Women’s Genitourinary Disorders

Macrene Alexiades

BACKGROUND

Women’s genitourinary disorders, historically treated using hormone replacement with variable efficacy, have additional potential therapeutic options with developments in the application of laser and energy device-based treatments to these prevalent concerns. The genitourinary disorders potentially amenable to vaginal treatment devices include (1) atrophic vaginitis also known as vulvovaginal atrophy or urogenital atrophy, (2) urinary incontinence (UI), and (3) pelvic prolapse or vulvovaginal atrophy. Collectively, these conditions have been termed the genitourinary syndrome of menopause (GSM).¹ They affect women who are postmenopausal postovarectomy, undergoing treatment for breast cancer, postradiation, and breastfeeding; GSM is estimated to affect 50% of postmenopausal women.¹ Clinical trials are underway to address Food and Drug Administration (FDA) concerns and attain clearance in treating these common conditions that significantly adversely affect the physiologic and sexual function of a large segment of the population.²,³

Under circumstances of diminishing estrogen, as in postmenopause, postovarectomy, antiestrogen therapy, and breastfeeding, many changes occur in the vulvovaginal tissues that produce symptoms negatively impacting quality of life.⁴ Vulvovaginal atrophy and laxity, UI, and sexual dysfunction are common sequelae of the effects of diminished or absent estrogens, which are often progressive and unlikely to resolve without intervention. It is estimated that up to 50% of postmenopausal women suffer from symptoms of atrophic vaginitis or vulvovaginal atrophy.⁴,⁵

Since 2014, the term GSM has been adopted to encompass a collection of symptoms and signs associated with a decrease in estrogen and other sex steroids syndrome, including genital symptoms of dryness, burning, and irritation; sexual symptoms of lack of
lubrication, discomfort or pain, and impaired function; and urinary symptoms of urgency, dysuria, and recurrent urinary tract infections.¹

For over 40 years, gynecologists and plastic surgeons have employed devices to ablate genitourinary tissues. Focused carbon dioxide (CO₂) laser has been used for incision and vaporization; defocused CO₂ laser for tissue contraction; and ablative CO₂ for genital wart ablation.⁵ Diode lasers have been used for myomectomy; photodynamic therapy with laser for lichen sclerosus; and radiofrequency (RF) for lower genital tract rejuvenation.⁶ However, in recent years, the number of devices and their applied uses in women’s genitourinary health have multiplied at a rapid rate.⁷

PRESENTATION

Patients who are postmenopausal, breastfeeding, breast cancer survivors, postovarectomy, or on estrogen inhibitors present with urogenital symptoms. These include vaginal dryness, burning or irritation, urine leakage, painful intercourse, chronic discharge, and pain on urination.

DIAGNOSIS

Clinical Diagnosis

Atrophic Vaginitis

On physical examination, external vulva appear pale and dry, and smooth and shiny with a loss of rugation. On internal examination, the vaginal canal is shortened and narrowed. A lack or decrease of moisture externally and vaginal secretions internally are noted. The epithelial integrity may be compromised leading to friability or bleeding on speculum insertion and removal. Examination of pH reveals a vaginal pH of >5 as compared with the normal <4.6.

Vulvovaginal Laxity

In cases of laxity, the labia majora and minora are lax and redundant. The introitus is lax, enlarged, and patent on external visualization. Herniation of pelvic structures such as the bladder may be observed within the vaginal canal.

Urinary Incontinence

Patients report urinary leakage with exercise and on Valsalva and a sense of urgency and frequency. Frequent urinary tract infections may be reported or observed. An increased postvoid residual is noted on urodynamic evaluation. A 1 and 24-hour pad weight test is helpful in confirming the diagnosis and severity. The 1-hour pad weight test has been standardized, and the protocol is as follows⁸:

0-15 min

Drinking 500 mL of sodium-free liquid, resting

15-45 min

Walking, climbing one flight of stairs (up and down)

45-60 min

Standing up from sitting (10 times)

Coughing vigorously (10 times)

Running in place (1 min)

Picking up small object from the floor (5 times)

Washing hands in running water (1 min)

The rating of UI severity is as follows⁹:

	1-h Test (mL)	24-h Test (mL)
Mild incontinence	<10	4.4-20
Moderate incontinence	11-50	21-74
Severe incontinence	>50	>75

GSM Scales

The following scales are employed to rate severity of GSM signs and symptoms:

VVA symptoms (vaginal dryness, vaginal burning, vaginal itching, dyspareunia, dysuria)
VHIS (vaginal health index score)
Female Sexual Function Index (FSFI and mv-FSFI)
Short Form 12 (SF-12)
Pelvic organ prolapse quantification (ICS-POP-Q) system
Female Sexual Distress Scale-Revised (FSDS-R)
Vaginal Laxity and Sexual Satisfaction Questionnaires

Histopathology

Normal Vaginal Tissue

The normal vaginal wall consists of 4 layers: (1) superficial nonkeratinized stratified squamous epithelium, estrogen dependent and glycogen rich; (2) lamina propria consisting of dense connective tissue, collagen, elastin, and blood vessels; (3) muscular layer of inner circular and outer longitudinal smooth muscle; and (4) adventitia consisting of loose connective tissue and collagen and elastin wall.¹⁰

Menopausal Vaginal Tissue

During menopause and with the absence of estrogen, the vaginal tract undergoes dramatic histological changes.¹¹ The vaginal epithelium becomes progressively thinned and flattened as large superficial, nonkeratinized squamous epithelial cells that are estrogen dependent and glycogen rich are replaced by flattened parabasal or intermediate cells. The vaginal epithelium becomes markedly atrophic and can superficially turn into a keratinized layer. The lamina propria, which premenopausally contains dense connective tissue, collagen and elastin, and blood vessels, undergoes significant alterations during menopause. The collagen type I to collagen type III ratio changes with loss of their trabecular disposition. Collagen fibrils become flattened; elastic fibers decrease in quantity; vascularization is markedly reduced; and the papillations and rugations disappear to yield a flattened epithelial-lamina propria interface.¹¹

Subtypes

Atrophic vaginitis/vulvovaginal atrophy/kraurosis vulvae
Urinary incontinence
Pelvic prolapse/vulvovaginal laxity

PATHOGENESIS

In the presence of endogenous estrogens, the dominant regulators of vaginal physiology, the vagina is characterized by a thickened rugated vaginal surface, abundant blood flow, and lubrication. The effects of estrogens include upregulating vascular perfusion, increasing epithelial thickness, reducing vaginal pH, and promoting secretions. Estrogen is also a factor in maintaining vaginal tissue elasticity. Spontaneous or induced menopause is associated with diminished estrogen, resulting in a diminution of epithelial thickness, connective tissue and vascularity of the lamina propria, increased pH levels, and an elevation in vaginal pH. These alterations correlate clinically with increased tissue fragility and higher risk of vaginal and urinary infections, irritation, dryness, urogenital pain, and vaginal tissue trauma. The vaginal tissue becomes progressively more atrophic, less elastic, and paler with loss of rugation; the surface becomes friable with petechiae, ulcerations, and bleeding with friction.⁵

TREATMENT

The treatment of genitourinary disorders requires a systematic algorithmic approach (Algorithm 16.1.1). First, localized medical treatments that are FDA approved should be employed as first line. Systemic options should be weighed before proceeding to surgical options. As of the printing of this text, laser-, light-, and energy-based technologies are FDA cleared for ablation, vaporization, incision, excision or coagulation of GU tissue (Table 16.1.1), but not for GSM or related conditions.

Medical

Atrophic Vaginitis

Localized

Vaginal lubricants: First line for atrophic vaginitis includes vaginal lubricants and moisturizers and regular sexual activity
Estrogens localized:
- Topical estrogen creams approved for treatment of atrophic vaginitis include 0.625 mg conjugated equine estrogens per gram of cream or estradiol (0.1 mg/gm of cream. Dosing regimens consist of daily use for 1-2 weeks followed by taper to maintenance at 1-3 times per week.
- Vaginal tablets containing 10-25 µg estradiol are indicated for use in atrophic vaginitis. The tablets are inserted daily for 2 weeks followed by weekly maintenance.
- Vaginal ring consisting of a 2 mg estradiol reservoir is reported for use in postmenopausal localized hormone replacement but must be monitored for endometrial thickening.
- DHEA (prasterone) has been approved for dyspareunia.

ALGORITHM 16.1.1 Approach to treatment for women’s genitourinary disorders. CO₂, carbon dioxide laser; OTC, over the counter. (Courtesy of Macrene Alexiades, MD, PhD.)

Systemic

Systemic therapy is indicated in cases of GSM with climacteric symptoms.

Oral estrogen agonists with hormone replacement therapy
Ospemifene is an estrogen agonist and antagonist indicated for vasomotor symptoms of menopause, atrophic vaginitis, and hypoestrogenism.

Urinary Incontinence

Behavioral therapies and absorbent products are the mainstay of medical treatment for urinary incontinence.

Systemic

Oral agents include α-Adrenergics, anticholinergics, antispasmodics, antidepressants, and estrogens

Intralesional

Botulinum toxin is indicated at 100 units for overactive bladder.

Vulvovaginal Laxity

Kegel exercises may improve pelvic floor muscle tone and stress urinary incontinence but not show to induce regression of pelvic prolapse.

TABLE 16.1.1 FDA-Cleared Devices and Indications

<Device	510K	Date	Indications^a
Joule Profile Multi-Platform System, diVA (Sciton), Er:YAG 2940 nm, 1470 nm	K060033 K101916	1/4/06 3/18/11	At 2940 nm: “ablation, vaporization, and coagulation of soft tissue and for skin resurfacing” and at 1470 nm: “Ablation, vaporization, hemostasis, or coagulation of soft tissue”
Lumenis Femtouch, CO₂	K100415	4/12/10	“Vaporization, incision, excision, ablation or photocoagulation of soft tissue in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry”
IntimaLase/IncontiLase (Fotona), Er:YAG 2940 nm, Nd:YAG 1064 nm	K101817 K143723	11/22/10 4/9/15	“Surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy”
Femilift (Alma), CO₂	K103501	1/14/11	“Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology for the treatment of: conization of the cervix, including cervical intraepithelial neoplasia, vulvar and vaginal intraepithelial neoplasia; condylomna acuminate, including cervical, genital, vulvar, perineal, and Bowen’s disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions; leukoplakia (vulvar dystrophies); incision and drainage of Bartholin’s and nubuthian cysts; herpes vaporization; urethral caruncle vaporization; cervical dysplasia; benign and malignant tumors; hemangiomas”
ThermiVA (Thermi), RF	K130689	11/15/13	“For use in dermatological and general surgical procedures for electrocoagulation and hemostasis”
SmartXide² CO₂, MonaLisa Touch, El En/DEKA/Cynosure	K133895	9/15/14	“Incision, excision, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing”
CORE Intima (Syneron), CO₂	K151655	9/14/15	“Surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy”
^aData from FDA.gov.

Pessaries or vaginal support devices are used by the majority of urogynecologists for patients with pelvic organ prolapse.
Estrogen both topically as a cream or as an intravaginal ring are also used for prolapse.

Cosmetic/Procedural

Laser-, light-, and energy-based devices are currently FDA cleared for general heating or ablation of genitourinary tissue (Table 16.1.1). The use of devices for specific diagnoses pertaining to the vaginal tract is currently being tested through clinical trials.²,³

Lasers and Devices

Device-based treatments have been aimed at resurfacing the vaginal epithelium and rejuvenating the lamina propria with the objective of reversing the atrophy and laxity associated with GSM.

Scientific Basis

Fractional Ablative and Nonablative Lasers. Fractional laser resurfacing is a class of laser technologies that deliver an array of microbeams of light to create microscopic columns of energy-mediated effects in the tissue.¹² The creation of microcolumns of treated tissue, separated by intervening areas of untreated skin, speeds recovery and decreases adverse events. In vaginal tissue, the microscopic lesions extend from the vaginal epithelium into the lamina propria, to depths determined by laser energy (fluence), duration of the laser pulse, and spot size. Fractional lasers used in vaginal tissue include ablative wavelengths, including carbon dioxide (CO₂) laser at 10 600 nm wavelength and erbium:yttrium-aluminum-garnet laser (Er:YAG) at 2970 nm, and nonablative lasers such as the 1470-nm diode. Ablative devices vaporize the microcolumns of tissue, whereas nonablative devices induce columns of thermal injury without vaporization. The vaporization or boiling point of water at 1 atmosphere is 100°C; the fluence necessary for pulsed-laser ablation of skin is 5 J/cm². During ablation, the skin temperature rises to 120° to 200°C. CO₂ laser at pulse duration <1 ms ablates 20 to 30 µm of tissue with a 100- to 150-µm-deep layer of residual thermal damage (RTD).¹² The fractionated CO₂ microbeam diameters among devices range from 100 µm to 1.25 mm, and beam power density differs accordingly; the penetration depths of the microcolumns vary from 50 µm to 1.6 mm.¹² Among fractional Er:YAG devices, the microspot ranges from 50 µm to 1.5 mm and penetration depth 1 to 3 µm of tissue per J/cm² yielding an ablative depth among devices of 25 to 1500 mm with a minimal RTD of 10 to 40 µm.¹² An additional technological feature of some fractional Er:YAG devices is the additional thermal coagulative pulse that may be administered immediately following the ablative pulse to provide additional thermal coagulation and hemostasis. The 2940-nm laser may be employed in a nonablative mode with a duration of 250 ms, consisting of a fast sequence of individual super-pulse mode (300 µs) micropulses with intrapulse intervals of 50 ms.⁵ In this mode, vaginal mucosa temperatures increased to 60° to 65°C, without inducing superficial ablation. Ablation and coagulation of vaginal tissue with 2 wavelengths such as 2940 and 1470 nm fired consecutively, termed “hybrid laser pulse,” combines ablation and thermal injury in microcolumns.⁵

Radiofrequency. RF emitting within a frequency range of 3 kHz to 24 GHz has been used to treat genitourinary tissue. The RF devices generate an electric field that produces an oscillating electric current in tissue. This current induces collisions and motion among charged and polar atoms and molecules resulting in energy transfer to the tissue as heat.¹³ The author’s published research supports the theory that the controlled volumetric heating induced by RF causes partial collagen denaturation triggering neocollagenesis and neoelastinogenesis, which correlates with tissue tightening.¹⁴ The configuration of electrodes in RF device can be monopolar, bipolar, or tripolar, and all have been used for cutaneous applications. In monopolar RF, the electric current passes through a single electrode in the handpiece to a grounding pad, whereas in bipolar RF the current passes between electrodes within the handpiece tip in a closed arclike circuit through the tissue.

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