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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
Awards & highlights

Study Summary

This study is evaluating whether a combination of two laser treatments is safe and effective for treating 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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.

Find a Location

Who is running the clinical trial?

Fotona d.o.o.Lead Sponsor
6 Previous Clinical Trials
388 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Intraurethral/Intravaginal 2940 nm Erbium Laser Treatment For Stress Urinary Incontinence
2018. "Intraurethral/Intravaginal 2940 nm Erbium Laser Treatment For Stress Urinary Incontinence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03676894.
All > Urinary Incontinence
~8 spots leftby Apr 2025
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