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.

Pelvic Organ Prolapse Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417413
• Other study ID #: POP+SUI
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2020
• Source: Poliklinika Novakov i saradnici
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystocele
• Enuresis
• Pelvic Organ Prolapse
• Prolapse
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
Serbia	Poliklinika Novakov i sar.	Novi Sad

Sponsors (1)

Lead Sponsor	Collaborator
Aleksandra Novakov Mikic

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cystocele stage	Assesment of POP grade using Baden-Walker scale	Before and at all follow ups (up to 3 months after last treatment)
Primary	Severity of stress urinary incontinence	assessment of SUI severity using ICIQ-UI questionnaire	Before and at all follow ups (up to 3 months after last treatment)
Secondary	Assesment of safety	Assesment of adverse effects	Before and at all follow ups (up to 3 months after last treatment)
Secondary	Patient satisfaction	Assesment of patient satisfaction using 0-10 VAS scale	Before and at all follow ups (up to 3 months after last treatment)