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.