Laser Therapy in Managing Vaginal Prolapse
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|ClinicalTrials.gov Identifier: NCT03714607|
Recruitment Status : Active, not recruiting
First Posted : October 22, 2018
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cystocele Vaginal Vault Prolapse Rectocele Enterocele||Device: Erbium Yttrium Aluminum Garnet (Er:YAG) laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Management of Vaginal Prolapse Using Laser Therapy: Randomized Controlled Trial|
|Actual Study Start Date :||November 30, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 2020|
Erbium Yttrium Aluminum Garnet (Er:YAG) laser therapies
Device: Erbium Yttrium Aluminum Garnet (Er:YAG) laser
5 Er:YAG laser therapies vaginally administered at monthly intervals
Other Name: Fotona
No Intervention: Control
- Pelvic Organ Prolapse Quantification System (POP-Q) [ Time Frame: Change from baseline to 4-6 months ]Physical examination
- Pelvic Floor Distress Inventory Short Form (PFDI) [ Time Frame: 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.
- International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) [ Time Frame: 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 [ Time Frame: 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 Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short form [ Time Frame: 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.
- Patients Global Impression of Improvement [ Time Frame: 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 [ Time Frame: Up to 3 months post-treatment ]Women will be asked to keep a diary reporting any adverse events occuring.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714607
|Urogynecological Unit of Alexandra Hospital|
|Athens, Greece, 11528|
|Study Director:||Stavros Athanasiou, Associate Proffesor||National and Kapodistrian University of Athens, Greece|