Vaginal CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome (OAB)

Overactive Bladder (OAB) Clinical Trial

Official title:

The Role of the Micro-ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03846895
• Other study ID #: 303/16-04-2018
• Status: Completed
• Phase: N/A
• Start date: May 12, 2018
• Est. completion date: February 15, 2022

Study information

• Verified date: September 2022
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the clinical efficacy and symptom relief of vaginal fractional CO2 laser treatment in post-menopausal women with Overactive Bladder syndrome(OAB). Post-menopausal women with OAB syndrome who receive β3 adrenergic receptors (mirabegron 50mg) treatment, will be randomized in two groups. Half participants will receive active CO2 laser therapy, while the other half will receive placebo CO2 laser therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 15, 2022
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Postmenopausal women (= 12 months of amenorrhea or FSH = 40 after hysterectomy with bilateral oophorectomy) who receive ß3 adrenergic receptors (mirabegron 50 mg) treatment for OAB
• Overactive bladder syndrome (OAB)
• = 3 months symptoms of urgency, with or without urinary incontinence, and = 8 micturitions / 24h
• At least 3 episodes of urgent urination (3rd-4th grade) as recorded in the patient perception intensity of urgency scale (PPiUS) during a 3 day urination calendar , with or without urinary incontinence.

Exclusion Criteria:

• Participants with:
• Pelvic Organ Prolapse (POP) > stage II of the pelvic organ prolapse quantitation system (POP-Q)
• Post void residual volume > 200 ml (measured by ultrasound)
• Use of moisturizers or lubricants the last month
• Use of vaginal estrogen in the last 6 months
• Use of drugs for urinary incontinence
• Use of psychotropic drugs
• Symptomatic urinary tract infection
• Active genital infection
• Kidney or liver disease
• Abnormal cardiac conduction, rate or rythm disorders
• Diabetic neuropathy
• Myasthenia gravis
• History of malignant disease
• Previous radio-chemo therapy

Related Conditions & MeSH terms

• Overactive Bladder (OAB)
• Urinary Bladder, Overactive

Intervention

Device:
• Microablative Fractional CO2 laser
3 therapies intravaginally administered will be applied 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	Overactive Bladder questionaire (OAB-q)	It consists of an 8 item symptom bother scale section and a 25 item health related quality of life scale section (HRQL). Scores of each domain of the 2 sections range from 0 to 100. Higher scores indicate higher impact of overactive bladder symptoms.	24 months
Primary	3 days voiding diary	Assesses bladder function (frequency of micturition, urgency and urinary incontinence)	24 months
Secondary	King's Health Questionnaire (KHQ)	It has 3 sections: 1) general health and overall health related to urinary symptoms with 2 questions, 2) incontinence impact, role limitations, physical limitations, social limitations, personal limitations, emotions, sleep and energy, and severity coping measures with 19 questions and 3) bother or impact of urinary symptoms with 11 questions. Scores of each domain of the 2 sections range from 0 to 100. Scores of the third section range from 0 to 3. Higher scores indicate higher impact of urinary incontinence.	24 months
Secondary	Patients Global Impression of Improvement (PGI-I)	It is a single question with 7 possible answers. Patients will chose the answer that applies at their impression of improvement after the laser therapy	24 months
Secondary	Urogenital Distress Inventory questionaire (UDI-6)	It is a 6 item questionaire evaluating symptom distress of urinary incontinence and its impact on daily life. Scores range from 0 to 100. Higher scores indicate higher impact of urinary incontinence.	24 months
Secondary	Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)	It is a 7 item questionaire evaluating how much bladder symptoms affect their activities, relationships, and feelings.	24 months