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Laser Therapy in Managing Vaginal Prolapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03714607
Recruitment Status : Active, not recruiting
First Posted : October 22, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Themos Grigoriadis, National and Kapodistrian University of Athens

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.

Condition or disease Intervention/treatment Phase
Cystocele Vaginal Vault Prolapse Rectocele Enterocele Device: Erbium Yttrium Aluminum Garnet (Er:YAG) laser Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Laser
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
No intervention



Primary Outcome Measures :
  1. Pelvic Organ Prolapse Quantification System (POP-Q) [ Time Frame: Change from baseline to 4-6 months ]
    Physical examination


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

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


Locations
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Greece
Urogynecological Unit of Alexandra Hospital
Athens, Greece, 11528
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
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Study Director: Stavros Athanasiou, Associate Proffesor National and Kapodistrian University of Athens, Greece
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Responsible Party: Themos Grigoriadis, Assistant Professor, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03714607    
Other Study ID Numbers: 310/26-04-2018
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectocele
Cystocele
Uterine Prolapse
Prolapse
Pelvic Organ Prolapse
Hernia
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Uterine Diseases
Genital Diseases, Female
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases