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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.

A

Aleksandra Novakov Mikic

Status

Completed

Conditions

Stress Urinary Incontinence
Cystocele
Pelvic Organ Prolapse

Treatments

Device: Fotona ProlapLase

Study type

Observational

Funder types

Other

Identifiers

NCT04417413
POP+SUI

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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