Clinical and quality-of-life outcomes after autologous fascial sling and tension-free vaginal tape: a prospective randomized trial

Objective To compare the long‐term outcomes of a tension‐free vaginal tape (TVT; Gynecare™, Somerville, NJ, USA), autologous fascial sling (AFS) and xenograft sling (porcine dermis, Pelvicol™; Bard, Murray Hill, NJ, USA) in the management of female stress urinary incontinence (SUI). Patients and Methods A multicentre randomised controlled trial carried out in four UK centres from 2001 to 2006 involving 201 women requiring primary surgery for SUI. The women were randomly assigned to receive TVT, AFS or Pelvicol. The primary outcome was surgical success defined as ‘women reporting being completely ‘dry’ or ‘improved’ at the time of follow‐up’. The secondary outcomes included ‘completely dry’ rates, changes in the Bristol Female Lower Urinary Tract Symptoms (BFLUTS) and EuroQoL EQ‐5D questionnaire scores. Results In all, 162 (80.6%) women were available for follow‐up with a median (range) duration of 10 (6.6–12.6) years. ‘Success’ rates for TVT, AFS and Pelvicol were 73%, 75.4% and 58%, respectively. Comparing the 1‐ and 10‐year ‘success’ rates, there was deterioration from 93% to 73% (P < 0.05) in the TVT arm and 90% to 75.4% (P < 0.05) in the AFS arm; ‘dry’ rates were 31.7%, 50.8% and 15.7%, respectively. Overall, the ‘dry’ rates favoured AFS when compared with Pelvicol (P < 0.001) and TVT (P = 0.036). The re‐operation rate for persistent SUI was 3.2% (two patients) in the TVT arm, 13.1% (five) in the Pelvicol arm, while none of the patients in the AFS arm required further intervention. Conclusions Our study indicates there is not enough evidence to suggest a difference in long‐term success rates between AFS and TVT. However, there is some evidence that ‘dry’ rates for AFS may be more durable than TVT.

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“…Amaro et al. compared subjective cure rates between TVT and AFS at 12 months and reported no difference (65% vs 57%, P = 2.24). Morgan et al.…”

Section: Discussionmentioning

confidence: 99%

Long‐term follow‐up of a multicentre randomised controlled trial comparing tension‐free vaginal tape, xenograft and autologous fascial slings for the treatment of stress urinary incontinence in women

et al. 2014

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“…10 Amaro et al performed a randomized controlled trial comparing autologous fascia slings to synthetic mesh. 21 There was no difference in cure at 12 months (57 percent versus 65 percent), patient satisfaction, and quality of life. Sharifiaghdas and Mortazavi found similar findings in another randomized controlled trial comparing autologous fascia slings to synthetic slings.…”

Section: Plastic and Reconstructive Surgery • November Supplement 2012mentioning

confidence: 87%

“…In contrast, Bai et al found that autologous rectus fascia slings had a higher cure rate (93 percent) compared with retropubic colposuspensions (88 percent) and synthetic slings (87 percent) 23 (Table 2). [15][16][17][18][19][20][21][22][23][24][25] A recent meta-analysis concluded that traditional slings using a variety of materials (porcine dermis, dura mata, fascia lata, vaginal wall, autologous dermis, and rectus fascia) appear to be as effective as minimally invasive slings, but have higher rates of adverse events. 26 Patients with porcine dermal slings may be at an increased risk of urinary retention and reoperation because of variation in the host response to the biological material compared with the predictable response to polypropylene mesh.…”

Section: Plastic and Reconstructive Surgery • November Supplement 2012mentioning

confidence: 99%

The Use of Biological Materials in Urogynecologic Reconstruction

Yurteri-Kaplan

Gutman

2012

Plastic and Reconstructive Surgery

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There are numerous randomized controlled trials examining biological materials in urogynecologic surgery. For prolapse surgery, the addition of a biological graft adds no benefit compared with native tissue repairs for rectocele repair. Conflicting data exist regarding cystocele repair. Synthetic mesh repairs provide superior anatomical support for sacral colpopexy and cystocele repair compared with biologic grafts. However, biological and synthetic mesh slings have equivalent success rates for the treatment of stress urinary incontinence. Contrary to prior assumptions that biologic grafts add tissue strength without graft-related complications, there appears to be no benefit to the use of biological materials for prolapse and incontinence surgery.

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“…Because of the higher efficacy and lower morbidity [13] several autologous (e.g. rectus fascia, vaginal wall and fascia lata) and synthetic (prolene or mersilene) materials are used as suburethral slings for the treatment of SUI in women [7]. Since its production, TVT has been shown to be as effective as fascial slings [14].…”

Section: Discussionmentioning

confidence: 99%

“…Several autologous and synthetic materials are used as suburethral slings for treating SUI in women. The use of synthetic materials decreases the duration of surgery, avoids the harvesting process, and seems to have a similar outcome to that from the fascial sling [7]. Special indications for autologous grafts include patients with a history of poor vaginal healing, pelvic bone trauma, pelvic radiotherapy, or previous urethral reconstruction [8].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of transvaginal slings using different materials in the management of female stress urinary incontinence

Teleb

Salem

Naguib

et al. 2011

Arab Journal of Urology

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PurposeTo evaluate tailored polypropylene (prolene) mesh, anterior rectus sheath, and vaginal wall slings positioned under the mid-urethra, to treat stress urinary incontinence (SUI) in women, as SUI is a common pathological condition causing considerable distress and compromising social, physical, psychological, and sexual health, and for which surgical treatment remains controversial.Patients and methodsThis prospective randomised study included 32 patients with SUI, evaluated by SEAPI (Stress, Emptying, Anatomy, Protection, and Instability) symptom score and urodynamics. According to sling material, 12 patients had tailored prolene mesh, 12 had anterior rectus sheath and eight had anterior vaginal wall slings. Operative variables (intraoperative bleeding, duration, complications and hospital stay) were documented, and postoperative complications and continence status were assessed. The follow-up was 12–18 months.ResultsPatients who received tailored prolene mesh slings had a lower operative duration and hospital stay, and less intraoperative bleeding. Postoperative complications, e.g. urinary retention and urgency, were <12%, with no significant differences. There was no significant difference among the three studied groups in the success rate (75%, 67% and 75%).ConclusionsTailored prolene mesh, anterior rectus sheath and the vaginal wall sling are good alternatives to treat SUI in women, with comparable results in a short-term follow up. The surgeon’s experience and the patient’s clinical circumstances should be considered when choosing a sling material, as success rates are comparable, being slightly better for the prolene sling in operative duration, bleeding and hospital stay.

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Clinical and quality-of-life outcomes after autologous fascial sling and tension-free vaginal tape: a prospective randomized trial

Cited by 21 publications

References 16 publications

Long‐term follow‐up of a multicentre randomised controlled trial comparing tension‐free vaginal tape, xenograft and autologous fascial slings for the treatment of stress urinary incontinence in women

Long‐term follow‐up of a multicentre randomised controlled trial comparing tension‐free vaginal tape, xenograft and autologous fascial slings for the treatment of stress urinary incontinence in women

The Use of Biological Materials in Urogynecologic Reconstruction

Evaluation of transvaginal slings using different materials in the management of female stress urinary incontinence

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