ter Meulen 2009.

Methods	Prospective RCT
Participants	47 recruited, 45 women treated with stress incontinence caused by urethral hypermobility and non‐successful conservative treatment.
Interventions	MPQ injections versus pelvis floor muscle exercise and home‐training programme.
Outcomes	Follow‐up at 3 months for both groups and at 12 months for MPQ group. Pad test, number of pads used Frequency volume chart, Physician and patient cure self assessment
Notes	Repeat MPQ at 3 months if requested by patient or clinically indicated. Further follow‐up of this group at 3 and 12 months following repeat treatment. 5 years taken to recruit to study.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	High risk
Blinding (performance bias and detection bias) All outcomes	High risk
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Intention‐to‐treat with missing values are imputed by general mean substitution. 47 patients recruited 45 treated, 1 excluded due to not fulfilling inclusion criteria, 1 patient included twice.
Selective reporting (reporting bias)	High risk	12‐month follow‐up for one group only.
Other bias	Unclear risk	Study sponsored by uroplasty BV, makers of Macroplastique™ and Macroplastique™ implantation system.

ALP = alkaline phophatase; BMI = body mass index; GAX‐collagen = Glutaraldehyde cross‐linked collagen; GSI = genuine stress incontinence; HRT = Hormone Replacement Therapy; IIQ = Incontinence Impact Questionnaire; IQR = Inter Quartile Range; ISD = Intrinsic Sphincter Deficiency; PVR = postvoid residual; MPQ = Macroplastique™; QoL = quality of life; RCT = randomised controlled trial; SD = standard deviation; SUDI = Short Urinary Distress Inventory; SUI = Stress Urinary Incontinence; VAS = visual analogue scale.