Hypothesis / aims of study
Traditionally, the management of stress urinary incontinence (SUI) has been: 1) pelvic floor physiotherapy, 2) vaginal ring pessary (Introl or Contiform) and 3) surgery. Historically, vaginal rings appeared to be more suitable for older women who were not fit for surgery or younger women who either wish to delay surgery until completion of their families or are only incontinent during certain activities. Previously the Contiform device has been proven to have a dry rate of 54% [1] but had low uptake due to short term durability and thus cost. A new device, the Continence Dish has been in use since 2011. However, to date, there has been one review article published which does not contain objective outcome data [2]. Thus, the aim of the present study was to determine the efficacy of the device (i.e. the improvement and cure rate) for stress urinary incontinence. Because our regional referral unit attracts many complex patients, mixed incontinence is much more common in our population than pure stress incontinence.
Study design, materials and methods
All patients fitted with the Continence Dish for SUI or mixed urinary incontinence since 2011 were contacted. The International Consultation on Incontinence Questionnaire (ICIQ, score 0-21) was collected prior to insertion of the dish along with basic demographics.
Subjective efficacy, i.e. quality of life, was measured by a post treatment ICIQ and Incontinence Impact Questionnaire (IIQ, score 0-21, commonly reported on a scale of 0 to 100 with Good being < 50, Moderate 50 to 70 and Poor > 70 [3]. Objective efficacy was measured by a 24-hour pad test with dish in situ. “Dry” was defined as <2g urine lost per 24 hours and an ICIQ score ≤6. Patients with pure SUI and Mixed Incontinence were analysed separately. Statistical analysis was by Wilcoxon signed rank using SPSS version 25.0.
Results
There were 92 patients with a primary complaint of SUI (+/- urge incontinence) who were fitted with a continence dish and were identified from the bookings Diary at urogynaecology out patients clinic . Of these, 43/92 did not continue to use the dish after insertion for the following reasons; A) inability to retain ring (7/43, 16%), B) minimal benefit (20/43, 46.5%), C) proceeded to surgical repair by patient choice (8/43, 18.6%). Data was unable to be collected in 8 (18.6%) patients: either because they declined to join the study, moved out of area or where found medically unfit to participate.
Thus, 49 patients who continued to use the Continence Dish were enrolled. Baseline demographic data, including age and duration of use are shown in Table 1. Outcome measure demonstrate a dry rate of 87.5% in pure SUI compared to lower rates of 37% in Mixed incontinence patients (Table 2) . The majority of women presented within the last 4 years (with 5 women seen earlier). More than half (27/49) of the women were able to self-removed and reinsert the dish.
Interpretation of results
The pure SUI group of women showed a marked improvement in their ICIQ score from pre and post treatment with the Continence Dish. Some women who were actually “dry” still recorded a “bother” score as they remain frustrated by having to wear a continence device.
Both incontinent groups had an IIQ score of “good” quality of life. However, we were surprised that quality of life in the mixed urinary incontinence group was higher than that of the pure SUI group: 36.7% with mixed urinary incontinence and 87.5% of women with pure SUI were dry on a 24-hour pad test.
Concluding message
To our knowledge, this is the first report of the subjective and objective success rate for the Continence Dish. Of those with pure stress incontinence, 87% were dry on a 24 hour pad test whilst 50% were dry on ICIQ, and 75% were rated “Good” on IIQ.
Not surprisingly, women with mixed incontinence had a much lower “dry” rate, however their ICIQ quality of life scores were improved and their IIQ scores indicated high degree of benefit.
With increasing concerns over the use of polypropylene mesh for mid-urethral slings, these data should be made available to women with stress and mixed incontinence.