Table 1. Baseline Characteristics of the Study Population.
| Baseline characteristics | Surgery group (n=221)a | Pessary group (n=218)a |
|---|---|---|
| Age, mean (SD), y | 64.7 (9.2) | 64.8 (9.5) |
| Body mass index, median (IQR)b | 25.3 (23.2-27.9) | 25.2 (23.4-27.2) |
| Risk-increasing aspects, No. (%)c | 58 (26.2) | 71 (32.6) |
| Parity, median (IQR) [No.] | 2 (2-3) [220] | 2 (2-3) [215] |
| History of third- or fourth-degree perineal tear, No./total (%) | 8/200 (4.0) | 6/195 (3.1) |
| Postmenopausal, No./total (%) | 185/205 (90.2) | 186/201 (92.5) |
| History of gynecological surgery, No. (%) | 28 (12.7) | 22 (10.1) |
| Hysterectomy, No. (%) | 14 (6.3) | 14 (6.4) |
| Family history of prolapse, No./total (%) | 107/216 (49.5) | 106/218 (48.6) |
| Duration of symptoms, median (IQR), mo. [No.] | 6 (3-24) [216] | 6 (2-24) [211] |
| Vaginal atrophy, No./total (%) | 110/192 (57.3) | 106/187 (56.7) |
| Prolapse stage, No. (%) | ||
| 2 (Moderate) | 102 (46.2) | 85 (39.0) |
| ≥3 (Severe) | 119 (53.8) | 133 (61.0) |
| Site of prolapse, No. (%)d | ||
| Cystocele | 192 (86.9) | 193 (88.5) |
| Rectocele | 63 (28.5) | 69 (31.7) |
| Uterine prolapse | 104 (47.0) | 98 (44.9) |
| PGI-S, No. (%) | (n=205) | (n=205) |
| 1 (Not severe) | 9 (4.4) | 13 (6.3) |
| 2 (Mild) | 50 (24.4) | 48 (23.4) |
| 3 (Moderate) | 112 (54.6) | 99 (48.3) |
| 4 (Severe) | 34 (16.6) | 45 (22.0) |
| PFDI-20 domain score, mean (SD)e | (n=208) | (n=210) |
| POPDI-6 | 28.7 (15.6) | 29.5 (19.3) |
| CRADI-8 | 12.1 (12.6) | 13.9 (15.1) |
| UDI-6 | 25.2 (20.0) | 26.0 (22.0) |
| PFDI-20 total score | 65.9 (37.8) | 69.3 (45.7) |
| PFIQ-7 domain score, mean (SD)e | (n=205) | (n=208) |
| UIQ-7 | 16.6 (19.3) | 18.0 (20.5) |
| CRAIQ-7 | 6.4 (12.7) | 8.3 (16.3) |
| POPIQ-7 | 14.8 (18.3) | 14.4 (19.9) |
| PFIQ-7 total score | 37.9 (41.0) | 40.8 (47.5) |
| PISQ-IR sexually active, mean (SD)f | (n=112) | (n=116) |
| Partner-related: indicates assessment of partner-related impactsg | 3.4 (0.6) | 3.4 (0.6) |
| Condition-specific: indicates assessment of condition-specific impacts on activityh | 4.5 (0.6) | 4.5 (0.6) |
| Global quality: indicates global quality rating of sexual qualityg | 2.6 (0.6) | 2.5 (0.6) |
| Condition impact: indicates condition-specific impact on sexual qualityg | 3.2 (0.8) | 3.4 (0.7) |
| Arousal-orgasm: indicates assessment of arousal, orgasmh | 3.4 (0.7) | 3.4 (0.6) |
| Desire: indicates assessment of sexual desireh | 2.8 (0.6) | 2.7 (0.6) |
| Summary scorei | 3.3 (0.3) | 3.3 (0.3) |
| PISQ-IR sexually inactive, mean (SD)j | (n=90) | (n=90) |
| Partner-related: indicates partner-related reasons for not being activeg | 2.6 (0.9) | 2.7 (1.0) |
| Condition-specific: indicates condition-specific reasons for not being activeg | 1.7 (0.9) | 1.6 (0.9) |
| Global quality: indicates global quality rating of sexual qualityh | 2.4 (0.6) | 2.4 (0.7) |
| Condition impact: indicates condition impact on sexual qualityg | 1.5 (0.8) | 1.4 (0.8) |
Abbreviations: CRADI-8, Colorectal-Anal Distress Inventory; CRAIQ-7, Colorectal-Anal Impact Questionnaire; MCID, minimally clinical important difference; PFDI-20, Pelvic Floor Distress Inventory; PFIQ-7, Pelvic Floor Impact Questionnaire; PGI-S, Patient Global Impression of Severity; PISQ-IR, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA [International Urogynecological Association]-Revised; POPDI-6, Pelvic Organ Prolapse Distress Inventory; POPIQ-7, Pelvic Organ Prolapse Impact Questionnaire; UDI-6, Urinary Distress Inventory, Short Form; UIQ-7, Urinary Impact Questionnaire.
Indicates the number of patients except for categories where another number is reported.
Calculated as weight in kilograms divided by height in meters squared.
Risk-increasing aspects includes at least 1 of the following: smoking, the use of antidepressants, chronic pulmonary disease, diabetes, and obesity.
Site of prolapse is not mutually exclusive.
For the PFDI-20 as well as for the PFIQ-7 subscale, scores range from 0 to 100. The total score is a sum of the subscale scores (range, 0-300). Higher scores indicate more impact of pelvic organ prolapse. The MCID for the total score of the PFDI-20 is −22.9 points, and for the the PFIQ-7, it is −28.6 points. The number of patients applies to all subscales.
Higher scores indicate better sexual functioning. The number of patients applies to all subscales.
Score range, 1 to 4.
Score range, 1 to 5.
The summary score ranges from 1 to 4.6 in cases with a sexual partner and from 1 to 4.71 without a sexual partner. The MCID for the summary score for women receiving surgery is 0.31 points.
Higher scores indicate greater impact of condition on sexual functioning. The number of patients applies to all subcategories.