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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
5 Er:YAG laser therapies vaginally administered at monthly intervals
Urogynecological Unit of Alexandra Hospital
Athens, Greece
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
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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