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.

Completed

• Conditions: Pelvic Organ Prolapse; Cystocele; Stress Urinary Incontinence

• Registration Number: NCT04417413
• Lead Sponsor: Aleksandra Novakov Mikic

Brief 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.

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.

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Cystocele stage	Before and at all follow ups (up to 3 months after last treatment)	Assesment of POP grade using Baden-Walker scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Poliklinika Novakov i sar.; 🇷🇸 Novi Sad, Serbia