Laser Therapy in Managing Vaginal Prolapse

Sponsor

National and Kapodistrian University of Athens (Other)

Overall Status

Unknown status

CT.gov ID

NCT03714607

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

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
Cystocele Vaginal Vault Prolapse Rectocele Enterocele	Device: Erbium Yttrium Aluminum Garnet (Er:YAG) laser	N/A

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:

Interventional

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 :

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

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

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

Secondary Outcome Measures

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.
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.
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
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.
Patients Global Impression of Improvement [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 [Up to 3 months post-treatment]
Women will be asked to keep a diary reporting any adverse events occuring.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)