IUL Study A Randomized Sham - Controlled Clinical Study
Stress Urinary Incontinence
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Laser therapy, Stress urinary incontinence, intraurethral
Eligibility Criteria
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
Sites / Locations
- Departement of Obstetrics and GynecologyRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Intraurethral laser therapy
Intraurethral SHAM laser therapy
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.
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.