Last reviewed:October 2019
Last updated:October  2019
30 Oct 2019

EMA’s safety committee recommends a 4-week limit for use of high-strength estradiol creams

The European Medicines Agency (EMA) pharmacovigilance risk assessment committee (PRAC) has recommended limiting the use of high-strength estradiol vaginal creams (containing 100 micrograms/g or 0.01%) to a single treatment period of up to 4 weeks.[48]

The PRAC review concluded that in postmenopausal women who had used these creams, the levels of estradiol in the blood were higher than normal postmenopausal levels and could result in similar side effects to those seen with systemic (oral or transdermal) hormone replacement therapy (HRT).

The side effects of HRT include venous thromboembolism, stroke, endometrial cancer, and breast cancer.

In the absence of safety data for long-term use of high-strength estradiol creams, the PRAC recommended that these creams should only be used for a single treatment period of a maximum of 4 weeks. This formulation should not be used in patients already on hormone replacement therapy. Other vaginal oestrogen formulations are available and may be preferred.

Treatment of recurrent UTI in postmenopausal women includes use of vaginally applied oestrogen therapy to restore the normal vaginal flora and reduce the risk of vaginal colonisation by Escherichia coli.[49] Vaginally applied oestrogen therapy demonstrated a decreased incidence and longer time to recurrence of UTI in hypo-oestrogenic women.[50] However, its use is inferior to continuous antibiotic suppression in prevention of UTIs.[51]

See Management: approachSee Management: treatment algorithm

Original source of update

Summary

Definition

History and exam

Key diagnostic factors

  • presence of risk factors
  • dysuria
  • urinary frequency
  • haematuria
  • back/flank pain
  • costovertebral angle tenderness
  • fever

Other diagnostic factors

  • urinary urgency
  • supra-pubic pain and tenderness

Risk factors

  • sexual activity
  • spermicide use
  • post-menopause
  • positive family history of UTIs
  • history of recurrent UTI
  • presence of a foreign body
  • insulin-treated diabetes
  • high lifetime number of UTIs
  • recent antibiotics
  • poor bladder emptying
  • increasing age

Diagnostic investigations

1st investigations to order

  • urine dipstick
  • urine microscopy
  • urine culture and sensitivity
Full details

Investigations to consider

  • post-void residual (PVR)
  • renal ultrasound
  • abdominal/pelvic CT scan
  • cystoscopy
Full details

Treatment algorithm

Contributors

Una J. Lee

Female Pelvic Medicine and Reconstructive Surgery

Section of Urology and Renal Transplantation

Virginia Mason Medical Center

Seattle

WA

Disclosures

UJL declares that she has no competing interests.

Dr Una J. Lee would like to gratefully acknowledge Dr Elliot Blau for his contribution to this monograph, and Dr Bhavin N. Patel and Dr Howard B. Goldman, previous contributors to this topic.

Peer reviewersVIEW ALL

Associate Staff

Cleveland Clinic Foundation

Cleveland

OH

Disclosures

PS declares that she has no competing interests.

Associate Residency Director

Texas Tech University Health Sciences Center

Amarillo

TX

Disclosures

TJB declares that he has no competing interests.

Professor of Primary Care Research

Community Clinical Sciences Division

University of Southampton

Southampton

UK

Disclosures

PL declares that he has no competing interests.

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