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Pelvic Organ ProlapsePeSuLifeNCT03919123

Evaluation of Functional Outcomes After Laparoscopic Promontofixation (PFL).

An observational study of Pelvic Organ Prolapse and Symptoms, run by University Hospital, Caen at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Prolapse of the pelvic organs is a common pathology in women with a strong impact on the quality of life. Its prevalence tends to increase due to increased life expectancy and obesity. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pelvic Organ Prolapse, Symptoms, Satisfaction
What is being tested?
Evaluation of laparoscopic promontofixation
How many people
200 participants
Where
1 siteFrance
Study dates
1 Jan 2019to Oct 2022
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: Patient over 18 years old who underwent a laparoscopic promontofixation for pelvic organ prolapse at the University Hospital of Caen between 2013 and 2018 in the departments of gynecology, urology and digestive surgery, and agreed to participate in the study after a written information

Who may be able to join

  • Patients who have had a laparoscopic promotofixation for genital prolapse at the University Hospital of Caen between 2013 and 2018 in the departments of gynecology, urology and digestive surgery.
  • Patient who received written information and agreed to participate in the study

Who cannot join

  • Minor patient, under guardianship, under trusteeship Patient not understanding French Refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

Estelle Jamard, Doctor contact

+33 6 88 32 32 11

estelle.jamard@hotmail.fr

France1 site, 1 recruiting

  • University Hospital

    Caen, Normandy, 14 000

    Estelle Jamard, Doctor, +33 6 88 32 32 11, estelle.jamard@hotmail.fr

    Recruiting

Other trials in France

About this study

Official title: Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)

Prolapse of the pelvic organs is a common pathology in women with a strong impact on the quality of life. Its prevalence tends to increase due to increased life expectancy and obesity.

The main treatment is surgical and involves all organ specialists dealing with pelvic-perineal functional disorders: urologists, gynecologists, digestive surgeons.

Read more

Our team wishes to evaluate, on a cohort of patients operated at the Caen University Hospital, the functional uro-gynecologic, digestive and sexual results of pelvic organ prolapse (POP) repair by Laparoscopic Promontofixation (PFL) through symptoms and quality of life validated questionnaires (QoL).

The analysis of the responses to these questionnaires will allow us to evaluate the functional results in the short and medium term (from 6 months to 5 years)

Read the detailed description

This is a retrospective cohort study conducted at the Universitary hospital of Caen in three surgical departments (gynecology, urology and digestive surgery).

Patients who had a laparoscopic promontofixation will be asked to respond to validated questionnaires of symptoms and quality of life after their surgery (PFDI-20, ICIQ-SF, PFIQ-7) and satisfaction (PGI-I)

Being tested
Evaluation of laparoscopic promontofixation
Keywords
Pelvic Organ Prolapse, laparoscopic promontofixation, symptoms, Satisfaction, Quality of Life
Medical subject headings
Pelvic Organ Prolapse, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation of laparoscopic promontofixationOther

    Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of laparoscopic promontofixation on urogynecologic and digestive symptoms

    The main objective is to collect the PFDI-20 score after the surgery. This score was developped to evaluate the genital, anorectal and digestive symptoms related to prolapse

    Measured: 3 years

Secondary outcomes (6)

  1. Effect of laparoscopic promontofixation on urinary incontinence

    Assessment of the ICIQ-SF score, a specific score developped to assess the impact urinary incontinence

    Measured: 3 years

  2. Sexual impact of laparoscopic promontofixation

    Evaluation of the PISQ-12 score after laparoscopic promontofixation. This score was developped specifically to evaluate sexual troubles in case of genital prolapse

    Measured: 3 years

  3. Evaluation of quality of life after prolapse surgery

    Evaluation of the quality of life using a score specifically developped in case of genital prolapse : the PFIQ-7 score

    Measured: 3 years

  4. Assessment of patient satisfaction after surgery

    Evaluation of the quality of life using the PGI-I score, developped to quantify the effect of urinary or prolapse treatments

    Measured: 3 years

  5. Specific evaluation of functional outcomes of laparoscopic rectopexy in rectocele or elytrocele indications

    Evaluation of the PFDI-20 score in women undergoing laparoscopic rectopexy

    Measured: 3 years

  6. Comparison of the different scores according to the operative indication (anterior promontofixation, double promontofixation, rectopexy alone)

    Comparison of the PFDI-20 scores according to the operative indication

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2019
  2. Study start1 Jan 2019
  3. Primary completionJun 2022 (estimated)
  4. Study completionOct 2022 (estimated)

Resources

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
Retrospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03919123
Sponsor's protocol ID
2018-A02927-48
Acronym
PeSuLife
Status last verified
Apr 2019
First submitted
15 Apr 2019
Last updated
18 Apr 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fritel X, Varnoux N, Zins M, Breart G, Ringa V. Symptomatic pelvic organ prolapse at midlife, quality of life, and risk factors. Obstet Gynecol. 2009 Mar;113(3):609-616. doi: 10.1097/AOG.0b013e3181985312.

    PubMed 19300324

  • Lousquy R, Costa P, Delmas V, Haab F. [Update on the epidemiology of genital prolapse]. Prog Urol. 2009 Dec;19(13):907-15. doi: 10.1016/j.purol.2009.09.011. Epub 2009 Nov 4. French.

    PubMed 19969258

  • Adjoussou SA, Bohoussou E, Bastide S, Letouzey V, Fatton B, de Tayrac R. [Functional symptoms and associations of women with genital prolapse]. Prog Urol. 2014 Jun;24(8):511-7. doi: 10.1016/j.purol.2013.11.015. Epub 2013 Dec 27. French.

    PubMed 24875570

  • Le Normand L, Cosson M, Cour F, Deffieux X, Donon L, Ferry P, Fatton B, Hermieu JF, Marret H, Meurette G, Cortesse A, Wagner L, Fritel X. Clinical Practice Guidelines: Synthesis of the guidelines for the surgical treatment of primary pelvic organ prolapse in women by the AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP. J Gynecol Obstet Hum Reprod. 2017 May;46(5):387-391. doi: 10.1016/j.jogoh.2017.05.001. Epub 2017 May 12. No abstract available.

    PubMed 28506877

  • Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014. doi: 10.1002/14651858.CD004014.pub5.

    PubMed 23633316

  • Maher CF, Feiner B, DeCuyper EM, Nichlos CJ, Hickey KV, O'Rourke P. Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. Am J Obstet Gynecol. 2011 Apr;204(4):360.e1-7. doi: 10.1016/j.ajog.2010.11.016.

    PubMed 21306698

  • Lucot JP, Cosson M, Bader G, Debodinance P, Akladios C, Salet-Lizee D, Delporte P, Savary D, Ferry P, Deffieux X, Campagne-Loiseau S, de Tayrac R, Blanc S, Fournet S, Wattiez A, Villet R, Ravit M, Jacquetin B, Fritel X, Fauconnier A. Safety of Vaginal Mesh Surgery Versus Laparoscopic Mesh Sacropexy for Cystocele Repair: Results of the Prosthetic Pelvic Floor Repair Randomized Controlled Trial. Eur Urol. 2018 Aug;74(2):167-176. doi: 10.1016/j.eururo.2018.01.044. Epub 2018 Feb 19.

    PubMed 29472143

  • Paraiso MF, Walters MD, Rackley RR, Melek S, Hugney C. Laparoscopic and abdominal sacral colpopexies: a comparative cohort study. Am J Obstet Gynecol. 2005 May;192(5):1752-8. doi: 10.1016/j.ajog.2004.11.051.

    PubMed 15902189

  • Hsiao KC, Latchamsetty K, Govier FE, Kozlowski P, Kobashi KC. Comparison of laparoscopic and abdominal sacrocolpopexy for the treatment of vaginal vault prolapse. J Endourol. 2007 Aug;21(8):926-30. doi: 10.1089/end.2006.0381.

    PubMed 17867956

  • Ganatra AM, Rozet F, Sanchez-Salas R, Barret E, Galiano M, Cathelineau X, Vallancien G. The current status of laparoscopic sacrocolpopexy: a review. Eur Urol. 2009 May;55(5):1089-103. doi: 10.1016/j.eururo.2009.01.048. Epub 2009 Feb 4.

    PubMed 19201521

  • Chevrot A, Droupy S, Linares E, de Tayrac R, Costa P, Wagner L. [Impact of laparoscopic sacrocolpopexy on symptoms, health-related quality of life and sexuality: A 3-year prospective study]. Prog Urol. 2016 Sep;26(10):558-65. doi: 10.1016/j.purol.2016.02.009. Epub 2016 Mar 24. French.

    PubMed 27052819

  • Loffeld CJ, Thijs S, Mol BW, Bongers MY, Roovers JP. Laparoscopic sacrocolpopexy: a comparison of Prolene and Tutoplast mesh. Acta Obstet Gynecol Scand. 2009;88(7):826-30. doi: 10.1080/00016340902883158.

    PubMed 19353330

  • Deprest J, De Ridder D, Roovers JP, Werbrouck E, Coremans G, Claerhout F. Medium term outcome of laparoscopic sacrocolpopexy with xenografts compared to synthetic grafts. J Urol. 2009 Nov;182(5):2362-8. doi: 10.1016/j.juro.2009.07.043. Epub 2009 Sep 16.

    PubMed 19762041

  • Govier FE, Kobashi KC, Kuznetsov DD, Comiter C, Jones P, Dakil SE, James R Jr. Complications of transvaginal silicone-coated polyester synthetic mesh sling. Urology. 2005 Oct;66(4):741-5. doi: 10.1016/j.urology.2005.04.027.

    PubMed 16230128

  • Sergent F, Resch B, Loisel C, Bisson V, Schaal JP, Marpeau L. Mid-term outcome of laparoscopic sacrocolpopexy with anterior and posterior polyester mesh for treatment of genito-urinary prolapse. Eur J Obstet Gynecol Reprod Biol. 2011 Jun;156(2):217-22. doi: 10.1016/j.ejogrb.2011.01.022. Epub 2011 Feb 26.

    PubMed 21353736

Questions about this trial

What is this clinical trial studying?

An observational study of Pelvic Organ Prolapse and Symptoms, 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 1 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 18 Apr 2019. 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 Estelle Jamard, Doctor (+33 6 88 32 32 11, estelle.jamard@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of laparoscopic promontofixation on urogynecologic and digestive symptoms (time frame: 3 years). 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 NCT03919123, which also lists 20 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 18 Apr 2019.

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