Clinical trial NCT04417413: 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.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystocele
Pelvic Organ Prolapse
Stress Urinary Incontinence
Lead sponsor: Poliklinika Novakov i saradnici
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cystocele stage
timeFrame: Before and at all follow ups (up to 3 months after last treatment)
measure: Severity of stress urinary incontinence
timeFrame: Before and at all follow ups (up to 3 months after last treatment)
Secondary outcomes:
measure: Assesment of safety
timeFrame: Before and at all follow ups (up to 3 months after last treatment)
measure: Patient satisfaction
timeFrame: Before and at all follow ups (up to 3 months after last treatment)
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Poliklinika Novakov i sar.
Study officials:
References: