Currently enrolling:

Evaluation Using Intragen Fractional Radiofrequency With NeuViVa for the Treatment of Vaginal Laxity and Urogynecology Symptoms #NCT03280446

Primary Outcome Measures  :

  1. To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity using the vaginal laxity questionnaire (VLQ). [ Time Frame: 12 months]
    The primary outcome measure is the mean change in the severity of the vaginal Laxity (VL) and in Female Sexual Function Inventory (FSFI) by using VLQ, assessment and visual analog scale compared to baseline.

Secondary Outcome Measures  :

  1. To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of urogynecological symptoms. [ Time Frame: 12 months]
    To measure improvement in subject sexual satisfaction and Urogynecological symptoms using sexual satisfaction Questionnaire (SSQ) and GRA (Global Response Assessment)

Restorelle® Mesh Versus Native Tissue Repair for Prolapse #NCT02162615

Primary Outcome Measures  :

  1. Recurrence of Prolapse [ Time Frame: 12 Month ]
    Recurrent Prolapse measured anatomically at the target compartment by leading edge of prolapse beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
  2. The rate of device and procedure-related serious adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures  :

  1. Recurrence of Prolapse [ Time Frame: 12 months ]
    Recurrent prolapse is measured anatomically by leading edge of prolapse in the target compartment at or beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
  2. Recurrence of Prolapse [ Time Frame: 36 months ]
    Recurrent Prolapse is measured anatomically by leading edge of prolapse in the target compartment beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
  3. Recurrence of Prolapse [ Time Frame: 36 months ]
    Recurrent Prolapse measured anatomically by leading edge of prolapse in the target compartment at or beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
  4. Device or Procedure related AEs of interest [ Time Frame: 36 months ]

Other Outcome Measures:

  1. Additional adverse events [ Time Frame: 36 months ]
  2. Changes in Quality of Life scores for PFDI-20, PISQ-12, and PFIQ-7 [ Time Frame: 36 months ]
  3. Subjects experiencing vaginal bulge [ Time Frame: 36 months ]
  4. Rates of revision and/or re-surgery [ Time Frame: 36 months ]

Results:

Fractional Handpiece CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy

Sherry Thomas, MD MPH, Sherry Thomas Professional Corporation
Romina Sifuentes MSII, Loyola University Chicago Stritch School of Medicine

Introduction

Vulvovaginal atrophy (VVA) is an inflammation of the vagina as a result of decreased lubrication and thinning and shrinkage of the tissues. This is due to a decrease in estrogen during perimenopause and increasingly so in post-menopause.

Vaginal atrophy symptoms can affect up to 50% of women. The symptoms include vaginal burning, itching, dysuria, dyspareunia and bleeding after sexual intercourse.

Various therapies have been used to treat VVA –herbs, lubricants, and hormonal treatments, which provide a transitory effect. However, fractional CO2 lasers, such as Neuviva Edge One promises a continued effect by stimulating the growth of new collagen, causing re-epithelialization and increasing the blood flow.

The primary goal of the study is to assess the feasibility and efficacy of the CO2 fractional handpiece in the treatment of vulvovaginal atrophy in post-menopausal women, particularly for vaginal dryness and dyspareunia.

Methods

Study Design

  • A prospective study with a total of 14 post-menopausal subjects clinically  diagnosed with vulvovaginal atrophy. 
  • Edge One laser treatments were repeated every 4 weeks for a total up to 3  treatments over 12 weeks. 
  • The CO2 laser was inserted and rotated along the vaginal canal.  Each treatment duration lasted 10-15mins.

Laser Specifications

The Edge One uses an enhanced pulse for high power ablation and variable continuous wave for controlled coagulation.
The fractional handpiece delivers fractionated laser energy through a special lens that divides the energy into a matrix of tiny spots. These spots create thermal damage and are spaced such that the tissue between each is left unaffected. 
Laser settings during treatments:
30W, 3 stacks, 1.6% density, 120mJ with 4000 ms, distance 0.8mm or 112 dot/cm2, Total Fluence 17. 3J/cm2

Analysis

  • Results are based on an N of 14 
  • R statistical program; a paired t-test and a signed ranked test were used. 
  • This is an interim analysis of an ongoing study that continues to  accrue subjects.

Results

Figure 1: Post-Treatment Changes in the 5 FSFI Domains

 

Fig 2. Individual FSFI Scores Before & After Laser Treatments (p<0.0001)

Figure 3: Post-Treatment Changes in the overall FSFI Score

Discussion

  • The participants showed a significant improvement in the 5 domains of the FSFI (desire, arousal, lubrication, orgasm, satisfaction, pain).
  • 11/14 patients reported at least a 2 point increase in regards to lubrication, and 11/14 showed at least a 2 point increase in desire (Fig.1)
  • In regards to arousal and satisfaction, most participants had a one point  improvement implying that the laser treatment demonstrates a minimal  effect on the excitatory signals originating from the brain (Fig.1)
  • 7/14 patients showed a 2 point increase or more in the orgasm score due  to the improvement in blood flow to the vaginal area. (p=0.0004, Fig.1)
  • 12/14 patients had at least a two-point improvement in pain because of  the increase in lubrication to the vaginal area (p<0.0001, Fig.1)
  • After the 3 laser treatments, a significant improvement in the overall FSFI  score was shown (p<0.0001). 7/14 patients had a 10 point increase in  their overall FSFI score (Fig.3)
  • Before the laser treatments, all the participants had an FSFI score of less  than 26.5. Thus, demonstrating sexual dysfunction. (Fig. 2)
  • After the laser treatments, 13/14 participants had FSFI scores greater than  26.5. Thus, reverting their sexual dysfunction. (Fig.2)
  • One patient had a score of 25 after the laser treatment. Despite continuing
    to have sexual dysfunction, her FSFI score increased greatly in comparison  to the score before the treatment. (Fig.2)

Conclusion

  • The data indicates that the CO2 Edge One Fractional Laser is feasible in the treatment of vulvovaginal atrophy in post-menopausal women, particularly in vaginal dryness and dyspareunia.
  • The laser treatments improved the participants’ sexual function greatly, and
  • Although the participants received 3 laser treatments, it is important to take into account that the number of laser treatments might vary depending on the menopausal age. 
  • In the future, it will be important to consider increasing the power per treatment so that the number of treatments may be reduced.