Secondary outcomes
Overactive bladder symptoms: ICIQ-FLUTS
To investigate the effect of surgery on overactive bladder symptoms at
12 years, symptoms were reviewed using questions 3, 4 and 5 on the ICIQ
FLUTS. Nocturia and urinary urgency were the most frequently reported
symptoms. At 12 years, 24(43.6%) TVT and 27(49.1%) TOT participants
reported nocturia and 46(83.6%) TVT and 42(76.4%) TOT reported any
degree of urgency. There are no significant differences between the
groups. Despite the high incidences, the majority of patients did not
report significant bother: median urinary urgency bother (question 4b
ICIQ FLUTS) for the TVT participants was 2 out of 10, and 4 out of 10
for the TOT participants (this difference was not significant).
Urgency urinary incontinence (UUI) was on average the most bothersome
urinary symptom at 12 years on the ICIQ FLUTS (question 5b), with a
median bother of 3 out of 10 for TVT respondents and 4 out of 10 for TOT
respondents. In response to the ICIQ question 5a ‘does urine leak before
you can get to the toilet’, the responses “never” and “occasionally”
were analysed as a measure of non-bothersome UUI: 34(61.8%) TVT and
30(54.6%) TOT participants had non-bothersome UUI. Of the remaining TVT
participants, 13(23.6%) reported UUI “sometimes”, and 8(14.6%)
“most of the time”, while 17(30.9%) of the TOT participants reported
UUI “sometimes”, 4(7.3%)“most of the time” and 4(7.3%) “all of
the time”. There was no difference in the prevalence of UUI between the
TVT and TOT groups at 12 years (p-value 0.56). Overall there was a
reduction in UUI prevalence following the procedure: 39 out of 76
participants who had UUI pre-op had resolution of UUI at 12 years:(21
TVT and 18 TOT participants). Five TVT and 4 TOT participants had
de-novo UUI at 12 years (Figure 1).
Vaginal and groin pain: pain questionnaire
As a paired short versus long term analysis for groin and vaginal pain
was not performed, all 121 returned questionnaires were analysed: 63 TVT
and 58 TOT. The presence of groin and vaginal pain was assessed using
the numeric rating scale pain questionnaire. The majority of respondents
reported no groin or vaginal pain at 12 years follow up: 52(82.5%) of
the TVT group and 47(81%) of the TOT group reported no groin pain,
while 55(87.3%) of the TVT group and 50 (86.2%) of the TOT group
reported no vaginal pain. Severe groin pain was reported by 3 (4.8%) of
the TVT and 1(1.7%) of the TOT participants, while severe vaginal pain
was reported by 3(4.8%) of the TVT and 1(1.7%) of the TOT participants
(Table 2). One patient reported both having severe vaginal and groin
pain, thus the total number of patients with severe pain was 7(5.8%) of
the 121 study participants. Only one of these participants reporting
severe pain had a vaginal tape exposure requiring further surgical
intervention. Of the remaining 6 participants, 2 had urinary urgency,
one had recurrent urinary tract infections causing pain, and the other 3
had no further follow-up after the one-year review. The remainder of
participants reported either mild or moderate pain at 12 years. Of note,
there were no reports of ‘10/10’ pain severity on the pain scores. There
was no difference between the groups in terms of pain severity or
incidence of pain.
c. Patient reported complications
On the free text space provided for additional comments on the pain
questionnaire, 60.9% of TVT and 71.9% of TOT participants reported no
other problems or concerns related to the surgery at 12 years follow up.
Of the remining participants, the most commonly reported complication in
both groups was recurrent urinary tract infections: 17/62 (27.4%) TVT
and 11/58 (19%) TOT at 12 years. How many were bacteriologically proven
is unknown. Urinary retention was the least reported complication, with
only 4 TVT (6.5%) and 2 TOT (3.4%) participants reporting urinary
retention. Of these, 3 TVT and 1 TOT participants required intermittent
self-catheterisation and the other 2 resolved spontaneously. There was
no statistical difference between the groups.
Analysis of the additional comments offered by the patients revealed
that the majority of women were pleased with their procedure.
Forty-three participants provided free text comments: 19 were positive
comments from participants who were satisfied with their procedure and
had no complications, and 24 participants provided negative comments.
Satisfied comments included “the operation transformed my life enabling
(me) to do all the sports I love without worrying”, “I am extremely
happy with the outcome of this operation”, “it has changed my life for
the better”, “ thank you very much”.
Five of the 19 women who were initially happy with the procedure and
reported no complications, had observed a deterioration in efficacy of
surgery after approximately 8-10 years: “I was very pleased with the
initial result”, “improved things for a while”, “for the first 8-9
years it was excellent”; “until approximately 2 years ago it was
brilliant”.
The negative comments associated with the procedures were similar to
those reported in the Cumberledge inquiry e.g. chronic vaginal pain
precluding sexual intercourse, overactive bladder symptoms and urinary
hesitancy. These comments included: “intercourse can be a little
painful”, “sexual intercourse ceased following surgery because of
severe pain”, “husband a little frustrated by this situation”.
Negative comments associated with bladder symptoms include: “I have to
go to the toilet as soon as I realise”, “I wet the bed”, “very
irritable bladder”, “bladder not emptying properly”, “I have to
catheterise 4 times daily”.
Satisfaction with the surgery: PGI-I
All 121 returned PGI-I questionnaires were assessed as PGI-I is not
validated for comparison of change over time. Analysis revealed
51(79.7%) TVT and 44(77.2%) TOT participants reported their symptoms
were either “very much better”, “much better” or “a little
better” at 12 years. The difference in satisfaction between the TVT
and TOT groups at 12 years is not significant (p >0.05)
(Table 3). One (1.6%) participant in the TVT group and 9 (15.8%)
from the TOT group reported no change in their symptoms at long term
follow up. The remainder reported a dissatisfaction with the
procedure, reporting their symptoms as either “a little worse”,
“much worse” or “very much worse” at 12 years: 12(18.8%) of the
TVT and 4(7%) of the TOT groups. There was no statistical difference
between the groups.
Hospital records review
The hospital records of consented patients only (in keeping with UK
research governance regulations) were reviewed for additional
information. They were unavailable for 8 patients, therefore the 12 year
outcomes for 113 participants who consented to the follow up study were
reviewed. Analysis revealed 86 participants who required no further
urogynaecology input following the 1year assessment. Of the remaining 27
participants who returned to urogynaecology clinics following the
primary surgery, the most common presenting complaint was overactive
bladder symptoms: 13/27 (48%):7 TVT and 6 TOT participants. They were
managed with bladder retraining, anticholinergics or intravesical
botulinum toxin injections. Fifteen participants had recurrent urinary
tract infections (UTI’s). These were managed in the community by the
General Practitioners. Only 8 of the 15 with recurrent UTI’s were seen
in secondary care.
Vaginal and/or groin pain was noted in 6 participants. Only one of these
had reported severe pain on the pain questionnaire. This participant had
vaginal tape exposure post-TOT procedure, which was excised. She was
subsequently diagnosed with bladder transitional cell carcinoma (TCC).
She had no bladder tape extrusion (i.e. into the bladder), and the TCC
was associated with a clear cell carcinoma of the right kidney, for
which she required a laparoscopic nephrectomy.
The remaining 5 participants identified from the hospital record review
with pain, reported either mild or moderate pain on the pain
questionnaire. This was associated with vaginal tape exposure in 3
participants (2.5% of study population: all TVT procedures) and
required return to theatre for tape excision. Following this, resolution
of pain was noted in 2 participants. The other participant is currently
undergoing treatment for chronic groin, lumbar and hip pain. The final 2
patients with pain not related to tape exposure, had recurrent UTIs
which resolved following low dose antibiotic treatment and eradication
of the UTI.
Six patients (2 TVT and 4 TOT) had ongoing stress urinary incontinence
requiring further surgery. These were managed with repeat retropubic
tape procedures, Bulkamid™ urethral injections, autologous facial slings
or a combination of these.
Voiding dysfunction requiring intermittent self-catheterisation was
present in 4 participants (3 TVT, 1 TOT). One participant had no
complications or problems associated with the mesh but presented for
review due to anxiety following the media reports about transvaginal
mesh.