Clinical trial NCT03615872: Pessary Satisfaction Criteria for Urogenital Prolapse
Official title: Evaluation of Patient Satisfaction With Pessary in the Treatment of Genital Prolapse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genital Prolapse
Pessary
Satisfaction
Keywords: quality of life
efficiency
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research protocol will be proposed to all patients with a symptomatic genital prolapse

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.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) in the first year after the installation of a pessary
timeFrame: 1 year
Secondary outcomes:
measure: Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) every year for five years after the installation of a pessary
timeFrame: 1 to 5 years
measure: EFFICACY of pessary on genital symptoms assessed by the Pelvic Floor Distress Inventory (PFDI-20) questionnaire before and after the installation of the pessary.
timeFrame: at 1 year, then every year for 5 years
measure: 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.
timeFrame: at 1 year, then every year for 5 years
measure: Sexual impact of pessary assessed by the Pelvic organ prolapse urinary Incontinence Sexual Questionnaire (PISQ-12)
timeFrame: at 1 year, then every year for 5 years
measure: QUALITY OF LIFE assessed by the Pelvic Floor Impact Questionnaire (PFIQ-7) before and after the installation of the pessary
timeFrame: at 1 year, then every year for 5 years
measure: INVESTIGATE the impact of age on the removal or expulsion of pessary
timeFrame: 1 year to 5 years
measure: INVESTIGATE the impact of menopausal status on the removal or expulsion of pessary
timeFrame: 1 year to 5 years
measure: INVESTIGATE the impact of weight on the removal or expulsion of pessary
timeFrame: 1 year to 5 years
measure: INVESTIGATE the impact of hysterectomy history on the removal or expulsion of pessary
timeFrame: 1 year to 5 years
measure: INVESTIGATE the impact of prolapse surgery history on the removal or expulsion of pessary
timeFrame: 1 year to 5 years
measure: INVESTIGATE the impact of the prolapse stage of on the removal or expulsion of pessary
timeFrame: 1 year to 5 years
measure: Complications of pessary use reported by their rate
timeFrame: 1 to 5 years
Other outcomes:
Locations:
city: Caen
country: France
facility: Pizzoferato
Study officials:
affiliation: Universitary Hospital of Caen
name: Anne Cecile PIZZOFERRATO, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.ajog.2007.02.018.
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. doi: 10.1016/j.ajog.2003.10.711.
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.
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.
citation: 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.
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.
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.
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. doi: 10.1016/j.ajog.2004.12.012.
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.
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.
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. doi: 10.1016/j.ajog.2006.01.060.