Long-term cystocele repair and improved quality of life

10/10/2016

Study of TiLOOP® Total 6 confirms benefit in pelvic organ prolapse surgery

Prolapse of the pelvic organs can severely reduce the quality of life of patients, not only with regard to the function of the bladder and bowel, but also in terms of their general well-being and sexuality. After just 12 months, a prospective, 36-month study showed that cystocele repair with an alloplastic mesh (TiLOOP® Total 6) enables stable reconstruction and improves the quality of life.

Cystocele repair with implantation of a titanium-coated polypropylene mesh (TiLOOP® Total 6) was carried out in 289 female patients with symptomatic cystocele (at least stage II or symptomatic stage I, POP-Q classification*) at nine German clinics. The study focused on the erosion rate and quality of life of the patients; these two factors were rated using the validated German version of the P-QoL** questionnaire. Adverse events were secondary endpoints of the study. In addition, the POP-Q classification was used to determine the anatomical result.

Anatomically stable result with continuously improving quality of life

The one-year data show that an anatomically stable result was achieved through the use of TiLOOP® Total 6. With 2.4%, the relapse rate in the surgically treated compartment was very low. "In our opinion, the apical and lateral fixation of the six-armed implant provides the necessary stability in the surgically treated compartment", Dr. Christian Fünfgeld, Chief Physician of Gynaecology and Obstetrics at Tettnang Clinic and Study Coordinator, interpreted the results. 

After as little as six months, the quality of life of the patients had already improved significantly in all areas surveyed. This included their general health, physical impairment and vitality. An improvement was also observed during the further course of the study. 

"The data show that TiLOOP® Total 6 significantly improves the quality of life of the patients not only with regard to complaints related to the prolapse, but also in other decisive areas of life", said Fünfgeld. "This form of implantation also offers high stability with an otherwise low relapse rate." 

For women with cystocele defects, sexuality is an important aspect of quality of life. Unlike alloplastic meshes of the first generation, which are thought to have a negative impact on sexuality, TiLOOP® Total 6 was shown to have a positive effect: of the sexually active women, 48.6% reported that the prolapse had a negative impact on their sexuality prior to the surgery. 6 months after the surgery, this was the case in only 20.2% of the women, and in only 17% of women after 12 months. Furthermore, more patients reported being sexually active after the surgery than before.

A first look at the 36-month data confirms the successful anatomical result and the continuous improvement in the quality of life.

Improvement in urge incontinence thanks to innovative surgical procedure

Of the patients suffering from urge incontinence prior to the surgery, 81.4% were symptom-free 12 months after the surgery. "The considerable improvement in the symptoms is most probably due to the fact that the apical fixation with the TiLOOP® Total 6 results in reconstruction of the uterosacral ligaments", Fünfgeld explained. The de-novo stress incontinence rate (20.3%) and the healing rate of pre-existin

Low rate of adverse events and erosions requiring surgical treatment

While meshes of the first generation are often discussed critically because of their adverse event rate, the use of TiLOOP® Total 6 is associated with a low complication rate. Complications included five intraoperative bladder lesions (1.7%), one ureter injury during the procedure (0.3%) and two post-discharge infections (0.7%).

Of the 286 patients seen for the 12-month follow-up, 30 (10.5%) exhibited erosions, 17 of which were asymptomatic. The surgery was carried out under general anaesthesia in only 13 cases. No explantation was required.

TiLOOP® Total 6: tension-free with six-armed mesh 

TiLOOP® Total 6 is designed for the surgical treatment of cystocele and rectocele defects. The titanium coating of the polypropylene mesh is applied in a special plasma coating procedure that pfm medical uses as the only manufacturer worldwide for mesh implants. 

The six-armed implant is put into position using a tunnelling needle and introduction sheaths via transobturator and ischiorectal accesses in preparation for apical fixation to the sacrospinal ligaments. Thanks to the introduction sheaths, the arms of the mesh can be adjusted in two directions, which allows the mesh to be placed without tension.

* POP-Q classification: Pelvic Organ Prolapse Quantification System

** P-QoL: Prolapse Quality of Life Questionnaire

References: Fünfgeld C et al. Frauenarzt 2015; 56 (12): 1068-1073

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More about the treatment of genital prolapse

Summary of the 12-months results of the TiLOOP® Total 6 study 

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Other mesh implants of pfm medical ag

TiLOOP® Bra mesh implants are used in reconstructive and plastic breast surgery. The TiMESH® mesh implant is suitable for the surgical repair of all kinds of hernias and surgical techniques including IPOM. The meshes are titanium-coated and particularly light-weight. The low relapse rate also offers an improved quality of life.

Short profile

pfm medical ranks among the leading German companies in the field of medical technology and services. The Cologne-based family company was founded in 1971, and has more than 500 employees at twelve locations around the world. In 2015, pfm medical realized an EBIT (earnings before interest and taxes) of 4.1 million euros from 102.1 million euros in sales. The medical products supplier has registered more than 80 patents, utility models and trademarks. As a specialist supplier of 3,100 products, the company offers an extensive portfolio which is distributed in more than 100 markets. Its product range covers the four medical fields of application infusion (e.g. infusion pumps and implantable port catheters), histotechnology (e.g. blades and laboratory appliances), cardiovascular technologies (e.g. occlusion implants and special catheters) and surgery (e.g. drainage systems and mesh implants).

pfm medical integrates products and services into a comprehensive solution package. For instance, the company provides training and advice to users such as medical practitioners, nursing staff, patients and their families to ensure optimal therapy outcomes in both inpatient and outpatient healthcare. In the development of innovative solutions in close cooperation with leading medical practitioners and specialist partners, pfm medical invariably focuses on improvements in the quality of work and the quality of life of both users and patients.

Contact

pfm medical ag 
Ute Ebers 
Head of Corporate Communications 
Wankelstraße 60 
50996 Köln 
T +49 (0)2236 9641-370 
F +49 (0)2236 9641-99-370 
ute.ebers[at]pfmmedical[dot]com

TiLOOP® Total 6