Colposuspension vs synthetic slings

StudyStudy type and ELNo. of patientsPatient characteristicsInterventionComparisonLength of follow-upOutcome measuresEffect sizeAdditional comments
Ward 2002659
2 year follow-up660
RCT
EL = 1++
344 randomised; 316 (92%) received tx as randomisedF mean age 50 years (42–59) who had completed their family; UD stress UI
Exclusions: DO, vaginal prolapse requiring tx; prior continence or prolapse surgery, major voiding dysfunction (voiding pressure > 50 cmH2O, PVR > 100 ml), neurological disease*
Tension-free vaginal tape (n = 175; 170 [97%] received tx as allocated, 167 [95%] followed up at 6 months; 78% at 2 years)Open colposuspension (n = 169; 146 [86%] received tx as allocated, 137 [81%] followed up at 6 months; 64% at 2 years)6 months659 and 2 years660Objective cure ( neg stress test on UD and < 1 g change in weight on 1 h pad test) at 6 months66% vs 57%; (95% CI for difference −4.7%, +21.3%)
(81% vs 67% neg stress test
73% vs 64% neg pad test)
Funding: Ethicon ltd.
14 centres (gynae or urology, uni teaching or DGHs).
target 436 pts for power calculation.
tape under LA and sedation (96%), colpo according to standard procedure of units (99% under GA). All investigators underwent training for tape insertion at a recognised centre.
*5 who had surgery violated protocol (4 DO, 1 voiding dysfunction); were included in analysis.
Baseline characteristics of pts who withdrew same as others, except for smaller reduction in pad weight for withdrawals vs those undergoing surgery.
LOCF = last observation carried forward.
Objective cure ( < 1 g on 1 h pad test) at 2 years81% vs 80% (OR 1.67, 95% CI 0.59 to 2.06) [completers analysed]
with assumptions for withdrawals:
OR 1.67 (1.09, 2.58) if all failures, P = 0.02
OR 0.86 (0.47, 1.58) if all cured
OR 1.64 (1.01, 2.65) with LOCF
OR 0.93 (0.54, 1.60) with LOCF and if presurgery withdrawals cured
(best and worst case cure rates for both arms 63–85% TVT, 51–87% colposuspension)
6 months659Symptoms (bladder diary)No sig. difference between grps in changes in leakage episodes, frequency, voided volume
6 months659 and 2 years6601 h pad testNo sig. difference between grps in reduction in pad weight at 6 months or 2 years
6 months659 and 2 years660QOLBFLUTS (6 months and 2 years):
sig. improvement in both grps in 21/30 questions (13/20 urinary, 6/6 lifestyle, 2/4 sexual)
SF-36:
less improvement in colposuspension grp in 4/8 domains (emotional role, social functioning, mental health, energy/vitality) at 6 months; still true for role emotional and mental health at 2 years
6 months659Time to return to (median, IQR)To normal activities 3 (2–4) vs 6 (4–8) weeks P < 0.001
To work 4 (3–7) vs 10 (8–12) weeks P < 0.001
6 months659Satisfaction85% vs 82% satisfied or very satisfied
4% vs 3% dissatisfied
84% vs 82% would recommend to friend
6 months659UDNo sig. difference between grps in changes in cystometry or UPP variables
6 months659Hospital parametersTheatre time (median, IQR, mins):
anaesthetic room 15 (10–50) vs 17 (14–25), P < 0.001
operating theatre 40 (30–48) vs 50 (35–60), P < 0.001
recovery area 41 (31–60) vs 85 (65–115), P < 0.001
Duration catheterisation:
38% vs 100% 1–7 days
5% vs 33% 8–28 days, P < 0.001
3% vs 13% 29 days to 6 months, P < 0.001
> 6 months 2% vs 8%, P = NS
Median hospital stay:
1 (1–2) vs 5 (5–7) days, P < 0.001
6 months659 and 2 years660Post-op complications, up to 6 months659 (all P = NS unless otherwise stated)39 vs 44.5% total
22% vs 32% UTI (in 6 weeks postop)
9% vs 2% bladder injury (perforation/trauma) P = 0.013
3% vs 0% vaginal perforation
2% vs 7% wound infection
1% vs 5% fever, P = 0.027
0% vs 2% DVT
N/A vs 2% incisional hernia
2% vs 0% retropubic haematoma
1% vs 0% vascular injury
1 vs N/A tape erosion
Complications and further procedures occurring between 6 months and 2 years (P = NS unless otherwise stated)5.9 vs 2.1% symptoms of recurrent UTI
voiding disorder requiring ISC 0 vs 2.7%, P = 0.0045
1.8 vs 3.4% surgery for UD SUI
0 vs 4.8% surgery for uterovaginal prolapse, P = 0.0042
n/a vs 3% incisional hernia repair
2% vs n/a division or trimming of tape
5% vs 3% □rethra□n
2% vs 0% urethral dilatation
0.6% (n = 1) vs 0 caesarean section
2 vs 0.7% abdominal hysterectomy
Liapis 2002661RCT (quasi randomisation)
EL = 1−
71F mean age ~47 years (32–64), UD stress UI with competent intrinsic urethral sphincter
Exclusions: greater than first degree prolapse, prior surgery for SUI, DO
Tension-free vaginal tape (n = 35)Open Burch colposuspension (n = 36)2 yearsObjective cure/ improvement*Cure 84% vs 86%
Improvement 7% vs 6%, P = NS
Funding: none declared.
Surgeon blinded.
[EL = 1−] procedures done alternately (= not true randomisation). Baseline data (age, parity, weight) shows no difference between grps.
*cure = pad weight difference < 1 g on 1 h test; improvement ≥ 50% reduction in leakage.
Hospital parametersDuration of procedure (range, mins) 16–25 vs 46–70, P < 0.01
Hospital stay (mean, days) 2.1 vs 5.7, P < 0.05
Return to normal activity 10 vs 21 days (Mean), P < 0.05
Complications11% vs 0% bladder perforation
14% vs 6% UTI
17% vs 14% DO
6% vs 3% sensory urgency
0% vs 6% haematoma
0% vs 9% retention
0% vs 11% pain at incision site
Wang 2003662RCT
EL = 1+
98 randomised (90 analysed)F mean age 52 (34–73) years, UD stress UI without POP
Exclusions: bladder outlet obstruction, prior continence surgery
Tension-free vaginal tape
(n = 49)
Modified Burch colposuspension
(n = 49; 41 analysed*)
Median 22 months (12–36)Objective cure/ improvement (cure: ≤ 2 g on 1 h pad; improvement > 50% reduction; failure > 2 g)Cure 82% vs 76%
Improvement 8% vs 12%
Failure 10% vs 12% (P = NS all comparisons)
Funding: none declared.
Fewer analysed than randomised in Burch grp; *all pts who withdrew moved abroad.
Tape procedure under LA; modified Burch under regional anaesthesia.
90 pts required for power calculation; this based on obstructive outcomes, not cure.
Subjective cure: no urine loss during physical exercise; improvement > 50% reduction in leakage; failure: reduction of < 50%.
Voiding also reported on Blaivas-Groutz nomogram as a measure of obstruction.
Subjective success (cure or improvement)92% vs 93% P = NS
Complications‘no sig. complications’ with either procedure; no further details given
El-Barky 2005663RCT
EL = 1−
50F mean age 50 years (SD 14) with UD stress UI
Exclusions: high grade cystocele, prior surgical failure for SUI, uninhibited detrusor contraction during bladder filling on urodynamic study and incompetent internal sphincters
Burch colposuspension (n = 25)TVT (n = 25)At least 2 years but results given at 3–6 monthsSubjective assessment of continence status (at 3–6 months)72% vs 72% ‘completely’ cured
16% vs 20% improved (had occasional UI)
12% vs 8% no improvement, P = NS for all
Funding: none declared.
[EL = 1−] No details of randomisation, whether ITT done, nor whether groups balanced at baseline in parameters other than age, parity, and duration of symptoms.
Operative careMean operating time 57 vs 20 min
Mean hospital stay 6.2 vs 3.1 days
Return to normal activity 21 vs 10 days
Complications0% vs 8% bladder perforation
12% vs 20% retention
12% vs 8% de novo urgency
12% vs 20% UTI
8% vs 0% wound infection
Bai 2005658RCT
EL = 1+
92F mean age 56–58 (SD ~3) years, UD stress UI, of Stamey grade 1 or 2
Exclusions: DO, UTI, ISD, POP > grade 2
Burch colposuspension (n = 33),Tension-free vaginal tape (n = 31)
Pubovaginal sling using autologous rectus muscle fascia (n = 28)
12 monthsCure (symptom-free and negative stress test)88 vs 87% vs 93%
P < 0.05 for sling vs Burch or TVT
Funding: none declared.
One surgeon performed all the procedures.
Some % cure rates in text differ from those in tables (at 3 months).
Complications9% vs 0 vs 0 de novo DO
3% hesitancy (difficulty initiating voiding)
0 vs 13% vs 7% urinary retention
Valpas 2004664 and 2003665 for complicationsRCT
EL = 1+
128 randomised (121 operated on)*F age 29–68 (means 50 and 48) UD stress UI recruited from gynaecological outpatient clinics
Exclusions: age > 70, prior continence surgery (except colporrhaphy), > 3 UTIs in past 3 years, UCP < 20, PVR < 100 ml
Polypropylene (tension-free vaginal tape)
n = 70
Lap mesh colposuspension
n = 51
12 monthsObjective cureNegative stress test:
86% vs 57%, (95% CI for difference 12.7 to 43.9), P = 0.000
Negative 48 h pad test ( < 8 g/24 h):
73% vs 59% (−2.8, +30.4) < P = NS
Funding: none declared.
Recruited fewer pts than required by power calculation (176).
Tape procedure under LA; lap suspension under GA, by senior gynaecologist who had performed ≥ 20 of each procedure.
*7 withdrawals: 4 refused surgery, 2 refused results of randomisation, 1 treated outside study centres. Of 121 treated, 6 lost to follow-up or withdrew (4 vs 2).
Severity scores at 12 monthsUISS (0–20): 1.1 vs 2.7, P = 0.02
VAS (1–10): 0.9 vs 2.2 P = 0.000
KHQ at 12 monthsNo sig. difference in general health perception, or sleep/energy
Sig. lower scores in TVT grp for incontinence impact, role/physical/social limitations, personal relationships, emotions, severity measures
Satisfaction (whether met pts expectations)totally 83% vs 59%
partially 11% vs 28%
not at all 0% vs 6%, P = 0.001 between grps
Hospital parameters665Operating time 29 (14–153) vs 47 (19–120) mins, P < 0.001
theatre time 60 (35–183) vs 91 (50–190) mins, P < 0.001
Complications6651% vs 2% (both n = 1) bladder perforation
3% vs 4% prolonged retention
0% vs 2% port site infection
1% vs 2% wound infection
0% vs 1% haematoma
4% vs 2% UTI
3% vs 0% urge symptoms
0% vs 4% other pain
Paraiso 2004666RCT
EL = 1+
72 randomised (71 treated as randomised)*
n = 63 (88%) at 1 year, 33 (46%) at 2 years
F mean age ~54 years (38–80), UD stress UI
No prior continence surgery, no DO on UD, no anterior vaginal wall prolapse to or beyond hymen.
47% vs 25% prior hysterectomy, 6% vs 3% prior anticholinergic tx
Tension-free vaginal tape
n = 36
Lap Burch colposuspension
n = 35
Mean 21 (SD 8), median 18 months, range 12–43 monthsLeakage episodes (mean)1 year: 1.8 vs 0.4, P = NS
2 years: 0 vs 0.3, P = NS
Funding: none declared.
Trial stopped early because of slow recruitment and lack of funding (recruited fewer pts than required by power calculation, n = 130).
Tape procedure under LA, GA or spinal; lap suspension under GA
*6 withdrawals: 1 colpo grp refused surgery. Of those treated, 2 both grps lost to follow-up, 1 from tape grp died (unrelated to surgery).
32 vs 35 concomitant procedures were performed (mainly hysterectomy [9 vs 8]; sig. difference in lysis of adhesions, 11% vs 32%; others included colporrhaphy, adnexal surgery, tubal ligation, bladder biopsy
24% vs 36% taking anticholinergics after surgery
**costs also calculated
Actual values rather than % change reported because no baseline data given.
QOL (UDI, IIQ; mean scores)UDI: 1 year: 6 vs 4
2 years: 4 vs 4, P = NS
IIQ: 1 year: 49 vs 38
2 years 33 vs 47, P = NS
Urodynamics (n = 63; % with)SUI: 3% vs 19%, P = NS (hence objective cure: 97% vs 81%)
DO: 19% vs 6% (with UI 3% vs 0%), P = NS
Voiding dysfunction 15% vs 15%
Satisfaction scores (VAS 0–10)1 year: 8.5 vs 8.4, P = NS
2 years: 8.2 vs 9.0, P = NS
Hospital parametersTotal operating time 79 vs 132 min, P = 0.003**
ComplicationsIntraoperative:
Tape: 3% blood transfusion, 6% cystotomies
Colpo: 3% bowel injury (repaired), 9% converted to open surgery
Postoperative:
both groups, 3% haematoma, 3% pelvic abscess
Tape: 3% vaginal erosion of mesh, 6% transection for voiding
Colpo: 3% postop ileus, 3% PE, 3% pyelonephritis
Ustun 2003667RCT
EL = 1−
46F mean age ~46 years (SD 10–11), UD stress UI
17% in tape group vs 0 in colposuspension grp had prior continence surgery
Polypropylene (tension-free vaginal) tape
n = 23
Lap Burch colposuspension
n = 23
Range 3–24 months
Mean 11.3 tape; 13.5 lap colpo
Cure (subjectively dry, negative stress test, dry on UD)83% vs 83%Funding: none declared.
Tape procedure under LA, GA or spinal; lap suspension under GA.
[EL = 1−] No info on randomisation or allocation concealment, no description of methods of analysis. No attempt to adjust for differences in mean follow-up between grps.
UD (pre vs post-op)Sig. incr. in VLPP in both grps, P ≤ 0.02 vs baseline (126% vs 105%)
Sig. reduction in max. flow rate in TVT grp (13%, P = 0.01)
Hospital parametersOperating time (mean, mins): 31 vs 82 P = 0.001
Duration catheterisation (median, range): 1 (0–7), 3 (1–5), P = 0.03
Hospital stay (mean, days): 2 vs 3.4, P = 0.003
ComplicationsTotal: 22% vs 22%
Incomplete info: in TVT grp
2 (9%) retention
2 (9%) bladder lacerations
1 (4%) de novo DO
In laparoscopy grp:
2 (9%) conversions to laparotomy (1 bleeding, 1 bladder laceration)
Sand 2000668 (3 months follow-up)
Culligan 2003669 (longer- follow-up)
RCT
EL = 1+
37 randomised, 36 operated on (1 excluded owing to cardiac risk)F mean age ~60–61 years, UD stress UI, urethral hypermobility (MUCP ≤ 20 in sitting position) and low-pressure urethra.
41% sling vs 95% Burch group had DO (P = 0.01); mean PVR pre-op 12.3 vs 25.4 ml P = 0.03. 9 vs 7 (47% vs 41% had undergone a total of 8 vs 10 continence procedures)
Exclusions: significant anterior or apical pelvic support defects
Suburethral polytetrafluoroethylene sling* (n = 17)Burch colposuspension (n = 19)3 months and longer-term (n = 28): mean 72.6 months (33–116)Objective cure (no leak on cough/Valsalva on UD )100% vs 90% P = NS at 3 months
longer-term (n = 28): 100 vs 84.6%, P = NS
Funding: none declared.
*Gore-Tex soft tissue patch, running from rectus fascia into the retropubic space and beneath urethra at level of urethrovesical junction.
Op in association with other procedure in 12% vs 21%.
Subjective cure (no urine loss during activities that incr. intra-abdominal pressure)100% vs 95% P = NS at 3 months
Longer-term (n = 28): 84% vs 93%, P = NS
Hospital parametersMean stay 5.1 (1.2) vs 5 (1.4) days, P = NS
Time to catheter removal 23.3 (24) vs 13.8 (16) days, P = NS
Complications24% vs 5% de novo DO
100% vs 61% persisting DO (of those who had DO at baseline)
0% vs 5% cystotomy
Longer-term:
2 (12%) vs 0 partial sling erosion
1 (6%) vs 0 reqd urethrolysis owing to prolonged urinary retention

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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