CystoceleNCT04417413
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.
An observational study of Cystocele and Pelvic Organ Prolapse, run by Aleksandra Novakov Mikic at 1 site in Serbia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystocele, Pelvic Organ Prolapse, Stress Urinary Incontinence
- What is being tested?
- Fotona ProlapLase
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Oct 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who failed to attend a follow-up appointment will be excluded from this retrospective case series study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Fotona ProlapLase
- Medical subject headings
- Cystocele, Pelvic Organ Prolapse, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fotona ProlapLaseDevice
Non-ablative SMOOTH mode intravaginal Er:YAG teratment for pelvic organ prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
Cystocele stage
Assesment of POP grade using Baden-Walker scale
Measured: 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
Measured: Before and at all follow ups (up to 3 months after last treatment)
Secondary outcomes (2)
Assesment of safety
Assesment of adverse effects
Measured: Before and at all follow ups (up to 3 months after last treatment)
Patient satisfaction
Assesment of patient satisfaction using 0-10 VAS scale
Measured: Before and at all follow ups (up to 3 months after last treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Oct 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aleksandra Novakov Mikic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aleksandra Novakov Mikic, Poliklinika Novakov i saradnici
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417413
- Sponsor's protocol ID
- POP+SUI
- Status last verified
- Nov 2020
- First submitted
- 2 Jun 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04417413
- Acronym / sponsor ID
- POP+SUI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Aleksandra Novakov MikicUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who failed to attend a follow-up appointment will be excluded from this retrospective case series study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fotona ProlapLaseNon-ablative SMOOTH mode intravaginal Er:YAG teratment for pelvic organ prolapse | Device | – |
Primary outcome
Cystocele stage
Time frame: Before and at all follow ups (up to 3 months after last treatment)
Assesment of POP grade using Baden-Walker scale
Severity of stress urinary incontinence
Time frame: Before and at all follow ups (up to 3 months after last treatment)
assessment of SUI severity using ICIQ-UI questionnaire
2 secondary outcomes
Assesment of safety
Time frame: Before and at all follow ups (up to 3 months after last treatment)
Patient satisfaction
Time frame: Before and at all follow ups (up to 3 months after last treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystocele and Pelvic Organ Prolapse, run by Aleksandra Novakov Mikic at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cystocele stage (time frame: Before and at all follow ups (up to 3 months after last treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.