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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pessary use | Device | evaluation of satisfaction of pessary use in case of symptomatic genital prolapse |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The research protocol will be proposed to all patients with a symptomatic genital prolapse
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Cecile PIZZOFERRATO, MD | Contact | +33231272723 | acpizzofe@gmail.com | |
| Anne VILLOT, MD | Contact | +33231272336 | villot-a@chu-caen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne Cecile PIZZOFERRATO, MD | Universitary Hospital of Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pizzoferato | Recruiting | Caen | 14000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17403437 | Background | 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. | |
| 15118635 | Background | 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. |
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The IPD will be shared with the researchers working with me for the study, i.e. Dr Villot and Miss Renouf
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| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001519 | Behavior |
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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 |
| 20171608 | Background | 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. |
| 21575953 | Background | 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. |
| 15295358 | Background | 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. |
| 27525693 | Background | 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. |
| 22453110 | Background | 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. |
| 16021064 | Background | 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. |
| 24165447 | Background | 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. |
| 18410935 | Background | 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. |
| 16647928 | Background | 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. |