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Laser Therapy

Intravaginal and intraurethral Treatment for Stress Incontinence

N/A
Waitlist Available
Research Sponsored by Fotona d.o.o.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months

Summary

Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence.

Eligible Conditions
  • Stress Incontinence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by Questionnaire for voiding symptoms (based on IPSS)
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by measure uroflow and post void residual (PVR)
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by recording the incidence and severity of complications
+2 more
Secondary study objectives
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by 24-Hour Pad-Weight Test
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by ICIQ-UI short form questionnaire
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording 3-day voiding diary
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Intravaginal and intraurethral TreatmentExperimental Treatment2 Interventions
Intravaginal and intraurethral Fotona SP Dynamis Treatment Intravaginal Treatment - energy delivered intravaginally and intraurethrally.
Group II: Intravaginal TreatmentActive Control1 Intervention
Intravaginal Fotona SP Dynamis Treatment - energy delivered intravaginally.
Group III: Sham TreatmentPlacebo Group1 Intervention
Sham Fotona SP Dynamis Treatment - minimum energy delivered through sham handpiece.

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Who is running the clinical trial?

Fotona d.o.o.Lead Sponsor
7 Previous Clinical Trials
413 Total Patients Enrolled
~7 spots leftby Nov 2025
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