Genital ProlapsePeSaCUPNCT03615872
Pessary Satisfaction Criteria for Urogenital Prolapse
An observational study of Genital Prolapse and Pessary, run by University Hospital, Caen at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genital Prolapse, Pessary, Satisfaction
- What is being tested?
- pessary use
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2018to Jun 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The research protocol will be proposed to all patients with a symptomatic genital prolapse
Who may be able to join
- 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-.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Pizzoferato
Caen, 14000
Anne Cecile Pizzoferrato, MD, +33231272336, pizzoferrato-ac@chu-caen.fr
About this study
Official title: 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.
Read the 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
- Conditions
- Genital Prolapse, Pessary, Satisfaction
- Being tested
- pessary use
- Keywords
- quality of life, efficiency
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pessary useDevice
evaluation of satisfaction of pessary use in case of symptomatic genital prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The PGI-I score was developed and validated to quantify the effect of urinary incontinence or prolapse treatments
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year to 5 years
Complications of pessary use reported by their rate
Rate of complications related to the use of a pessary (frequencies)
Measured: 1 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start20 Jun 2018
- Primary completion20 Jun 2018
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Genital ProlapseStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Cecile PIZZOFERRATO, MD, Principal investigator, Universitary Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615872
- Sponsor's protocol ID
- 2018-A00004-51
- Acronym
- PeSaCUP
- Status last verified
- Aug 2024
- First submitted
- 16 Jul 2018
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD will be shared with the researchers working with me for the study, i.e. Dr Villot and Miss Renouf
Publications
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.
PubMed 17403437Clemons 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.
PubMed 15118635Patel 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.
PubMed 20171608Lone 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.
PubMed 21575953Clemons 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.
PubMed 15295358Panman 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.
PubMed 27525693Markle 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.
PubMed 22453110Mutone 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.
PubMed 16021064Geoffrion 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.
PubMed 24165447Kuhn 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.
PubMed 18410935Jelovsek 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.
PubMed 16647928
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Satisfaction With Pessary in the Treatment of Genital Prolapse
- ClinicalTrials.gov ID
- NCT03615872
- Acronym / sponsor ID
- PeSaCUP / 2018-A00004-51
- Conditions
- Genital Prolapse, Pessary, Satisfaction
- Keywords
- quality of life, efficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- Jun 2025 (estimated)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The research protocol will be proposed to all patients with a symptomatic genital prolapse
Key inclusion criteria (2 listed)
- 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-.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pessary useevaluation of satisfaction of pessary use in case of symptomatic genital prolapse | Device | – |
Primary outcome
Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) in the first year after the installation of a pessary
Time frame: 1 year
The PGI-I score was developed and validated to quantify the effect of urinary incontinence or prolapse treatments
12 secondary outcomes
Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) every year for five years after the installation of a pessary
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: at 1 year, then every year for 5 years
INVESTIGATE the impact of age on the removal or expulsion of pessary
Time frame: 1 year to 5 years
INVESTIGATE the impact of menopausal status on the removal or expulsion of pessary
Time frame: 1 year to 5 years
INVESTIGATE the impact of weight on the removal or expulsion of pessary
Time frame: 1 year to 5 years
INVESTIGATE the impact of hysterectomy history on the removal or expulsion of pessary
Time frame: 1 year to 5 years
INVESTIGATE the impact of prolapse surgery history on the removal or expulsion of pessary
Time frame: 1 year to 5 years
INVESTIGATE the impact of the prolapse stage of on the removal or expulsion of pessary
Time frame: 1 year to 5 years
Complications of pessary use reported by their rate
Time frame: 1 to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Background: PubMed 17403437Cundiff 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.
- Background: PubMed 15118635Clemons 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.
- Background: PubMed 20171608Patel 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.
- Background: PubMed 21575953Lone 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.
- Background: PubMed 15295358Clemons 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.
- Background: PubMed 27525693Panman 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.
- Background: PubMed 22453110Markle 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.
- Background: PubMed 16021064Mutone 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.
- Background: PubMed 24165447Geoffrion 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.
- Background: PubMed 18410935Kuhn 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.
- Background: PubMed 16647928Jelovsek 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Cecile PIZZOFERRATO, MD principal investigator
Universitary Hospital of Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genital Prolapse and Pessary, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Cecile PIZZOFERRATO, MD (+33231272723, acpizzofe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) in the first year after the installation of a pessary (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615872, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.