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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.

NCT ID: NCT04417413

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2019-12-31

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.

Conditions

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Cystocele Pelvic Organ Prolapse Stress Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Fotona ProlapLase

Non-ablative SMOOTH mode intravaginal Er:YAG teratment for pelvic organ prolapse

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aleksandra Novakov Mikic

OTHER

Sponsor Role lead

Responsible Party

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Aleksandra Novakov Mikic

Prof Dr

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Poliklinika Novakov i sar.

Novi Sad, , Serbia

Site Status

Countries

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Serbia

Other Identifiers

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POP+SUI

Identifier Type: -

Identifier Source: org_study_id