Comparing laser therapy to sham treatment for stress urinary incontinence in women
Intraurethral Laser Therapy for Stress Urinary Incontinence: A Randomized Sham - Controlled Clinical Study
This study is testing whether a new laser treatment can help women with stress urinary incontinence feel better compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Medical University of Graz Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Graz, Styria) |
| Trial ID | NCT04707690 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intraurethral laser therapy in women diagnosed with stress urinary incontinence (SUI). It is a randomized, double-blinded, sham-controlled study where participants will receive either the active laser treatment or a sham treatment. The primary outcome will assess the impact of SUI on the visual analogue scale (VAS) three months post-treatment. Secondary outcomes include subjective and objective measures of SUI, quality of life, treatment satisfaction, and intraurethral microbiome analysis.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-80 with diagnosed SUI I-II° and experiencing at least one incontinence episode per day.
Not a fit: Patients with active urinary tract infections or significant urinary tract complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for women suffering from stress urinary incontinence.
How similar studies have performed: While intraurethral laser therapy is a novel approach, similar studies have shown promising results in treating urinary incontinence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Graz, Styria
- Departement of Obstetrics and Gynecology — Graz, Styria, Austria (Recruiting)
Study contacts
- Study coordinator: Daniela Gold, MD PhD
- Email: daniela.gold@medunigraz.at
- Phone: 0043316 385 81437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.