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## Complete Summary

#### GUIDELINE TITLE

Pelvic organ prolapse.

#### BIBLIOGRAPHIC SOURCE(S)

American College of Obstetricians and Gynecologists (ACOG). Pelvic organ
prolapse. Washington (DC): American College of Obstetricians and
Gynecologists (ACOG); 2007 Sep. 13 p. (ACOG practice bulletin; no. 85).
\[82 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: American College of
Obstetricians and Gynecologists (ACOG). Pelvic organ prolapse.
Washington (DC): American College of Obstetricians and Gynecologists
(ACOG); 2007 Feb. 13 p. (ACOG practice bulletin; no. 79).

### \*\* 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](http://www.fda.gov/medwatch/safety/2008/safety08.htm#Mesh):
    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)

Pelvic organ prolapse, including prolapse of the:

-   Uterine cervix

-   Vaginal apex

-   Anterior vagina

-   Posterior vagina

-   Peritoneum of the cul-de-sac

#### GUIDELINE CATEGORY

Evaluation\
Risk Assessment\
Treatment

#### CLINICAL SPECIALTY

Obstetrics and Gynecology\
Surgery\
Urology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

-   To aid practitioners in making decisions about appropriate obstetric
    and gynecologic care

-   To review current treatment options for pelvic organ prolapse

#### TARGET POPULATION

Women with pelvic organ prolapse

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Evaluation**

1.  Pelvic symptom assessment

2.  Stress testing with and without prolapse reduction

3.  Classification of pelvic organ prolapse

    -   Baden-Walker system

    -   Stages of pelvic organ prolapse

    -   Pelvic organ prolapse quantification system

4.  Risk assessment

**Treatment**

1.  Nonsurgical treatment

    -   Observation

    -   Pessaries

    -   Symptom-directed therapy: weight loss, exercise

    -   Pelvic floor muscle rehabilitation: Kegel exercises

2.  Surgical Treatment

    -   Hysterectomy

    -   Abdominal sacral colopexy

    -   Uterosacral and sacrospinous ligament fixation by vaginal
        approach

    -   Sacral hysteropexy by abdominal approach

    -   Transvaginal posterior colporrhaphy

    -   Colpocleisis

    -   Intraoperative cystoscopy

    -   Burch procedure

    -   Round ligament suspension (considered but not recommended)

#### MAJOR OUTCOMES CONSIDERED

-   Surgical procedure complication rates

-   Anesthetic complication rate

-   Perioperative complication rate

-   Procedure failure rates

-   Reoperation rate

-   Postoperative stress incontinence rate

-   Prolapse recurrence rate

-   Operative time

-   Mortality

### 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 August 2006. 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

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 Recommendations\" 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 and conclusions are based on good and
consistent scientific evidence (Level A)**:

-   The only symptom specific to prolapse is the awareness of a vaginal
    bulge or protrusion. For all other pelvic symptoms, resolution with
    prolapse treatment cannot be assumed.

-   Pessaries can be fitted in most women with prolapse, regardless of
    prolapse stage or site of predominant prolapse.

-   Cadaveric fascia should not be used as graft material for abdominal
    sacral colpopexy because of a substantially higher risk of recurrent
    prolapse than with synthetic mesh.

-   Stress-continent women with positive stress test results (prolapse
    reduced) are at higher risk for developing postoperative stress
    incontinence after prolapse repair alone compared with women with
    negative stress test results (prolapse reduced).

-   For stress-continent women planning abdominal sacral colpopexy,
    regardless of the results of preoperative stress testing, the
    addition of the Burch procedure substantially reduces the likelihood
    of postoperative stress incontinence without increasing urgency
    symptoms or obstructed voiding.

-   For women with positive prolapse reduction stress test results who
    are planning vaginal prolapse repair, tension-free vaginal tape
    (TVT) midurethral sling (rather than suburethral fascial plication)
    appears to offer better prevention from postoperative stress
    incontinence.

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

-   Clinicians should discuss the option of pessary use with all women
    who have prolapse that warrants treatment based on symptoms. In
    particular, pessary use should be considered before surgical
    intervention in women with symptomatic prolapse.

-   Alternative operations for uterine preservation in women with
    prolapse include uterosacral or sacrospinous ligament fixation by
    the vaginal approach, or sacral hysteropexy by the abdominal
    approach.

-   Hysteropexy should not be performed by using the ventral abdominal
    wall for support because of the high risk for recurrent prolapse,
    particularly enterocele.

-   Round ligament suspension is not effective in treating uterine or
    vaginal prolapse.

-   Compared with vaginal sacrospinous ligament fixation, abdominal
    sacral colpopexy has less apical failure and less postoperative
    dyspareunia and stress incontinence, but is also associated with
    more complications.

-   Transvaginal posterior colporrhaphy is recommended over transanal
    repair for posterior vaginal prolapse.

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

-   Clinicians should discuss with women the potential risks and
    benefits in performing a prophylactic anti-incontinence procedure at
    the time of prolapse repair.

-   Women with prolapse who are asymptomatic or mildly symptomatic can
    be observed at regular intervals, unless new bothersome symptoms
    develop.

-   For women who are at high risk for complications with reconstructive
    procedures and who no longer desire vaginal intercourse,
    colpocleisis can be offered.

-   Cystoscopy should be performed intraoperatively to assess for
    bladder or ureteral damage after all prolapse or incontinence
    procedures during which the bladder or ureters may be at risk of
    injury.

**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 Recommendation**

**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 treatment of pelvic organ prolapse

#### POTENTIAL HARMS

**Surgical Approaches**

-   Longer procedure time and longer patient recovery time for some
    surgical procedures

-   Intra-abdominal adhesions

-   Small-bowel obstruction

-   Ureteral injury

-   Hemorrhage, hematoma

-   Buttock pain

-   Recurrent prolapse

-   Wound infection

-   Incisional hernia

-   Mesh erosion

-   Postoperative dyspareunia

-   Perioperative complications in older women: blood loss, pulmonary
    edema, heart failure

-   Need for reoperation

-   Postoperative stress incontinence

**Poor Surgical Candidates**

-   In general, perioperative risk is increased in patients with
    concomitant medical problems. However, if surgery becomes necessary,
    limited data support its relative safety; morbidity occurs
    frequently but mortality is rare.

-   Complications were more frequent in women aged 80 years and older
    and in women who had reconstructive rather than obliterative
    surgery.

**Women Considering Pregnancy**

Ideally, childbearing should be complete before considering surgery for
prolapse to avoid the theoretical but plausible risk of recurrent
prolapse after subsequent pregnancy and delivery. For women who become
pregnant after prolapse repair, decisions regarding mode of delivery
should be made on a case-by-case basis; evidence to guide such decisions
is lacking.

### 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

Audit Criteria/Indicators

For information about
[availability](#identifying-information-and-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

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

American College of Obstetricians and Gynecologists (ACOG). Pelvic organ
prolapse. Washington (DC): American College of Obstetricians and
Gynecologists (ACOG); 2007 Sep. 13 p. (ACOG practice bulletin; no. 85).
\[82 references\]

#### ADAPTATION

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

#### DATE RELEASED

2007 Feb (revised 2007 Sep)

#### 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.

This guideline updates a previous version: American College of
Obstetricians and Gynecologists (ACOG). Pelvic organ prolapse.
Washington (DC): American College of Obstetricians and Gynecologists
(ACOG); 2007 Feb. 13 p. (ACOG practice bulletin; no. 79).

#### GUIDELINE AVAILABILITY

Electronic copies: None available

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](http://www.acog.org/bookstore/).

#### AVAILABILITY OF COMPANION DOCUMENTS

Proposed performance measures are included in the original guideline
document.

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI Institute on October 5, 2007. The
information was verified by the guideline developer on December 3, 2007.
This summary was updated by ECRI Institute on July 29, 2008. The updated
information was verified by the guideline developer on August 20, 2008.
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

#### NGC DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/10/2008