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Completed

NCT Number: NCT04417413

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.

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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Key information

Conditions

Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Signs and Symptoms Stress Urinary Incontinence Urinary Bladder Diseases Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Poliklinika Novakov i sar.

Novi Sad, 21000, Serbia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fotona ProlapLase

Device

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

Primary outcomes

  1. Cystocele stage

    Time frame: Before and at all follow ups (up to 3 months after last treatment)

    Assesment of POP grade using Baden-Walker scale

  2. Severity of stress urinary incontinence

    Time frame: Before and at all follow ups (up to 3 months after last treatment)

    assessment of SUI severity using ICIQ-UI questionnaire

Secondary outcomes

  1. Assesment of safety

    Time frame: Before and at all follow ups (up to 3 months after last treatment)

    Assesment of adverse effects

  2. Patient satisfaction

    Time frame: Before and at all follow ups (up to 3 months after last treatment)

    Assesment of patient satisfaction using 0-10 VAS scale

Sponsors and collaborators

Lead sponsor

Aleksandra Novakov Mikic

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 4, 2020
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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