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TVT case series – 3 or more years follow-up

StudyStudy type and ELNo. patientsPatient characteristicsInterventionLength of follow-upOutcome measuresEffect sizeAdditional comments
Debodinance 2002807Case series
EL = 3
256F mean age 57 years (29–96) with stress UI (21% mixed)
10% had prior continence surgery
25% also underwent prolapse surgery
TVT under SA
and GA
3 months, 1, 2 and 3 yearsObjective data (all patients)At 3 months (n = 251)
90% cure
8% improved
2% failed
1 year (60%)
91% cure
1% improved
1% failed
6.4% recurrent
At 2 years (27%)
83% cure
0% improved
10% failed
7.2% recurrent (global 14%)
At 3 years (6%)
87% cure
0% improved
13% failed
13% global recurrent
Funding: none declared.
Setting: France.
Objective criteria data:
Cure = completely dry during stress.
Improved = occasional leakage.
Failed = leakage unchanged or worse.
Data available from:
251 women at 3 months
154 women at 1 year
69 women at 2 years
15 women at 3 years.
Objective data (mixed UI group [21%])At 3 months (n = 52)
75% cure
17% improved
8% failed
1 year (52%)
85% cure
4% improved
4% failed
7.4% recurrent
At 2 years (29%)
60% cure
0% improved
20% failed
33% recurrent (global 14%)
Intra- and post-op complications6% bladder perforation
Short-term:
1% haematomas
3% UTI
0.4% urethral wound
0.4% ureteral fistula
13% transient urinary
etention
0.4% acute renal failure
Long-term:
16% urinary urgency
12% de novo urgency
26% objective dysuria
23% subjective dysuria
20% de novo dysuria
0 defective healing
0 tape rejection
Satisfaction with
TVT
64% very satisfied
31% satisfied
3% not satisfied
2% disappointed
Bunyavejchevin 2005808Case series
EL = 3
63F mean age 52 (35–71), UD stress UI
None had previous surgery
33 had genital prolapse
50 menopausal
Mean parity: 3.8 (1–4)
TVT under SA and CS3 yearsObjective data95% cure
5% improved
10% failed
Funding: none declared.
Setting: Thailand.
CS = conscious sedation.
Objective criteria:
Cure = no incontinence on stress provocation, no urinary retention/residual urine > 150 ml.
Improved = no incontinence on stress provocation.
Failed = none of the above.
Intra- and post-op complications3% bladder injury
1.6% urinary retention
5% de novo DO
Operative careMean operation time 32.2 ± 10 min
Mean hospital stay 1.5 ± 2.0 days
Rezapour 2001747–749Case series
EL = 3
Prospective
163A) F with recurrent UD stress UI (n = 34)
Mean age: 58.9 ± 10 years
Mean parity: 2 (0–4)
33% had < 2 previous operations, 10% had < 5 previous operations (16 Burch colposuspension,
7 MMK , 10 paraurethral bulking injections, 7 anterior repairs, 11 different sling procedures)
TVT
via sagittal suburethral vaginal incision under LA
Tape not fixed
4 years
(range 3–5)
Objective cure/ improvement (group A )82% cure**
9% Improved
9% failed (1 had 2 previous failed colposuspensions)
Funding: none declared.
Setting: Sweden.
TVT performed by experienced urogynaecologists.
Cure if urinary leakage < 10 g/24 h pad test, if no leakage during a cough test, if patient satisfaction > 90% according to ‘QOL’ evaluation. ‘Improved’ = if did not leak on cough provocation and had a QOL improved > 75% < 90%.
‘Failed’ = did not meet the above criteria.
QOL reported to be assessed but not stated how.
Routine post-op ultrasonography.
*5 in women > 70 years with a urethral pressure of < 10 cmH2O and an immobile urethra).
**overall cure rate 81%.
Post-op complications (group A )3% uneventful bladder perforation (previously undergone MMK 3 times before TVT)
41% prophylactic suprapubic bladder drainage (previously experienced post-op voiding difficulties after incontinence operations)
Operative care (group A )Mean hospital stay
4 days (range 1–6)
B) F with ISD (MUCP < 20), n = 49.
Mean age: 66.1 ± 11 years
Mean parity: 2 (0–5)
(8 with immobile urethra; no cystocele or rectocele diagnosed)
All postmenopausal women were treated with systemic or local oestrogen therapy for 3 months before TVT
Objective cure/ improvement (group B)74% cure**
12% improved
14% failed*
Post-op complications (group B)2% uneventful bladder perforation
10% haematoma
22% temporary voiding problems
Operative care (group B)Mean operation time 35 ± 12 min
Hospital stay 1 day
C) Women with mixed UI (n = 80)
Mean age: 59.2 ± 11 years
Mean parity: 2 (0–4)
(Urge component: premature voiding reflex or urethral relaxation)
49 postmenopausal women were treated with systemic or local oestrogen therapy
Objective cure/ improvement (group C)85% cure**
4% improved
11% failed
Urgency without incontinence (group C)20 (25% of ‘cure’ or ‘improved’ women)
Post-op complications (group C)1.3% bladder perforation
18% voiding problems
8% haematoma (1 laparotomy performed to exclude vessel injury – patient was on anti-coagulant therapy)
Tsivan 2004809Case series
EL = 3
retrospective
55F mean age 63 years (37–83), with UD stress UI
76% had concomitant procedures (hysterectomy, colporrhaphy, vaginal vault suspension)
TVT under SA (67%) and GA (33%)Mean time 55 months (48- 65)Subjective cure79%Funding: none declared.
Setting: Israel.
Operations by experienced surgeons well trained in vaginal surgery.
3 loss to follow-up.
Criteria for ‘success’ = complete continence and freedom from pad protection.
Post-op complications6% bladder perforations
2% urethral injury
2% UTI
36% short-term voiding difficulties
12% de novo urgency
4% vaginal erosion
2% bladder erosion
4% obstructed urethra requiring urethrolysis
Operative careMean operation time 28 min
Post-op hospital stay 2.7 days (1–8)
Glavind 2004745Case series
EL = 3
84 (81% responded to queationnaire)Women with SUI
Pre-op:
79% sexually active
26 (49%) had incontinence during intercourse
1 stated incontinence as reason for not being sexually active
TVT or IVSWithin a period of 4.5 yearsPost-op sexual function19 cure of incontinence during intercourse: 10/19 (50%) had an improved sexual life
7% reduced libido
0 de novo incontinence during intercourse
Funding: none declared.
Setting: Denmark.
Subjective criteria assessed by retrospective questionnaire.
Ulmsten 1999734
10 of these patients included in Ulmsten 1998735 series
Case series
EL = 3
50F mean age 57 (SD 11) years, UD stress UI
None had prior continence surgery
All postmenopausal women were taking systemic or local oestrogen therapy
Exclusions: Urge UI, prolapse
TVT under LA3 yearsSubjective and objective data combined86% cure
12% improved
2% failed
Funding: none declared.
cure = negative pad-test ( < 10 g/24 h); no incontinence on stress provocation test, and patient satisfaction > 90% according to QOL evaluation (VAS); no voiding problems (PVR > 100 ml).
‘Significantly improved’ = no incontinence on stress provocation; had a QOL improved > 75% < 90%; no post-op urinary retention/ urge incontinence.
‘Failed’ = did not meet the above criteria.
Post-op complications4% women needed repeated catheterisation 2–3 days
6% women needed indwelling catheter for up to 12 days
0 severe bleeding ( > 300 ml)
0 PVR > 100 ml
0 defective healing
0 tape rejection
Operative careMean operation time 29 min (range 16–47)
Olsson 1999 952Case series
EL = 3
51F mean age: 53 years (34–80), UD stress UI
Mean parity: 2 (0–5)
28 post menopausal using HRT or local oestrogen
25% previous pelvic surgery
20% also underwent prolapse repair
TVT under LA3 yearsObjective and subjective data combined90% cure
6% improved
4% failed
Funding: none declared.
Subjective cure ≥ 90% improvement QOL (VAS); sig. improvement = between 70–90% improvement in QOL and no UI on stress test, and ‘sig.’ reduction in leakage on 24 h pad.
Objective cure: < 10 g/24 h pad test, negative stress test on coughing.
Post-op complications2% bladder perforation
8% temporary urge symptoms
2% healing defect of vaginal wall
2% cystitis
2% recurrent cystitis
0 severe bleeding ( > 300 ml), PVR > 100 ml, or defective healing or tape rejection
Operative careMean operation: 45 min (20–60)
Mean sick leave: 21 days (7–30)
Mean hospital stay 2 days
Nilsson 2001810
5 year follow-up of Ulmsten 1998735
Case series
EL = 3
90
prospective

median age at follow-up: 57 years (40–91)
28% also had symptoms of urgency
TVT under LAmedian time 56 months (48–70)Objective and subjective data combined85% cure
11% improved
5% failed
Funding: None declared.
Setting: Sweden.
TVT performed by experienced urogynaecologists.
Objective and subjective criteria:
Cure = negative 24 h pad test, cough stress test, QOL improved ≥ 90%.
Improved = > 50% reduction in pad test, < 15 g loss.
Failed = did not meet the above criteria.
5 gave subjective data only.
Post-op complications3% retropubic haematoma
1% bladder perforation
3% intra-operative bleeding of > 200 ml
4% initial post-op voiding difficulty
7% UTI
1% wound infection
1% recurrent UTI
5% de novo urge symptoms
0 tape rejection
56% of women with pre-op urge symptoms were relieved of them post-op
Operative careMean operation time 30 min (15–55)
Post-op hospital stay 2 days (1–5)
Nilsson 2004811
7 year follow-up of Ulmsten 1998735
Case series
EL = 3
Prospective
90 (71% fully evaluated
prospective

median age at follow-up: 60 years (42–94)
TVT under LAMean time 91.1 months (7.6 years)
(78–100)
Objective and subjective data combined81% cure
(84% negative pad test, 95% negative stress test)
Funding: None declared.
Setting: Sweden.
Objective criteria:
24 h pad test, cough stress test, 2 day voiding diary.
Subjective criteria
QOL by VAS.
Questionnaire on ‘cure’ data.
10 lost to follow-up.
16 gave subjective data only.
Medical status of 18 urge symptoms:
4 diabetes
4 cardiovascular disease
3 asthma
1 bladder cancer
1 anal incontinence
5 de novo urge unrelated to any disease.
Subjective data81% cure
16% improved
3% failed
Change in continence status since 5 year follow-up:
87.5% unchanged
5% improved
7.5% worse
84% claiming dry on stress
84% VAS score < 10 (on 0–100 scale)
Post TVT complications23% urge symptoms
8% asymptomatic pelvic prolapse
8% UTI
6%) de novo urge symptoms
0 voiding difficulty or tape rejection
Holmgren 2005812Case series
EL = 3
692Women with stress or mixed UI
SUI (n = 580 [84%])
Mean age: 61 years, mean parity:2.4. BMI: 27; 55% oestrogen treatment.
6% prolapse surgery, 2% radiation for gynae cancer, 9% chronic bronchitis, 22% recurrent UTI, 5% chronic constipation
MUI (n = 112 [16%]); mean age: 67 years, mean parity:2.3, BMI: 30; 69% oestrogen treatment
10% prolapse surgery, 5% radiation for gynae cancer, 10% chronic bronchitis, 26% recurrent UTI, 11% chronic constipation
TVT under LA2–8 years
Stress UI:
16% with 2 years follow-up, 20% with 3, 19% with 4, 18% with 5, 27% with 6–8 years
Mixed UI:
26% with 2 years follow-up, 29% with 3, 19% with 4, 15% with 5, 12% with 6–8 years
Subjective dataSUI group:
80–90% ‘cure’ and ‘almost cure’ from 2–8 years
8.2% nocturnal incontinence
MUI group:
60% ‘cure’ up to 3 years
30% ‘cure’ at 6–8 years (P = 0.02)
27.3% nocturnal incontinence
Funding: none declared.
Setting: Sweden.
Operated by 10 surgeons.
Questionnaire (unspecified) on SUI and urgency incontinence.
Pre- and post-op complicationsSUI group (n = 580):
3% intra-op complications
9% post-op complications
24.5 ml post-op residual urine
0.9 day hospital care
16 days sick leave
9% subsequent tape correction
MUI group (n = 112):
2% intra-op complications
4% post-op complications
20 ml post-op residual urine
1 day hospital care
14 days sick leave
3.6% subsequent tape correction
Cure rates according to no. of TVT procedures performed by surgeons250 TVT performed: 87% cure
103 TVT: 79% cure
81 TVT: 85% cure
57 TVT: 86% cure
40 TVT: 85% cure
18 TVT: 72% cure
15 TVT: 87% cure
11 TVT: 91% cure

From: Evidence tables for included studies

Cover of Urinary Incontinence
Urinary Incontinence: The Management of Urinary Incontinence in Women.
NICE Clinical Guidelines, No. 40.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2006 Oct.
Copyright © 2006, National Collaborating Centre for Women’s and Children’s Health.

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