Pub. No: US 2011/0184500 A1
United States
Patent Application Publication
Reil

CORRECTION OF FEMALE URINARY INCONTINENCE AND SKIN REDUCTION

Inventor: Julie Ann Reil, Billings, MT (US)

ABSTRACT

The invention relates to devices and compositions useful for and methods of female genital skin reduction, improvement of skin tone and treatment of female urinary incontinence, as well as the treatment or improvement of other clinical conditions, including but not limited to those involving the female genitalia.

Female Urinary Incontinence Resolution with Advanced Infrared Light Treatment
Julie Reil, M.D., Charlotte Ayre, R.N., B.A., R.N.C. J.N. Buchwald, B.A., Polly Gumm, R.N., B.A., R.N.C.

ABSTRACT

Objective: To evaluate the safety and efficacy of external urethral and genital infrared light treatment (ILT), a novel therapy for resolution or reduction of female urinary incontinence (UI).
Methods: Female volunteers (n=108) with UI were enrolled in the single-center study. Treatment group (n=98) received 1-4 ILTs; control group (n=10), received 3 sham ILTs. Primary outcome measures were patient-reported %UI improvement, resolution of urethral hypermobility (UH), ability to perform pelvic muscle exercises. Secondary outcomes included UI severity, UI improvement during activity, sanitary pad usage, and genital laxity.
Results: There were no major complications and very few minor complications; no recovery period was required. At 1-3 months, controls reported no change in UI; whereas, all treatment group patients reported UI improvement. Results of 1-4 ILTs ranged from 20%-100% (mean=78.2; median=90.0). Number of treatments was directly related to %UI improvement (r=0.44; p<0.0001). Treatment-group patients experienced significant mean reduction from baseline in physician-rated UI severity (3.6±1.4 vs 1.3±1.3; p<0.001; 95% CI, 2.1-2.6) and number of treatments (1-4 ILTs) was inversely related to post-treatment UI severity (r=-0.35; p<0.0001). Logistic regression showed number of ILTs to be an independent predictor of achieving treatment goal (OR=9.32, 95% CI, 3.44-25.28). Treatment group experienced significant proportional change in UH (79.6% vs 39.8%; p<0.001) and ability to perform pelvic muscle exercises (7.1% vs 50.0%; p<0.001). Retention of treatment effect at 1-16 months was 92.7% (median=100).
Conclusions: In this first clinical test of noninvasive ILT for UI, ILT was safe and effective. At first follow-up, 100% of patients receiving 1-4 treatments, regardless of UI severity, experienced UI improvement (20%-100%); 52% reported ≥90% improvement. At second follow-up, 78% of patients reported complete treatment benefit retention.

The Benefits of Genityte:

• Improved holding when bladder is full
  
  
• Decreased frequency and intensity of urinary urges
  
  
• Decreased nighttime urination
  
  
• Improved tone and support of tissues making Kegel exercises more effective
  
  
• Improved starting and stopping of urination
  
  
• Improved confidence
  
  
• Improved vaginal wall tone; treating prolapse, cystocele and rectocele
  
  
• Improved perineal and rectal tone; treating rectal incontinence
  
  
• Improved hemorrhoids
  
  
• Genityte is extremely safe with remarkably consistent results
  
  
• No limitations of age or skin color
  
  
• No limitations with severity of leaking; can treat very mild as well as very severe leaking
  
  
• No limitation for use in patients with a sling or previous surgery
  
  
• No pain, no downtime, no recovery
  

JOURNAL OF LASERS IN SURGERY AND MEDICINE
BASIC GENITYTE PROCEDURE
May 2008, first clinical investigation, thirty patients, having three basic procedures each, reported average improvement of 88.1% for Stress Incontinence and 72.2% for Stress and Urge (Mixed) Incontinence.

This data led to improvement of the basic procedure – expanding the treatment area to include the entire pelvic floor and improving patient positioning for optimum treatment of each area. These advancements significantly improved treatment outcome and retention of the toning and strengthening effect from Genityte, and became known as the advanced Genityte procedure.

The results of the first study were presented at the American Society of Lasers in Medicine and Surgery annual conference on April 5th, 2009 with publication 'A NEW APPLICATION OF AN INFRARED LIGHT BASED DEVICE FOR TREATMENT OF STRESS URINARY INCONTINENCE' by Julie Reil, MD, in the Journal of Lasers in Surgery and Medicine, July 2009,Vol 41; S21, Abstract 27.

ADVANCED GENITYTE PROCEDURE
Data collected over 24 months, N=145, 345 procedures Five Treatment Groups: Stress Group -53 patients, mean age 48 yrs; Mixed Group -45 patients, mean age 62.4 yrs; Urge/Other Group -7 patients, mean age 53.3yrs; Control Group -10 patients, mean age 58.9 yrs; First Treatment Group -30 patients, mean age 43 yrs

CONTROL GROUP
Control Patients (30 sham treatments) had 0% improvement in Urinary Incontinence.

STRESS INCONTINENCE GROUP
Stress Incontinence patients had 90% to 100% improvement of leaking when treatment goal was reached *100% of Stress Incontinence patients at treatment goal had =90% Improvement of Leaking *70% of Stress Incontinence patients at treatment goal had 100% Complete Resolution of Leaking *Treatment goal was reached, typically after 3 to 4 Genityte treatments in series The minimum improvement reported in the Stress Group: after 1 treatment was 25%, after 2 treatments was 50%, after 3 treatments was 60%, after 4 treatments was 90%.

STRESS AND URGE (MIXED) INCONTINENCE GROUP
Mixed Incontinence patients had 80% to 100% improvement of leaking when treatment goal was reached *93% of Mixed Incontinence patients at treatment goal had =90% Improvement of Leaking *43% of Mixed Incontinence patients at treatment goal had 100% Complete Resolution of Leaking *Treatment goal was reached, typically after 3 to 4 Genityte treatments in series The minimum improvement reported in the Stress and Urge (Mixed) Group: after 1 treatment was 20%, after 2 treatments was 25%, after 3 treatments was 60%, after 4 treatments was 65%.

Articles

Genityte: Ending the Silent Suffering of Women (click to view full article)
Featured in Yellowstone Valley Women Magazine, April/May 2011

Doctor: Procedure restores bladder control (click to view full article) Featured in the Billings Gazette September 21, 2009