General

Guideline Title

Technical update on pessary use.

Bibliographic Source(s)

Robert M, Schulz JA, Harvey MA. Technical update on pessary use. J Obstet Gynaecol Can. 2013 Jul;35(7 eSuppl):S1-11. [54 references]

Guideline Status

This is the current release of the guideline.

Recommendations

Major Recommendations

The quality of evidence (I-III) and classification of recommendations (A-E, L) are defined at the end of the “Major Recommendations.”

Summary Statements

Most women can be successfully fitted with a pessary when they present with prolapse. (II-2)
Complications of pessary use are usually minor, and vaginal discharge is the most common complaint. (II-3)
Vaginal erosions can be treated with removal of the pessary and optional vaginal estrogen supplementation. (II-2)
Satisfaction rates with pessary use are very high. (II-2)

Recommendation

Pessaries should be considered in all women presenting with symptomatic prolapse and/or urinary stress incontinence. (II-1A)

Definitions:

Quality of Evidence Assessment*

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

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

II-2 : Evidence from well-designed cohort (prospective or retrospective) or case–control studies, preferably from more than one centre or research group

II-3 : Evidence obtained from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category

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

Adapted from The Evaluation of Evidence criteria described in the Canadian Task Force on Preventive Health Care.

Classification of Recommendations†

A. There is good evidence to recommend the clinical preventive action

B. There is fair evidence to recommend the clinical preventive action

C. The existing evidence is conflicting and does not allow to make a recommendation for or against use of the clinical preventive action; however, other factors may influence decision-making

D. There is fair evidence to recommend against the clinical preventive action

E. There is good evidence to recommend against the clinical preventive action

L. There is insufficient evidence (in quantity or quality) to make a recommendation; however, other factors may influence decision-making

† Adapted from the Classification of Recommendations criteria described in the Canadian Task Force on Preventive Health Care.

Clinical Algorithm(s)

None provided

Scope

Disease/Condition(s)

Pelvic organ prolapse
Urinary stress incontinence

Guideline Category

Counseling
Diagnosis
Evaluation
Management
Treatment

Clinical Specialty

Obstetrics and Gynecology
Urology

Intended Users

Advanced Practice Nurses
Nurses
Physician Assistants
Physicians

Guideline Objective(s)

To review the use, care, and fitting of pessaries

Target Population

Women presenting with prolapse and/or urinary incontinence

Interventions and Practices Considered

Pessary use, care and fitting

Major Outcomes Considered

Accuracy of fit
Incidence and severity of complications
Patient satisfaction
Quality of life
Symptom relief

Methodology

Methods Used to Collect/Select the Evidence

Searches of Electronic Databases
Searches of Unpublished Data

Description of Methods Used to Collect/Select the Evidence

PubMed and Medline were searched for articles published in English to September 2010, using the key words pessary, prolapse, incontinence, fitting, and complications. Results were restricted to systematic reviews, randomized control trials (RCTs)/controlled clinical trials, and observational studies. Searches were updated on a regular basis, and articles were incorporated in the guideline to May 2012. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies.

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

Quality of Evidence Assessment*

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

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

II-2: Evidence from well-designed cohort (prospective or retrospective) or case–control studies, preferably from more than one centre or research group

II-3: Evidence obtained from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category

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

* Adapted from The Evaluation of Evidence criteria described in the Canadian Task Force on Preventive Health Care.

Methods Used to Analyze the Evidence

Systematic Review

Description of the Methods Used to Analyze the Evidence

The quality of evidence was rated with use of the criteria described by the Canadian Task Force on Preventive Health Care. Recommendations for practice were ranked according to the method described by the Task Force (see the “Rating Scheme for the Strength of the Evidence” and the “Rating Scheme for the Strength of the Recommendations” fields).

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations

Classification of Recommendations †

A. There is good evidence to recommend the clinical preventive action

B. There is fair evidence to recommend the clinical preventive action

C. The existing evidence is conflicting and does not allow to make a recommendation for or against use of the clinical preventive action; however, other factors may influence decision-making

D. There is fair evidence to recommend against the clinical preventive action

E. There is good evidence to recommend against the clinical preventive action

L. There is insufficient evidence (in quantity or quality) to make a recommendation; however, other factors may influence decision-making

† Adapted from the Classification of Recommendations criteria described in the Canadian Task Force on Preventive Health Care.

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

This technical update has been prepared by the Urogynaecology Committee, reviewed by the Family Practice Advisory Committee, and approved by the Executive of the Society of Obstetricians and Gynaecologists of Canada.

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the “Major Recommendations” field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate management of pessary use in women with pelvic organ prolapse and/or urinary stress incontinence.

Potential Harms

Minor complications of pessary use such as vaginal discharge, odour, and erosions can usually be successfully treated.
Major complications have been seen only with neglected pessaries. In case reports documenting complications including vesicovaginal fistulae, bowel fistulae, incarcerated pessaries, 91% were related to neglected pessaries.

Qualifying Statements

This document reflects emerging clinical and scientific advances on the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions. They should be well documented if modified at the local level. None of these contents may be reproduced in any form without prior written permission of the Society of Obstetricians and Gynaecologists of Canada (SOGC).

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools

Chart Documentation/Checklists/Forms
Foreign Language Translations
Patient Resources

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need

Getting Better
Staying Healthy

IOM Domain

Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)

Robert M, Schulz JA, Harvey MA. Technical update on pessary use. J Obstet Gynaecol Can. 2013 Jul;35(7 eSuppl):S1-11. [54 references]

Adaptation

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

Date Released

2013 Jul

Guideline Developer(s)

Society of Obstetricians and Gynaecologists of Canada - Medical Specialty Society

Source(s) of Funding

Society of Obstetricians and Gynaecologists of Canada (SOGC)

Guideline Committee

Urogynaecology Committee

Composition of Group That Authored the Guideline

Principal Authors : Magali Robert, MD, Calgary AB; Jane A. Schulz, MD, Edmonton AB; Marie-Andrée Harvey, MD, Kingston ON

Urogynaecology Committee : Danny Lovatsis, MD ( Co-Chair ), Toronto ON; Jens-Erik Walter, MD ( Co-Chair ), Montreal QC; Queena Chou, MD, London ON; William A. Easton, MD, Scarborough ON; Annette Epp, MD, Saskatoon SK; Scott A. Farrell, MD, Halifax NS; Roxana Geoffrion, MD, Vancouver BC; Lise Girouard, RN, Winnipeg MB; Chander K. Gupta, MD, Winnipeg MB; Marie-Andrée Harvey, MD, Kingston ON; Annick Larochelle, MD, St-Lambert QC; Kenny D. Maslow, MD, Winnipeg MB; Grace Neustaeder, RN, Calgary AB; Dante Pascali, MD, Ottawa ON; Marianne Pierce, MD, Halifax NS; Magali Robert, MD, Calgary AB; Sue Ross, PhD, Calgary AB; Joyce Schachter, MD, Ottawa ON; Jane A. Schulz, MD, Edmonton AB; Vyta Senikas, MD, Ottawa ON; David H.L. Wilkie, MD, Vancouver BC

Financial Disclosures/Conflicts of Interest

Disclosure statements have been received from all contributors.

Scott Farrell is Vice-President Medical and a major stakeholder of EastMed Inc. (Halifax, NS), the company marketing Uresta.

Roxana Geoffrion is a shareholder of EastMed Inc.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the Society of Obstetricians and Gynaecologists of Canada (SOGC) Web site. Also available in French from the SOGC Web site.

Print copies: Available from the Society of Obstetricians and Gynaecologists of Canada, La société des obstétriciens et gynécologues du Canada (SOGC) 780 promenade Echo Drive Ottawa, ON K1S 5R7 (Canada); Phone: 1-800-561-2416.

Availability of Companion Documents

The appendix of the original guideline document contains a sample patient care guideline and information sheet on pessary care guidelines and follow-up.

Patient Resources

The following is available:

Urinary incontinence. Women’s health information. Electronic copies: Available from the Society of Obstetricians and Gynaecologists of Canada (SOGC) Web site. Also available in French from the SOGC 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 September 27, 2013. The information was verified by the guideline developer on October 30, 2013.

Copyright Statement

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

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