Laser Therapy in Managing Vaginal Prolapse

National and Kapodistrian University of Athens (Other)
Overall Status
Unknown status ID

Study Details

Study Description

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
  • Device: Erbium Yttrium Aluminum Garnet (Er:YAG) laser

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.

Study Design

Study Type:
Actual Enrollment :
30 participants
Intervention Model:
Parallel Assignment
Single (Outcomes Assessor)
Primary Purpose:
Official Title:
Management of Vaginal Prolapse Using Laser Therapy: Randomized Controlled Trial
Actual Study Start Date :
Nov 30, 2018
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Jan 1, 2020

Arms and Interventions

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 Names:
  • Fotona
  • No Intervention: Control

    No intervention

    Outcome Measures

    Primary Outcome Measures

    1. Pelvic Organ Prolapse Quantification System (POP-Q) [Change from baseline to 4-6 months]

      Physical examination

    Secondary Outcome Measures

    1. 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.

    2. 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.

    3. 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

    4. 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.

    5. Patients Global Impression of Improvement [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 [Up to 3 months post-treatment]

      Women will be asked to keep a diary reporting any adverse events occuring.

    Eligibility Criteria


    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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)

    Contacts and Locations


    Site City State Country Postal Code
    1 Urogynecological Unit of Alexandra Hospital Athens Greece 11528

    Sponsors and Collaborators

    • National and Kapodistrian University of Athens


    • Study Director: Stavros Athanasiou, Associate Proffesor, National and Kapodistrian University of Athens, Greece

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Themos Grigoriadis, Assistant Professor, National and Kapodistrian University of Athens Identifier:
    Other Study ID Numbers:
    • 310/26-04-2018
    First Posted:
    Oct 22, 2018
    Last Update Posted:
    Sep 17, 2019
    Last Verified:
    Sep 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 17, 2019