An interventional study of Erbium Yttrium Aluminum Garnet (Er:YAG) laser in Cystocele, Vaginal Vault Prolapse and Rectocele, sponsored by National and Kapodistrian University of Athens. Status unknown at 1 site in Greece. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-17.
Sponsored by National and Kapodistrian University of Athens · Not applicable, Interventional, and Treatment
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.
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.
71 studies on the registry are indexed under Cystocele; 5 are open to participants now.
This study's enrollment of 30 is below the median of 75 across 46 interventional studies indexed under Cystocele.
Browse Cystocele studies →National and Kapodistrian University of Athens is the lead sponsor of 176 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Erbium Yttrium Aluminum Garnet (Er:YAG) laser therapies
Device: Erbium Yttrium Aluminum Garnet (Er:YAG) laser
No intervention
5 Er:YAG laser therapies vaginally administered at monthly intervals
Also known as: Fotona
Pelvic Organ Prolapse Quantification System (POP-Q)
Physical examination
Time frame: Change from baseline to 4-6 months
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 months post-treatment
Started Nov 2018 (actual). Primary completion is estimated for Dec 2019, 13 months after the start.
Of 19 interventional studies with no phase under Cystocele, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 76. This study's planned 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National and Kapodistrian University of Athens →