Smartmesh Technology in Pelvic Floor Repair Procedures (Restorelle)

Transvaginal Treatment of Anterior and Apical Genital Prolapses Using an Ultra Lightweight Mesh: Restorelle® Direct FixTM: a Retrospective Study on Feasibility and Morbidity.

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: pelvic organ prolapse repair

Detailed Description

Between January 2013 and December 2016, in the participating centers, all 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 are eligible. Collected data are about the peri-operative period and the data available at the last consultation.

• Study Type: Observational
• Enrollment (Actual): 272

Contacts and Locations

Study Locations

• France
  • Grande Synthe, France
    • Ch Dunkerque
  • La Rochelle, France
    • Groupe Hospitalier de la Rochelle Ré Aunis
  • Lambres-lez-Douai, France
    • Clinique Saint Amé
  • Laon, France
    • CH de Laon
  • Nantes, France
    • Clinique Jules Verne
  • Nimes, France
    • CHU Nimes
  • Paris, France
    • Hôpital des Diaconesses
  • Paris, France
    • Hôpital Kremlin-Bicêtre
  • Quimper, France
    • CH de Cornouaille
  • Quimper, France
    • Clinique St Michel et St Anne
  • Reims, France
    • Polyclinique de Courlancy
  • Rennes, France
    • Clinique La sagesse
  • Sarreguemines, France
    • CH Robert Pax
  • Strasbourg, France
    • Agyl
  • Suresnes, France
    • Hôpital Foch
  • Thonon les Bains, France
    • Hopitaux du Leman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Opposed to the use of her data

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding	Perioperative morbidity	up to 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Early Complications	Urinary retention, urinary tract infection, hematoma, ureteral complication, second surgery	up to 30 days after surgery
Number of Patients With Late Complications	self-catheterization, recurrent urinary tract infections, de novo urinary stress incontinence, chronic pain, vaginal prosthesis exposure, prolapse recurrence, secondary surgery, other	up to 4 years after surgery
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery	Pelvic organ prolapse quantification (POP-Q) Staging Criteria Prolapse is staged using POP-Q criteria that can range from good support (no organ descent) reported as a POP-Q stage 0 or I to a POP-Q score of IV (complete procidentia or vault eversion)	preoperative, within 48 hours before surgery
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery	Pelvic organ prolapse quantification (POP-Q) Staging Criteria Prolapse is staged using POP-Q criteria that can range from good support (no organ descent) reported as a POP-Q stage 0 or I to a POP-Q score of IV (complete procidentia or vault eversion)	up to 4 years after surgery
Number of Patients With Preoperative Urinary Signs	urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence	within 4 weeks before surgery
Number of Patients With Postoperative Urinary Signs	urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence	up to 4 years after surgery
Number of Patients With Preoperative Digestive Signs	dyschezia, incontinence	within 4 weeks before surgery
Number of Patients With Postoperative Digestive Signs	dyschezia, incontinence	up to 4 years after surgery
Number of Patients With Preoperative Active Sexuality	Patients reporting active sexuality	within 4 weeks before surgery
Number of Patients With Preoperative Dyspareunia	Patients reporting pain	within 4 weeks before surgery
Number of Patients With Postoperative Active Sexuality	Patients reporting active sexuality	up to 4 years after surgery
Number of Patients With Postoperative Dyspareunia	Patients reporting pain	up to 4 years after surgery
Preoperative Score at Numeric Pain Rating Scale	The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)	Within 48 hours before surgery
Postoperative Score at Numeric Pain Rating Scale	The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)	up to 48 hours after surgery

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
• Collaborators: Coloplast A/S
• Investigators: Study Director: Philippe Ferry, MD, Groupe Hospitalier de la Rochelle Ré Aunis

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Association Française de Normalisation (AFNOR). Norme Française (NF) S 94-801 implants de renfort mis en place par voie vaginale pour cure d'incontinence urinaire d'effort et/ou de prolapsus des organes pelviens. Essais pré-cliniques et essais cliniques

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): September 26, 2017
• Study Completion (Actual): September 26, 2017

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 2016/P05/179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No