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Pessaries (mechanical devices) for pelvic organ prolapse in women

  1. Carol Bugge1,*,
  2. Elisabeth J Adams2,
  3. Deepa Gopinath3,
  4. Fiona Reid4

Editorial Group: Cochrane Incontinence Group

Published Online: 28 FEB 2013

DOI: 10.1002/14651858.CD004010.pub3


How to Cite

Bugge C, Adams EJ, Gopinath D, Reid F. Pessaries (mechanical devices) for pelvic organ prolapse in women. Cochrane Database of Systematic Reviews 2013, Issue 2. Art. No.: CD004010. DOI: 10.1002/14651858.CD004010.pub3.

Author Information

  1. 1

    University of Stirling, School of Nursing, Midwifery and Health, Stirling, UK

  2. 2

    Liverpool Women's Hospital, Dept of Urodynamics, Liverpool, UK

  3. 3

    Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK

  4. 4

    St. Mary's Hospital, Urogynaecology, Manchester, UK

*Carol Bugge, School of Nursing, Midwifery and Health, University of Stirling, Stirling, FK9 4LA, UK. carol.bugge@stir.ac.uk.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 28 FEB 2013

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Characteristics of included studies [ordered by year of study]

MethodsMulticentre randomised crossover trial


Participants134 women with symptomatic pelvic organ prolapse of stage II or greater on POP-Q (Bump 1996). 54% of women had a predominantly anterior compartment prolapse; 35% a predominantly apical compartment and 10% a predominately posterior compartment prolapse.


InterventionsRing pessary with support or Gellhorn pessary


OutcomesOutcomes were assessed at 1 week, 6 weeks and 12 weeks and at time of drop out. Multiple outcome measures were reported in the methods (PFDI, PfIQ, VAS, POP-Q, perineal descent, perineal reflexes, atrophy, erosions and wet prep). The study power calculation was based on the outcome "symptom relief", which probably equates to the POP-DI outcome. However no primary outcome was formally stated.


NotesThis study had a very high drop-out rate: only 85 of the original 134 completed the study. However some results appear to have been reported on the total number 134. Most results do not specify the number of subjects.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"Randomization used computer-generated random numbers in permuted blocks of variable size (6-10)." Initial randomisation appropriate however then patient preference took priority over randomisation. Although these patients were then excluded from the analysis it may affect the results.

Allocation concealment (selection bias)Low risk"allocated by sealed opaque envelopes"

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskIt was not possible to blind patients to the type of pessary used because they were taught to remove them.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskThe data collected were coded to permit blinding during the analysis of results.

Incomplete outcome data (attrition bias)
All outcomes
High riskThe study had a high drop-out rate: only 85 of the 134 completed the study.

Selective reporting (reporting bias)High riskThere was no formally stated primary outcome. Not all of the outcomes described in the methods have been reported in the results. There is no report on vaginal discharge or bleeding.

Appropriateness of cross-over designUnclear riskThere is some suggestion in the literature (Handa 2002) that pessaries may improve the stage of prolapse therefore there is the potential for a carryover effect.

Randomised treatment orderLow riskRandom allocation was by computer generated random numbers using permuted blocks of variable size. Allocation was stored in opaque sealed envelopes.

Risk of carry-over effectsUnclear riskGiven the possibility of pessaries improving stage of prolapse (Handa 2002) there may be some risk of carryover effect.

 
Characteristics of studies awaiting assessment [ordered by study ID]

MethodsRCT

Participants16 women with symptomatic pelvic organ prolapse of POP-Q stage I-IV (8 intervention and 8 control)

InterventionsPessary plus PFMT versus pessary alone

Outcomes

Notes

 
Summary of findings for the main comparison. Pessaries (mechanical devices) for pelvic organ prolapse in women

Mechanical devices for pelvic organ prolapse in women

Patient or population: patients with pelvic organ prolapse in women
Settings:
Intervention: mechanical devices

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlMechanical devices

Patients perceived improvement in symptoms of prolapse assessed using validated symptom questionnaire at 1 year - not reportedSee commentSee commentNot estimable-See comment

Acceptability/satisfaction with treatment at 1 year - not reportedSee commentSee commentNot estimable-See comment

Grade of prolapse with device in situ at 1 year - not reportedSee commentSee commentNot estimable-See comment

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.