None listed
Conditions
Brief summary
This is a study to determine if vaginal laxity (looseness of the vagina) can be successfully treated using vaginal laser therapy. Currently there is no known effective treatment for this condition. For participants enrolled in the study, they will be assigned with equal likliehood to an active treatment with vaginal laser or sham (fake treatment) arm. Participants will receive 3 treatments, 4 weeks apart. We want to know how many women still have vaginal laxity 3,6 and 12 months after their final treatment.
Interventions
Er:YAG laser using the Fotona SMOOTH laser treatment versus sham randomized in equal probability. This study will not alter or interfere with any treatment or care given routinely to women as there is no routine treatment recommended currently.
Prior to Er:YAG laser, a urogynaecology nurse consultant who holds the randomization codes will inform of allocation. The doctor involved in the trial will perform the laser or sham treatment. The Fotona Er:YAG laser delivery system will be used to provi
Er:YAG laser using the Fotona SMOOTH laser treatment versus sham randomized in equal probability. This study will not alter or interfere with any treatment or care given routinely to women as there is no routine treatment recommended currently. Prior to Er:YAG laser, a urogynaecology nurse consultant who holds the randomization codes will inform of allocation. The doctor involved in the trial will perform the laser or sham treatment. The Fotona Er:YAG laser delivery system will be used to provide fractional treatment. The treatment protocol using the two phase IntimaLase ® protocol with glass speculum will be following the standard parameters by the manufacturer: Firstly, treatment will be with Phase I IntimaLase laser speculum with a fluence of 3J/cm, a 7mm spot size and SMOOTH mode frequency 2 Hz; Secondly, Phase II IntimaLase a fluence 10J/cm 2, 7mm spot size and SMOOTH mode frequency 1.6Hz. Treatment complication and discomfort evaluation will be performed after each treatment and treatment acceptability evaluation will be performed after the first treatment only. The study will include a screening visit, then 3 visits, four weeks apart for active or sham treatment and 3 follow up visits at 3 months and 6 months and 1 year after last treatment visit. The screening visit may be combined with the first1 treatment visit if all eligibility and consent procedures have been undertaken. Most visits will take approximately 10 minutes. The visits are detailed in the table below. Participants will have their next appointment made before leaving to improve adherence to treatments and be contacted if they miss an appointment.
Sponsors
Anna Rosamilia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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
Outcome results
None listed