Long-term study shows: continously more quality of life after cystocele repair with multi-armed mesh TiLOOP® Total 6

Most patients with genital prolapse suffer a significant reduction in their quality of life. For patients with a cystocele (bladder prolapse) for whom no other form of treatment helps quality of life can significantly be improved through a surgical procedure with a multi-armed mesh implant. This finding was the result of the 36-month data of a prospective, multicentre study conducted in 9 German hospitals (ClinicalTrials.gov NCT01084889).

This observational study was designed to assess in particular the impact of mesh-supported surgery in the anterior compartment on the patients' quality of life, as well as the anatomical success and the complication rate. 

A total of 289 patients at nine hospitals were treated with a titanized mesh implant (TiLOOP® Total 6) with distal, apical and lateral fixation for the vaginal cystocele repair. The patients all were diagnosed with at least a grade II cystocele or a grade I symptomatic cystocele according to the ICS Prolapse Quantification (POP-Q1). Primary as well as relapse treatment was allowed. The average age of the patients was 67 years (±8 years, 43-87). They had given birth to an average of 2,3 (±1,2) children.

Primary study objective among others was the quality of life after six months. Secondary study objectives were the adverse events after 6, 12 and 36 months, the quality of life after 12 and 36 months as well as the viability of the mesh implantation.

The patients were clinically examined (POP-Q-Klassifikation1) in accordance with the study protocol before the surgery and 6, 12 and 36 months after the surgery and asked about their quality of life with a validated questionnaire (P-QoL2). General perception of health, impairment as a result of the prolapse, role impairment, physical impairment, personal relationships including sexuality, emotions, sleep and other impairments were recorded. The data were recorded in an electronic database (electronic case report form, eCRF). A monitor checked the entire data collection. The adverse events reported during the study were reviewed and evaluated by an independent external "clinical event committee".

The most significant results after 36 months:

Improved quality of life & sexuality

The patients' quality of life improved significantly, even in the much discussed area of sexuality.

Improvement in quality of life

Positive improvement in quality of life due to the surgery increases further during the 36 months after surgery.
(Results from the validated P-QoL questionnaire.)

Positive effect on sexuality

The impairment of sexuality decreases in the 36 months following the surgery.
(Results from the validated P-QoL questionnaire in relation to partnership and sexuality.)

Anatomically excellent reconstruction

Mesh-supported prolapse surgery in the anterior compartment with TiLOOP® Total 6 provides very good anatomical results with a very low relapse rate in the anterior compartment (4,5 %; 12/269).4

Comparison of cystocele stages pre-OP vs. 36 months post-OP shows a clear tendency towards slighter indications.
(Results from documentation of anatomic results following the POP-Q-system.)

Decrease of urge-incontinence

Comparison of patient group with urge incontinence pre-surgery and 36 months post-surgery

Safe method

The number of intraoperative events demonstrates that the method is safe. The following events were recorded for the 289 procedures:3

  • Bladder lesion: 1.7 % (n=5)
  • Ureteral lesion: 0.3 % (n=1)
  • Rectal lesion: 0.7 % (n=2)
  • Diffuse bleeding: 0,3 % (n=1)

The low relapse rate (cystocele) of just 4,5 % (12/269) after 36 months also underlines this.4

Outlook

An observational study with 50 patients at five clinical centres was started in early 2016 (ClinicalTrials.gov NCT02690220). The new 3 mm mesh TiLOOP® PRO Plus Anterior is being used. Slings and introducers are still being applied the same way. The mesh shape is optimised. The study will assess whether or not an advantage can be gained by using the larger pores.

References

  1. POP-Q-Klassifkation: Pelvic Organ Prolapse Quantification System
  2. Prolapse Quality of Life Questionnaire (P-Qol)t: general perception of health, impairment as a result of the prolapse, role impairment, physical impairment, personal relationships including sexuality, emotions, sleep and other impairments
  3. J. Farthmann, M. Mengel, B. Henne, M. Grebe, D. Watermann, J. Kaufhold, M. Stehle, C. Fuenfgeld: Improvement of pelvic floor-related quality of life and sexual function after vaginal mesh implantation for cystocele: primary endpoint of a prospective multicentre trial. Arch Gynecol Obstet. 2016 Jul; 294(1):115-21. doi: 10.1007/s00404-016-4014-0. Epub 2016 Jan 18.  
  4. pfm medical ag, data on file, AbschlussberichtTiLOOP® Total 6-Studie (Clinical Investigational Report – Final Report)

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Dr. Christian Fünfgeld talks about cystocele repair.

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