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.

NCT04417413 — Completed, 41 participants, Aleksandra Novakov Mikic

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Registry	NCT04417413
Status	Completed
Study type	Observational
Enrollment	41 (Actual)
Sponsor	Aleksandra Novakov Mikic (Other)
Conditions	Cystocele, Pelvic Organ Prolapse, Stress Urinary Incontinence
Interventions	Fotona ProlapLase (Device)
Dates	start 2019-10-01, primary completion 2019-12-31, completion 2019-12-31, first posted 2020-06-04, last updated 2020-11-13
Locations	1 site in Serbia

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Fotona ProlapLase (Device): Non-ablative SMOOTH mode intravaginal Er:YAG teratment for pelvic organ prolapse

+Outcome measures

Primary outcomes

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

Secondary outcomes

Assesment of safety [Before and at all follow ups (up to 3 months after last treatment)]: Assesment of adverse effects
Patient satisfaction [Before and at all follow ups (up to 3 months after last treatment)]: Assesment of patient satisfaction using 0-10 VAS scale

+Eligibility

Sex: Female, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Poliklinika Novakov i sar.	Novi Sad	Serbia