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Laser Therapy in Managing Vaginal Prolapse

Primary Purpose

Cystocele, Vaginal Vault Prolapse, Rectocele

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Erbium Yttrium Aluminum Garnet (Er:YAG) laser
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystocele

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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)

Sites / Locations

  • Urogynecological Unit of Alexandra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Laser

Control

Arm Description

Erbium Yttrium Aluminum Garnet (Er:YAG) laser therapies

No intervention

Outcomes

Primary Outcome Measures

Pelvic Organ Prolapse Quantification System (POP-Q)
Physical examination

Secondary Outcome Measures

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.
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.
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
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.
Patients Global Impression of Improvement
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
Women will be asked to keep a diary reporting any adverse events occuring.

Full Information

First Posted
October 13, 2018
Last Updated
September 15, 2019
Sponsor
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT03714607
Brief Title
Laser Therapy in Managing Vaginal Prolapse
Official Title
Management of Vaginal Prolapse Using Laser Therapy: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystocele, Vaginal Vault Prolapse, Rectocele, Enterocele

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser
Arm Type
Experimental
Arm Description
Erbium Yttrium Aluminum Garnet (Er:YAG) laser therapies
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Device
Intervention Name(s)
Erbium Yttrium Aluminum Garnet (Er:YAG) laser
Other Intervention Name(s)
Fotona
Intervention Description
5 Er:YAG laser therapies vaginally administered at monthly intervals
Primary Outcome Measure Information:
Title
Pelvic Organ Prolapse Quantification System (POP-Q)
Description
Physical examination
Time Frame
Change from baseline to 4-6 months
Secondary Outcome Measure Information:
Title
Pelvic Floor Distress Inventory Short Form (PFDI)
Description
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.
Time Frame
Change from baseline το 4-6 months
Title
International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
Description
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.
Time Frame
Change from baseline to 4-6 months
Title
Pelvic Floor Impact Questionnaire short Form
Description
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
Time Frame
Change from baseline to 4-6 months
Title
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short form
Description
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.
Time Frame
Change from baseline to 4-6 months
Title
Patients Global Impression of Improvement
Description
It is a single-item questionnaire aiming to evaluate patients impression of improvement following therapeutic intervention.
Time Frame
4-6 months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Women will be asked to keep a diary reporting any adverse events occuring.
Time Frame
Up to 3 months post-treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavros Athanasiou, Associate Proffesor
Organizational Affiliation
National and Kapodistrian University of Athens, Greece
Official's Role
Study Director
Facility Information:
Facility Name
Urogynecological Unit of Alexandra Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
32720552
Citation
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.
Results Reference
derived

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Laser Therapy in Managing Vaginal Prolapse

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