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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.

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04417413
Enrollment
41
Registered
2020-06-04
Start date
2019-10-01
Completion date
2019-12-31
Last updated
2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystocele, Pelvic Organ Prolapse, Stress Urinary Incontinence

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.

Interventions

DEVICEFotona ProlapLase

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

Sponsors

Aleksandra Novakov Mikic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cystocele stageBefore and at all follow ups (up to 3 months after last treatment)Assesment of POP grade using Baden-Walker scale
Severity of stress urinary incontinenceBefore and at all follow ups (up to 3 months after last treatment)assessment of SUI severity using ICIQ-UI questionnaire

Secondary

MeasureTime frameDescription
Assesment of safetyBefore and at all follow ups (up to 3 months after last treatment)Assesment of adverse effects
Patient satisfactionBefore and at all follow ups (up to 3 months after last treatment)Assesment of patient satisfaction using 0-10 VAS scale

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026