Laser Therapy in Managing Vaginal Prolapse

Not Applicable

• Conditions: Cystocele; Vaginal Vault Prolapse; Rectocele; Enterocele

• Registration Number: NCT03714607
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-10-13
• Study First Submitted QC: 2018-10-19
• Study First Posted: 2018-10-22
• Study Start: 2018-11-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-15
• Last Update Posted: 2019-09-17
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pelvic Organ Prolapse Quantification System (POP-Q)	Change from baseline to 4-6 months	Physical examination

Secondary Outcome Measures

Name	Time	Method
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 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.
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.

Trial Locations

Locations (1)

Urogynecological Unit of Alexandra Hospital; 🇬🇷 Athens, Greece