CystoceleNCT03714607
Laser Therapy in Managing Vaginal Prolapse
A study testing Erbium Yttrium Aluminum Garnet (Er:YAG) laser in people with Cystocele and Vaginal Vault Prolapse, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
Efficacy of laser therapy in postmenopausal women with symptomatic prolapse stage >1. Assessment tools will include prolapse stage quantification system (POP-Q) and validated condition related questionnaires. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cystocele, Vaginal Vault Prolapse, Rectocele
- What is being tested?
- Erbium Yttrium Aluminum Garnet (Er:YAG) laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 30 Nov 2018to Jan 2020
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Symptomatic prolapse stage >1 (cystocele, vaginal vault prolapse, enterocele, rectocele) according to POP-Q System
- Negative Pap-smear
Who cannot join
- Asymptomatic prolapse
- prolapse stage <=1
- prolapse of uterus
- presence of any type of genital infections (i.e herpes, vaginitis etc)
- vaginal bleeding
- underlying pathologies that could interfere in patients compliance (i.e psychiatric)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Vaginal Prolapse Using Laser Therapy: Randomized Controlled Trial
Efficacy of laser therapy in postmenopausal women with symptomatic prolapse stage >1. Assessment tools will include prolapse stage quantification system (POP-Q) and validated condition related questionnaires.
Read the detailed description
Postmenopausal women with symptomatic cystocele and/or rectocele stage 2 or 3 will be 1:1 randomly allocated to Er:YAG laser or watchful waiting group. Participants in the Er:YAG laser group will receive laser therapies at monthly intervals, while participants in the watchful waiting group will receive no treatment. All outcomes in both groups will be evaluated at baseline, 4-months and 6-months from baseline.
- Conditions
- Cystocele, Vaginal Vault Prolapse, Rectocele, Enterocele
- Being tested
- Erbium Yttrium Aluminum Garnet (Er:YAG) laser
- Medical subject headings
- Cystocele, Pelvic Organ Prolapse, Rectocele, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erbium Yttrium Aluminum Garnet (Er:YAG) laserDevice
Also called Fotona
5 Er:YAG laser therapies vaginally administered at monthly intervals
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | Erbium Yttrium Aluminum Garnet (Er:YAG) laser therapies Receives: Device: Erbium Yttrium Aluminum Garnet (Er:YAG) laser |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Organ Prolapse Quantification System (POP-Q)
Physical examination
Measured: Change from baseline to 4-6 months
Secondary outcomes (6)
Pelvic Floor Distress Inventory Short Form (PFDI)
Total score is calculated by adding the scores of 3 scales (Urogenital Distress Inventory (UDI)-6, Pelvic Organ Prolapse Distress Inventory (POPDI)-6 and Colorectal Anal Distress Inventory (CRADI)-8) with a possible range from 0 to 300. Each scale-item could receive values from 0 to 4 applying to a score ranging from 0 to 100 for each scale. The higher the score the more intense are the symptoms.
Measured: Change from baseline το 4-6 months
International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
It is a 12-items questionnaire evaluating nocturia, urgency, bladder pain, frequency, hesitancy, straining, intermittency, urinary incontinence (UI) (urge, stress and unexplained), frequency of urinary incontinence and nocturnal enuresis. Filling, voiding and incontinence symptoms subscales range from 0 to 15, 0 to 12 and 0 to 20, respectively. Additionally, it evaluates impact of individual symptoms with bothering scales that are not incorporated in the overall scores.
Measured: Change from baseline to 4-6 months
Pelvic Floor Impact Questionnaire short Form
Includes 3 domains (incontinence impact questionnaire (IIQ), Pelvic Organ Prolapse Impact Questionnaire (POPIQ) and Colorectal-anal Impact Questionnaire (CRAIQ) with overall 21-items (7 items in each domain). The total score of PFIQ-7 ranges from 0 to 300 (each domain may receive scores from 0 to 100). The highest the score the greater is the impact
Measured: Change from baseline to 4-6 months
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short form
It includes 12 items corresponding to behavioral-emotive, physical and partner related domains. Likert scale ranging from always (0 score) to never (4 score) is encompassed. Scores are obtained for all domains individually. The sum of all scores create a total PISQ score. PISQ total score range from 0-125. Higher values indicate better sexual functioning.
Measured: Change from baseline to 4-6 months
Patients Global Impression of Improvement
It is a single-item questionnaire aiming to evaluate patients impression of improvement following therapeutic intervention.
Measured: 4-6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Women will be asked to keep a diary reporting any adverse events occuring.
Measured: Up to 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start30 Nov 2018
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Themos Grigoriadis, National and Kapodistrian University of Athens
- Investigators
- Stavros Athanasiou, Associate Proffesor, Study director, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714607
- Sponsor's protocol ID
- 310/26-04-2018
- Status last verified
- Sep 2019
- First submitted
- 13 Oct 2018
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Athanasiou S, Pitsouni E, Cardozo L, Zacharakis D, Petrakis E, Loutradis D, Grigoriadis T. Can pelvic organ prolapse in postmenopausal women be treated with laser therapy? Climacteric. 2021 Feb;24(1):101-106. doi: 10.1080/13697137.2020.1789092. Epub 2020 Jul 28.
PubMed 32720552
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Vaginal Prolapse Using Laser Therapy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03714607
- Acronym / sponsor ID
- 310/26-04-2018
- Conditions
- Cystocele, Vaginal Vault Prolapse, Rectocele, Enterocele
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 22 Oct 2018 (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.
Efficacy of laser therapy in postmenopausal women with symptomatic prolapse stage >1. Assessment tools will include prolapse stage quantification system (POP-Q) and validated condition related questionnaires.
Detailed description
Postmenopausal women with symptomatic cystocele and/or rectocele stage 2 or 3 will be 1:1 randomly allocated to Er:YAG laser or watchful waiting group. Participants in the Er:YAG laser group will receive laser therapies at monthly intervals, while participants in the watchful waiting group will receive no treatment. All outcomes in both groups will be evaluated at baseline, 4-months and 6-months from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Device: Erbium Yttrium Aluminum Garnet (Er:YAG) laserErbium Yttrium Aluminum Garnet (Er:YAG) laser therapies |
| Control | No intervention | –No intervention |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic prolapse stage >1 (cystocele, vaginal vault prolapse, enterocele, rectocele) according to POP-Q System
- Negative Pap-smear
Key exclusion criteria (6 listed)
- Asymptomatic prolapse
- prolapse stage <=1
- prolapse of uterus
- presence of any type of genital infections (i.e herpes, vaginitis etc)
- vaginal bleeding
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 |
|---|---|---|
| Erbium Yttrium Aluminum Garnet (Er:YAG) laserAlso: Fotona5 Er:YAG laser therapies vaginally administered at monthly intervals | Device | Laser |
Primary outcome
Pelvic Organ Prolapse Quantification System (POP-Q)
Time frame: Change from baseline to 4-6 months
Physical examination
6 secondary outcomes
Pelvic Floor Distress Inventory Short Form (PFDI)
Time frame: Change from baseline το 4-6 months
International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
Time frame: Change from baseline to 4-6 months
Pelvic Floor Impact Questionnaire short Form
Time frame: Change from baseline to 4-6 months
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short form
Time frame: Change from baseline to 4-6 months
Patients Global Impression of Improvement
Time frame: 4-6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Up to 3 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Derived from this study: PubMed 32720552Athanasiou S, Pitsouni E, Cardozo L, Zacharakis D, Petrakis E, Loutradis D, Grigoriadis T. Can pelvic organ prolapse in postmenopausal women be treated with laser therapy? Climacteric. 2021 Feb;24(1):101-106. doi: 10.1080/13697137.2020.1789092. Epub 2020 Jul 28.
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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.
Stavros Athanasiou, Associate Proffesor study director
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erbium Yttrium Aluminum Garnet (Er:YAG) laser in people with Cystocele and Vaginal Vault Prolapse, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Sep 2019. 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 Greece. 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?
Results are not available in the source record.
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?
Pelvic Organ Prolapse Quantification System (POP-Q) (time frame: Change from baseline to 4-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03714607, which also lists 1 linked publication.
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 17 Sep 2019.