Fractional Handpiece CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy #NCT03271944 

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 purpose of this study is to evaluate efficacy and safety of CO2 laser (EdgeTM CO2 Laser) with a fractional headpiece in the treatment of vulvovaginal atrophy (VVA) in post- menopausal women and its effect on the patient VHIS (vaginal health index score). The primary endpoint is to assess the changes in the vaginal dryness by mean of a visual analog scale (10 cm VAS)

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:
  • 30 W, 3 stacks, 1.6% density, 120 mJ with 4000 ms, distance 0.8 mm or 112 dot/cm2, Total Fluence 17. 3 J/cm2

Primarily 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.

Multi-center Study of Uphold LITE Versus Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse (Uphold LITE) #NCT01917968 (Closed)

Introduction

Pelvic organ prolapse (POP) of the anterior and posterior vaginal wall, and the vaginal apex, are among the most challenging and conman aspects of traditional pelvic reconstructive surgery. As life expectancy increases, significantly greater numbers of women will present with POP and stress urinary incontinence (SUI) requiring surgical intervention.

The main goal of POP surgery is restoration of normal anatomy to achieve proximal vaginal suspension, mid-vaginal lateral attachments and distal vaginal fusion to the urogenital fascia and perineum. Women undergoing pelvic reconstructive surgery for POP hope to achieve relief of symptoms, restoration of normal anatomy, maintenance of vaginal capacity for sexual function and improvement in the quality of life.

In recent years, surgical methods such as vaginal mesh repair (VMR) have become available as an option for treating more advance and challenging cases.

Uphold(TM) Lightweight Surgical Mesh (Uphold LITE) is an FDA 510(k) cleared mesh implant intended for tissue reinforcement and stabilization of fascial structures of the pelvic floor in vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect. Use of synthetic mesh grafts in surgical repair of vaginal prolapse has been shown to significantly increase success rates and reduce recurrent prolapse.

The primary objective is to evaluate clinical effectiveness of transvaginal mesh repair against traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse. Secondary objectives are to evaluate mesh-related complications and subject reported outcomes.

Success will be based on a composite of objective and subjective measures. Also, a co-primary endpoint of the study is to achieve non-inferiority of mesh to native tissue repair for safety by comparing rates of serious device or serious procedure-related complications between baseline and the 36 month time point.

Methods

Study Design

• This is a prospective, non-randomized, parallel cohort, multi-centered study conducted in partnership with the AUGS PFD registry.
• The primary endpoint will be assessed once all per protocol subjects have completed the 36 month study visit. All per protocol subjects will be followed to 36 months, until study completion, or until discontinued prior to month 36.
• All study procedures will be standardized for uniformity.
• All enrolled patients will have an anterior and/or apical defect. All concomitant procedures performed will be recorded

Autologous Muscle Derived Cells for Female Urinary Sphinter Repair NCT01893138 (Active, Not Recruiting)

Primary Outcomes :

1. Number of leaks due to stress incontinence episodes, as recorded in a diary [ Time Frame: 12 months ]

Secondary Outcomes : 

1. Stress leak frequency [ Time Frame: 12 months ]

Methods

Study Design

• This is a randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.

Adaptive Design Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair (CELLEBRATE) NCT03104517

Primary Outcomes :

1. Number of leaks due to stress incontinence episodes, as recorded in a diary [ Time Frame: 12 months ]
   Stress leak frequency

Methods

Study Design

• This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared to a placebo in the treatment of stress urinary incontinence (SUI) in adult female patients. Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.

Pursuit: Real World Use of the Eclipse System (PURSUIT) NCT03940573 (Active: Recruiting)

Primary Outcomes :

1. Fit Rate [ Time Frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening ]
   Proportion of patients successfully fit
2. Device Size Distribution [ Time Frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening ]
   Size distribution of devices among successfully fit patients
3. St. Mark’s Score (Vaizey) [ Time Frame: 12 months ]
   Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
4. PGI-I Score [ Time Frame: 12 months ]
   Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)

Secondary Outcomes : 

1. St. Mark’s Score (Vaizey) [ Time Frame: 3 months ]
   Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
2. St. Mark’s Score (Vaizey) [ Time Frame: 6 months ]
   Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
3. St. Mark’s Score (Vaizey) [ Time Frame: 9 months ]
   Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
4. PGI-I Score [ Time Frame: 3 months ]
   Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
5. PGI-I Score [ Time Frame: 6 months ]
   Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)e
6. PGI-I Score [ Time Frame: 9 months ]
   Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)

Methods

Study Design

• A prospective, open label post-market registry to collect Patient Reported Outcomes and Fitting metrics (e.g. sizes used) in subjects using the Eclipse System in a commercial setting.
• Up to 150 subjects enrolled, in up to 25 sites. Population of all adult female patients with Fecal Incontinence (FI) who present at, or are identified at, participating sites are eligible. This includes patients who are newly prescribed Eclipse, and those already using Eclipse who return for an annual renewal visit during the enrollment period.
• Includes fitting of the patient for the Eclipse System with collection of relevant health history data. Patients are provided a temporary device for a trial usage period. Multiple device sizes may be attempted to find the correct fit for the patient, at which point the patient is provided with the long term use Eclipse Insert and enters the treatment period.
• During the fitting and treatment period, patient experience will be assessed by surveys, St. Mark’s (Vaizey) scores, and the validated global PGI-I index (Patient Global Impression of Improvement). Surveys will be perform at the fitting follow up and at 12 months of device usage, and optionally at 3, 6, and 9 months of device usage.