IUL Study A Randomized Sham - Controlled Clinical Study

Medical University of Graz

Status: Enrolling

Conditions: Stress Urinary Incontinence

Treatments: Device: Intraurethral SHAM laser therapy; Device: Intraurethral laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04707690

V1

Details and patient eligibility

About

Primary aim of the study is to compare the impact of SUI on the VAS (visual analogue scale) 3 months after laser therapy versus sham laser therapy.

Full description

Background: Stress urinary incontinence (SUI) has a huge impact on the quality of life (QoL) in women and its treatment is challenging. Intraurethral laser may be an additional treatment option.

Study aim: The aim is to study the effectiveness of intraurethral laser therapy in women with SUI.

Design: randomized double blinded sham - controlled clinical study

Study population: women which have been diagnosed with SUI I-II°, aged between 18-80 years.

Study groups: Participants will be randomized (1:1), without stratification. The Intervention group will receive 2 treatments of intraurethral laser therapy and the Control group will receive 2 treatments of intraurethral SHAM laser therapy.

Sample size: A sample size of 20 women, 8 per group including a 20% Drop Out Rate, was calculated.

Primary outcome: impact of SUI on the VAS scale 3 months after laser therapy versus sham laser therapy.

Secondary study outcomes were defined as subjective SUI, objective SUI, QoL, treatment satisfaction, intraurethral microbiome, 3 months after laser therapy versus sham laser therapy.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female between 18 and 80 years
• Confirmed SUI through cough stress test within the last 24 months
• SUI I-II° for more than 6 months
• At least one incontinence episode per 24 hour period measured over three days according to a bladder diary
• Valsalva leak-point pressure (VLPP) ≤60 cm H2O
• Maximum cystometric capacity ≥250 mL
• No pelvic surgery within last 6 months (including prolapse repair, subjects who have residual or recurrent SUI following colposuspension or a sling procedure may be included in the study if the procedure was conducted at least 6 months prior to screening /baseline visit)
• BMI (body mass index) ≤35 kg/m2
• Willing to give informed consent and complete the follow up schedule

Exclusion criteria

• Active lower urinary tract infections (urethritis, cystitis or vaginitis)
• Three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months
• Detrusor overactivity on urodynamics
• Postvoiding residual (PVR) > 100 ml
• Previous urethral surgery (i.e. fistula or diverticula)
• Pelvic organ prolapse grade > 3 as defined by POP-Q and symptomatic
• Known polyuria (>3l/24h)
• Unevaluated macro hematuria
• Neurogenic bladder
• Evidence of dysplasia in a Pap smear (done in the last 24 months)
• Tumours of the Urinary tract
• Previous radiation or brachytherapy to treat pelvic cancer
• Uncontrolled diabetes
• Active herpes genitalis
• Pregnancy
• Vaginal delivery within 6 months prior to the Screening/Baseline Visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Intraurethral laser therapy

Active Comparator group

Description:

Before treatment the vulva will be carefully inspected to rule out signs of infection or recent trauma. A local anesthetic fluid (Cathejell ®) will be applied to the urethral meatus. Before laser therapy, an intraurethral swab will be taken before treatment in order to determine the intraurethral microbiome. Vulvovaginal laser therapies will be performed with the non-ablative 2940 nm Er:YAG laser (Smooth XS, Fotona, Slovenia) in the Incontinence mode according to the manufacturer's guidelines and recommendations. The spot size (diameter of the laser beam) is 7 mm, with a pulse at a frequency of 1.6 Hz, and a fluence (laser energy delivered per unit area) of 5.0 to 10.0 J/cm2.

Treatment:

Device: Intraurethral laser therapy

Intraurethral SHAM laser therapy

Placebo Comparator group

Description:

Clinical examination and preparations will be identical to the intervention group. Sham laser treatments will be performed with the same laser and the same device. However, a specially designed placebo probe, which blocks the emission of radiation, will be used. Women will therefore receive no therapeutic laser treatment. Before treatment, a study assistant, who is aware of the study allocation, will prepare the laser with the placebo probe, which looks identically to the "normal" probe. The treating physician will not be aware of the study allocation and the type of probe in use.

Treatment:

Device: Intraurethral SHAM laser therapy