5 years outcome on TVT-Exact for female stress urinary incontinence

Kadam P1, Han H1

Research Type

Basic Science / Translational

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 777
Non Discussion Abstract
Scientific Non Discussion Abstract Session 37
Female Mixed Urinary Incontinence Stress Urinary Incontinence Retrospective Study Surgery
1.Department of Urogynaecology, KK Women's and Children's Hospital
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Abstract

Hypothesis / aims of study
To study the 5-year outcome in patients with stress urinary incontinence (SUI) undergoing Tension free vaginal tape-Exact (TVT-Exact) surgery at KK Hospital.
Study design, materials and methods
This was a retrospective study conducted at a single centre at KK Women’s and Children’s Hospital, Singapore.The patient data was recorded on standardised patient proforma.

Patients with pure SUI or mixed incontinence with SUI as the predominant symptom who underwent TVT-Exact surgery between 1 February 2012 and 30 November 2014 were identified. Patients who underwent pelvic organ prolapse surgeries with concomitant SUI surgeries were excluded.

The patient records were studied to get the following information: demographic data, presenting symptoms, pre and post-operative urodynamic study results, operative details, post-operative recovery, symptomatic improvement and occurrence of new symptoms if any. The patients were followed up at 1 week, 1 month, 6 months, 1 year and annually thereafter for 5 years after surgery. At each follow up visit a standard symptomatology questionnaire checking for frequency, nocturia, SUI, urgency urge incontinence (UUI), urine flow, dysuria, vaginal pain and dyspareunia was completed. A speculum and per vaginal examination were done to exclude vaginal tape extrusion. A urodynamic study was done at 6 months post operation. Patient satisfaction in terms of surgical results and subjective and objective cure rates were recorded. Upon successful completion of the follow up period of 5 years the patients were given the option of regular annual follow up or a need based follow up.

The operations were performed by a single surgeon or his team under his supervision using the standard technique for the placement of retropubic mid-urethral sling, TVT-Exact. Medical records of patients who underwent TVT-Exact between 1 February 2012 and 30 November 2014 were traced and reviewed.
Results
A total of 80 patients underwent TVT-Exact between 1 February 2012 and 30 November 2014. Almost 60 % of the patients were post-menopausal. On pressure flow study, urodynamic stress incontinence (USI) was seen in 54 (72%) and mixed incontinence in 21(28%) patients.

24 (30%) patients underwent regional anaesthesia and 56 (70%) patients underwent general anaesthesia. The mean operative time was 19 mins with an average blood loss of 13 mls. There were 7 (8.7%) patients with bladder perforation requiring tape re-positioning and catheterisation for 48 hours. There were no cases with haematoma formation. There were no major vascular or bowel complications. 

Five (6.25%) patients had initial voiding difficulty post-operatively which resolved after a short period (2 -7 days) of catheter drainage. None of the patients had urine retention needing catheterisation for more than 7 days. 

One patient reported thigh pain radiating to the knee, which resolved with anti-inflammatory and analgesic medications and physiotherapy for 3-4 weeks. None of the patients developed urinary tract infection.The average inpatient stay was 1 day.  3 patients (5.1%) reported dyspareunia at 6 months which resolved at 1 year follow up. 

Symptomatic relief in the pre-existing urgency urge incontinence symptoms ranged from 24% at 2 years to 43% at 5 years. De novo urgency urge incontinence was seen in 2 patients, ranging from 3.4% at 6 months to 10% at 5 years. None of the patients under follow up had vaginal or urethral tape extrusion or tape erosion into the bladder at 5 years.

The subjective cure rate varied between 88.1% at 6 months and 90.5% at 5 years after operation. The objective cure rate varied between 89% at 6 months and 100% at 5 years.
Interpretation of results
Our subjective cure rates of 88.1% at 6 months and 90.5% at 5 years are similar to the previous international studies. The improvement in symptoms of urgency urge incontinence of 24% at 2 years and 43% at 5 years are also similar to previous studies. Only 1 patient had a recurrence of SUI symptoms at 4 years follow up and underwent a repeat TVT-Exact, which suggests a failure rate of 1.3%, much lower than quoted in the previous studies. Intraoperatively, the most common reported complication of bladder perforation was 8.7% which is comparable to other studies (0-23%). 

We started with a total of 80 patients undergoing TVT-Exact, with 59 (73.8%) follow up rate at 6 months further dropping to 33 (41.3%) at 2 years and 21 (30%) at 5 years. The drop in the follow up rate could be attributed to the symptomatic improvement and cure rate.
Concluding message
Our study confirms that the TVT-Exact continues to be an effective and less invasive surgery for women with stress urinary incontinence. The recovery and hospital stay are short with an early return to daily activities. The complications are few and easily manageable. Proper pre-operative counselling is important.
References
  1. GB Boustead. Tension free vaginal tape for treating female stress urinary incontinence. BJU International (2002), 89:687-693.
Disclosures
<span class="text-strong">Funding</span> NA <span class="text-strong">Clinical Trial</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> SingHealth Centralised Institutional Review Board <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes