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7.4 Drugs for genito-urinary disorders

7.4.1 Drugs for urinary retention

Alpha-blockers relax smooth muscle in benign prostatic hyperplasia producing an increase in urinary flow rate and 
improvement in obstructive symptoms.  Watchful waiting may be preferable to treatment in men with mild to moderate
symptoms. Alpha-blockers are the treatment of choice for benign prostatic obstruction, and are likely to provide symptom relief in
men with prostates of any size. The effect should be noticed within several days, with full response after 4-6 weeks.  They appear
to be equally effective but there are differences in tolerability. All alpha-blockers reduce blood pressure, and first doses may
cause drowsiness and dizziness. Modified release preparations may reduce these effects. Patients also receiving antihypertensives 
may need lower doses and supervision. 
Tamsulosin capsules m/r should be used first line, but some patients may experience a higher incidence of adverse sexual
dysfunction, so alfuzosin m/r is often preferable for those in whom this is an issue.
 
First Line  
GREEN      Tamsulosin  capsules m/r 400microgram
 
Second Line 
GREEN      Alfuzosin  tablets m/r 5mg, 10mg 
                                     tablets 2.5mg
GREEN      Doxazosin tablets 1mg, 2mg, 4mg 
                   (Note M/R preps of Doxazosin should NOT be prescribed.)
GREEN      Terazosin tablets 2mg, 5mg
AMBER     Tamsulosin 400mcg/dutasteride 500mcg  
 
Parasympathomimetics  
AMBER      Bethanechol tablets 10mg, 25mg (rarely used)
RED            Distigmine tablets 5mg (for post-operative use in gynaecology patients only)
 

7.4.2 Drugs for urinary frequency, enuresis and incontinence

Urinary incontinence
Bladder training lasting for a minimum of 6 weeks should be offered as first-line treatment to women with urge or mixed  urinary
incontinence. A trial of supervised pelvic floor muscle training of at least 3 months’ duration should be offered as first-line
treatment to women with stress or mixed Urinary incontinence. Tolterodine or Oxybutynin should be offered to women with  
Over Active Bladder (OAB) or mixed Urinary Incontinence as first-line drug treatment if bladder training has been ineffective.
When offering antimuscarinic drugs to treat OAB always take account of:

       >     coexisting conditions (for example, poor bladder emptying, constipation, glaucoma)  
       >     use of other existing medication affecting the total antimuscarinic load
       >     risk of adverse effects
 
Discuss with patient:
      >     the likelihood of success and associated common adverse effects, and
      >     the frequency and route of administration, and
      >     that some adverse events such as dry mouth and constipation may indicate that treatment is starting to have  an effect, 
             and that they may not see the full benefits until they have been taking the treatment for 4 weeks.
 
Oxybutynin immediate release is recommended by NICE but some patients may not tolerate its adverse effects if used  on a
regular basis. However, some patients prefer to use an  immediate release product to enable them to take prior to certain
situations, allowing them to use it 'as required'. This can also be helpful in allowing patients to balance the benefits with the side 
effects, enabling them to retain control of the timing of their treatment.
If after a 4 week trial first choice treatment is ineffective or not tolerated then solifenacin, darifenacin or trospium should be
considered as second line alternatives. Women should be counselled about the adverse effects of antimuscarinic drugs.
The need for continuing antimuscarinic drug therapy should be reviewed after 6 months.
In accordance with NICE TA290 Mirabegron is recommended as an option ONLY for patients in whom antimuscarinic  drugs are
ineffective, contra-indicated, or not tolerated.
If treatment remains ineffective or is not tolerated patients should be referred to secondary care for further investigations.
Propiverine and Fesoterodine are  available as treatment options as AMBER traffic light drugs.
 
First Line Choices
GREEN      Tolterodine capsules (IR) 2mg (twice daily)
GREEN      Tolterodine capsules (m/r) 4mg (once daily) 
GREEN      Oxybutynin tablets (I/R) 5mg (2-3 times daily
GREEN      Oxybutynin tablets m/r 5mg, 10mg (once daily)
AMBER      Oxybutynin patches 3.9mg/24hrs (Kentera®)
 
Second Line Choices  
GREEN      Solifenacin tablets 5mg, 10mg 
GREEN     Darifenacin tablets m/r 7.5mg, 15mg 
GREEN     Trospium capsules m/r 60mg
 
Other options available to secondary care  
AMBER    Propiverine Hydrochloride tablets 15mg 
AMBER    Propiverine Hydrochloride m/r capsules 30mg
AMBER    Fesoterodine MR tablets  4mg, 8mg
 
Mirabegron is recommended by NICE TA290 as an option for treating the symptoms of overactive bladder only for people in whom
antimuscarinic drugs are contraindicated or clinically ineffective, or have unacceptable side effects. The dose needs to be reduced
in renal/hepatic impairment. Patient’s should be reviewed 4 weeks after initiating.
 
Following a review by the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency (MHRA),
there are now new recommendations for the use of Betmiga▼ (mirabegron).   
The new recommendations follow a review by the European Medicines Agency of cumulative data associated with mirabegron and
increased blood pressure. Serious cases of hypertension and increased blood pressure have been reported in patients on
mirabegron treatment.
In addition, there have been some reports of hypertensive crisis and cerebrovascular and cardiac events associated with
hypertension with a clear temporal relationship with the use of mirabegron.
Its use in patients with severe uncontrolled high blood pressure is now contraindicated. Blood pressure should be measured 
at the start of treatment and monitored regularly, especially in patients with hypertension.
 
GREEN      Mirabegron tablets 25mg, 50mg
 
Oxybutyin patches are not routinely recommended and should be reserved only for individuals who are unable to tolerate oral
medication.
 
 A guideline for the management of the condition can be found here 
 

7.4.3 Drugs used in urological pain

Alkalinisation of urine
GREEN      Potassium citrate (30%) mixture BP [Consider OTC/Self care]              
RED           Potassium citrate matrix tablets (Urocit-K®) 5mEq, 10mEq (unlicensed) 
                   For use in specific group of patients only 
GREEN      Sodium bicarbonate capsules 500mg 
GREEN      Sodium bicarbonate tablets 600mg
 
Acidification of urine
GREEN      Ascorbic acid (Vitamin C) tablets 500mg 7.4.4 Bladder instillations and urological surgery

Pentosan polysulfate sodium may be used for bladder pain or discomfort associated with interstitial cystitis.
RED           Pentosan polysulfate sodium (Elmiron®) 100mg tablets -(Unlicensed) 
 
Pentosan polysulfate sodium is recommended as an option for treating bladder pain syndrome with glomerulations or Hunner's  
lesions in adults with urinary urgency and frequency, and moderate to severe pain as per NICE TA610
RED          Pentosan polysulfate sodium (Elmiron®) 100mg tablets                                                                     CCG Commissioned
 

7.4.4 Bladder instillations and urological surgery


Irrigation for infected bladder or dissolution of blood clots 
GREEN      Sodium chloride solution 0.9%

Interstitial cystitis
Dimethyl sulphoxide may be used for symptomatic relief in patients with interstitial cystitis. Treatment may be repeated every two
weeks but long term use requires ophthalmic,  renal and hepatic assessment every 6 months.
RED           Dimethyl sulphoxide (DMSO) bladder instillation 50% (50mL) – (unlicensed) 
 
Chondroitin Sulphate may be used as a bladder coating therapy to treat the symptoms of interstitial cycstitis.
Chondroitin sulphate may be used as a bladder coating therapy to treat the symptoms of interstitial cystitis. 
RED           Chondroitin sulphate 0.2% (Gepan® instil) intravesical instillation prefilled syringe  

 
Urological surgery
RED           Purisole® irrigation solution 
 
Catheter Patency Solutions
GREEN      Sodium chloride 0.9% (OptiFlo S® solution 50ml)
GREEN      Solution G (OptiFlo G® solution 50mL)
GREEN      Solution R (OptiFlo R® solution 50mL) 
 
Bladder Cancer Installations see section 8.2.4 (BCG) and 8.1.2 (Mitomycin) 


7.4.5 Drugs for erectile dysfunction

An amendment to the SLS regulations, effective from the 1 August 2014 means that prescribers will no longer be required to
annotate prescriptions for the generic erectile dysfunction tablet sildenafil with the letters "SLS".
Following consultation the Department of Health (DH) selected to remove sildenafil from the list of medicines that may only 
be prescribed where they meet the selected list scheme requirements.
Whilst generically written prescriptions for sildenafil no longer require the prescriber to annotate the prescription with the letters
“SLS”  the branded version of the drug -  Viagra should be annotated “SLS” in order to be valid for NHS prescribing. Viagra is
BLACK lighted in East Lancashire.
 
The regulation amendment applies only to generic sildenafil.  Other oral PDE5 for erectile dysfunction remain subject to the “SLS”
requirements.
 
Prescribers should make clear to any patients prescribed sildenafil outside the selected list scheme that they will not be eligible 
for other treatment options for erectile dysfunction on NHS prescription, unless they met the appropriate “SLS” criteria. If 
treatment with sildenafil proves unsuccessful and patients do not meet SLS criteria then any alternative treatment for erectile
dysfunction should be offered on a private prescription.
 
Prescribing of other PDE5  preparations should be in line with the Health Service Circular Guidelines (HSC 1999/115). NHS 
prescriptions (endorsed "SLS") can be issued for alprostadil, tadalafil, vardenafil and certain vacuum tumescence devices to men
suffering from erectile dysfunction who have these medical conditions: diabetes, prostate cancer or prostatectomy, spinal cord
injury, radical pelvic surgery or severe pelvic injury, parkinson's disease, renal failure requiring dialysis or following transplant,
multiple sclerosis, spina bifida, poliomyelitis, single gene neurological disease, plus men who were receiving treatment for erectile

dysfunction who was a member of the EU before 14th September 1998. GPs can issue private prescriptions for the above drugs and devices for patients on their list who do not meet these criteria, but cannot charge patients for issuing a private prescription. In cases where erectile dysfunction is causing severe distress ALL prescribing should only be carried out from specialist services.

Sildenafil
When used for any unlicensed indication e.g. Raynaud's all prescribing must be retained by the specialists. GP's are unable to
prescribe due to the restrictions for all PDE-5 inhibitors.
The PPD will not re-imburse prescriptions for any unlicensed use.
 
First Line
GREEN     Generic Sildenafil tablets 25mg, 50mg, 100mg  
Trial lowest effective dose. Consider moving to second line choice only when maximum strength dose has been tried on eight
 occasions.
 
Second line
GREEN      Tadalafil tablets 10mg, 20mg* 
 
GREEN - Note Tadalafil has a long half-life ~72hours.  More than one treatment a week may be considered in patients such as 
those suffering from severe distressPrescribing and supply for this group of patients should either be retained by the psychosexual service or a maximum of 3 month’s supply can be issued by a GP at the request of the psychosexual service 
whilst under specialist care. Treatment beyond 3 months is not recommended. 
 
AMBER     Alprostadil (Caverject® or Viridal Duo®) Injection: 10microgram, 20microgram
AMBER     Papaverine injection (unlicensed) 
 
Vardenafil remains available on formulary for any patients started on this drug prior to July 2012
 
AMBER     Alprostadil (Vitraos®) Cream
                  treatment option in line with Erectile Dysfunction Guidelines if resistant to PDE5 inhibitors 
GREEN      Alprostadil (Vitraos®) Cream 
                  treatment option in line with Erectile Dysfunction Guidelines if PDE5 inhibitors not tolerated or contra-indicated
AMBER     Alprostadil (Muse®) urethral sticks
                  treatment option in line with Erectile Dysfunction Guidelines -  SPECIALIST INITIATION
 
Please refer to the Erectile Dysfunction Guideline click here
Specilaist initiation only, Reserved for patients not responding or intolerant to Alprostadil, as an option before referral for surgical
procedure.
AMBER    Aviptidil with Phentolamine Mesilate  25mcg/2mg/0.35ml (Invicorp®) 
                 solution for injection
 
 
 
 
 
 

All material in this section is aimed at health care professionals, but is information currently held in the public domain, members of the  
public seeking advice on medicine-related matters are advised to speak with their GP, pharmacist, nurse or contact NHS111 Service. 
  Email: info.elmmb@nhs.net
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