Intervention
Patients were given 2 questionnaires to complete as in the original study: the validated Patient Global Impression of Improvement (PGI-I)8 and the International Consultation on Incontinence Modular Questionnaire Female Urinary Tract Symptoms (ICIQ FLUTS)9. A non-validated pain numeric rating scale questionnaire with space for free text comments (Appendices S1) was also used. This questionnaire was added to capture the impact of groin and/ or vaginal pain associated with the mid-urethral slings in the long term. Hospital records of all consented patients were reviewed for complete data. Permission was not given to access those patients notes who had not consented to this follow-up study due to UK research governance regulations.
The primary outcome (as in the original study) was the percentage of participants in each treatment arm who were cured of SUI in the long-term. “Cured” is defined as the answer “no” to question 8a on the ICIQ-FLUTS ‘does urine leak when you are physically active, exert yourself, cough or sneeze?’. The secondary objectives included the assessment of satisfaction with the surgery according to the PGI-I, patient reported complications between the two groups as well as persisting or de-novo symptoms such as pain, voiding dysfunction, overactive bladder symptoms or recurrent urinary tract infection. A review of hospital records was performed to establish any further complications and/or the need for further surgery.