Ward 2002.

Methods	RCT of TVT versus Burch colposuspension ITT analysis (non‐attenders as failures)
Participants	Women who had completed their family who presented with USI unresponsive to pelvic floor muscle training were included. Excluded were those with detrusor overactivity, vaginal prolapse requiring treatment, previous surgery for prolapse or incontinence, a major degree of voiding dysfunction (defined at cystometry as a voiding pressure > 50 cm H20, maximum flow < 15 ml/s, and residual urine volume > 100 ml), neurological disease, and allergy to local anaesthetic. Urodynamic evaluation was performed. Patients were asked to complete a urinary diary for one week, and a 1‐hour perineal pad test was performed according to the recommendations of the International Continence Society. Patients' perceptions of changes in their symptoms and treatment outcome were measured with the generic SF­36 and the disease‐specific Bristol Female Lower Urinary Tract Symptoms (B‐FLUTS) questionnaire. Six weeks after surgery a postal questionnaire was sent out comprising the SF­36 and questions about recovery. Six months after surgery reassessment was undertaken with symptom review, clinical examination, the one‐hour pad test, and urodynamic studies. Other assessments were performed at 1 year, 2 years and 5 years after surgery.
Interventions	Group 1: TVT (N = 170) Group 2: Colposuspension (N = 146)
Outcomes	The primary outcome measure was objective cure of stress incontinence defined as a negative stress test on urodynamic testing and a negative one‐hour pad test (< 1 g change in weight). Secondary outcome measures included subjective cure of incontinence and the development of voiding problems, urge symptoms, and vaginal prolapse. These were measured with the B‐FLUTS questionnaire and by interview with patients
Notes	344 women were randomised. Five from TVT and 23 from colposuspension did not receive allocated treatment because of withdrawn consent, declined surgery, ineligibility for trial. At 6 months 2 women withdrew and 1 was lost to follow up from the TVT group and 1 withdrew and 8 lost to follow up from the colposuspension group. (The baseline characteristics of the patients who withdrew before surgery were similar to the participants, with the exception of a lower change in pad weight in the colposuspension group) Complete data was available in 152 and 127 women from TVT and colposuspension groups respectively at 6‐months' follow‐up Complete data was available in 125 and 101 respectively at 2‐years' follow‐up Complete data was available in 72 and 49 respectively at 5‐years' follow‐up
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"randomization was computer‐generated using randomly varying block sizes of 4 and 6"
Allocation concealment (selection bias)	Low risk	"via a telephone system which allocated trial identification number and treatment group"
Blinding (performance bias and detection bias) All outcomes	High risk	"not possible to blind patients or investigators"
Blinding of participants and personnel (performance bias) All outcomes	High risk	"not possible to blind patients or investigators"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	not mentioned
Incomplete outcome data (attrition bias) All outcomes	Low risk	more patients in the colposuspension group did not receive treatment as allocated (23 versus 5), more patients lost to follow‐up in colposuspension group; however results reported and analysed by intention to treat
Other bias	Unclear risk	no other bias identified

BMI = body mass index; CLPP + cough leak point pressure; DI = detrusor instability; Excl = exclusion criteria; FUL = functional urethral length; GSI = genuine stress incontinence; GUTSS = Genito‐urinary Treatment Satisfaction Scale; Gyne = gynaecology; Incl = inclusion criteria; ISD = intrinsic sphincter deficiency; ITT = intention to treat; MCC = maximum cystometric capacity; MMK = Marshall‐Marchetti‐Krantz; MUCP = maximum urethral closing pressure; Ob&Gyne = obstetrics and gynaecology; PFMT = pelvic floor muscle training; POP = pelvic organ prolapse; PTR = pressure transmission ratio; PVR = post‐void residual volume;Qmax = maximum urine flow, SIIQ = Short Incontinence Impact Questionnaire; SUDI = Short Urinary Distress Inventory; RCT = randomised controlled trial; RU = residual urine; TOT = transobturator tape procedure; TVT = tension‐free vaginal tape; UDS = urodynamic; SUI = stress urinary incontinence; UI = urinary incontinence; UTI = urinary tract infection; VAS = visual analogue score; lap = laparoscopic; VLPP = Valsalva leak point pressure