Emerging evidence suggests that sexual minorities with prostate cancer may experience significant health disparities in urinary function after cancer treatment [1]. To date, there have been no investigations on the severity or course of change in urinary incontinence among sexual minorities after prostate cancer treatment, nor have there been any investigations into their response to conservative treatments for urinary incontinence. These disparities may be related to heteronormative care that is not tailored to the needs of sexual minorities. Restore 2 is the first NIH funded randomized controlled trial investigating the effectiveness of a rehabilitation program designed to improve urinary and sexual dysfunction in sexual minority prostate cancer survivors [1]. This analysis examines the impact of Restore 2 on urinary incontinence by 1) describing change in the severity of urinary incontinence over two years; 2) determining if participating in the treatment arm improved severity of urinary incontinence over two years; and 3) identifying subgroups with greater urinary incontinence severity and response to treatment over two years.

This is a two year longitudinal analysis of 401 participants enrolled in the Restore 2 trial. Participants were randomly assigned to the intervention group (N=204) or to the usual care control group (N=197). The intervention was an online, tailored, multi-component rehabilitation program addressing urinary and sexual dysfunction. Participants self-selected the components they wanted to address. Treatment options for urinary incontinence included pelvic floor muscles exercises, urge suppression techniques, bladder training, avoiding bladder irritants, adequate hydration, and constipation prevention. The pelvic floor exercise prescription was to do 10 quick contractions followed by 10 long contractions three times a day. Treatment options for sexual dysfunction included sildenafil, masturbation exercises, vacuum pump exercises, and anal dilators. Participants were sexual minorities who self-identified as gay, bisexual or as a man who has sex with men. They were recruited mainly from online dating sites, prostate cancer survivor support groups, and social networking sites. Participants had to have been diagnosed with prostate cancer with curative treatment completed, ongoing, or scheduled within two months of beginning the study, be fluent in English, and live in the United States. Data was collected online using Qualtrics software©. Urinary incontinence type and severity was measured with the International Consultation on Incontinence Questionnaire – short form (ICIQ) at baseline, 3, 6, 12, 18, and 24 months follow-up. Adherence to pelvic floor muscle exercises were self-reported as never, less than monthly, 1-3 times a month, 1-4 times a week, and 5-7 times a week at 3, 6, 12, 18, and 24 months. The following self-reported baseline demographic, health, and prostate cancer status characteristics were used to determine their association with urinary incontinence severity over time: age, race, obesity, number of alcoholic drinks consumed in a typical day, health related quality of life measured with the Functional Assessment of Cancer Therapy: General subscale (FACT-G), number of comorbidities, use of anti-incontinence medications, use of sildenafil, HIV status, time since prostate cancer diagnosis, prostate cancer stage, type of prostate cancer treatment, Expanded Prostate Cancer Index Composite (EPIC) bowel and sexual subscales, and climacturia. Descriptive statistics described sample characteristics. Linear mixed effects regression models with unstructured covariance matrixes described change in ICIQ scores over time. Demographic, health, and prostate cancer status characteristics significantly associated (p<.10) with ICIQ growth parameters in univariate models were included in a multivariate model to identify independent predictors of incontinence severity and change.

Participants had a mean age of 63.5 years, were on average 5.3 years past diagnosis, and were treated with surgery (59%), radiation (23%), surgery and radiation (11%) or other treatments (7%). The mean ICIQ score at baseline was 6.6(4.9) and only 16 (4%) participants reported no urinary incontinence during the study. Unconditional models showed ICIQ scores varied at baseline (β=6.44, p<.0001), but did not change over two years (β=-.009, p=.295). Treatment group assignment did not predict severity (β=-.38, p=.372) or change in ICIQ scores (β=-.009, p=.293). Age, race, and prostate cancer stage were not associated with severity or change in ICIQ scores. In univariate models, the following characteristics were associated with ICIQ severity, but not change in ICIQ scores over time: obesity (β=1.63, p=.003 ), health related quality of life (β=-.08, p<.0001), comorbidities (β=.44, p=.004), use of anti-incontinence medications (β=1.94, p=.007), time since prostate cancer diagnosis (β=.09, p=.045), EPIC bowel symptoms (β=-.08, p<.0001), EPIC sexual symptoms (β=-.05, p<.0001), climacturia (β=3.33, p<.0001), and adherence to pelvic floor muscles exercises (p<.0001). The type of prostate cancer treatment predicted the severity of ICIQ scores in the following rank order: radiation and surgery (β=1.65, p=.013), surgery only (p<.0001), radiation only (β=-2.04, p<.0001), other treatments (β=-3.14, p<.0001). The type of urinary incontinence predicted severity of ICIQ scores in the following rank order: mixed urinary incontinence (β=8.3, p<.0001), stress urinary incontinence (β=6.61, p<.0001), insensible or continuous urinary incontinence (β=5.06, p<.0001), urgency urinary incontinence (β=4.28, p<.0001), and post-void urinary incontinence (β=4.1, p<.0001). Table 1 presents the multivariate model which showed ICIQ scores were more severe in the control group and were independently associated with obesity, health related quality of life, adherence to pelvic floor muscles exercises, the type of urinary incontinence, and climacturia. Figure 1 illustrates differences between the treatment and control groups in the ICIQ scores predicted by the multivariate model.

Participating in an online, tailored, multi-component rehabilitation program for sexual minority prostate cancer survivors did not change incontinence severity over two years and no subgroups of participants emerged as having benefited more. While we did not find a treatment effect we gained knowledge to inform future research. First, we had excellent retention of participants indicating they found the tailored content and online approach acceptable. We are also the first to describe the severity and course of change in urinary incontinence over two years in sexual minorities treated for prostate cancer. We found great variability in incontinence severity, but no change in severity over time. On average participants had their cancer treatment five years ago, and most likely represent long term cancer survivors with persistent urinary incontinence. Our inclusion criteria may have been too broad and the treatment options too many to improve urinary incontinence. While participants were provided with information on several conservative treatment options for incontinence, the emphasis was on pelvic floor muscle exercises which participants self-selected as a treatment option. Even though participants with more severe incontinence did more pelvic floor muscle exercises, they did not benefit. However, self-selection of incontinence treatments may not be ideal. Participants reported different types of incontinence, some of which are less amenable to pelvic floor muscle exercises. A comprehensive assessment and management plan produced by a continence specialist may help identify the best conservative treatments in future studies.

Incontinence severity did not change over two years for sexual minorities enrolled in an online, tailored, multi-component rehabilitation program for urinary and sexual dysfunction after prostate cancer treatment. This lack of treatment effect may be attributed to the wide heterogeneity in the type and severity of incontinence experienced by participants. Future trials should enroll participants most likely to benefit from conservative treatment and provide more guidance on the types of treatments that will be most effective for their type of incontinence.

Rosser BRS, Polter EJ, Talley KMC, et al. Health disparities of sexual minority patients following prostate cancer treatment: Results from the Restore-2 study. Front. Oncol. 2022;12:812117.

Continence 2S2 (2022) 100383
DOI: 10.1016/j.cont.2022.100383