Smartmesh Technology in Pelvic Floor Repair Procedures

Pelvic Organ Prolapse Clinical Trial

— Restorelle  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098641
• Other study ID #: 2016/P05/179
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: September 26, 2017

Study information

• Verified date: October 2023
• Source: Groupe Hospitalier de la Rochelle Ré Aunis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: September 26, 2017
• Est. primary completion date: September 26, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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

Locations

Country	Name	City	State
France	CH Dunkerque	Grande Synthe
France	Groupe Hospitalier de la Rochelle Ré Aunis	La Rochelle
France	Clinique Saint Ame	Lambres-lez-Douai
France	CH de Laon	Laon
France	Clinique Jules Verne	Nantes
France	CHU Nîmes	Nimes
France	Hôpital des Diaconesses	Paris
France	Hôpital Kremlin-Bicêtre	Paris
France	CH de Cornouaille	Quimper
France	Clinique St Michel et St Anne	Quimper
France	Polyclinique de Courlancy	Reims
France	Clinique la Sagesse	Rennes
France	CH Robert Pax	Sarreguemines
France	Agyl	Strasbourg
France	Hôpital Foch	Suresnes
France	Hôpitaux du Léman	Thonon les Bains

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Rochelle Ré Aunis	Coloplast A/S

Country where clinical trial is conducted

France, 

References & Publications (8)

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 — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding	Perioperative morbidity	up to 30 days after surgery
Secondary	Number of Patients With Early Complications	Urinary retention, urinary tract infection, hematoma, ureteral complication, second surgery	up to 30 days after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Patients With Preoperative Urinary Signs	urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence	within 4 weeks before surgery
Secondary	Number of Patients With Postoperative Urinary Signs	urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence	up to 4 years after surgery
Secondary	Number of Patients With Preoperative Digestive Signs	dyschezia, incontinence	within 4 weeks before surgery
Secondary	Number of Patients With Postoperative Digestive Signs	dyschezia, incontinence	up to 4 years after surgery
Secondary	Number of Patients With Preoperative Active Sexuality	Patients reporting active sexuality	within 4 weeks before surgery
Secondary	Number of Patients With Preoperative Dyspareunia	Patients reporting pain	within 4 weeks before surgery
Secondary	Number of Patients With Postoperative Active Sexuality	Patients reporting active sexuality	up to 4 years after surgery
Secondary	Number of Patients With Postoperative Dyspareunia	Patients reporting pain	up to 4 years after surgery
Secondary	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
Secondary	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

External 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