Smartmesh Technology in Pelvic Floor Repair Procedures

NCT03098641 | Completed Results

• 1 other identifier: 2016/P05/179
• Study Type: observational
• Target: 272
• Locations: 1 country
• Sites: 16

Brief Summary

Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical. According to detailed medical history and a thorough physical exam, surgical techniques may be performed by high abdominal, low vaginal or mixed routes with or without the use of a reinforcing implant. Restorelle Direct Fix is indicated for transvaginal anterior and posterior surgical repair either as mechanical support or as reinforcement of pelvic floor defects. Advantages and disadvantages of vaginal prostheses are known but only limited data have been reported on the use of Restorelle® in the treatment of pelvic organ prolapse. This study is designed to collect data on the safety and efficacy of Restorelle® Direct Fix in pelvic organ prolapse repair.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding

  Perioperative morbidity

  up to 30 days after surgery

Secondary Outcomes (14)

• Number of Patients With Early Complications

  up to 30 days after surgery

• Number of Patients With Late Complications

  up to 4 years after surgery

• Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery

  preoperative, within 48 hours before surgery

• Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery

  up to 4 years after surgery

• Number of Patients With Preoperative Urinary Signs

  within 4 weeks before surgery

Interventions

pelvic organ prolapse repair PROCEDURE

Surgery to repair pelvic organ prolapse through the vagina using stitches with the addition of surgical mesh.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis

You may qualify if:

• Over 18
• woman who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis
• informed and not opposed to the use of her data

You may not qualify if:

• Opposed to the use of her data

Sponsors & Collaborators

• Groupe Hospitalier de la Rochelle Ré Aunis: lead
• Coloplast A/S: collaborator

Study Sites (16)

CH Dunkerque

Grande-Synthe, France

Location

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

Location

Clinique Saint Ame

Lambres-lez-Douai, France

Location

CH de Laon

Laon, France

Location

Clinique Jules Verne

Nantes, France

Location

CHU Nîmes

Nîmes, France

Location

Hôpital des Diaconesses

Paris, France

Location

Hôpital Kremlin-Bicêtre

Paris, France

Location

CH de Cornouaille

Quimper, France

Location

Clinique St Michel et St Anne

Quimper, France

Location

Polyclinique de Courlancy

Reims, France

Location

Clinique la Sagesse

Rennes, France

Location

CH Robert Pax

Sarreguemines, France

Location

Agyl

Strasbourg, France

Location

Hôpital Foch

Suresnes, France

Location

Hôpitaux du Léman

Thonon-les-Bains, France

Location

Related Publications (8)

• 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: Summary of recommendations for first surgical treatment of female pelvic organ prolapse by 5 French academic societies: AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP]. Prog Urol. 2016 Jul;26 Suppl 1:S1-7. doi: 10.1016/S1166-7087(16)30424-9. French.

  PMID: 27595623 BACKGROUND

• Khunda A, Vashisht A, Cutner A. New procedures for uterine prolapse. Best Pract Res Clin Obstet Gynaecol. 2013 Jun;27(3):363-79. doi: 10.1016/j.bpobgyn.2012.12.004. Epub 2013 Jan 5.

  PMID: 23298608 BACKGROUND

• Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.

  PMID: 9083302 BACKGROUND

• Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.

  PMID: 18799443 BACKGROUND

• Persu C, Chapple CR, Cauni V, Gutue S, Geavlete P. Pelvic Organ Prolapse Quantification System (POP-Q) - a new era in pelvic prolapse staging. J Med Life. 2011 Jan-Mar;4(1):75-81. Epub 2011 Feb 25.

  PMID: 21505577 BACKGROUND

• 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.

  PMID: 19969258 BACKGROUND

• Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016 Feb 9;2(2):CD012079. doi: 10.1002/14651858.CD012079.

  PMID: 26858090 BACKGROUND

• Ferry P, Bertherat P, Gauthier A, Villet R, Del Piano F, Hamid D, Fernandez H, Broux PL, Salet-Lizee D, Vincens E, Ntshaykolo P, Debodinance P, Pocholle P, Thirouard Y, de Tayrac R. Transvaginal treatment of anterior and apical genital prolapses using an Ultra lightweight mesh: Restorelle(R) Direct Fix. A retrospective study on feasibility and morbidity. J Gynecol Obstet Hum Reprod. 2018 Nov;47(9):443-449. doi: 10.1016/j.jogoh.2018.06.001. Epub 2018 Jun 18.

  PMID: 29920380 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Philippe Ferry
• Organization: Groupe Hospitalier de la Rochelle Ré Aunis

philippe.ferry@ch-larochelle.fr

+33 5 46 45 50 50

Study Officials

• Philippe Ferry, MD

  Groupe Hospitalier de la Rochelle Ré Aunis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 4, 2017
• Study Start: May 1, 2017
• Primary Completion: September 26, 2017
• Study Completion: September 26, 2017
• Last Updated: November 13, 2023
• Results First Posted: June 3, 2019

Record last verified: 2023-10

Locations

FR (16)