• Scottish Intercollegiate Guidelines Network (SIGN). Management of urinary incontinence in primary care. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2004 Dec. 41 p. (SIGN publication; no. 79). [128 references]

Urinary incontinence, including:

• Stress urinary incontinence
• Urge urinary incontinence
• Detrusor overactivity incontinence
• Mixed urinary incontinence

Assessment of Therapeutic Effectiveness
Evaluation
Management
Treatment

Family Practice
Geriatrics
Internal Medicine
Nursing
Obstetrics and Gynecology
Urology

Advanced Practice Nurses
Allied Health Personnel
Nurses
Patients
Physical Therapists
Physician Assistants
Physicians

• To identify opportunities and effective techniques within primary care for assessing and treating urinary incontinence in adults
• To offer the primary care practitioner an indication of the factors that should lead to an onward referral

Adults with urinary incontinence

Evaluation

1. Risk factor assessment
2. Assessment via:
   • Clinical history
   • Questionnaires
   • Pelvic floor assessment
   • Urinalysis
   • Post void residual volume (via catheterization and/or ultrasound bladder scan)
   • Flow rate
   • Digital rectal examination
   • Voiding diaries
   • Pad tests

Management/Treatment

1. Client counseling regarding treatment options
2. Pelvic floor muscle exercises (PFME)
3. Physiotherapy
4. Biofeedback
5. Electrical stimulation
6. Intravaginal devices
7. Acupuncture
8. Bladder retraining
9. Lifestyle interventions including massive (surgically induced) weight loss, moderate weight loss, adjustment of fluid intake, and reduce caffeine intake
10. Pharmacotherapy
    • Combined noradrenaline and serotonin reuptake inhibitors: Duloxetine
    • Antimuscarinics (oxybutynin, tolterodine, trospium and propiverine)
    • The following medications were discussed but not recommended: flavoxate; oestrogens; adrenoreceptor agonists; antidepressants
11. Containment products including disposable pads, bed pads, sheaths, female urinals, catheters, catheter valves, and urine drainage bags
12. Referral to secondary care, when appropriate

• Incontinence episode frequency and severity
• Quality of life

Searches of Electronic Databases

The evidence base for this guideline was synthesised in accordance with the Scottish Intercollegiate Guideline Network (SIGN) methodology. A systematic review of the literature was carried out using an explicit search strategy devised by the SIGN Information Officer in collaboration with members of the guideline development group.

Literature searches were initially conducted in Medline, Embase, Cinahl, and the Cochrane Library using the year range 1995–2003. The literature search was updated to cover the period up to May 2004. Key Web sites on the Internet were also used, such as the National Guidelines Clearinghouse. These searches were supplemented by the reference lists of relevant papers and group members' own files. The Medline version of the main search strategies can be found on the SIGN website.

Not stated

Weighting According to a Rating Scheme (Scheme Given)

Levels of Evidence

1++: High quality meta-analyses, systematic reviews of randomized controlled trials (RCTs), or RCTs with a very low risk of bias

1+: Well conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias

1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias

2++: High quality systematic reviews of case control or cohort studies

High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal

2+: Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal

2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal

3: Non-analytic studies (e.g. case reports, case series)

4: Expert opinion

Review of Published Meta-Analyses
Systematic Review with Evidence Tables

Expert Consensus

The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation.

A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results

B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D: Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group.

A formal cost analysis was not performed and published cost analyses were not reviewed.

External Peer Review
Internal Peer Review

A national open meeting is the main consultative phase of Scottish Intercollegiate Guidelines Network (SIGN) guideline development, at which the guideline development group presents its draft recommendations for the first time. The national open meeting for this guideline was held on 24^th November 2003 and was attended by 168 representatives of all the key specialties relevant to the guideline. The draft guideline was available on the SIGN Web site for a limited period at this stage to allow those unable to attend the meeting to contribute to the development of the guideline.

The guideline was also reviewed in draft form by a panel of independent expert referees, who were asked to comment primarily on the comprehensiveness and accuracy of interpretation of the evidence base supporting the recommendations in the guideline.

As a final quality control check, the guideline is reviewed by an Editorial Group to ensure that the specialist reviewers' comments have been addressed adequately and that any risk of bias in the guideline development process as a whole has been minimised.

Each member of the guideline development group then approved the final guideline for publication.

Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the original guideline document.

The strength of recommendation grading (A-D) and level of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field.

Quality of Life, Patient Information, and Health Promotion

Quality of Life

Objective Assessment

B - Health care practitioners should consider using a validated quality of life and incontinence severity questionnaire to evaluate the impact of urinary symptoms and to audit the effectiveness of any management strategy.

Patient Information, Advice, and Support

D - Patients with urinary incontinence should be offered information and advice on the treatment options available to them in both primary and secondary care.

D - Patients with urinary incontinence should have access to trained health care professionals who have the relevant knowledge and skills to offer appropriate advice and information.

D - Patients with urinary incontinence should be made aware that they are able to access specially trained staff in primary care without general practitioner (GP) referral.

Health Promotion

C - Strategies using a number of different approaches and delivery media should be employed to raise awareness of urinary continence and promote incontinence services to a range of target audiences.

Assessment of Urinary Incontinence

Risk Factors for Developing Urinary Incontinence

Risk Factors for Women

B - Health professional should be vigilant and adopt a proactive approach in consultations with patients who are at greatest risk of developing urinary incontinence through factors including age, the menopause, pregnancy and childbirth, high body mass index (BMI), and experience of continence problems in childhood.

Initiating an Assessment of Urinary Incontinence

C - Health care professionals should recognize the difficulty that some patients have in raising concerns about continence and should be proactive in questioning patients about continence during consultations.

C - Health professional should have a positive attitude to continence problems.

B - Assessment, treatment, and referral, as appropriate, should be offered to all patients with urinary continence problems.

Primary Care Assessment Tools

Assessment Tool Recommendations

D - Initial assessment of a male patient with urinary incontinence should include completion of a voiding diary, urinalysis, estimation of post void residual volume, and digital rectal examination.

D - Initial assessment of a female patient with urinary incontinence should include completion of a voiding diary, urinalysis, and, where symptoms of voiding dysfunction or repeated urinary tract infections (UTIs) are present, estimation of post void residual volume.

Physical Therapies

Pelvic Floor Muscle Exercises

A - Pelvic floor muscle exercises should be the first choice of treatment offered to patients suffering from stress or mixed incontinence. Exercise programmes should be tailored to be achievable by the individual patient.

D - Pelvic floor muscle exercises should be considered as part of a treatment plan for patients with urge urinary incontinence.

D - Digital assessment of pelvic floor muscle function should be undertaken prior to initiating any pelvic floor muscle exercise treatment.

A - Where group physiotherapy is available patients should be offered the choice of attending or being seen individually.

Pelvic Floor Muscle Exercises in Men Undergoing Radical Prostatectomy

B - Pelvic floor muscle exercise treatment should be considered for patients following radical prostate surgery.

Bladder Retraining

C - Bladder retraining should be offered to patients with urge urinary incontinence.

Pharmacotherapy

Stress Incontinence

Combined Noradrenaline and Serotonin Reuptake Inhibitors

A - Duloxetine should be used only as part of an overall management strategy in addition to pelvic floor muscle exercises and not in isolation. A 4-week trial of duloxetine is recommended for female patients with moderate to severe stress incontinence. Patients should be reviewed again after 12 weeks of therapy to assess progress and determine whether it is appropriate to continue treatment.

Detrusor Overactivity and Urge Incontinence

Antimuscarinics

A - A trial of oxybutynin, propiverine, tolterodine, or trospium should be given to patients with significant urgency with or without urge incontinence. The dose should be titrated to combat adverse effects.

Containment

Product Evaluation

D - All patients should undergo a continence assessment before product issue. Issue of products should not take the place of therapeutic interventions.

Referral

Referral to Secondary Care

All Patients

D - Patients should be referred to secondary care if previous surgical or non-surgical treatments for urinary incontinence have failed or if surgical treatments are being considered.

Female Patients

D - Female patients with suspected voiding dysfunction should be referred to secondary care.

D - Female patients with symptomatic pelvic organ prolapse should be referred to secondary care.

Male Patients

D - Male patients with reduced urinary flow rates or elevated post void residual volumes should be referred to secondary care.

Definitions:

Levels of Evidence

1++: High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias

1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias

1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias

2++: High quality systematic reviews of case control or cohort studies

High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal

2+: Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal

2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal

3: Non-analytic studies (e.g. case reports, case series)

4: Expert opinion

Grades of Recommendation

A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results

B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D: Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Algorithms are provided in the original guideline document for the management of urinary incontinence in male patients and in female patients.

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Effective treatment and management of urinary incontinence resulting in reduced incontinence episode frequency, reduced urgency, increased patient satisfaction, improved quality of life, and reduced incidence of potential harms (e.g., falls and fractures).

• There are inherent risks of trauma and infection with catheterisation and there may be issues around patient dignity and acceptability that should be considered.
• Side effects of adrenoreceptor agonists were noted to be minor, although rare and potentially serious side effects, such as cardiac arrhythmias and hypertension, were reported.
• Nausea was the most commonly reported adverse event in one study of duloxetine.
• The most common side effects of antimuscarinic drugs are dry mouth, blurred vision, abdominal discomfort, drowsiness, nausea, and dizziness. Urinary retention is a potentially serious but less common side effect. Oxybutynin immediate release (IR) preparation has the highest incidence of side effects.
• Offering disposable pads prematurely can lead to psychological dependence upon them and reluctance to accept active treatment.

• This guideline is not intended to be construed or to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. Adherence to guideline recommendations will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate judgement regarding a particular clinical procedure or treatment plan must be made by the appropriate health care professional, following discussion of the options with the patient, in light of the diagnostic and treatment choices available. It is advised, however, that significant departures from the national guideline or any local guidelines derived from it should be fully documented in the patient's case notes at the time the relevant decision is taken.
• The guideline cannot take the place of clinical judgment in the assessment of each patient as an individual but aims to collate research evidence, in as accessible format, to support clinical decision making.

Getting Better
Living with Illness

Effectiveness
Patient-centeredness

• Scottish Intercollegiate Guidelines Network (SIGN). Management of urinary incontinence in primary care. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2004 Dec. 41 p. (SIGN publication; no. 79). [128 references]

Not applicable: The guideline was not adapted from another source.

2004 Dec

Scottish Intercollegiate Guidelines Network - National Government Agency [Non-U.S.]

Scottish Executive Health Department

Not stated

Guideline Development Group: Mrs Linda Morrow (Chair) Professional Adviser Continence, The Care Commission, Musselburgh; Mrs Joyce Wilkinson (Secretary) Registered Health Visitor, Doctoral Candidate, University of St. Andrews; Mrs Mary Ballentyne, Senior Clinical Nurse Specialist, Southern General Hospital, Glasgow; Mrs Mary Brown, Continence Nursing Team Manager, Lothian Primary Care Trust, Edinburgh; Ms Jane Camp, Clinical Governance Practice Development Nurse, Gartnavel Royal Hospital, Glasgow; Dr Paul Dewart, Consultant Obstetrician/Gynaecologist, St. John's Hospital, Livingston; Mrs Ann Gilchrist, Superintendent Physiotherapist/Clinical Lead, Falkirk Royal Infirmary; Sister Chris Harris, Urology Nurse Specialist, Western General Hospital, Edinburgh; Mrs Linda Haworth, Superintendent Physiotherapist/Clinical Specialist, Carnegie Clinic, Dunfermline; Ms Fiona Lamont, Patient Representative, Glasgow; Mr David Lyth, Consultant Urologist, Queen Margaret Hospital, Dunfermline; Mrs Jan MacCallum, Continence Adviser, Broxburn, West Lothian; Dr David Marshall, Professional Adviser-Pharmacy, The Care Commission, Hamliton; Ms Cathy McKerrell, INCONTACT Project Manager (Scotland); Dr Simon Nicholson, Consultant Gynaceologist, St John's Hospital, Livingston; Mr Duncan Service, Senior Information Officer, SIGN; Dr Lorna Thompson, Programme Manager, SIGN

Declarations of interests were made by all members of the guideline development group. Further details are available from the Scottish Intercollegiate Guidelines Network (SIGN) executives.

This NGC summary was completed by ECRI on March 3, 2005. The information was verified by the guideline developer on March 17, 2005. This summary was updated by ECRI on October 20, 2005, following the U.S. Food and Drug Administration advisory on Cymbalta (duloxetine hydrochloride). This summary was updated by ECRI Institute on November 9, 2007, following the U.S. Food and Drug Administration advisory on Antidepressant drugs.