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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser | Experimental | Erbium Yttrium Aluminum Garnet (Er:YAG) laser therapies |
|
| Control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erbium Yttrium Aluminum Garnet (Er:YAG) laser | Device | 5 Er:YAG laser therapies vaginally administered at monthly intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Organ Prolapse Quantification System (POP-Q) | Physical examination | Change from baseline to 4-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Stavros Athanasiou, Associate Proffesor | National and Kapodistrian University of Athens | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urogynecological Unit of Alexandra Hospital | Athens | 11528 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32720552 | Derived | 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. |
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| ID | Term |
|---|---|
| D052858 | Cystocele |
| D056887 | Pelvic Organ Prolapse |
| D020047 | Rectocele |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| 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. | 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 | 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. | 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. | 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. | Up to 3 months post-treatment |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |