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.