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. 2017 Jul 31;2017(7):CD006375. doi: 10.1002/14651858.CD006375.pub4

Okulu 2013.

Methods RCT of Vypro mesh (Ethicon, USA) vs Ultrapro mesh (Ethicon) vs Prolene light mesh (condensed monofilament non‐absorbable polypropylene)
Participants 144 women with SUI in Turkey
Inclusion criteria: previous incontinence surgery or hysterectomy; SUI or USI; positive stress test
Exclusion criteria: urodynamically MUI and DO; ≥ 100 ml PVR; contraindication to anaesthesia; POP; pregnancy; neurogenic bladder; bladder outlet obstructions; urinary fistula; or active urinary or vaginal infection
Mean age (years; SD): Group A: 50.06 (9.2); Group B: 50.9 (8.8); Group C: 48.1 (7.9)
Mean BMI kg/m² (SD): Group A: 27.8 (3.4); Group B: 27.9 (4.1); Group C: 27.7 (2.9)
Post menopausal: Group A: 10/48; Group B: 11/48; Group C: 8/48
Previous incontinence surgery: Group A: 4/48; Group B: 5/48; Group C:4/48
Interventions Group A: Vypro mesh: (n = 48; multifilament)
Group B: Ultrapro mesh: (n = 48; monofilament + biological combined mesh)
Group C: Prolene light mesh: (n = 48; monofilament)
Outcomes Primary outcome: urinary continence rates at 4‐year follow‐up
Secondary outcomes assessed at 4‐year follow‐up:

  • urinary retention

  • suture granuloma rates at 4 years.

  • cure defined as no need for pad use or pad weight of < 2g on 24‐hr pad test

    • Subjective cure at 12 months

    • Subjective cure at 48 months

  • bladder perforation

  • major vascular visceral injury

  • de novo urgency

  • tape erosion

  • mean 24hr pad weight at 12 months and 48 months

  • QOL: ICIQ‐SF questionnaire at pre‐op, 12 months follow up and 48 months follow up.
Notes Follow‐up at 6, 12, 24 and 48 months
Loss to follow‐up Group A: 2/48; Group B: 0/48; Group C: 1/48
QoL and incontinence was evaluated with the ICIQ‐SF
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “The patients and the mesh materials were randomised
1:1:1 to each group in blocks of three via a centralized computerized system to ensure a good balance of participant characteristics in each group."
Allocation concealment (selection bias) Low risk Quote: “via a centralized computerized system to ensure a good balance of participant characteristics in each group”
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No information