Genitourinary syndrome of menopause and its relief with estriol over 3 months

Not yet recruiting

• Conditions: Other intraoperative and postprocedural complications and disorders of genitourinary system,

• Registration Number: CTRI/2020/03/023903
• Lead Sponsor: AIIMS Research Institute

Brief Summary

Estrogen levelsplummet after menopause, due to declining ovarian function, causing atrophicurogenital symptoms in 1/3 rd of women to the tune of almost as high as50-60%.The most commonly perceived symptoms are dryness, itching, burning ,irritation of vagina, dyspareuniaie pain during intercourse, dysuria, urgency,frequency and recurrent urinary tract infections. They are together called asthe Genitourinary syndrome of menopause.(1) Most of the women report them as moderate tosevere in severity. In 2014 , this  newterminology was introduced by the International society of women’s sexualhealth and the North American Menpause Society in replacement of the olderterm(VVA)ie Vulvar-vaginal atrophy(2) .Vulva, vagina, urethra, bladder and pelvicmusculature  conspicuously showchanges  with connective tissuethinning,due to estrogen deficiency  dueto the presence of estrogen receptors in these tissues.The urinary tract isalso affected alongside these vaginal and vulval changes, due to their commonembryological origin, causing recurrent urinary tract infections without apositive urine culture due to atrophic urethritis.(1)

The effectivenessof  local application of vaginal estrogencream for treating urogenital atrophy has been well established  beyond doubt in literature(3). Intravaginal estrogen use is assosciated withrelief of  genitourinary symptoms ofmenopause and improved quality of life with lesser incidence of recurrenturinary tract infections, and incontinence observed with a maximal effect overa period of 12 weeks treatment.(1)

 Nice guidelines 2015recommends intravaginal estrogen therapy for urogenital atrophy  for as long asneeded , including in women on  systemicHRT. It’s efficacy and tolerability is to be reviewed every 3 months.It is alsorecommended to increase the dose of intravaginal estrogen, if the current dosefails to provide adequate relief to the patient. Adverse effects due to localestrogen use are very rare and hence, no routine monitoring of endometrialthickness during treatment has been recommended till date for unopposed lowdose estrogen usage.(3,(4)) In the past, systemic HRT use was stressed onupon, for the genitourinary symptoms of menopause, but recently , the interesthas shifted upon the local estrogen use due to increased and better efficacywith  delivery of locally applied drug tothe target areas with no side effects.(5). Relief of incontinence symptoms  of both Sui and Overactive bladder inmenopausal women have been attributed to local estrogen use with statisticalsupremacy in various studies in literature. Intravaginal estrogen increasesurethral coaptation by increasing MUCP, in lieu of increased blood supply dueto local estrogen use , reducing Sui symptomatology over 3 months usage(6)Also, frequency of uninhibited uterinecontractions and their amplitude are dampened with local estrogen use asestrogen deficiency is an etiological factor in irritated bladder withincreased frequency, urgency and nocturia , as its manifestations -according toa Cochrane review, published in 2003, and updated in 200(7). The sensory threshold of bladder is alsoincreased promoting relaxation of the bladder –proving to be very usefulin  relieving urge incontinencesymptomatology of menopausal  women(8).The use of local vaginal estrogen therapy isassosciated with significant improvement in women’s self-reported priorbothersomeness and improvement in quality of life post treatment.(9)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-16
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Sexual active women with sexual activity in the past 4 weeks 2.
• Women having a recent pap smear in the last 1 year.

Exclusion Criteria

• 1.Women on OAB drugs/ or who have undergone some Sui surgery 2.Women with POF 3.Women with surgical menopause 4.Women with an abnormal pap/abnormal endometrial thickness inappropriate for age.
• 5.Women with vaginal infections/ contact allergy/irritation 6.Women with vulvovaginal/urethral premalignant/ malignant lesions 7.Women with postmenopausal bleeding 8.Women with bilateral oophorectomy/ surgical menopause 9.Women with UTI(Urinary tract infections) 10.Women with history of estrogen dependent tumours 11.Pregnancy/Lactation 12.Women with SLE, Migraine, severe headaches 13.Women with unexplained vaginal bleeding 14.Increased risk of getting an estrogen sensitive cancer such as having a mother, sister or grandmother having a known, past or suspected breast cancer.
• 15.Women with unexplained vaginal bleeding 16.Women with history of heart attack, stroke, angina, liver disease, porphyria, hypertension, gall stones, diabetes mellitus, epilepsy, asthma or otosclerosis 17.Women with history of any bleeding disorder 18.Women who have received radiotherapy.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
use of local vaginal estrogen therapy is assosciated with significant improvement in women’s self-reported prior bothersomeness and improvement in quality of life post treatment	after 3 months

Secondary Outcome Measures

Name	Time	Method
NA	NA

Trial Locations

Locations (1)

All India Institute of Medical Sciences New Delhi; 🇮🇳 Delhi, DELHI, India

All India Institute of Medical Sciences New Delhi

🇮🇳Delhi, DELHI, India

Dr Rajesh Kumari

Principal investigator

9911226176

drrajeshkumari@yahoo.com