288 0
at 3 months after the last treatment.
Secondary outcome [3] 433289 0
To determine subjective cure rate
Timepoint [3] 433289 0
3 months, 6 months and 12 months post last treatment
Secondary outcome [4] 433290 0
To assess the reduction in standardised 1 hr pad weight test following treatment compared with Sham.
Timepoint [4] 433290 0
between baseline and at 6 months after the last treatment
Secondary outcome [5] 433291 0
To assess the intention of retreatment
Timepoint [5] 433291 0
at 6 months after the last treatment
Secondary outcome [6] 433293 0
To examine change in urethral rotation, retrovesical angle and bladder neck descent. This will be assessed as a composite outcome
Timepoint [6] 433293 0
pre-intervention and 3 months, 6 months and 12 months after the last laser treatment.
Secondary outcome [7] 433975 0
Urinary distress
Timepoint [7] 433975 0
baseline and 6 months after last treatment. Patients will be followed-up until 12 months post last treatment.

Eligibility
Key inclusion criteria
• Adult Female, 18 years of age or older
• Slight to severe stress urinary incontinence, based on the Severity Index for Urinary Incontinence in women.
• No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training
• Capable of providing informed consent and able to return for follow-up.
• Normal Cervical screening test within last five years
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Very severe stress urinary incontinence, based on the Severity Index for Urinary Incontinence in women.
• Diagnosis of OAB wet, based on UDI-6, question 2 “urine leakage related to the feeling of urgency” – answer “Moderately OR Greatly”.
• Presence of vesicovaginal fistula
• Fecal incontinence
• Pregnant subjects or women less than 12-months post-partum
• Actively breastfeeding or ceased breastfeeding less than three menstrual cycles
• Any previous prolapse surgery
• Any previous incontinence surgery
• Any radical pelvic surgery
• Transvaginal mesh or sling implant
• Pre-existing bladder pathology including prior radiation treatment.
• Previous surgery in the treatment area in the last year.
• Active genital infection
• Subject presenting with a cervical screening test demonstrating cervical dysplasia or another reason for colposcopic assessment
• Systemic steroids use within the last 3 months
• Pelvic organ prolapse (POP) > stage 2 according to pelvic organ prolapse quantification system
• Diagnosis of collagen disorders eg. Benign joint hypermobility/Ehlers-Danlos/Marfan etc.
• Serious systemic disease or any chronic condition that could interfere with study compliance.
• Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
• Other contraindications to laser treatment: UTI, injury or bleeding in areas of tissue to be treated (vestibule and anterior vaginal wall), Morbid obesity (BMI>40), Diabetes, A history of Photosensivity disorder or use of photosensitivity medications, abnormal scarring, excessive sun exposure, preoperative histology findings indicative of malignancy.
• Unwillingness or inability to complete follow-up schedule
• Unwillingness or inability to give Informed Consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized with 2:1 probability to Er:YAG or sham using a central computer-generated random allocation in blocks of 4-8. Subjects will be randomised in order of entry into the study. Treatment visits will be booked.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
1/01/2026
Actual
Date of last data collection
Anticipated
1/05/2028
Actual
Sample size
Target
147
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 315260 0
Self funded/Unfunded
Name [1] 315260 0
Country [1] 315260 0
Primary sponsor type
Individual
Name
Anna Rosamilia
Address
Monash Health, 823-865 Centre Rd, Bentleigh East, Vic 3165
Country
Australia
Secondary sponsor category [1] 317294 0
None
Name [1] 317294 0
Address [1] 317294 0
Country [1] 317294 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314178 0
Monash Health HREC
Ethics committee address [1] 314178 0
823-865 Centre Rd, Bentleigh East, Vic 3165
Ethics committee country [1] 314178 0
Australia
Date submitted for ethics approval [1] 314178 0
21/11/2023
Approval date [1] 314178 0
Ethics approval number [1] 314178 0

Summary
Brief summary
The aim of this study is to evaluate the use of Er:YAG laser treatment as a potential treatment for women with slight to severe stress urinary inconctinence. We hypothesize that Er:YAG Laser is superior to sham therapy in women who have slight to severe stress urinary incontinence, based on the Severity Index for Urinary Incontinence in women, with subjective improvement rates defined as a Minimal Important Difference (MID) of 4 points on the ICIQ-UI-SF questionnaire.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130690 0
Prof Anna Rosamilia
Address 130690 0
Monash Health,823-865 Centre Rd, Bentleigh East, Vic 3165
Country 130690 0
Australia
Phone 130690 0
+61 0395096500
Fax 130690 0
Email 130690 0
Anna.rosamilia@monashhealth.org
Contact person for public queries
Name 130691 0
Dr Sascha Vereeck
Address 130691 0
Monash health, 823-865 Centre Rd, Bentleigh East, Vic 3165
Country 130691 0
Australia
Phone 130691 0
+61 0395096500
Fax 130691 0
Email 130691 0
sascha.vereeck@monashhealth.org
Contact person for scientific queries
Name 130692 0
Dr Sascha Vereeck
Address 130692 0
Monash health, 823-865 Centre Rd, Bentleigh East, Vic 3165
Country 130692 0
Australia
Phone 130692 0
+61 0395096500
Fax 130692 0
Email 130692 0
sascha.vereeck@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.