Management of Vaginal Prolapse Using Laser Therapy: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pelvic Organ Prolapse Quantification System (POP-Q)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- 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)
Arms & Interventions
Laser
Erbium Yttrium Aluminum Garnet (Er:YAG) laser therapies
Intervention: Erbium Yttrium Aluminum Garnet (Er:YAG) laser (Device)
Control
No intervention
Outcomes
Primary Outcomes
Pelvic Organ Prolapse Quantification System (POP-Q)
Time Frame: Change from baseline to 4-6 months
Physical examination
Secondary Outcomes
- International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)(Change from baseline to 4-6 months)
- Pelvic Floor Distress Inventory Short Form (PFDI)(Change from baseline το 4-6 months)
- Pelvic Floor Impact Questionnaire short Form(Change from baseline to 4-6 months)
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short form(Change from baseline to 4-6 months)
- Patients Global Impression of Improvement(4-6 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Up to 3 months post-treatment)
Investigators
Themos Grigoriadis
Assistant Professor
National and Kapodistrian University of Athens