Clinical trial NCT03098641: Smartmesh Technology in Pelvic Floor Repair Procedures
Official title: Transvaginal Treatment of Anterior and Apical Genital Prolapses Using an Ultra Lightweight Mesh: Restorelle® Direct FixTM: a Retrospective Study on Feasibility and Morbidity.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
Sponsor class: OTHER
Collaborators: name: Coloplast A/S
First posted: 2017-04-04
Enrollment: 272
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding
timeFrame: up to 30 days after surgery
Secondary outcomes:
measure: Number of Patients With Early Complications
timeFrame: up to 30 days after surgery
measure: Number of Patients With Late Complications
timeFrame: up to 4 years after surgery
measure: Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
timeFrame: preoperative, within 48 hours before surgery
measure: Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
timeFrame: up to 4 years after surgery
measure: Number of Patients With Preoperative Urinary Signs
timeFrame: within 4 weeks before surgery
measure: Number of Patients With Postoperative Urinary Signs
timeFrame: up to 4 years after surgery
measure: Number of Patients With Preoperative Digestive Signs
timeFrame: within 4 weeks before surgery
measure: Number of Patients With Postoperative Digestive Signs
timeFrame: up to 4 years after surgery
measure: Number of Patients With Preoperative Active Sexuality
timeFrame: within 4 weeks before surgery
measure: Number of Patients With Preoperative Dyspareunia
timeFrame: within 4 weeks before surgery
measure: Number of Patients With Postoperative Active Sexuality
timeFrame: up to 4 years after surgery
measure: Number of Patients With Postoperative Dyspareunia
timeFrame: up to 4 years after surgery
measure: Preoperative Score at Numeric Pain Rating Scale
timeFrame: Within 48 hours before surgery
measure: Postoperative Score at Numeric Pain Rating Scale
timeFrame: up to 48 hours after surgery
Other outcomes:
Locations:
city: Grande Synthe
country: France
facility: CH Dunkerque
city: La Rochelle
country: France
facility: Groupe Hospitalier de la Rochelle Ré Aunis
city: Lambres-lez-Douai
country: France
facility: Clinique Saint Ame
city: Laon
country: France
facility: CH de Laon
city: Nantes
country: France
facility: Clinique Jules Verne
city: Nimes
country: France
facility: CHU Nîmes
city: Paris
country: France
facility: Hôpital des Diaconesses
city: Paris
country: France
facility: Hôpital Kremlin-Bicêtre
city: Quimper
country: France
facility: CH de Cornouaille
city: Quimper
country: France
facility: Clinique St Michel et St Anne
city: Reims
country: France
facility: Polyclinique de Courlancy
city: Rennes
country: France
facility: Clinique la Sagesse
city: Sarreguemines
country: France
facility: CH Robert Pax
city: Strasbourg
country: France
facility: Agyl
city: Suresnes
country: France
facility: Hôpital Foch
city: Thonon les Bains
country: France
facility: Hôpitaux du Léman
Study officials:
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
name: Philippe Ferry, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.