NCT03615872

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

September 20, 2024

Status Verified

August 1, 2024

Enrollment Period

Same day

First QC Date

July 16, 2018

Last Update Submit

September 19, 2024

Conditions

Genital ProlapsePessarySatisfaction

Keywords

quality of lifeefficiency

Outcome Measures

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

    1 year

Secondary Outcomes (12)

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

    1 to 5 years

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

    at 1 year, then every year for 5 years

  • 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.

    at 1 year, then every year for 5 years

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

    at 1 year, then every year for 5 years

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

    at 1 year, then every year for 5 years

  • +7 more secondary outcomes

Interventions

pessary useDEVICE

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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-.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pizzoferato

Caen, 14000, France

RECRUITING

Related Publications (11)

  • 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.

    PMID: 17403437BACKGROUND

  • 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.

    PMID: 15118635BACKGROUND

  • 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.

    PMID: 20171608BACKGROUND

  • 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.

    PMID: 21575953BACKGROUND

  • 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.

    PMID: 15295358BACKGROUND

  • 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.

    PMID: 27525693BACKGROUND

  • 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.

    PMID: 22453110BACKGROUND

  • 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.

    PMID: 16021064BACKGROUND

  • 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.

    PMID: 24165447BACKGROUND

  • 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.

    PMID: 18410935BACKGROUND

  • 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.

    PMID: 16647928BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Anne Cecile PIZZOFERRATO, MD

    Universitary Hospital of Caen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Cecile PIZZOFERRATO, MD

CONTACT

+33231272723acpizzofe@gmail.com

Anne VILLOT, MD

CONTACT

+33231272336villot-a@chu-caen.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2018

First Posted

August 6, 2018

Study Start

June 20, 2018

Primary Completion

June 20, 2018

Study Completion

June 1, 2025

Last Updated

September 20, 2024

Record last verified: 2024-08

Locations

FR(1)