Zullo 2007.
| Methods | RCT comparing TVT and TVT‐O | |
| Participants | 72 women Inclusion criteria: women affected by SUI with no contraindications to vaginal surgery Excluded criteria: women with urogenital prolapse > stage 1; DO; symptoms of OAB; intrinsic urethral sphincter deficiency; urinary retention; previous anti‐incontinence surgery; neurologic bladder; and psychiatric disease Age (years; SD): Group A: 52.8 (11.8); Group B: 53.4 (10.7) BMI kg/m²: Group A: 25.7 (2.9); Group B: 26.5 (2.7) Menopausal: Group A: 6/35; Group B: 8/37 POP stage 1 and 2: Group A: 34/35; Group B: 35/37 |
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| Interventions | Group A: TVT (n = 35) Group B: TVT‐O (n = 37) |
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| Outcomes |
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| Notes | Intraoperative cystoscopy only performed in the TVT group 12 participants did not return for 5‐year follow‐up: 3 participants were lost (2 in the TVT group and 1 in the TVT‐O group), and 9 withdrew (4 in the TVT group and 5 in the TVT‐O group) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: " .. were randomly allocated to undergo a TVT or TVTO procedure by using a predetermined computer‐generated randomisation code" |
| Allocation concealment (selection bias) | Low risk | Allocation concealed |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | " ... outcome assessors at 5 years follow up blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No differential loss to follow‐up or differential attrition |
Abbreviations
BFLUTS: Bristol lower urinary tract symptoms questionnaires
BMI: body‐mass index
DO: detrusor overactivity
DUP: distal urethral polypropylene sling
EQOL‐5D: Euro Quality of life ‐5 Dimension
g: gram
hr: hour
HRT: hormone replacement therapy
ICIQ: International Consultation on Incontinence questionnaire
ICIQ‐FLUTS: International Consultation on Incontinence questionnaire ‐ female lower urinary tract symptoms
ICIQ‐ LUTSquol: International Consultation on Incontinence questionnaire ‐ lower urinary tract quality of life questionnaire
ICIQ‐SF: International Consultation on Incontinence questionnaire short form
ICIQ‐SF15: International Consultation on Incontinence questionnaire short form 15
IIQ: Incontinence Impact questionnaire
ICS: International Continence Society
I‐QoL: Incontinence Quality of Life questionnaire
ISD: intrinsic sphincter deficiency
IVS: intravaginal slingoplasty
KHQ: King's Health questionnaireMUI: mixed urinary incontinence
MUCP: Maximum urethral closure pressure
MUI: mixed urinary incontinence
OAB: overactive bladder
PGI‐I: Patient Global Impression of Improvment
PGI‐S: Patient Global Impression of Severity
PISQ‐12: pelvic organ prolapse/urinary incontinence sexual questionnaire
POP: pelvic organ prolapse
POP‐Q: pelvic organ prolapse quantification
POP‐Q ICS: pelvic organ prolapse quantification International Continence Society
PVR: post void residual
RCT: randomized controlled trial
RPR: retropubic route
QoL: quality of life
QRCT: quasi‐randomised trial
SEAPI‐QMM: Stress related leak, Empyting ability, Anatomy, Protection, Inhibition‐Quality of life, Mobility and Mental status incontinence classification system
SD: standard deviation
SIS: Single incision sling
SPARC: suprapubic arc (procedure)
SUI: stress urinary incontinence
TOR: transobturator
TOT: transobturator tape
TOT‐ARIS: transobturator tape‐ARIS
TVT: tension‐free vaginal tape
TVT‐O: transobturator tension‐free vaginal tape
UDI: Urinary Distress Impact questionnaire
UDI‐6: Urinary Distress Impact questionnaire short form
UDS: urodynamics study
UI: urinary incontinence
UISS: urinary incontinence severity score
USI: urodynamic stress incontinence
USS: ultrasound
UTI: urinary tract infection
UUI: urgency urinary incontinence
VAS: visual analogue scale
VLPP: Valsalval leak point pressure