Pessary Satisfaction Criteria for Urogenital Prolapse

Satisfaction Clinical Trial

— PeSaCUP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03615872
• Other study ID #: 2018-A00004-51
• Status: Recruiting
• Start date: June 20, 2018
• Est. completion date: June 2023

Study information

• Verified date: August 2021
• Source: University Hospital, Caen
• Contact: Anne Cecile PIZZOFERRATO, MD
• Phone: +33231272723
• Email: acpizzofe[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2023
• Est. primary completion date: June 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Genital Prolapse
• Pessary
• Prolapse
• Satisfaction

Intervention

Device:
• pessary use
evaluation of satisfaction of pessary use in case of symptomatic genital prolapse

Locations

Country	Name	City	State
France	Pizzoferato	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Complications of pessary use reported by their rate	Rate of complications related to the use of a pessary (frequencies)	1 to 5 years