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.

NCT04417413 | Completed

• 1 other identifier: POP+SUI
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystocele; Pelvic Organ Prolapse; Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• Cystocele stage

  Assesment of POP grade using Baden-Walker scale

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

• 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 Outcomes (2)

• Assesment of safety

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

• Patient satisfaction

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

Interventions

Fotona ProlapLase DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 were included in this retrospective study.

You may qualify if:

• 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.

You may not qualify if:

• Patients who failed to attend a follow-up appointment will be excluded from this retrospective case series study.

Sponsors & Collaborators

• Aleksandra Novakov Mikic: lead

Study Sites (1)

Poliklinika Novakov i sar.

Novi Sad, 21000, Serbia

Location

MeSH Terms

Conditions

Cystocele; Pelvic Organ Prolapse; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: October 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)