Previous changes

July 2024 — minor update. Neuroleptic malignant syndrome and stress cardiomyopathy have been added as possible adverse effects of duloxetine following an update to the manufacturer’s Summary of Product Characteristics (SPC).

January 2024 — minor update. Information on the licensed dose of desmopressin for women with troublesome nocturia and urgency incontinence has been added.

April 2023 — minor update. Minor typographical error corrected. 

September to October 2019 — reviewed. A literature search was conducted in August 2019 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials (RCTs) published since the last revision of this topic. Referral recommendations have been amended in line with the 2015 National Institute for Health and Care Excellence (NICE) guideline Suspected cancer: recognition and referral. 

January 2017 — minor update. The section on drug interactions of intravaginal oestrogens has been updated in line with a manufacturer's SPC.

November 2016 — minor update.

• Severe hypertension, dizziness, constipation, diarrhoea, headache, and dizziness have been added as possible adverse effects of mirabegron based on the manufacturer's SPC.
• Severe uncontrolled hypertension has been added as a contraindication of mirabegron based on a Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update.

June 2015 — minor update. Nausea has been added as a common adverse effect of mirabegron following an update to the manufacturer's SPC. 

February 2015 — minor update. Angioedema has been added as a rare adverse effect of mirabegron following an update to the manufacturer's SPC. 

October to December 2014 — reviewed. A literature search was conducted in October 2014 to identify evidence-based guidelines, UK policy, systematic reviews, and key RCTs published since the last revision of this topic. The following changes have been made:

• The choice of antimuscarinic drugs for women who have urinary urge with overactive bladder as a predominant symptom has been changed and is now in line with NICE guidance.
• Mirabegron has been added as a new drug option for women who have urinary urge with overactive bladder as a predominant symptom.
• The following new scenarios have been added: Management of mixed urinary incontinence, Management of overflow incontinence, and Management of urogenital fistula.

January 2013 — minor update. The black triangle status has been removed from fesoterodine as it is no longer a black triangle drug.

June 2011 — minor update.

• The black triangle status has been removed from desmopressin as it is no longer a black triangle drug.
• The topic structure has been revised to ensure consistency across CKS topics. No changes to clinical recommendations have been made.
• A prescription for estriol 0.01% vaginal cream (Gynest®) has been added. 

December 2010 — minor update. The prescription for Premarin^® vaginal cream (conjugated oestrogens) has been removed because the product has been discontinued. 

November 2008 to June 2009 — this is a new CKS topic. The evidence base has been reviewed in detail, and recommendations are clearly justified and transparently linked to the supporting evidence.

New evidence

Evidence-based guidelines

No new evidence-based guidelines since 1 September 2024.

HTAs (Health Technology Assessments)

No new HTAs since 1 September 2024.

Economic appraisals

No new economic appraisals published since 1 September 2024.

Systematic reviews and meta-analyses

No new systematic reviews or meta-analysis which reach the CKS threshold for inclusion since 1 September 2024.

Primary evidence

No new primary evidence published since 1 September 2024.

New policies

No new national policies or guidelines since 1 September 2024.

New safety alerts

No new safety alerts since 1 September 2024.

Changes in product availability

No change in product availability since 1 September 2024.

Assessing pelvic floor muscle contractions

• The strength of pelvic floor muscle contractions can be assessed digitally. A grading scale, such as the Oxford grading system, may be used to quantify the strength of the contraction [Laycock, 2001]:
  • 0 = no contraction. No discernible muscle contraction.
  • 1 = flicker. A flicker or pulsation is felt under the examiner's finger.
  • 2 = weak. An increase in tension is detected, without any discernible lift.
  • 3 = moderate. There is lifting of the muscle belly and also elevation of the posterior vaginal wall.
  • 4 = good. Increased tension and a good contraction elevate the posterior vaginal wall against resistance (pressure by the examining finger applied to the posterior vaginal wall).
  • 5 = strong. Strong resistance is applied to the elevation of the posterior vaginal wall. The examiner's finger is squeezed and drawn into the vagina.

Basis for recommendation

These recommendations are largely based on the NICE guideline Urinary incontinence and pelvic organ prolapse in women: management [NICE, 2019], and the European Association of Urology (EAU) Guidelines on management of non-neurogenic female lower urinary tract symptoms [EAU, 2023].

History

• The recommendation to take a detailed history is based on the NICE and EAU guidelines [NICE, 2019; EAU, 2023].
  • NICE recommends categorizing urinary incontinence (UI) into stress urinary incontinence (SUI), mixed urinary incontinence (MUI), or urgency urinary incontinence/overactive bladder (UUI/OAB) and starting initial treatment based on this.
  • The EAU states that despite the lack of formal evidence, there is universal agreement that history-taking should be the first step in assessing people with UI. The history should help classify UI as SUI, UUI, MUI, or overflow incontinence and identify people needing specialist referral.

Examination

• The recommendation to perform a general examination is based on expert opinion in a review article, which states that a general inspection provides useful information on the person’s overall health, including weight, gait abnormalities, and obvious neurological disease [Itam, 2017]. 
• The recommendations to perform abdominal and pelvic examinations are based on the NICE guideline [NICE, 2019].
  
  • NICE notes the ability of abdominal examination to identify a significantly enlarged bladder (which may indicate chronic urinary retention) or other abdominal or pelvic mass.
  • The NICE guideline committee emphasises the importance of a pelvic assessment and states that it should include vaginal examination and, if clinically indicated, a rectal examination.
    
    • A pelvic examination can identify the presence of a pelvic organ prolapse (associated with an increased risk of urinary retention) as well as uterine and ovarian enlargement (on bimanual examination), atrophic changes, and the ability to contract the pelvic floor muscles. 
    • A vaginal examination can assess pelvic organ prolapse and identify atrophic changes, infection, and excoriation.
    • When rectal examination is undertaken, it is used to further evaluate posterior vaginal wall prolapse and, where indicated by a history of constipation, prolapse or faecal incontinence.
• The EAU states that although there is little trial evidence that a clinical examination improves care, wide consensus suggests that it is an essential part of assessing people with UI [EAU, 2023].
  • It should include an abdominal examination (to detect an enlarged bladder or other abdominal mass) and a perineal examination (to assess oestrogen status and pelvic organ prolapse).
  • A cough test may reveal SUI if the bladder is sufficiently full. 

Investigations 

• The recommendation to perform urinary dipstick analysis in all women presenting with UI is based on the NICE guideline [NICE, 2019] and is consistent with the EAU guideline [EAU, 2023] and expert opinion in a review articles [Itam, 2017; BMJ Best Practice, 2023]. 
  • Urinalysis can help to identify underlying medical conditions that may contribute to UI. For example, glycosuria-induced polyuria, as seen in diabetes, can produce overactive bladder symptoms [BMJ Best Practice, 2023].
  • Urinary tract infections can mimic, cause, or worsen UI symptoms [Itam, 2017; EAU, 2023].
  • Detection of haematuria, pyuria, and glycosuria can suggest a co-existing condition which may require further investigation [EAU, 2023]. 
• The recommendation to assess renal function is extrapolated from the NICE guideline Acute kidney injury Prevention, detection and management up to the point of renal replacement therapy, which states that urinary tract obstruction accounts for about 10% of adult acute kidney injury [NICE, 2024a].

Bladder diaries

• Bladder diaries are used to document each cycle of filling and voiding over several days. They can provide information on urinary frequency, urgency, diurnal and nocturnal cycles, functional bladder capacity, and total urine output. They also record leakage episodes, fluid intake, and pad changes, indicate the severity of wetness, and may be used to monitor treatment outcomes [NICE, 2019].
• NICE recommends that treatment diaries should be used in the initial assessment of women with UI or OAB. This recommendation is based on evidence from five case series that analyzed bladder diaries kept for 1 day (one study), 3 days (one study), and 7 days (three studies). Although the optimum duration of bladder diaries was unclear from the studies, NICE recommends that they be kept for a minimum of 3 days [NICE, 2019].
• The EAU found voiding diaries kept for 3–7 days to be a reliable tool for measuring mean voided volume, day- and night-time frequency, urgency episodes, incontinence episodes, fluid intake, and pad usage [EAU, 2023].

When should I refer a woman with urinary incontinence?

• Refer using a suspected cancer pathway referral for bladder cancer (for an appointment within 2 weeks) if the woman is:
  • Aged 45 years and over with unexplained visible haematuria without urinary tract infection (UTI).
  • Aged 45 years and over with visible haematuria that is persistent or recurrent after successful treatment of UTI.
  • Aged 60 years and over with unexplained non-visible haematuria and dysuria or a raised white cell count on a blood test.
    • For more information on bladder cancer, see the CKS topic on Urological cancers - recognition and referral.
• Refer to an appropriate specialist (urologist, urogynaecologist, or nephrologist), using clinical judgement to determine urgency, if there is:
  • Persistent bladder or urethral pain — refer urgently if cancer is suspected.
  • Voiding difficulty.
  • A history of chronic urinary retention.
  • A bladder that is palpable on abdominal or bimanual examination after voiding.
  • A pelvic mass that is clinically benign.
  • Associated faecal incontinence.
  • Suspected neurological disease.
  • Suspected urogenital fistulae.
  • A history of previous incontinence surgery, pelvic cancer surgery, or radiation therapy.
  • Recurrent UTI — consider non-urgent referral for bladder cancer in women aged 60 years and over with recurrent or persistent unexplained UTIs.

How should I manage a woman with urinary incontinence?

If referral is not indicated:

• Ensure that the woman has completed a bladder diary.
• Offer appropriate lifestyle advice. 
  • This should include:
    • Weight loss (for women with a body mass index [BMI] over 30 kg/m²). For more information, see the CKS topic on Obesity.
    • Modifying fluid intake (increasing if too low or decreasing if too high).
    • Caffeine reduction (for women with overactive bladder).
    • Smoking cessation (for women who smoke). For more information, see the CKS topic on Smoking cessation. 
  • When discussing lifestyle changes:
    • Motivate women to make changes by focusing discussions on how this will improve their symptoms.
    • Encourage women to keep up with the changes, as it may take weeks or months to notice a benefit.
• Provide information on self-help resources, such as from the NHS website, the British Association of Urological Surgeons (BAUS), and Age UK.
• Identify and manage:
  • Reversible causes or contributing factors of UI, such as:
    • Constipation. For more information, see the CKS topic on Constipation.
    • Uncontrolled diabetes. For more information, see the CKS topics on Diabetes - type 1 and Diabetes - type 2.
  • Complications of UI, such as:
    • Anxiety. For more information, see the CKS topic on Generalized anxiety disorder.
    • Depression. For more information, see the CKS topic on Depression.
    • Increased risk of falls. For more information, see the CKS topic on Falls - risk assessment.
    • Sleep disturbance. For more information, see the CKS topic on Insomnia.
• If the woman requests further management, see sections on:
  • Managing stress urinary incontinence.
  • Managing urgency incontinence/overactive bladder.
  • Managing mixed urinary incontinence.

How should I further manage a woman with stress incontinence?

If referral is not indicated and initial management fails or the woman requests further management:

• Offer a referral for a trial of at least 3 months of supervised pelvic floor muscle training (PFMT).
  • Training should be done by an appropriate practitioner (such as a continence adviser, nurse specialist in urogynaecology, or physiotherapist specialising in women's health). 
  • A minimum of eight pelvic floor muscle contractions should be performed at least three times daily.
• If symptoms persist despite PFMT, refer to a urogynaecologist, gynaecologist, or urologist (depending on local service provision) for assessment and consideration of surgical treatment.
  • Surgical treatment options include colposuspension, autologous rectus fascial sling, retropubic mid-urethral mesh sling, and intramural urethral bulking agents.
• If surgical treatment is unsuitable or the woman prefers pharmacological treatment, offer duloxetine and counsel the woman on the possible adverse effects.
  • For more information, see the prescribing information section on Duloxetine.
• Do not routinely offer containment products (such as absorbent products, hand-held urinals, or toileting aids) to treat urinary incontinence. 
  • Offer them only: 
    • To cope with urinary leakage whilst awaiting assessment and treatment.
    • As an adjunct to ongoing treatment. 
    • For long-term management, only after treatment options have been explored.
  • Offer a review at least once a year to women using absorbent containment products for long-term management of UI. The review should be carried out or overseen by a healthcare professional trained in assessing continence and referring to specialist services and should cover the following:
    • Routine assessment of continence.
    • Assessment of skin integrity.
    • Changes to symptoms, comorbidities, lifestyle, mobility, medication, BMI, and social and environmental factors.
    • The efficacy of the absorbent containment product and the quantities used.
    • The suitability of alternative treatment options.

How should I further manage a woman with urgency urinary incontinence/overactive bladder?

If referral is not indicated and initial management fails or the woman requests further management:

• Offer a referral for at least 6 weeks of bladder training.
  • This may be available from the local continence nurse, continence physiotherapist, or urology clinic.
• If symptoms persist and frequency is a troublesome symptom, encourage the woman to continue bladder training and consider adding a medicine for overactive bladder.
• Identify and manage other associated symptoms.
  
  • If the woman has troublesome nocturia, consider prescribing desmopressin. For detailed prescribing information, see the section on Desmopressin.   
  • If the woman is post-menopausal and has vaginal atrophy, consider intravaginal oestrogen therapy. For prescribing information, see the section on Intravaginal oestrogen.
• Do not routinely offer containment products (such as absorbent products, hand-held urinals, or toileting aids) to treat urinary incontinence. 
  • Offer them only: 
    • To cope with urinary leakage whilst awaiting assessment and treatment.
    • As an adjunct to ongoing treatment. 
    • For long-term management, only after treatment options have been explored.
  • Offer a review at least once a year to women using absorbent containment products for long-term management of UI. The review should be carried out or overseen by a healthcare professional trained in assessing continence and referring to specialist services and should cover the following:
    • Routine assessment of continence.
    • Assessment of skin integrity.
    • Changes to symptoms, comorbidities, lifestyle, mobility, medication, BMI, and social and environmental factors.
    • The efficacy of the absorbent containment product and the quantities used.
    • The suitability of alternative treatment options.

How should I further manage a woman with mixed urinary incontinence?

If referral is not indicated and initial management fails or the woman requests further management:

• Direct treatment towards the predominant symptom.
  
  • If stress incontinence is the predominant symptom:
    • Discuss with the woman the benefit of non-surgical management and medicines for overactive bladder before offering referral for surgery.
    • See the sections on Managing stress urinary incontinence and Medicines for overactive bladder for more information.
  • If urgency incontinence is the predominant symptom:
    • See the section on Managing urgency incontinence/overactive bladder for management information.

What are the contraindications and cautions for antimuscarinic (anticholinergic) treatment?

This section contains general information on the contraindications and cautions for antimuscarinic (anticholinergic) treatment. For detailed information on individual antimuscarinic medicines, including use in pregnancy, breastfeeding, and renal or hepatic impairment, see the electronic Medicines Compendium (eMC) or the British National Formulary (BNF).

• Do not prescribe antimuscarinic medicine to people with: 
  • Angle-closure glaucoma.
  • Gastrointestinal obstruction.
  • Intestinal atony.
  • Myasthenia gravis (but some antimuscarinics may be used to decrease muscarinic adverse effects of anticholinesterases).
  • Paralytic ileus.
  • Pyloric stenosis.
  • Severe ulcerative colitis.
  • Significant bladder outflow obstruction.
  • Urinary retention.
  • Toxic megacolon.
• Prescribe antimuscarinic medicine with caution to: 
  • People with:
    • Acute myocardial infarction.
    • Arrhythmias (may be worsened).
    • Congestive heart failure (may be worsened).
    • Coronary artery disease (may be worsened).
    • Conditions associated with tachycardia, including cardiac insufficiency, cardiac surgery, and hyperthyroidism.
    • Autonomic neuropathy (such as those with Parkinson's disease).
    • Diarrhoea.
    • Gastro-oesophageal reflux disease.
    • Hiatus hernia with reflux oesophagitis.
    • Hypertension.
    • Susceptibility to angle-closure glaucoma.
    • Pyrexia.
    • Ulcerative colitis.
  • Older people (especially if frail) — risk of cognitive impairment.
    • NICE recommends that oxybutynin (immediate release) should not be offered to older women who may be at higher risk of a sudden deterioration in their physical or mental health [NICE, 2019]. 

[BNF, 2025]

How should I start and titrate antimuscarinic (anticholinergic) treatment?

• For information on the licensed dosages of individual antimuscarinic (anticholinergic) medicines, see the electronic Medicines Compendium (eMC) or the British National Formulary (BNF).

What are the adverse effects of antimuscarinic (anticholinergic) medicines?

This section contains general information on the adverse effects of antimuscarinic (anticholinergic) treatment. For detailed information on the adverse effects of individual antimuscarinic medicines, see the electronic Medicines Compendium (eMC) or the British National Formulary (BNF).

• The most common adverse effects of antimuscarinic medicines are:
  • Dry mouth.
  • Nausea, constipation, vomiting, and dyspepsia.
  • Dizziness, drowsiness, flushing, headache, and palpitations.
  • Skin reactions.
  • Tachycardia.
  • Urinary disorders.
  • Vision disorders.
• Rare or very rare adverse effects include:
  • Angioedema.
  • Confusion (especially in older people).

[BNF, 2025]

What are the key drug interactions of antimuscarinic (anticholinergic) medicines?

• For information on drug interactions of individual antimuscarinic (anticholinergic) medicines, see the electronic Medicines Compendium (eMC) or the British National Formulary (BNF).

What monitoring is required for antimuscarininc (anticholinergic) medicines?

• After starting or adjusting antimuscarinic treatment, review the woman 4 weeks later (or sooner if adverse effects are intolerable).
• If the treatment is effective and the woman wishes to continue, review every 12 months (or every 6 months for women aged over 75 years).

[NICE, 2019; BNF, 2025]

What are the contraindications and cautions for desmopressin?

• Do not prescribe desmopressin to women with:
  • Cardiac insufficiency.
  • Conditions treated with diuretics.
  • History of hyponatraemia.
  • History of psychogenic polydipsia or alcohol abuse.
  • Syndrome of inappropriate antidiuretic hormone (ADH) secretion.
  • von Willebrand's Disease Type IIB (may result in pseudothrombocytopenia).
  • Moderate renal impairment (estimated glomerular filtration rate [eGFR] 30–59 mL/minute/1.73 m²)
  • Severe renal impairment (eGFR 15–29 mL/minute/1.73 m²).
• Avoid desmopressin:
  
  • In women aged 65 years or over with cardiovascular disease or hypertension [NICE, 2019].
  • For treating nocturia associated with multiple sclerosis in women aged over 65 years [BNF, 2025].
• Prescribe desmopressin with caution to:
  
  • Women with:
    • Fluid overload.
    • Conditions characterized by fluid or electrolyte imbalance. 
    • Cystic fibrosis.
    • Epilepsy.
    • Cardiovascular disease.
    • Hypertension. 
    • Mild renal impairment (eGFR 60–89 mL/minute/1.73 m²) — antidiuretic effect may be reduced.
  • Older women — increased risk of hyponatraemia and renal impairment.
  • Pregnant women — small oxytocic effect in third trimester; increased risk of pre-eclampsia. 

[EMC, 2016; BNF, 2025]

How should I start and titrate desmopressin?

• Desmopressin is indicated for the treatment of idiopathic nocturnal polyuria in females.
  • The recommended dosage for this indication is 25 micrograms once daily. 
  • The dose should be administered sublingually without water and taken one hour before bedtime.
  • Fluid intake must be limited to a minimum from 1 hour before until 8 hours after administration. Treatment without concurrent reduction of fluid intake may lead to prolonged fluid retention and/or hyponatremia with or without accompanying warning signs and symptoms.
• Reassess the need for continued treatment after 3 months by withdrawing treatment for at least 1 week.
  • A dose increase is not recommended in older people (65 years and older).

[EMC, 2016; BNF, 2025]

What are the adverse effects of desmopressin?

• The most serious adverse effect of desmopressin is hyponatraemia. 
  • Hyponatraemia is an antidiuretic effect arising from increased water re-absorption by the renal tubules and osmotic dilution of plasma.
  • It is associated with headache, nausea, vomiting, decreased serum sodium, weight increase, malaise, abdominal pain, muscle cramps, dizziness, confusion, reduced consciousness, and, in severe cases, convulsions and coma.
  • Women have a higher risk of hyponatraemia than men, possibly due to increased sensitivity of the kidney tubules to vasopressin and its analogues.
  • The risk of hyponatraemia is minimized by the recommendation of a lower treatment dose in women.
• Other adverse effects of desmopressin include:
  • Common or very common: dry mouth.
  • Uncommon: constipation, abdominal discomfort, fatigue, and peripheral oedema.
  • Rare or very rare: allergic dermatitis and emotional disorder.
  • Frequency unknown: fluid retention.

[EMC, 2016; BNF, 2025]

What are the key drug interactions of desmopressin?

• Drug interactions of desmopressin include: 
  • Drugs known to induce syndrome of inappropriate antidiuretic hormone secretion (SIADH) — there is an increased risk of water retention or hyponatraemia during concurrent treatment with drugs known to induce SIADH, such as tricyclic antidepressants, selective serotonin reuptake inhibitors, chlorpromazine, diuretics, carbamazepine, and lamotrigine. 
    
    • Monitor serum sodium closely during concurrent treatment.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) — may potentiate the antidiuretic effect of desmopressin, leading to water overload and/or hyponatraemia. 
    • Caution is advised during concurrent use, with more frequent monitoring of serum sodium [Preston, 2024].
  • Loperamide — may increase desmopressin plasma concentrations.
    • Monitor the effects of desmopressin, reducing the dose as necessary [Preston, 2024].

[EMC, 2016; BNF, 2025]

What monitoring is required for desmopressin?

• In women with nocturia:
  • Monitor weight and blood pressure to assess for fluid overload.
• In older women:
  • Check serum sodium concentration before starting treatment, in the first week of treatment (4–8 days), one month after initiation, and periodically thereafter.
  • Discontinue desmopressin if levels fall below the normal range.
  • Review treatment if there is no therapeutic benefit after 3 months.
• In pregnant women:
  • Monitor blood pressure due to the increased risk of pre-eclampsia.

[EMC, 2016; BNF, 2025]

What are the contraindications and cautions for duloxetine?

• Do not prescribe duloxetine to women with:
  • Hepatic impairment.
  • Severe renal impairment (creatinine clearance less than 30 mL/min).
  • Uncontrolled hypertension.
• Avoid duloxetine in:   
  • Pregnant women with stress urinary incontinence (in other conditions, use only if the potential benefit outweighs the risk) — risk of neonatal withdrawal symptoms if used near term.
  • Breastfeeding women — present in milk.
• Prescribe duloxetine with caution to women with:
  • Cardiac disease.
  • History of bleeding disorders.
  • History of seizures.
  • History of mania or bipolar disorder.
  • Hypertension.
  • Raised intraocular pressure.
  • Susceptibility to angle-closure glaucoma.
  • Increased risk for hyponatraemia, such as older, cirrhotic, or dehydrated women or those treated with diuretics.

[EMC, 2024a; BNF, 2025]

How should I start and titrate duloxetine?

• Duloxetine is indicated for the treatment of moderate to severe stress urinary incontinence in women.
  • The recommended dosage for this indication is 40 mg twice daily. Alternatively, a lower starting dosage of 20 mg twice daily can be prescribed for 2 weeks, then increased to 40 mg twice daily to reduce the risk of adverse effects.
  • Reassess the woman after 2–4 weeks of treatment to evaluate the benefit and tolerability of the treatment.
• If duloxetine treatment is to be discontinued, reduce the dose gradually over at least 1–2 weeks to reduce the risk of withdrawal reactions.
  • If intolerable withdrawal reactions occur after a dose reduction or on stopping treatment, resume the previously prescribed dose and continue decreasing the dose more gradually.

[EMC, 2024a; BNF, 2025]

What are the adverse effects of duloxetine?

• The most common adverse effects of duloxetine are:
  • Nausea.
  • Dry mouth.
  • Fatigue.
  • Constipation. 
• Other adverse effects include:
  • Cardiac effects, such as:
    • Uncommon: palpitation and tachycardia.
    • Rare: supraventricular arrhythmia, mainly atrial fibrillation.
    • Frequency unknown: stress cardiomyopathy (Takotsubo cardiomyopathy).
  • Gastrointestinal (GI) effects, such as:
    • Common: diarrhoea, abdominal pain, vomiting, and dyspepsia.
    • Uncommon: GI bleeding, gastroenteritis, stomatitis, gastritis, dysphagia, flatulence, and halitosis.
    • Rare: microscopic colitis.
  • Nervous system effects:
    • Common: headache, dizziness, lethargy, somnolence, tremor, and paraesthesia.
    • Uncommon: nervousness, disturbance in attention, dysgeusia, and poor sleep quality.
    • Rare: serotonin syndrome, convulsion, myoclonus, akathisia, psychomotor restlessness, extra-pyramidal symptoms, dyskinesia, and restless legs syndrome. Neuroleptic malignant syndrome (NMS) may occur, and in its most severe form, serotonin syndrome can resemble NMS.
  • Psychiatric effects:
    • Common: anxiety, sleep disorders, insomnia, agitation, and sexual dysfunction (symptoms may persist after treatment has stopped).
    • Uncommon: bruxism, disorientation, abnormal dreams, and apathy.
    • Rare: suicidal behaviour/ideation, mania, hallucination, aggression, and anger.
  • Skin and subcutaneous tissue effects:
    • Common: increased sweating.
    • Uncommon: rash, urticaria, and dermatitis.
    • Rare: Stevens-Johnson syndrome, photosensitivity, and angioneurotic oedema.
  • Vascular effects:
    • Common: hypertension and flushing.
    • Uncommon: syncope.
    • Rare: hypertensive crisis, orthostatic hypertension, and peripheral coldness.
  • Eye and ear effects:
    • Common: blurred vision and vertigo.
    • Uncommon: visual impairment, dry eyes, tinnitus, and ear pain.
  • Other effects:
    • Common: asthenia, chills, and decreased appetite.
    • Uncommon: laryngitis, hypersensitivity disorder, hypothyroidism, dehydration, yawning, urinary problems, hepatitis, acute liver injury, and elevated liver enzymes, blood cholesterol, or creatine phosphokinase.
    • Rare: anaphylaxis, syndrome of inappropriate antidiuretic hormone secretion (SIADH), hyponatraemia, hypoglycaemia (especially in people with diabetes), and hyperkalemia.

[EMC, 2024a; BNF, 2025]

What are the key drug interactions of duloxetine?

• Drug interactions with duloxetine include:
  • Monoamine oxidase inhibitors (MAOIs) — serious and potentially life-threatening reactions (serotonin syndrome) can develop if duloxetine and non-selective, irreversible MAOIs (such as phenelzine) are given concurrently or even sequentially if insufficient time is left in between. 
    • Concurrent use is contraindicated.
    • Duloxetine should be stopped 5 days before starting an MAOI, and MAOIs should be stopped for 14 days before starting duloxetine.
  • Selective serotonin reuptake inhibitors (SSRIs) — concentrations of duloxetine can be increased by SSRIs, leading to an increased risk of serotonin syndrome. Additionally, the combination of duloxetine and an SSRI can increase the risk of bleeding, hyponatraemia, and sedation.
    • Concurrent use with fluvoxamine is contraindicated, as fluvoxamine markedly increases duloxetine exposure. 
    • If concurrent use with another SSRI is indicated, monitor for increased duloxetine adverse effects and symptoms of serotonin syndrome (such as fever, tremors, diarrhoea, and agitation).
  • Tricyclic antidepressants (TCAs) — concentrations of TCAs (such as clomipramine) may be increased by duloxetine, leading to an increased risk of hyponatraemia and sedation. Theoretically, the combination of duloxetine and a TCA may lead to potentially fatal serotonin syndrome.
    • Monitor for increased tricyclic adverse effects (such as blurred vision, dry mouth, and confusion).
    • Consider the theoretical risk of serotonin syndrome in case of any unexpected effects with concurrent use.
  • Other serotonergic drugs — caution is advised if duloxetine is used concurrently with other serotonergic drugs, such as St John's wort, triptans, buprenorphine, and tramadol.
  • Centrally acting drugs  — additive central nervous system (CNS) effects are possible during concurrent treatment with other centrally acting drugs, such as alcohol, benzodiazepines, antipsychotics, phenobarbital, and sedating antihistamines. 
    • Warn the woman about the potential effects.
    • Counsel against driving or undertaking other skilled tasks. 
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelets, and anticoagulants — increased risk of bleeding if taken with duloxetine.
    • Advise the woman to report any signs of bleeding.
    • Consider gastroprotection (such as a proton pump inhibitor) if there are risk factors for gastrointestinal (GI) bleeding, such as history of GI bleeding and older age.
  • Drugs metabolized by cytochrome P450 (CYP) 2D6 liver enzyme — duloxetine is a moderate inhibitor of CYP2D6.
    • Caution is advised if duloxetine is co-administered with drugs that are predominantly metabolized by CYP2D6, such as risperidone, flecainide, and metoprolol.

[EMC, 2024a; Preston, 2024; BNF, 2025]

What monitoring is required for duloxetine?

• In women with hypertension or other cardiac disease:
  • Monitor blood pressure, especially during the first month of treatment. If a sustained increase in blood pressure occurs, consider a dose reduction or gradual discontinuation of duloxetine.

[EMC, 2024a]

What are the contraindications and cautions for intravaginal oestrogens?

This section contains general information on the contraindications and cautions for all oestrogen preparations. For detailed information on individual intravaginal oestrogens, see the electronic Medicines Compendium (eMC) or the British National Formulary (BNF).

• Do not prescribe oestrogen preparations to:
  • Women with:
    • Active or recent arterial thromboembolic disease (such as angina and myocardial infarction).
    • Known or suspected oestrogen-dependent malignant tumours (such as endometrial cancer).
    • Known, past, or suspected breast cancer.
    • Previous or current venous thromboembolism (deep venous thrombosis or pulmonary embolism).
    • Known thrombophilic disorders (for example, protein C, protein S, or antithrombin deficiency).
    • Undiagnosed genital bleeding.
    • Untreated endometrial hyperplasia.
    • Acute liver disease or a history of liver disease (if liver function tests have failed to return to normal).
  • Pregnant or breastfeeding women.
• Prescribe oestrogen preparations with caution in women with:
  • Acute porphyrias.
  • Hepatic impairment.
  • Renal impairment.
  • Diabetes (increased risk of heart disease).
  • Factors predisposing to thromboembolism.
  • History of breast nodules or fibrocystic disease — closely monitor breast status (risk of breast cancer).
  • History of endometrial hyperplasia.
  • Hypophyseal tumours.
  • Increased risk of gallbladder disease.
  • Migraine (or migraine-like headaches).
  • Presence of antiphospholipid antibodies (increased risk of thrombotic events).
  • Risk factors for oestrogen-dependent tumours (such as breast cancer in a first-degree relative).
• Discontinue oestrogen treatment immediately in the following situations:
  • Jaundice or deterioration in liver function.
  • Significant increase in blood pressure.
  • New onset of migraine-type headache.
  • Pregnancy.

[BNF, 2025]

Which intravaginal oestrogen preparation should I prescribe, and what is the recommended dosage?

• Intravaginal oestrogen is available as a tablet, pessary, cream, gel, and ring. 
  • The lowest effective dose should be used for the shortest duration possible (to minimize systemic absorption).
  • For available preparations and recommended dosages, see the British National Formulary (BNF).

[BNF, 2025]

What are the adverse effects of intravaginal oestrogens?

This section contains general information on the adverse effects of oestrogens. For detailed information on the adverse effects of individual intravaginal oestrogen preparations, see the electronic Medicines Compendium (eMC) or the British National Formulary (BNF).

• Adverse effects of oestrogen preparations include:
  • Common or very common:
    • Dysuria.
    • Genital abnormalities.
    • Skin reactions.
    • Vulvovaginal disorders.
  • Uncommon:
    • Anorectal discomfort.
    • Candidal infection.
    • Headache.
    • Pelvic pain.
  • Unknown frequency:
    • Nausea or vomiting.
    • Breast abnormalities.
    • Increased cervical mucus.
    • Dementia.
    • Erythema nodosum.
    • Gallbladder disorder.
    • Neoplasms.
    • Vaginal bleeding.
    • Increased risk of coronary artery disease, ischaemic stroke, and venous thromboembolism.

[BNF, 2025]

What are the key drug interactions of intravaginal oestrogen?

• The manufacturers of some intravaginal oestrogen preparations advise that due to vaginal administration and minimal systemic absorption, clinically relevant drug interactions are unlikely. However, interactions with other locally applied vaginal treatments should be considered. 
• For more information on individual intravaginal oestrogen preparations, see the electronic Medicines Compendium (eMC) or the British National Formulary (BNF).

What advice should I give to a woman prescribed an intravaginal oestrogen?

• Advise the woman that:
  • Topical oestrogens should be used in the lowest effective dose to minimize systemic absorption.
  • She should seek medical advice if she experiences breakthrough bleeding or spotting at any time during treatment. 
  • Some intravaginal oestrogen preparations can damage contraceptive condoms and diaphragms. 

[BNF, 2025]

What monitoring is required for intravaginal oestrogens?

• In all women:
  • Review treatment at least annually to reassess the need for continued treatment and to monitor for symptoms of endometrial hyperplasia or carcinoma in women with a uterus. If bleeding or spotting occurs during treatment, the reason should be investigated.
• In women with a history of breast nodules or fibrocystic disease:
  •  Closely monitor breast status due to the risk of breast cancer.
• Discontinue oestrogen treatment immediately in the following situations:
  • Jaundice or deterioration in liver function.
  • Significant increase in blood pressure.
  • New onset of migraine-type headache.
  • Pregnancy.

[BNF, 2025]

What are the contraindications and cautions for mirabegron?

• Do not prescribe mirabegron to women with: 
  • Severe uncontrolled hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher).
  • Severe renal impairment (estimated glomerular filtration rate [eGFR] 15–29 mL/minute/1.73 m²) and concurrent use of a potent cytochrome P450 (CYP) 3A4 inhibitor. 
  • End-stage renal disease (eGFR less than 15 mL/minute/1.73 m²).
  • Severe hepatic impairment (Child-Pugh Class C).
  • Moderate hepatic impairment (Child-Pugh Class B) and concurrent use of a potent CYP3A4 inhibitor.
• Avoid mirabegron in:
  • Pregnant women — toxicity in animal studies.
  • Breastfeeding women — present in milk in animal studies.
• Prescribe mirabegron with caution to women with: 
  • A history of QT interval prolongation.
  • Bladder outflow obstruction.
  • Hypertension (systolic blood pressure of 160 mm Hg or higher, or diastolic blood pressure of 100 mm Hg or higher).
• Prescribe a reduced dose of mirabegron to women with: 
  • Mild renal impairment (eGFR 60–89 mL/minute/1.73 m²) and concurrent use of a potent CYP3A4 inhibitor.
  • Moderate renal impairment (eGFR 30–59 mL/minute/1.73 m²) and concurrent use of a potent CYP3A4 inhibitor.
  • Severe renal impairment (eGFR 15–29 mL/minute/1.73 m²).
  • Mild hepatic impairment (Child-Pugh Class A) and concurrent use of a potent CYP3A4 inhibitor.
  • Moderate hepatic impairment (Child-Pugh Class B).

[EMC, 2024b; BNF, 2025]

How should I start and titrate mirabegron?

• Mirabegron is indicated for the symptomatic treatment of urgency, increased micturition frequency, and/or urgency incontinence in people with overactive bladder.
  • The recommended dosage for this indication is 50 mg once daily.
• Prescribe a reduced dose of 25 mg once a day for women with:
  • Mild renal impairment (estimated glomerular filtration rate [eGFR] 60–89 mL/minute/1.73 m²) and concurrent use of a potent cytochrome P450 (CYP) 3A4 inhibitor).
  • Moderate renal impairment (eGFR 30–59 mL/minute/1.73 m²) and concurrent use of a potent CYP3A4 inhibitor.
  • Severe renal impairment (eGFR 15–29 mL/minute/1.73 m²).
    • Avoid if the woman is also taking a potent CYP3A4 inhibitor.
  • Mild hepatic impairment (Child-Pugh Class A) and concurrent use of a potent CYP3A4 inhibitor.
  • Moderate hepatic impairment (Child-Pugh Class B).
    • Avoid if the woman is also taking a potent CYP3A4 inhibitor.

[EMC, 2024b; BNF, 2025]

What are the adverse effects of mirabegron?

• The most common adverse effects of mirabegron are:
  • Constipation.
  • Nausea.
  • Diarrhoea.
  • Dizziness.
  • Headache.
  • Increased risk of infection.
  • Arrhythmias.
• Other adverse effects include:
  • Uncommon: cystitis, dyspepsia, gastritis, joint swelling, palpitations, skin reactions, and vulvovaginal pruritus.
  • Rare or very rare: angioedema, eyelid oedema, hypersensitivity vasculitis, hypertensive crisis, lip swelling, and urinary retention.
  • Frequency unknown: insomnia.

[EMC, 2024b; BNF, 2025]

What are the key drug interactions of mirabegron?

• Drug interactions of mirabegron include:
  • Cytochrome P450 (CYP) 3A4 inhibitors — mirabegron is a substrate for CYP 3A4. Plasma concentrations may be increased by concurrent use with potent CYP3A inhibitors, such as clarithromycin, itraconazole, or ritonavir.
    • Avoid or reduce the dose of mirabegron in people with renal or hepatic impairment who are also taking one of these drugs. 
  • Digoxin — mirabegron may increase plasma concentrations of digoxin.
    • If concurrent use is indicated, prescribe the lowest dose of digoxin initially.
    • Monitor serum digoxin concentrations and adjust the dose to achieve the desired clinical effect.
  • P-glycoprotein (P-gp) substrates — high concentrations of mirabegron may inhibit P-glycoprotein (P-gp) drug transport.
    • Consider the potential for this interaction if mirabegron is combined with sensitive P-gp substrates, such as dabigatran and edoxaban.
• Mirabegron may increase plasma concentrations of the following drugs: colchicine, metoprolol, everolimus, sirolimus, fexofenadine, and loperamide.   
  
  • Monitor for adverse effects of the concurrent drug, adjusting the dose if necessary.

[EMC, 2024b; BNF, 2025]

What monitoring is required for mirabegron?

• Monitor blood pressure before starting mirabegron and regularly during treatment, especially in people with pre-existing hypertension.

[EMC, 2024b; BNF, 2025]

What are the contraindications and cautions for vibegron?

• Do not prescribe vibegron to women with:
  • Rare hereditary problems of galactose intolerance.
  • Total lactase deficiency.
  • Glucose-galactose malabsorption.
  • End-stage renal disease (estimated glomerular filtration rate [eGFR] less than 15 mL/minute/1.73 m² with or without haemodialysis) — vibegron has not been studied in this group.
  • Severe hepatic impairment (Child-Pugh C) — vibegron has not been studied in this group.
• Avoid vibegron in: 
  • Pregnant women — toxicity in animal studies.
  • Breastfeeding women — present in milk in animal studies.
• Prescribe vibegron with caution to:
  • Women with bladder outlet obstruction or conditions predisposing to bladder outlet obstruction — increased risk of urinary retention.
  • Women taking a muscarinic antagonist concurrently with vibegron — increased risk of urinary retention.

[EMC, 2024c; BNF, 2025]

How should I start and titrate vibegron?

• Vibegron is licensed for the symptomatic treatment of overactive bladder in adults.
  • The recommended dosage for this indication is  75 mg once daily.
• No dose adjustment is recommended for mild, moderate, or severe renal impairment (estimated glomerular filtration rate [eGFR] 15–89 mL/minute/1.73 m²). Do not prescribe if eGFR is less than 15 mL/minute/1.73 m² with or without haemodialysis.
• No dose adjustment is recommended for mild to moderate hepatic impairment (Child-Pugh A and B). Do not prescribe in people with severe hepatic impairment (Child-Pugh C).

[EMC, 2024c; BNF, 2025]

What are the adverse effects of vibegron?

• The most common adverse effects are:
  • Constipation.
  • Diarrhoea.
  • Headache.
  • Nausea.
  • Urinary tract infection.
  • Increased residual urine volume.
• Other adverse effects include (uncommon):
  • Hot flush.
  • Rash (including rash pruritic and rash erythematous).
  • Urinary retention (including urinary straining).

[EMC, 2024c; BNF, 2025]

What are the key drug interactions of vibegron?

• Drug interactions of vibegron include:
  • Digoxin — vibegron may increase plasma concentrations of digoxin.
    • If concurrent use is indicated, prescribe the lowest dose of digoxin initially.
    • Monitor serum digoxin concentrations and adjust the dose to achieve the desired clinical effect.
  • Cytochrome P450 (CYP) 3A4 and P-gp inhibitors — vibegron is a substrate for CYP 3A4 and P-gp. Plasma concentrations may be increased by potent and moderate inhibitors of CYP3A/P-gp, such as ketoconazole and diltiazem, respectively.
    
    • The manufacturer states that no vibegron dose adjustment is needed. However, consider this interaction in the event of increased adverse effects.
  • P-gp substrates — vibegron is a substrate for P-gp.
    • Consider the potential for interaction if vibegron is combined with a sensitive P-gp substrate with a narrow therapeutic index, such as dabigatran, apixaban, or rivaroxaban.

 [EMC, 2024c]

What monitoring is required for vibegron?

• Monitor for signs and symptoms of urinary retention before and during the treatment with vibegron, particularly in women with clinically significant bladder outlet obstruction, in conditions predisposing for bladder outlet obstruction, and in women who are also taking a muscarinic antagonist.

[EMC, 2024c]