Transvaginal Treatment of Anterior and Apical Genital Prolapses Using an Ultra Lightweight Mesh: Restorelle® Direct FixTM: a Retrospective Study on Feasibility and Morbidity.
Conditions: Pelvic Organ Prolapse
Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

 
PROTOCOL 
 n°2016/P05/179 
 
 
Transvaginal treatment of anterior and apical genital prolapses 
using an Ultra lightweight mesh: Restorelle® Direct FixTM. 
A retrospective study on feasibility and morbidity. 
 
Date: December 20 2016 
Version 1.1 
 
 
Study coordinator: Dr Philippe Ferry 
 
Groupe Hospitalier de la Rochelle Ré Aunis 
Service de gynécologie 
Rue du Dr Schweizer 
17019 La Rochelle 
Philippe.ferry@ch-larochelle.fr  
 
 
 
 
 
 
 

 
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Content 
1 
Background ...................................................................................................................................... 3 
2 
Participants ...................................................................................................................................... 3 
3 
Study design and settings ................................................................................................................ 3 
4 
Data ................................................................................................................................................. 4 
5 
Information for data collection ....................................................................................................... 4 
6 
Statistical analysis ............................................................................................................................ 4 
7 
Number of subjects ......................................................................................................................... 5 
8 
Ethical and legal aspects .................................................................................................................. 5 
9 
References ....................................................................................................................................... 6 
 
 
 

 
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1 Background 
Pelvic organ prolapse (POP) is a functional disease that has a significant impact on quality of life (1). 
The prevalence of pelvic organ prolapse stage 2 or higher, according to the Pelvic Organ Prolapse 
Quantification system (POP-Q), ranges from 37 to 50% (2,3). Treatment methods can be conservative 
or surgical. Conservative treatments are for patients with moderate prolapse, while treatment of 
symptomatic prolapse remains essentially surgical (4). Surgical techniques can be performed by 
abdominal or vaginal approach depending on medical history and physical exam. Laparoscopic 
sacrocolpopexy is often the method of choice and is successful in 80% to 100% of cases (5–8). 
However, this technique is not always appropriate, especially for patients who have a high 
anaesthesia risk and/or a multi-operated abdomen. In these cases, a vaginal approach offers an 
interesting surgical alternative. 
Transvaginal mesh was developed to maintain the advantage of a vaginal procedure, while reducing 
the risk of recurrent prolapse compared with native tissue repair. Four percent of women require 
repeated surgery due to prolapse recurrence after surgery without mesh, and from 1% to 7% after 
surgery with mesh.  
The US Food and Drug Administration (FDA) published two safety alerts (in 2008, then in 2011)(9) 
concerning the risks of transvaginal placement of surgical mesh to treat pelvic organ prolapse and 
urinary incontinence. However, most studies have evaluated mesh types that are no longer available 
on the market. They have been replaced by new lighter mesh which lack evidence of safety (10). 
Restorelle® Direct FixTM is a single incision mesh indicated for transvaginal anterior and posterior 
surgical repair as reinforcement of pelvic floor defects. It is an Ultra lightweight (19 g/m2) pre-cut 
macroporous mesh with four lateral arms. It allows an anterior sacrospinous ligament (SSL) 
approach, using a disposable device (Digitex®) (Erreur ! Source du renvoi introuvable.) intended to 
deliver a suture to the operative site without direct visualization. The proximal arms of the mesh are 
sutured to the SSL and the distal arms of the mesh are sutured in the arcus tendinous fascia pelvis 
with the same device. 
 
2 Participants 
All adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with 
anterior Restorelle® Direct FixTM mesh (with or without posterior mesh) were eligible. Patients are 
excluded if they did not attend their follow up visit within 30 days of surgery. 
 
 
3 Study design and settings 
This is a retrospective multicenter study in gynaecology.  
Data collection from patients taken care between January 2013 and December 2016, in 10 secondary 
and tertiary French care centers.  
 

 
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4 Data  
Preoperative assessment consists of  
- 
a detailed medical history, 
- 
a urogynecological examination, 
- 
and prolapse quantification by the simplified Pelvic Organ Prolapse Quantification (POP-Q) 
system (measurement of total vaginal length at rest and points Ba, C/D, and Bp at maximum 
Valsalva) (11,12).  
Anaesthesia type and concomitant surgery are reported.  
Perioperative complications are graded using the Clavien-Dindo classification (13) and their 
management and outcome are described.  
Perioperative, early (< 30 days post-operative) and late (> 30 days post-surgery) postoperative 
symptoms and complications are recorded. 
 
5 Information for data collection 
All information required by the protocol must be recorded on the case report forms and an 
explanation must be provided for each missing data. The data must be collected as it is obtained and 
transcribed in these case report forms clearly and legibly. 
 
 
6 Statistical analysis 
The primary outcome measure is the perioperative morbidity (up to 30 days after surgery). It 
comprised the number of patients with bladder wound, ureteral wound, rectum wound, abnormal 
bleeding requiring blood transfusion, urinary retention, urinary tract infection, hematoma, ureteral 
complication, second surgery, or fail of procedure. 
The secondary outcome is the number of patients with late complications (up to 3 years after 
surgery). It includes self-catheterization, recurrent urinary tract infections, de novo urinary stress 
incontinence, chronic pain, vaginal mesh exposure, prolapse recurrence, de novo dyspareunia, 
secondary surgery, vaginal granuloma, anatomic (Ba point ≤ −1) and functional failure. 
A descriptive analysis of the data will be reported. Median, range, numbers, percentages and 
confidence intervals were used to describe quantitative and qualitative variables, respectively. 
Association between demographic and clinical factors (age, body mass index, history of 
hysterectomy, of POP and stress urinary incontinence surgery, cystocele ≥ 3, concomitant 
hysterectomy and concomitant sub uretral sling) and perioperative complications will be studied. 
Bivariate ORs and 95 % confidence intervals will be estimated. Outcomes after surgery with 
Restorelle® anterior alone or with sling will be compared using a chi-square or a Fisher test. 
An alpha level of 0.05 will be used. 
 

 
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7  Number of subjects 
The largest users of Restorelle Direct Fix have been selected from all the centers specialized in the 
management of genital prolapse in France. This series will collect data from the first French installers. 
This is to obtain a representative sample of at least 100 patients, in accordance with AFNOR NF S94-
801 standard (4). 
 
8 Ethical and legal aspects 
Data access 
Acceptance of participation in the protocol implies that the investigators will make available the 
individual documents and data strictly necessary for monitoring, quality control and audit to those 
who have access to these documents in accordance with the laws and regulations in force. 
Source data 
Source data are all information in original documents or in authenticated copies of these documents 
relating to clinical examinations, observations or other research activities necessary for the 
evaluation of the research. The documents in which the source data are stored are called the source 
documents. 
Data confidentiality 
In accordance with current legislation, those with direct access to the source data will take all 
necessary precautions to ensure the confidentiality of information about experimental data, and 
participating patients and, in particular, their identity and the results obtained. These persons, in the 
same way as the investigators themselves, are subject to professional secrecy. 
During and after the research, the data collected from the patients and forwarded to the sponsor by 
the investigators (or other specialists) will be made anonymous. They must in no case show clearly 
the names of the concerned persons or their address. 
The sponsor will ensure that each participating patient to the research has given his consent for 
access to his individual data. 
Ethical conduct of the study 
The sponsor and the investigators ensure that this research is carried out in accordance with the 
current applicable Law on research involving human subject and is in agreement with good clinical 
practice (ICH version 4 of November 9th 2016 and Decision of November 24th 2006) and the Helsinki 
Declaration (which can be found in its full version at http://www.wma.net). 
The data recorded are subject to a computerized treatment in compliance with the law n°78-17 of 
January 6th 1978 relating to data processing, files and freedoms as amended by Law 2004-801 of 
August 6th 2004. 
 
  
 

 
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9 References 
1. Le Normand L et al. Recommandations pour la pratique clinique ; synthèse des recommandations 
pour le traitement chirurgical du prolapsus génital non récidivé de la femme par l'AFU, le CNGOF, la 
SIFUD-PP, la SNFCP et la SCGP. Progrès en urologie. 2016, Vol. 26, S1-S7. 
2. HAS. Soutènement vésical par implant de renfort synthétique infravésical, par voie transvaginale et 
par voie transobturatrice. 2012. 
3. Coloplast. Notice d'utilisation Restorelle Direct Fix. 70002220 Rev. 2016-03. 
4. Association Française de Normalisation AFNOR. 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. www.afnor.org. [En ligne]  
5. Kundha, A, Vashist, A et Cutner , A. New procedure for uterine prolapse. Best Practice & Research 
Clinical Obstetrics and Gynaecology. 2013, Vol. 27, pp. 363-379. 
6. Olsen, A L, et al. Epidemiology of surgically managed pelvic organ prolapse and urinay 
incontinence. Obstet. Gynecol. 1997, Vol. 89, pp. 501-506. 
7. Nygard, I, et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008, pp. 
1311-16. 
8. Persu, C, et al. Plevic organ prolapse quantification system (POP-Q) - A new era in pelvic prolapse 
staging. J Med Life. 2011, Vol. 4, 1, pp. 75-81. 
9. Cosson M et al,. Prolapsus génitaux. Encyclopédie médico-chirurgicale. 2002, Vol. 290-A-10. 
10. Lousquy R et al,. Etat des lieux de l'épidémologie des prolapsus géntaux. Progrès en urologie. 
2009, Vol. 19, 907-915. 
11. Maher, C, et al. Transvaginal mesh or grafts compared with native tissue repair for vaginal 
prolapse (Review). Cochrane. 2016.