Study: NCT00803959

Adverse event: Bladder perforation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 18 affected / 315 at risk

Adverse event: Mesh complication: erosion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 315 at risk

Adverse event: Mesh complication: exposure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 315 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Recurrent UTI is defined as presumed UTI with treatment, 3 or more in one year after 6 weeks post surgery with no time limit for reporting.
Frequency: 3 affected / 315 at risk

Adverse event: Voiding dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 315 at risk

Adverse event: Other: Fascial Wound Dehiscence
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 315 at risk

Adverse event: Procedural haemorrhage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 315 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 315 at risk

Adverse event: Mesh complication: erosion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 315 at risk

Adverse event: Mesh complication: exposure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 315 at risk

Adverse event: Surgical site infection: superficial incisional
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 315 at risk

Adverse event: Surgical site infection: deep incisional
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 315 at risk

Adverse event: Culture proven UTI
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 315 at risk

Adverse event: Empiric UTI
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 315 at risk

Adverse event: Excessive granulation tissue
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 315 at risk

Adverse event: Voiding dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 315 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 9 affected / 315 at risk

Adverse event: Bladder perforation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 12 affected / 315 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 315 at risk

Adverse event: Mesh complication: exposure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 315 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Recurrent UTI is defined as presumed UTI with treatment, 3 or more in one year after 6 weeks post surgery with no time limit for reporting.
Frequency: 1 affected / 315 at risk

Adverse event: Excessive granulation tissue
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 315 at risk

Adverse event: Voiding dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 315 at risk

Adverse event: Other: Vaginal Perforation with sling
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 315 at risk

Adverse event: Other: episode of postoperative bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 315 at risk

Adverse event: Anaesthetic complication
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 315 at risk

Adverse event: Procedural haemorrhage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 315 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 315 at risk

Adverse event: Mesh complication: erosion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 315 at risk

Adverse event: Mesh complication: exposure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 315 at risk

Adverse event: Surgical site infection: superficial incisional
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 315 at risk

Adverse event: Surgical site infection: organ/space
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 315 at risk

Adverse event: Culture proven UTI
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 315 at risk

Adverse event: Empiric UTI
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 315 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 315 at risk

Adverse event: Excessive granulation tissue
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 315 at risk

Adverse event: Voiding dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 315 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 12 affected / 315 at risk