Objective
The objectives of this study were to: (1) assess differences in goal attainment of self-described goals after treatment of symptomatic pelvic organ prolapse (POP) for women who chose surgery compared to women who chose pessary; and (2) compare patient global improvement between groups.
Study Design
Women who had symptomatic stage ≥II prolapse presenting for care of POP to the urogynecology clinic at the University of New Mexico were recruited. Patients listed up to 3 goals they had for their treatment. In addition, they completed the short forms of the Pelvic Floor Distress Inventory (PFDI-20), the POP/Urinary Incontinence Sexual Questionnaire, and the Body Image Scale. Goals listed by patients were then categorized into 10 categories. Each of the listed goals was categorized based on a consensus of 5 providers. At 3 months’ follow-up patients listed if they had met their self-described goals on a scale of 0-10 and also answered the Patient Global Improvement Index (PGI-I).
Results
There were no significant differences between the 2 groups’ baseline characteristics. Surgery patients ranked their goal attainment higher than pessary patients for all the 3 goals listed. Similarly, PGI-I scores were also higher in the surgical (2.4 ± 1.1) than the pessary (1.93 ± 0.8) treatment groups ( P < .04). Patients in the surgery group also had better symptom improvement as measured by the PFDI-20 ( P < .02).
Conclusion
Patients who chose surgery had better global improvement and met their goals better compared to patients who chose pessary.
Goal attainment scaling is a technique for measuring goal achievement after therapy that is commonly used to assess patient-centered goals and outcomes. Identification of self-selected goals may help to tailor individual patients’ needs to specific therapeutic interventions. This is particularly important in fields where functional outcomes are the primary objective. Understanding patient goal attainment may be especially important for diseases such as pelvic organ prolapse (POP) when treatment is typically recommended to improve quality of life rather than treat or prevent a life-threatening disease.
Among women with pelvic floor dysfunction, others have shown that patient goals and expectations vary and are linked to treatment satisfaction. Conversely, unmet goals are closely associated with patient dissatisfaction after treatment. These prior studies included only a small proportion of women seeking treatment for POP and did not compare goal attainment between those who chose pessary vs surgery treatment. For these reasons, goal attainment scaling may prove a valid outcome measure to directly compare outcomes between surgery and pessary use for treatment of symptomatic POP. In addition, goal setting may help women and their providers to better choose treatment plans when women are eligible for both surgery or pessary treatment of symptomatic prolapse.
The objectives of this study were to prospectively compare the attainment of self-selected goals in women who choose a pessary vs those who choose surgery for treatment of symptomatic stage ≥II POP. We also aimed to assess if women who choose pessary for treatment of symptomatic stage ≥II POP report the same global improvement in their condition as women who choose surgery for treatment of their POP.
Materials and Methods
This study is a follow-up of our initial study comparing baseline goal differences between patients who choose surgery vs pessary for treatment of symptomatic stage II POP. Women presenting for care of symptomatic POP to the urogynecology clinic at the University of New Mexico were recruited for participation. Women with symptomatic stage ≥II prolapse as measured on POP quantification examination, and who were deemed eligible for either surgical or pessary treatment by the attending physician were eligible for participation. All subjects were age >18 years, able to read and write in English, and gave written informed consent. The study was approved by the institutional review board of the University of New Mexico Health Sciences Center (HHRC#10-370).
In addition to standardized pelvic examinations, patient characteristics and medical and surgical history data were collected. After clinical assessment, but prior to discussion of therapeutic interventions, women were asked to list up to 3 treatment goals. They ranked these goals from 1-3, with 1 being the most important goal. In addition patients completed the short form of the validated Pelvic Floor Distress Inventory (PFDI-20), short form of the POP/Urinary Incontinence Sexual Questionnaire (PISQ-12), and the Body Image Scale (BIS). At 3-month follow-up, women were asked if they met the goals listed at the initial visit and were asked to score how well they met their goals on a scale of 0-10; 0 represented not meeting the goal at all and 10 represented meeting the goal completely. Goals listed by the patients were categorized through an iterative process by a consensus of 5 providers expert in the treatment of pelvic floor dysfunction. The 5 providers individually categorized each listed goal and met to compare categorizations. When assigned categories for goals varied between experts, discussion was conducted until consensus was reached. Three months after treatment, women completed the validated Patient Global Improvement Index (PGI-I), as well as repeated the PFDI-20, PISQ-12, and BIS.
Although a power analysis conducted for the parent study determined the need to recruit 50 patients for each of the surgery and pessary arms, we based our power analysis for this study to ensure our aims were met appropriately, on a report by Srikrishna et al, who found a mean goal achievement score of 9.0 ± 1.55 (SD) on a scale of 0-10 after treatment for prolapse in the validation study of the PGI-I. Assuming 80% power and alpha of .05, a sample size of 29 women per arm was adequate to detect a 1.2-point difference between the 2 study arms on a 10-point Visual Analog Goal Attainment Scale. For the parent study, we had determined that we would need 100 women (50 in each group) to have adequate power to compare initial goal rankings. Assuming that 10 women per arm would not follow up and that 10 women per arm would not adhere to their original treatment plan, we anticipated that we would have approximately 30 women in each arm to evaluate for this aim. Based on this, of the initial 100 women recruited for the parent study, we determined that a subset of 60 women would be required to have the 3-month follow-up for the current study. Descriptive statistics were reported as mean ± SD or percentage as appropriate. Comparisons between the 2 treatment groups were done by t tests and verified by Wilcoxon rank sum test. Categorical outcomes were compared by Fisher exact test. P < .05 was considered statistically significant.
Results
We recruited 100 women, 50 who chose surgery and 50 who chose pessary for the initial study. In the initial study, there were no differences in goal setting between patients who chose surgery compared to those who chose pessary. In all, 65 women received treatment and gave follow-up data; 30 in the pessary group and 35 in the surgery group (the Figure outlines patient flow through the study). Pessary and surgery groups did not differ in age, ethnicity, body mass index, and history of treatment for POP at baseline ( Table 1 ). The list of surgeries includes 15 laparoscopic sacral colpopexies, 15 vaginal hysterectomies with uterosacral ligament suspensions, and 5 colpocleisis procedures.
| Variable | Pessary n = 50 | Surgery n = 50 | P value |
|---|---|---|---|
| Age, y (mean ± SD) | 62.3 ± 10 | 61.2 ± 8.7 | NS |
| Caucasian race | 57% | 59% | NS |
| Hispanic | 46% | 48% | NS |
| Parity (SD) | 3 (1) | 3 (1) | NS |
| Body mass index (SD) | 34.5 (5.8) | 33.1 (5.2) | NS |
| Prior treatment | 36% | 42% | NS |
| Sexually active | 10 | 14 | NS |
As determined qualitatively by expert review, goals were assigned into 10 categories including symptom goals (4 categories: prolapse, urinary, bowel, pain); quality-of-life goals (3 categories: physical activity, emotional, sex); avoidance goals (1 category); body image goals (1 category); and other (1 category). Examples of goals and their categorizations are shown in Table 2 . The majority of patients in both groups sought to have prolapse symptoms addressed as their first goal (60 vs 49%, surgery vs pessary P = not significant). Initial ranking varied between groups for the second and third goals. Treatment of urinary symptoms was the second most common goal in the surgery group (37% of the surgery group listed this second) and quality of life–activity was the second commonest goal in the pessary group (17% pessary). Avoidance was the third most common goal in both groups (20 vs 23%, surgery vs pessary, P = not significant).
| Goal category | Examples |
|---|---|
| Symptoms–prolapse | “Want the bulge to go away”; “don’t want to sit on a lump” |
| Symptoms–urinary | “Have no leakage”; “not have to wear wet pads” |
| Symptoms–bowel | “Have normal bowel movements”; “have no leakage of feces” |
| Symptoms–pain | “Get rid of pain and pressure in vaginal area” |
| QOL–activity | “Be able to play with grandchildren”; “to exercise normally” |
| QOL–emotional | “Not have to worry about this problem” |
| QOL–sex | “Have lot of sex” |
| Avoidance | “Make sure problem does not get worse”; “avoid surgery”; “not have to do something later when older” |
| Body image | “Be more confident about my body” |
| Other | “Live a happy life” |
At 3 months following treatment, both groups improved significantly from baseline in PFDI-20, BIS, and PISQ-12 scores after their respective treatments ( Table 3 ). Between-group improvements were not different except for PFDI-20 total scores; the surgery group showed greater improvement from baseline ( Table 3 ). Average goal attainment for both groups for each goal category is shown in Table 4 . Surgery patients ranked their goal attainment higher than pessary patients for all goals listed. Similarly, PGI-I scores were also higher in the surgical than the pessary treatment groups ( Table 5 ). Since the only difference was sexual activity and only a subset of women were sexually active, despite controlling for the significantly different baseline PISQ-12 scores in sexually active women, there remained significant differences in both goal attainment and PGI-I scores between the surgery and pessary groups. Not all women in each of the surgery and pessary groups were sexually active and PISQ-12 results only relate to patients who are sexually active. Therefore this may have contributed to the statistically significant differences between the 2 groups as far as goal attainment and PGI-I. To remove this confounder, an analysis was performed to control for this and there remained statistically significant differences between the 2 groups.
| Variable | Pessary group, n = 30; mean change (SD) | Change from baseline P value | Surgery group, n = 35; mean change (SD) | Change from baseline P value | Differences between groups P value |
|---|---|---|---|---|---|
| PFDI-20 | –43.2 (79.8) | .005 | –89.0 (68.6) | < .0001 | .02 |
| POPDI-6 | –12.5 (34.8) | .055 | –38.8 (25.4) | < .0001 | .09 |
| CRADI-8 | –10.5 (24.5) | .023 | –24.9 (25.1) | < .0012 | .40 |
| UDI-6 | –31.3 (30.3) | .0009 | –34.4 (27.3) | < .0001 | .055 |
| BIS | –6.4 (7.6) | .0001 | –6.2 (7.0) | < .0001 | .91 |
| PISQ-12 | 9.1 (3.1) | < .0001 | 7.5 (3.1) | < .0001 | .22 |
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