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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fotona ProlapLase | Device | Non-ablative SMOOTH mode intravaginal Er:YAG teratment for pelvic organ prolapse |
| 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) |
| 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 |
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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.
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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 were included in this retrospective study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poliklinika Novakov i sar. | Novi Sad | 21000 | Serbia |
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| Before and at all follow ups (up to 3 months after last treatment) |
| ID | Term |
|---|---|
| D052858 | Cystocele |
| D056887 | Pelvic Organ Prolapse |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
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