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RecruitingNCT03615872PeSaCUPUpdated Sep 20, 2024

Pessary Satisfaction Criteria for Urogenital Prolapse

An observational study in Genital Prolapse, Pessary and Satisfaction, sponsored by University Hospital, Caen. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-20.

Sponsored by University Hospital, Caen · Observational

From the registry’s dates

  • Started Jun 2018; still recruiting 8 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
Female
01

Study summary

Genital prolapse is a common pathology with a prevalence ranging from 2.9 to 11.4% or 31.8% to 97.7%, depending on whether a questionnaire or clinical examination is used. The use of pessary in the treatment of prolapse remains discussed despite a satisfaction rate of 50 to 80% in the literature and a minimal complications rate.

The main objective of this study is to assess the satisfaction of patients carrying a pessary in the first year after the laying.

Read the detailed description

This is a prospective observational cohort conducted at the Universitary hospital of Caen over a total period of 5 years.

Patients with a symptomatic genital prolapse will all be offered the installation of a pessary. If they agree to participate in the study, they will be asked to respond to validated questionnaires: symptom questionnaires (PFDI-20, ICIQ-SF, USP), a sexuality questionnaire (PISQ-12), a quality of life questionnaire (PFIQ-7, BIS) and Satisfaction (PGI-I), several times: Before the installation of the pessary, at one month, at 6 months, then annually over 5 years

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Conditions studied

  • Genital Prolapse
  • Pessary
  • Satisfaction

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Keywords

  • quality of life
  • efficiency
03

In context

Personal Satisfaction

541 studies on the registry are indexed under Personal Satisfaction; 93 are open to participants now.

This study's planned enrollment of 150 is below the median of 180 across 115 observational studies indexed under Personal Satisfaction.

Browse Personal Satisfaction studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 512 studies on the registry; 82 are open to participants now.

Browse University Hospital, Caen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The research protocol will be proposed to all patients with a symptomatic genital prolapse

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The research protocol will be proposed to all patients with a symptomatic genital prolapse, over 18 years of age, who speak French and who agree to participate in this study
  • Prolapse defined according to the International Classification POP-Q-.

Exclusion criteria

Exclusion Criteria:

  • Minors under 18 years of age
  • Pregnant or lactating women
  • Women Not speaking French (the good understanding of French is necessary to answer questionnaires and for informed information)
  • Women unable to understand due to cognitive impairment or degenerative disease (dementia/ Alzheimer's disease)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • Devicepessary use

    evaluation of satisfaction of pessary use in case of symptomatic genital prolapse

06

What researchers measure

Primary outcomes

  1. Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) in the first year after the installation of a pessary

    The PGI-I score was developed and validated to quantify the effect of urinary incontinence or prolapse treatments

    Time frame: 1 year

Secondary outcomes

  1. Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) every year for five years after the installation of a pessary

    The PGI-I score was developed and validated to quantify the effect of urinary incontinence or prolapse treatments

    Time frame: 1 to 5 years

  2. EFFICACY of pessary on genital symptoms assessed by the Pelvic Floor Distress Inventory (PFDI-20) questionnaire before and after the installation of the pessary.

    This score was developped to evaluate the genital, anorectal and urinary symptoms related to genital prolapse

    Time frame: at 1 year, then every year for 5 years

  3. EFFICACY of pessary on urinary symptoms assessed by the International Consultation of Incontinence Questionnaire-Short Form (ICIQ-UI SF) and the Urinary Symptom Profile score (USP) before and after the installation of the pessary.

    These scores are self-questionnaires specifically validated to evaluate urinary incontinence and urinary tract dysfunctions

    Time frame: at 1 year, then every year for 5 years

  4. Sexual impact of pessary assessed by the Pelvic organ prolapse urinary Incontinence Sexual Questionnaire (PISQ-12)

    Evaluation of the PISQ-12 score after the installation of a pessary. This score was developped specifically to evaluate sexual troubles in case of genital prolapse

    Time frame: at 1 year, then every year for 5 years

  5. QUALITY OF LIFE assessed by the Pelvic Floor Impact Questionnaire (PFIQ-7) before and after the installation of the pessary

    The PFIQ-7 was developped to evaluate the impact of the symptoms on the quality of life

    Time frame: at 1 year, then every year for 5 years

  6. INVESTIGATE the impact of age on the removal or expulsion of pessary

    Impact of age (years) on treatment failure (removal or expulsion of pessary)

    Time frame: 1 year to 5 years

  7. INVESTIGATE the impact of menopausal status on the removal or expulsion of pessary

    Impact of menopausal status (yes/no) on treatment failure (removal or expulsion of pessary)

    Time frame: 1 year to 5 years

  8. INVESTIGATE the impact of weight on the removal or expulsion of pessary

    Impact of weight (Kg) on treatment failure (removal or expulsion of pessary)

    Time frame: 1 year to 5 years

  9. INVESTIGATE the impact of hysterectomy history on the removal or expulsion of pessary

    Impact of hysterectomy history (yes/no) on the removal or expulsion of pessary

    Time frame: 1 year to 5 years

  10. INVESTIGATE the impact of prolapse surgery history on the removal or expulsion of pessary

    Impact of prolapse surgery history (yes/no) on the removal or expulsion of pessary

    Time frame: 1 year to 5 years

  11. INVESTIGATE the impact of the prolapse stage of on the removal or expulsion of pessary

    Impact of the prolapse stage (assessed by the validated POP-Q classification) of on the removal or expulsion of pessary. The stage of prolapse is ranged from 1 to 4 in the POP-Q classification

    Time frame: 1 year to 5 years

  12. Complications of pessary use reported by their rate

    Rate of complications related to the use of a pessary (frequencies)

    Time frame: 1 to 5 years

07

Study locations

1 of 1 sites recruiting
  • Pizzoferato
    Caen, 14000, France
    Recruiting
08

References and documents

Publications

  • Cundiff GW, Amundsen CL, Bent AE, Coates KW, Schaffer JI, Strohbehn K, Handa VL. The PESSRI study: symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries. Am J Obstet Gynecol. 2007 Apr;196(4):405.e1-8. doi: 10.1016/j.ajog.2007.02.018. PubMed 17403437 ↗
  • Clemons JL, Aguilar VC, Tillinghast TA, Jackson ND, Myers DL. Patient satisfaction and changes in prolapse and urinary symptoms in women who were fitted successfully with a pessary for pelvic organ prolapse. Am J Obstet Gynecol. 2004 Apr;190(4):1025-9. doi: 10.1016/j.ajog.2003.10.711. PubMed 15118635 ↗
  • Patel M, Mellen C, O'Sullivan DM, LaSala CA. Impact of pessary use on prolapse symptoms, quality of life, and body image. Am J Obstet Gynecol. 2010 May;202(5):499.e1-4. doi: 10.1016/j.ajog.2010.01.019. Epub 2010 Feb 20. PubMed 20171608 ↗
  • Lone F, Thakar R, Sultan AH, Karamalis G. A 5-year prospective study of vaginal pessary use for pelvic organ prolapse. Int J Gynaecol Obstet. 2011 Jul;114(1):56-9. doi: 10.1016/j.ijgo.2011.02.006. Epub 2011 May 14. PubMed 21575953 ↗
  • Clemons JL, Aguilar VC, Sokol ER, Jackson ND, Myers DL. Patient characteristics that are associated with continued pessary use versus surgery after 1 year. Am J Obstet Gynecol. 2004 Jul;191(1):159-64. doi: 10.1016/j.ajog.2004.04.048. PubMed 15295358 ↗
  • Panman CM, Wiegersma M, Kollen BJ, Burger H, Berger MY, Dekker JH. Predictors of unsuccessful pessary fitting in women with prolapse: a cross-sectional study in general practice. Int Urogynecol J. 2017 Feb;28(2):307-313. doi: 10.1007/s00192-016-3107-4. Epub 2016 Aug 15. PubMed 27525693 ↗
  • Markle D, Skoczylas L, Goldsmith C, Noblett K. Patient characteristics associated with a successful pessary fitting. Female Pelvic Med Reconstr Surg. 2011 Sep;17(5):249-52. doi: 10.1097/SPV.0b013e31822f00ae. PubMed 22453110 ↗
  • Mutone MF, Terry C, Hale DS, Benson JT. Factors which influence the short-term success of pessary management of pelvic organ prolapse. Am J Obstet Gynecol. 2005 Jul;193(1):89-94. doi: 10.1016/j.ajog.2004.12.012. PubMed 16021064 ↗
  • Geoffrion R, Zhang T, Lee T, Cundiff GW. Clinical characteristics associated with unsuccessful pessary fitting outcomes. Female Pelvic Med Reconstr Surg. 2013 Nov-Dec;19(6):339-45. doi: 10.1097/SPV.0b013e3182a26174. PubMed 24165447 ↗
  • Kuhn A, Bapst D, Stadlmayr W, Vits K, Mueller MD. Sexual and organ function in patients with symptomatic prolapse: are pessaries helpful? Fertil Steril. 2009 May;91(5):1914-8. doi: 10.1016/j.fertnstert.2008.02.142. Epub 2008 Apr 14. PubMed 18410935 ↗
  • Jelovsek JE, Barber MD. Women seeking treatment for advanced pelvic organ prolapse have decreased body image and quality of life. Am J Obstet Gynecol. 2006 May;194(5):1455-61. doi: 10.1016/j.ajog.2006.01.060. PubMed 16647928 ↗

Individual participant data

Plan to share: Undecided — The IPD will be shared with the researchers working with me for the study, i.e. Dr Villot and Miss Renouf

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Jun 2018, 0 months.

Of 36 non-industry observational studies under Personal Satisfaction, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 28. This study's 0 months is below that.

Counting every sponsor, half of 44 studies reached it within 14 months; a quarter within 4 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2018
First posted
Aug 6, 2018
StartActual
Jun 20, 2018
Primary completionActual
Jun 20, 2018
CompletionEst.
Jun 2025
Last update
Sep 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03615872
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Aug 6, 2018
Start date
Jun 20, 2018
Primary completion
Jun 20, 2018
Completion
Jun 2025 (estimated)
Last update
Sep 20, 2024

Study contacts

Anne Cecile PIZZOFERRATO, MD
Contact
acpizzofe@gmail.com
+33231272723
Anne VILLOT, MD
Contact
villot-a@chu-caen.fr
+33231272336
Anne Cecile PIZZOFERRATO, MD
principal investigator · Universitary Hospital of Caen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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