Safety and Efficacy of Non-ablative Er:YAG Laser Therapy for the Treatment of Pelvic Organ Prolapse and Coexisting Stress Urinary Incontinence: A Retrospective Case Series.

Study Overview
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Brief Summary
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The objective of the study is to retrospectively collect the data on patients who underwent pelvic organ prolapse treatment using a non-ablative Er:YAG laser with SMOOTH mode and to conduct an objective evaluation of safety and efficacy of Er:YAG laser treatment. In a group of patients that have concomitant stress urinary incontinence symptoms, the effectiveness of the treatments on these symptoms will be evaluated as well.

Detailed Description
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Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) affect many women and can dramatically decrease their quality of life. Most of the patients diagnosed with stress urinary incontinence also have a degree of pelvic organ prolapse and vice-versa. One of the more promising new approaches in treating disorders connected to pelvic floor dysfunction has been the introduction of vaginal erbium laser treatment for pelvic organ prolapse. The primary aim of the present retrospective study was toassess the effectiveness of vaginal erbium laser with SMOOTH mode for the treatment of patients with pelvic organ prolapse and co-existing stress urinary incontinence, if present.

Official Title
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Safety and Efficacy of Non-ablative Er:YAG Laser Therapy for the Treatment of Pelvic Organ Prolapse and Coexisting Stress Urinary Incontinence: A Retrospective Case Series.

Conditions
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Cystocele, Pelvic Organ Prolapse, Stress Urinary Incontinence

Intervention / Treatment
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* Device: Fotona ProlapLase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients that had pelvic organ prolapse with or without concomitant stress urinary incontinence and that were treated using non-ablative Fotona Er:YAG laser (ProlapLase treatment) in the time period from 2015 to 2016 will be included in this retrospective study. Exclusion Criteria: Patients who failed to attend a follow-up appointment will be excluded from this retrospective case series study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Fotona ProlapLase|Non-ablative SMOOTH mode intravaginal Er:YAG teratment for pelvic organ prolapse|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cystocele stage | Assesment of POP grade using Baden-Walker scale | Before and at all follow ups (up to 3 months after last treatment) | 
| Severity of stress urinary incontinence | assessment of SUI severity using ICIQ-UI questionnaire | Before and at all follow ups (up to 3 months after last treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assesment of safety | Assesment of adverse effects | Before and at all follow ups (up to 3 months after last treatment) | 
| Patient satisfaction | Assesment of patient satisfaction using 0-10 VAS scale | Before and at all follow ups (up to 3 months after last treatment) |