Definition of Success after Surgery for Female Stress Incontinence or Voiding Dysfunction: An Attempt at Standardization.

CONTEXT: There is currently no standardized definition of success for surgery for stress urinary incontinence (SUI) and voiding dysfunction (VD) in women.

OBJECTIVE: To review the use of outcome measures (OMs) and definitions of success in the literature on SUI and VD surgery in women in an attempt to provide recommendations for future publications.

EVIDENCE ACQUISITION: A PubMed search of all English language full-text articles on SUI and VD surgery in women published between 2010 and 2015 was performed. A list of randomized trials and prospective and retrospective studies was obtained. Specific objective and subjective OMs used to define success were reviewed.

EVIDENCE SYNTHESIS: Some 95 articles met the inclusion criteria for SUI surgery outcomes. Most trials reported outcomes at 12 mo after surgery. The majority (n=48) reported their primary outcomes using both objective and subjective success measures, 24 defined success using subjective OMs alone, and 23 using objective OMs alone. The OMs most frequently used for objective success were a negative cough stress test (CST), a negative pad test, and the absence of retreatment for SUI. The definition of subjective success most often involved questionnaires. The questionnaires most frequently used were Patient Global Impression of Improvement (PGI-I), Urinary Distress Inventory (UDI)/UDI-6, International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and Medical Epidemiologic and Social Aspects of Aging (MESA). Only 11 studies on OMs used for VD surgery were published between 2010 and 2015. The two most common criteria used for success were measurement of postvoid residual urine (PVR) and subjective resolution of VD symptoms.

CONCLUSIONS: There is great heterogeneity in the definition of success used after surgery for SUI or VD in women. For SUI surgery, we recommend use of the CST and a 1-h pad test for the definition of objective success, and of the UDI/UDI-6, Incontinence Impact Questionnaire (IIQ), King's Health Questionnaire (KHQ), ICIQ-SF, or PGI-I questionnaire for subjective success. For VD surgery, cure should include measurement of PVR and self-reported resolution of VD symptoms.

PATIENT SUMMARY: We looked at the definition of success used for surgery for stress urinary incontinence (SUI) and voiding dysfunction (VD) in women. We found that there is great heterogeneity among studies, making study comparison extremely difficult. According to the outcome measures used most frequently, we make recommendations regarding the definition of cure for SUI and VD in women to be used in future publications.