Pessary Satisfaction Criteria for Urogenital Prolapse (PeSaCUP)

Evaluation of Patient Satisfaction With Pessary in the Treatment of Genital Prolapse

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.

Study Overview

• Status: Recruiting
• Conditions: Satisfaction; Genital Prolapse; Pessary
• Intervention / Treatment: Device: pessary use

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

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Anne Cecile PIZZOFERRATO, MD; Phone Number: +33231272723; Email: acpizzofe@gmail.com
• Study Contact Backup: Name: Anne VILLOT, MD; Phone Number: +33231272336; Email: villot-a@chu-caen.fr

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • Pizzoferato
    • Contact: Anne Cecile Pizzoferrato, MD; Phone Number: +33231272336; Email: pizzoferrato-ac@chu-caen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• 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

Description

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:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	This score was developped to evaluate the genital, anorectal and urinary symptoms related to genital prolapse	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.	These scores are self-questionnaires specifically validated to evaluate urinary incontinence and urinary tract dysfunctions	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)	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	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	The PFIQ-7 was developped to evaluate the impact of the symptoms on the quality of life	at 1 year, then every year for 5 years
INVESTIGATE the impact of age on the removal or expulsion of pessary	Impact of age (years) on treatment failure (removal or expulsion of pessary)	1 year to 5 years
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)	1 year to 5 years
INVESTIGATE the impact of weight on the removal or expulsion of pessary	Impact of weight (Kg) on treatment failure (removal or expulsion of pessary)	1 year to 5 years
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	1 year to 5 years
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	1 year to 5 years
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	1 year to 5 years
Complications of pessary use reported by their rate	Rate of complications related to the use of a pessary (frequencies)	1 to 5 years

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Anne Cecile PIZZOFERRATO, MD, Universitary Hospital of Caen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Actual): June 20, 2018
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; efficiency
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: 2018-A00004-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The IPD will be shared with the researchers working with me for the study, i.e. Dr Villot and Miss Renouf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No