Laser Therapy in Managing Vaginal Prolapse

Cystocele Clinical Trial

Official title:

Management of Vaginal Prolapse Using Laser Therapy: Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03714607
• Other study ID #: 310/26-04-2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: January 2020

Study information

• Verified date: September 2019
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Cystocele
• Enterocele
• Hernia
• Pelvic Organ Prolapse
• Prolapse
• Rectocele
• Uterine Prolapse
• Vaginal Vault Prolapse

Intervention

Device:
• Erbium Yttrium Aluminum Garnet (Er:YAG) laser
5 Er:YAG laser therapies vaginally administered at monthly intervals

Locations

Country	Name	City	State
Greece	Urogynecological Unit of Alexandra Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic Organ Prolapse Quantification System (POP-Q)	Physical examination	Change from baseline to 4-6 months
Secondary	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.	Change from baseline t? 4-6 months
Secondary	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.	Change from baseline to 4-6 months
Secondary	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	Change from baseline to 4-6 months
Secondary	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.	Change from baseline to 4-6 months
Secondary	Patients Global Impression of Improvement	It is a single-item questionnaire aiming to evaluate patients impression of improvement following therapeutic intervention.	4-6 months
Secondary	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.	Up to 3 months post-treatment