Cystocele, Enterocele, Rectocele, Vaginal Vault Prolapse
Conditions
Brief 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.
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.
Interventions
DEVICEErbium Yttrium Aluminum Garnet (Er:YAG) laser
5 Er:YAG laser therapies vaginally administered at monthly intervals
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Symptomatic prolapse stage \>1 (cystocele, vaginal vault prolapse, enterocele, rectocele) according to POP-Q System * Negative Pap-smear
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Organ Prolapse Quantification System (POP-Q) | Change from baseline to 4-6 months | Physical examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) | Change from baseline to 4-6 months | 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. |
| Pelvic Floor Impact Questionnaire short Form | Change from baseline to 4-6 months | 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 |
| Pelvic Floor Distress Inventory Short Form (PFDI) | Change from baseline το 4-6 months | 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. |
| Patients Global Impression of Improvement | 4-6 months | It is a single-item questionnaire aiming to evaluate patients impression of improvement following therapeutic intervention. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Up to 3 months post-treatment | Women will be asked to keep a diary reporting any adverse events occuring. |
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short form | Change from baseline to 4-6 months | 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. |
Countries
Greece
Outcome results
None listed