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Complete Summary

GUIDELINE TITLE

Urinary incontinence in women.

BIBLIOGRAPHIC SOURCE(S)

    GUIDELINE STATUS

    This is the current release of the guideline.

    ** REGULATORY ALERT **

    FDA WARNING/REGULATORY ALERT

    Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

    • October 22, 2008, Surgical mesh devices: The U.S. Food and Drug Administration (FDA) informed healthcare professionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The FDA provided recommended actions for both physicians and patients to reduce the risks.

    COMPLETE SUMMARY CONTENT

     ** REGULATORY ALERT **
     SCOPE
     METHODOLOGY - including Rating Scheme and Cost Analysis
     RECOMMENDATIONS
     EVIDENCE SUPPORTING THE RECOMMENDATIONS
     BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
     QUALIFYING STATEMENTS
     IMPLEMENTATION OF THE GUIDELINE
     INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
     IDENTIFYING INFORMATION AND AVAILABILITY
     DISCLAIMER

    SCOPE

    DISEASE/CONDITION(S)

    Urinary incontinence

    GUIDELINE CATEGORY

    Diagnosis
    Management
    Treatment

    CLINICAL SPECIALTY

    Family Practice
    Internal Medicine
    Obstetrics and Gynecology
    Surgery
    Urology

    INTENDED USERS

    Physicians

    GUIDELINE OBJECTIVE(S)

    • To aid practitioners in making decisions about appropriate obstetric and gynecologic care
    • To consider the best available evidence for evaluating and treating urinary incontinence in women

    TARGET POPULATION

    Women with urinary incontinence

    INTERVENTIONS AND PRACTICES CONSIDERED

    Diagnosis

    1. Medical and medication history
    2. Voiding diary
    3. Physical examination, including gynecologic and lower neurologic examinations
    4. Measurement of urethral mobility
    5. Urinalysis
    6. Blood tests (blood urea nitrogen, creatinine, glucose, calcium) for suspected renal compromise
    7. Urine cytology, in limited cases
    8. Voiding assessment of urinary bladder (transurethral catheterization, ultrasound)
    9. Urodynamic tests (cystometry, uroflowmetry, postvoid residual urine volume, pressure flow voiding study, electromyography)
    10. Cystourethroscopy
    11. Urethral pressure profilometry and leak point pressure measurement – not recommended

    Management

    1. Absorbent products
    2. Behavioral modification (lifestyle intervention, scheduled or prompted voiding, bladder training, pelvic muscle rehabilitation)
    3. Medical management (estrogen, anticholinergic agents [oxybutynin chloride, tolterodine], tricyclic antidepressants [imipramine], musculotropic drugs)
    4. Surgical treatments (retropubic laparoscopic or open Burch colposuspension and sling procedures, tension-free vaginal tape procedure, anterior colporrhaphy, pubovaginal fascial bladder neck sling)
    5. Injection of bulking agents (collagen, carbon-coated beads, fat) as second-line therapy or for women ineligible for surgery
    6. Pessaries
    7. Hysterectomy (for concomitant uterine prolapse or specific uterine pathology)
    8. Paravaginal defect repair (not recommended as primary treatment of urodynamic stress incontinence)

    MAJOR OUTCOMES CONSIDERED

    • Cure rate
    • Relapse rate
    • Duration of improvement
    • Quality of life
    • Patient satisfaction
    • Complication rates of surgery

    METHODOLOGY

    METHODS USED TO COLLECT/SELECT EVIDENCE

    Hand-searches of Published Literature (Primary Sources)
    Hand-searches of Published Literature (Secondary Sources)
    Searches of Electronic Databases

    DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

    The MEDLINE database, the Cochrane Library, and the American College of Obstetricians and Gynecologists' own internal resources and documents were used to conduct a literature search to locate relevant articles published between January 1985 and February 2005. The search was restricted to articles published in the English language. Priority was given to articles reporting results of original research, although review articles and commentaries also were consulted. Abstracts of research presented at symposia and scientific conferences were not considered adequate for inclusion in this document. Guidelines published by organizations or institutions such as the National Institutes of Health and the American College of Obstetricians and Gynecologists were reviewed, and additional studies were located by reviewing bibliographies of identified articles.

    NUMBER OF SOURCE DOCUMENTS

    Not stated

    METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

    Weighting According to a Rating Scheme (Scheme Given)

    RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

    Studies were reviewed and evaluated for quality according to the method outlined by the U.S. Preventive Services Task Force:

    I: Evidence obtained from at least one properly designed randomized controlled trial.

    II-1: Evidence obtained from well-designed controlled trials without randomization.

    II-2: Evidence obtained from well-designed cohort or case–control analytic studies, preferably from more than one center or research group.

    II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments also could be regarded as this type of evidence.

    III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

    METHODS USED TO ANALYZE THE EVIDENCE

    Review of Published Meta-Analyses
    Systematic Review

    DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

    Not stated

    METHODS USED TO FORMULATE THE RECOMMENDATIONS

    Expert Consensus

    DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

    Analysis of available evidence was given priority in formulating recommendations. When reliable research was not available, expert opinions from obstetrician–gynecologists were used. See also the "Rating Scheme for the Strength of" field regarding Grade C recommendations.

    RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

    Based on the highest level of evidence found in the data, recommendations are provided and graded according to the following categories:

    Level A — Recommendations are based on good and consistent scientific evidence.

    Level B — Recommendations are based on limited or inconsistent scientific evidence.

    Level C — Recommendations are based primarily on consensus and expert opinion.

    COST ANALYSIS

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

    METHOD OF GUIDELINE VALIDATION

    Internal Peer Review

    DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

    Practice Bulletins are validated by two internal clinical review panels composed of practicing obstetrician-gynecologists generalists and sub-specialists. The final guidelines are also reviewed and approved by the American College of Obstetricians and Gynecologists (ACOG) Executive Board.

    RECOMMENDATIONS

    MAJOR RECOMMENDATIONS

    The grades of evidence (I-III) and levels of recommendation (A-C) are defined at the end of the "Major Recommendations" field.

    The following recommendations are based on good and consistent scientific evidence (Level A):

    • Behavioral therapy, including bladder training and prompted voiding, improves symptoms of urge and mixed incontinence and can be recommended as a noninvasive treatment in many women.
    • Pelvic floor training appears to be an effective treatment for adult women with stress and mixed incontinence and can be recommended as a noninvasive treatment for many women.
    • Pharmacologic agents, especially oxybutynin and tolterodine, may have a small beneficial effect on improving symptoms of detrusor overactivity in women.

    The following recommendations are based on limited or inconsistent scientific evidence (Level B):

    • Cystometric testing is not required in the routine or basic evaluation of urinary incontinence.
    • Bulking agents are a relatively noninvasive method of treatment for stress incontinence and can be used in women for whom any form of operative treatment is contraindicated.
    • Long-term data suggest that Burch colposuspension and sling procedures have similar objective cure rates; therefore, selection of treatment should be based on patient characteristics and the surgeon's experience.
    • The combination of a hysterectomy and a Burch colposuspension does not result in higher continence rates than a Burch procedure alone.
    • Tension-free vaginal tape and open Burch colposuspension have similar success rates.
    • Anterior colporrhaphy, needle urethropexy, and paravaginal defect repair have lower cure rates for stress incontinence than Burch colposuspension.

    The following recommendations are based primarily on consensus and expert opinion (Level C):

    • After the basic evaluation of urinary incontinence, simple cystometry is appropriate for detecting abnormalities of detrusor compliance and contractibility, measuring postvoid residual volume, and determining capacity.
    • Patients with urinary incontinence should undergo a basic evaluation that includes a history, physical examination, measurement of postvoid residual volume, and urinalysis.

    Definitions:

    Grades of Evidence

    I: Evidence obtained from at least one properly designed randomized controlled trial.

    II-1: Evidence obtained from well-designed controlled trials without randomization.

    II-2: Evidence obtained from well-designed cohort or case–control analytic studies, preferably from more than one center or research group.

    II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments also could be regarded as this type of evidence.

    III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

    Levels of Recommendations

    Level A — Recommendations are based on good and consistent scientific evidence.

    Level B — Recommendations are based on limited or inconsistent scientific evidence.

    Level C — Recommendations are based primarily on consensus and expert opinion.

    CLINICAL ALGORITHM(S)

    None provided

    EVIDENCE SUPPORTING THE RECOMMENDATIONS

    TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

    BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

    POTENTIAL BENEFITS

    Appropriate evaluation and management of patients with urinary incontinence

    POTENTIAL HARMS

    Medical Intervention

    • The response to pharmacologic treatment often is unpredictable, and side effects are common with effective doses.
    • The most typical side effect of anticholinergic therapy is dry mouth; other side effects most frequently reported were blurred vision, constipation, nausea, dizziness, and headache.

    Surgical Intervention

    • Intraoperative or immediate postoperative complications of surgery for stress incontinence include direct surgical injury to the lower urinary tract, hemorrhage, bowel injury, wound complications, retention, and urinary tract infection. Gynecologic surgeons may perform cystoscopy during or after retropubic and sling procedures to verify ureteral patency and the absence of sutures or sling material in the bladder. Most of the chronic complications after Burch colposuspension and sling procedures relate to voiding dysfunction and urge symptoms (see Table 2 in the original guideline document).
    • Retropubic suspensions and sling procedures are associated with slightly higher complication rates, including longer convalescence and postoperative voiding dysfunction.
    • A multicenter randomized trial found no difference between Burch colposuspension and tension-free vaginal tape procedures, with objective cure rates for urodynamic stress incontinence of 57% and 66%, respectively. Bladder injury was more common during the tension-free vaginal tape procedure (P = .013); delayed voiding, operation time (P <.001), and return to normal activity (P <.001) were all longer after colposuspension.

    QUALIFYING STATEMENTS

    QUALIFYING STATEMENTS

    These guidelines should not be construed as dictating an exclusive course of treatment or procedure. Variations in practice may be warranted based on the needs of the individual patient, resources, and limitations unique to the institution or type of practice.

    IMPLEMENTATION OF THE GUIDELINE

    DESCRIPTION OF IMPLEMENTATION STRATEGY

    An implementation strategy was not provided.

    IMPLEMENTATION TOOLS

    Patient Resources

    For information about availability, see the "Availability of Companion Documents" and "Patient Resources" fields below.

    INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

    IOM CARE NEED

    Getting Better
    Living with Illness

    IOM DOMAIN

    Effectiveness
    Patient-centeredness

    IDENTIFYING INFORMATION AND AVAILABILITY

    BIBLIOGRAPHIC SOURCE(S)

      ADAPTATION

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

      DATE RELEASED

      2005 Jun

      GUIDELINE DEVELOPER(S)

      American College of Obstetricians and Gynecologists - Medical Specialty Society

      SOURCE(S) OF FUNDING

      American College of Obstetricians and Gynecologists (ACOG)

      GUIDELINE COMMITTEE

      American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins-Gynecology

      COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

      Not stated

      FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

      Not stated

      GUIDELINE STATUS

      This is the current release of the guideline.

      GUIDELINE AVAILABILITY

      AVAILABILITY OF COMPANION DOCUMENTS

      None available

      PATIENT RESOURCES

      The following is available:

      • Urinary incontinence. Atlanta (GA): American College of Obstetricians and Gynecologists (ACOG); 2005.

      Electronic copies: Available from the American College of Obstetricians and Gynecologists (ACOG) Web site.

      Print copies: Available for purchase from the American College of Obstetricians and Gynecologists (ACOG) Distribution Center, PO Box 4500, Kearneysville, WV 25430-4500; telephone, 800-762-2264, ext. 192; e-mail: sales@acog.org. The ACOG Bookstore is available online at the ACOG Web site.

      Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

      NGC STATUS

      This NGC summary was completed by ECRI Institute on October 9, 2007. The information was verified by the guideline developer on December 3, 2007. This summary was updated by ECRI Institute on October 27, 2008 following the U.S. Food and Drug Administration (FDA) advisory on surgical mesh devices.

      COPYRIGHT STATEMENT

      This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

      DISCLAIMER

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