Vaginal Laser therapy for Treatment of Vaginal Looseness

Not Applicable

• Conditions: Vaginal Laxity; Renal and Urogenital - Other renal and urogenital disorders; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12619001098123
• Lead Sponsor: Anna Rosamilia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-09
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

All participants between the ages of 18-80 with subjective vaginal laxity as defined as a score of 3 or less on the vaginal laxity scale.
Capable of providing informed consent and able to return for follow up.
Normal Cervical screening test within last five years or Papanicolau Test within 2 years.

Exclusion Criteria

Pregnant subjects or women less than 12-months post-partum
Actively breastfeeding or ceased breastfeeding less than three menstrual cycles
Any previous prolapse surgery
Previous surgery in the treatment area in the last year
Active genital infection
Subject presenting with abnormal PAP result from the last three years with any of the findings according to the Bethesda (2001) system classification
Systemic steroids use within the last 3 months
Vaginal lubricants within 7 days prior to enrollment
Pelvic organ prolapse (POP) > stage 2 according to pelvic organ prolapse quantification system
Transvaginal mesh or sling implant
Serious systemic disease or any chronic condition that could interfere with study compliance
Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety
Other contraindications to laser treatment: UTI, injuries of bleeding in areas of tissue to be treated (vestibule and anterior vaginal wall), Morbid obesity (BMI>40), Diabetes, A history of Photosensivity disorder disorder or use of photosensitivity medications, abnormal scarring, scarring, excessive sun exposure, preoperative histology findings indicative of malignancy, anatomic findings consistent with the diagnosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified