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.

• Sponsor: Aleksandra Novakov Mikic (Other)
• Overall Status: Completed
• CT.gov ID: NCT04417413
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Actual Duration (Months): 3
• Patients Per Site Per Month: 13.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystocele; Pelvic Organ Prolapse; Stress Urinary Incontinence	Device: Fotona ProlapLase

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 Design

• Study Type: Observational
• Actual Enrollment: 41 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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.
• Actual Study Start Date: Oct 1, 2019
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Outcome Measures

Primary Outcome Measures

1. Cystocele stage [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 [Before and at all follow ups (up to 3 months after last treatment)]

   assessment of SUI severity using ICIQ-UI questionnaire

Secondary Outcome Measures

1. Assesment of safety [Before and at all follow ups (up to 3 months after last treatment)]

   Assesment of adverse effects

2. Patient satisfaction [Before and at all follow ups (up to 3 months after last treatment)]

   Assesment of patient satisfaction using 0-10 VAS scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Poliklinika Novakov i sar.	Novi Sad		Serbia	21000

Sponsors and Collaborators

• Aleksandra Novakov Mikic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aleksandra Novakov Mikic, Prof Dr, Poliklinika Novakov i saradnici
• ClinicalTrials.gov Identifier: NCT04417413
• Other Study ID Numbers: POP+SUI
• First Posted: Jun 4, 2020
• Last Update Posted: Nov 13, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Cystocele; Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Nov 13, 2020