Study Type – Therapy (case series)
Level of Evidence 4
Study Type – Therapy (case series)
To evaluate the long-term safety and efficacy of the tension-free vaginal tape (TVT) for the treatment of stress urinary incontinence (SUI) in women with neuropathic bladder dysfunction.
PATIENTS AND METHODS
Twelve women (mean age 53.3 years, range 41–80) with neuropathic bladder dysfunction and SUI confirmed by video-cystometrography (VCMG) were treated with a TVT in one institution by an expert neuro-urologist between November 1997 and December 2000. The patient’s notes, clinical annual follow-up and VCMG after the procedure, and the incontinence impact questionnaire (IIQ) forms (Urinary Distress Inventory, and IIQ-7) were assessed during the long-term clinical follow-up for SUI, in addition to a health-related quality of life assessment. The cure of SUI was defined as no loss of urine on physical exercise, confirmed VCMG after the procedure, and by clinical assessment.
The mean (range) follow-up was 10 (8.5–12) years. Nine patients were using clean intermittent self-catheterization before the insertion of TVT and continued to do so afterward. At 10 years of follow-up, one patient had died (with failed TVT initially), and two were lost to follow-up at 5 years after surgery, but up to 5 years they did not complain of UI and VCMG did not show SUI. The remaining seven of the nine patients were completely dry, and two improved and were satisfied with using one or two pads/day. Two patients showed neurogenic detrusor overactivity confirmed on VCMG, with no evidence of SUI. One patient needed a transient urethral catheter for urinary retention after surgery, one had a bladder injury that required leaving the catheter for 5 days, but no urethral erosions were reported during the follow-up.
In women with neuropathic bladder dysfunction secondary to a variety of spinal cord pathologies, and who have SUI necessitating a definitive intervention, insertion of TVT should be considered a desirable treatment, with very good long-term outcomes.
(stress) urinary incontinence
spinal cord injury
(neurogenic) detrusor overactivity
tension-free vaginal tape
clean intermittent self-catheterization
health-related quality of life
Urinary incontinence (UI) is a common and potentially devastating condition. The current evidence indicates that stress UI (SUI) affects 10–25% of the female population aged 15–64 years ; 37% of women aged >60 years have some form of UI . The incidence in patients with spinal cord injury (SCI) is unknown, but 10–20% of females in the general population are known to be affected .
Women with SCI and SUI have additional and unique problems compared to the general population. Specifically, neuropathic patients might have neurogenic detrusor overactivity (NDO) combined with detrusor sphincter dyssynergia in an upper motor neurone injury, or they might have an underactive bladder (UAB) with a weak urethral sphincter in a lower motor neurone injury. Also, the sphincter deficiency might be combined with urethral hypermobility .
Treatment of SUI in women has progressed rapidly over the last decade. Pharmacological therapy, periurethral injections, pubovaginal slings, insertion of an artificial urinary sphincter and retropubic colposuspension are well-recognized treatment options. Among these, pubovaginal slings and retropubic colposuspension procedures have proved to have adequate cure rates.
Pharmacological therapy with duloxetine, a relatively balanced serotonin and noradrenaline reuptake inhibitor, is effective, but the effectiveness is extremely variable and the drug is associated with troublesome cardiovascular side-effects . Peri-urethral injections have been used successfully as bulking agents in the short term, but long-term results tend to be poor .
Over the last decade pubovaginal slings have gained increasing approval in the treatment of SUI in women . Autologous or cadaveric fascia has been used but there have been problems with fascial harvesting and infection . However, synthetic slings are considered to be the standard treatment for SUI.
A new treatment for female SUI, the synthetic polypropylene tension-free vaginal tape (TVT), has shown good results . The placement of the TVT at the mid-urethral level is based on anatomical and pathophysiological studies , and supported by the findings of Zaccharin  on the role of pubourethral ligaments in maintaining continence.
The artificial urinary sphincter is effective in controlling SUI in women, but patients with UI of neurogenic origin have the highest complication rate, and the worst results in relation to vascularization and tissue trophic abnormalities . SUI in this group of patients is influenced by the presence of DO or UAB, and the damage to vesical sensory function affects the management options. It is imperative to suppress the bladder adequately with anticholinergics before correcting the SUI in the presence of DO. However, of patients who have acontractile bladder dysfunction many need to use clean intermittent self-catheterization (CISC) to empty their bladders effectively, and to avoid the sequelae of residual urine in the bladder. Hence, the need to use CISC is an acceptable outcome after surgery for SUI in neuropathic patients, but is less acceptable in non-neuropathic patients.
The aim of the present retrospective study was to evaluate the long-term safety and efficacy of TVT to restore continence in selected women with urodynamically confirmed SUI of neurogenic origin.
PATIENTS AND METHODS
Twelve women with SCI and SUI were treated with insertion of TVT between November 1997 and December 2000. The mean (range) age of the patients was 53 (41–80) years and the cause of neuropathic bladder dysfunction in these patients is shown in Table 1. All of the patients had SUI confirmed on preoperative video-cystometrography (VCMG). There was no urgency UI in any of the patients on VCMG, and only one had NDO corresponding to a suprasacral spinal cord lesion, which was corrected by complete detrusor suppression with anticholinergic medication before the procedure. The remaining 11 patients had UAB.
|Patient/age, years||Level of injury||Type of bladder dysfunction||Bladder management||Follow-up, years|
|1/41||T12 incomplete SCI||NDO||CISC||12|
|2/44||L1 complete SCI||UAB||CISC||9.5|
|3/46||L4 incomplete SCI||UAB||Voids on urge||9|
|4/41||Disc surgery L1/L2||UAB||CISC||lost follow up|
|5/59||Disc surgery L2/L3/L4||UAB||Voids on urge||9.5|
|6/55||Disc surgery L5/S1||UAB||CISC||10|
|7/69||Disc surgery L5/S1||UAB||CISC||9|
|8/64||Disc surgery L5/S1||UAB||Voids on urge||9.5|
|9/50||Disc surgery L5/S1||UAB||CISC||lost follow up|
|10/41||Spinal stenosis L5/S1||UAB||CISC||12|
|11/50||Spinal stenosis L5||UAB||CISC||9|
|12/80||Spinal stenosis L5/S1||UAB||CISC||failed (Died)|
Bladder drainage before surgery in the 12 patients was by Crede manoeuvre (suprapubic compression) in three and CISC in the remaining nine. Four patients had undergone a previous procedure for SUI, with no benefit (colposuspension in two, polydimethylsiloxane injection into the external urethral sphincter in two).
The TVT surgery was performed under spinal anaesthesia; one dose of prophylactic i.v. gentamicin 120 mg was administered at induction. One surgeon performed the operations, using the procedure described previously by Hamid et al..
One patient had transient urethral obstruction which self-resolved and was attributed to postoperative oedema, and one had a bladder perforation on insertion of the TVT, managed successfully with extended use of a urethral catheter for 5 days after surgery. However, three patients developed a UTI after surgery, treated successfully with oral antibiotics.
We reviewed the patients’ notes, annual clinical follow-up and VCMG after the procedure. The Incontinence Impact Questionnaire-7 and Urinary Distress Inventory-6 were completed by nine patients at their 10-year follow-up to evaluate the long-term effectiveness of TVT; the assessment also included an assessment of health-related quality of life (HRQL). The clinical follow-up was conducted at 3, 6 and 12 months, and then annually for all the patients, whereas VCMG was used at 3, 12 and 60 months, and then when it was clinically indicated for SUI or any other urinary symptoms.
At 10 years of follow-up, of the 12 patients who had TVT, in one the procedure failed initially and the patient died after 3 years from an unrelated cause. Two more were lost to follow-up after 5 years, and their VCMG did not show SUI at the last follow-up. The remaining nine patients were followed for a mean (range) of 10 (9–12) years. Seven of the nine were completely dry at the mean follow-up and the other two showed an improvement, reporting a decrease in the number of pads used; one to two pads were used by these two patients daily for minimal leakage which did not affect their daily activity or their HRQL.
Two patients had overactive bladder (OAB) symptoms after TVT surgery, confirmed on VCMG; one was classified as de novo DO as she had no NDO on VCMG before surgery, whilst the other had NDO on VCMG before surgery that persisted afterward. These were effectively corrected with anticholinergic medication, and the second patient underwent cystoscopy and injection with botulinum toxin, after which both reported complete resolution of their OAB symptoms. Each of the nine patients with a long-term follow-up was satisfied with the results and efficacy of the procedure (Table 2).
|Outcome, n||5 years||10 years|
|No. of patients||12||9|
|Improved (1–2 pads/day and happy)||1||2|
|Wet (failed)||1||1 (died)|
|Lost to follow-up||0||2|
|Changing bladder management||1 OAB*||2 OAB after TVT† (1 known before TVT; 1 newly developed)|
|Cured/improved||11/12||9/10 + 2 lost to follow-up|
The three patients who voided spontaneously or by suprapubic compression continued to do so after surgery, with no problems. All of the patients who were using CISC before surgery continued with the same management, with no complications.
The treatment of female SUI has progressed rapidly with the use of popular less-invasive methods. Our series is the first to evaluate the long-term effectiveness of TVT in patients with SUI of neurogenic origin. The results show a very good long-term outcome for this procedure, with a high success rates for correcting SUI, in nine of 10 patients. Two patients were lost to the long-term follow-up, but they had good results up to 5 years after surgery (11/12). One patient had transient urethral obstruction which self-resolved and was attributed to postoperative oedema.
During the follow-up one patient was diagnosed with de novo urgency due to DOA, confirmed on VCMG. This is lower than in non-neuropathic patients (15%) , albeit with only one patient. This patient was treated effectively by appropriate management with anticholinergics; it has been suggested that the DOA might be due to the activation of the voiding reflex by stimulation of the afferent receptors in the proximal urethra . However, in the patient with pre-existing NDO there was no worsening of the condition on VCMG, and the SUI was cured. Also, there was no significant increase in intravesical pressures after surgery in those patients who had been ‘strain voiding’.
It has been suggested that patients with DOA and SUI might have a less favourable outcome from TVT surgery; Lee et al. reported that urgency was the only predictive factor affecting patient satisfaction. We feel that UI must be defined precisely in this patient group. If patients have SUI with NDO confirmed on VCMG (as in our study), then TVT can resolve the SUI without exacerbating NDO (as in one of the present patients). However, if the SUI is related to NDO then the anticholinergics and botulinum toxin will alleviate this problem.
The insertion of TVT in neuropathic patients might exacerbate bladder dysfunction in different ways. It might result in de novo DOA or lead to exacerbation of pre-existing NDO; it was suggested that this might be due to activation of the voiding reflex by stimulation of the afferent receptors in the proximal urethra .
In conclusion, in women with neuropathic bladder dysfunction secondary to a variety of spinal cord pathologies and who have SUI necessitating a definitive intervention, insertion of the TVT should be considered a desirable treatment, with very good long-term outcomes.
CONFLICT OF INTEREST