Status:
RECRUITING
IUL Study A Randomized Sham - Controlled Clinical Study
Lead Sponsor:
Medical University of Graz
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
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.
Detailed 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. Stud...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04707690
Start Date
January 8 2021
End Date
January 1 2025
Last Update
January 18 2024
Active Locations (1)
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1
Departement of Obstetrics and Gynecology
Graz, Styria, Austria, 8036