Urinary incontinence, defined as the involuntary leakage of urine, has multiple causes which may require different interventions. Urinary stress incontinence is common during pregnancy and after childbirth. Pelvic floor exercises during and after pregnancy are therefore advised for all pregnant women, both in the treatment and prevention of urinary stress incontinence. Pharmacological treatment of pregnancy-associated stress incontinence is not routinely indicated.
If pharmacological treatment of urinary incontinence during pregnancy is being considered, for example, for woman with complex neurological conditions, specialist input should be sought. A wide range of drugs are currently used, including off-license, to reduce symptoms of urinary frequency, enuresis and incontinence. These include: darifenacin, fesoterodine, flavoxate, mirabegron, oxybutynin, propantheline, propiverine, solifenacin, tolterodine and trospium. Fetal risk with use in pregnancy is, however, unknown for the majority, with no published human pregnancy safety data available for darifenacin, fesoterodine, flavoxate, mirabegron, propantheline, propiverine, solifenacin, tolterodine and trospium. Data from a single prospective cohort study of pregnant women are available for oxybutynin. While this study does not provide reliable evidence of an increased risks of miscarriage or malformation, the study was vastly underpowered to exclude anything other than major increased risks. Pregnancy outcome data is available from UKTIS for a small number of pregnancy exposures to oxybutynin, solifenacin, tolterodine, fesoterodine, mirabegron, propantheline and trospium; no major malformations have been described.
Adverse fetal effects have been observed in preclinical reproductive toxicity studies of darifenacin, fesoterodine, mirabegron, oxybutynin, propiverine and tolterodine; however, exposure was often at maternally toxic doses. A careful risk-benefit analysis in discussion with the patient is therefore required if use in pregnancy of any of these drugs is being considered.
Exposure to drugs used to reduce symptoms of urinary frequency, enuresis, and incontinence at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy; however, due to the lack of data, additional fetal monitoring may be warranted. Other risk factors may also be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.