Table 1.
Participant Baseline Demographic and Clinical Characteristics by Surgical Repair Performed
| Characteristics | Mesh Repair (N=45) | Native Tissue Repair (N=43) | Risk Difference/ Location Shift (95% CI) | p-valuea |
|---|---|---|---|---|
| Patient Demographics | ||||
| Age (years), Median (P25, P75) | 63.4 (59.7, 67.8) | 65.4 (60.7, 72.3) | −1.5 (−5.0 to 1.6) | 0.39 |
| White, n/N (%) | 36/45 (80) | 36/43 (84) | −4 (−21 to 13) | 0.78 |
| Hispanic/Latina, n/N (%) | 5/43 (12) | 4/41 (10) | 2 (−13 to 17) | >0.99 |
| Married, n/N (%) | 28/45 (62) | 29/43 (67) | −5 (−25 to 15) | 0.66 |
| Associates Degree or Higher, n/N (%) | 27/43 (63) | 30/43 (70) | −7 (−27 to 13) | 0.65 |
| Medicare/Medicaid, n/N (%) | 20/45 (44) | 22/43 (51) | −7 (−28 to 15) | 0.67 |
| Medical History | ||||
| Height (cm), Median (P25, P75) | 160.0 (155.0, 165.0) | 160.0 (157.0, 165.0) | 0.0 (−3.0 to 3.0) | 0.89 |
| Weight (kg), Median (P25, P75) | 73.0 (66.0, 81.0) | 70.0 (64.0, 79.0) | 2.0 (−3.0 to 7.0) | 0.45 |
| BMI (kg/m2), Median (P25, P75) | 28.3 (25.4, 31.6) | 26.4 (24.2, 30.1) | 1.2 (−0.8 to 2.8) | 0.21 |
| Obese (BMI ≥ 30), n/N (%) | 15/45 (33) | 13/43 (30) | 3 (−17 to 23) | 0.82 |
| Gravidity, Median (P25, P75) | 3.0 (2.0, 4.0) | 3.0 (2.0, 4.0) | 0 (0 to 1) | 0.38 |
| Cesarean Delivery, n/N (%) | 3/45 (7) | 4/43 (9) | −3 (−16 to 11) | 0.71 |
| Vaginal Deliveries, Median (P25, P75) | 3.0 (2.0, 3.0) | 2.0 (2.0, 3.0) | 0 (0 to 1) | 0.32 |
| Post-Menopausal, n/N (%) | 43/45 (96) | 42/43 (98) | −2 (−13 to 8) | >0.99 |
| Oral Estrogen, n/N (%) | 2/45 (4) | 3/43 (7) | −3 (−15 to 9) | 0.67 |
| Vaginal Cream/Tablet Estrogen, n/N (%) | 15/45 (33) | 13/43 (30) | 3 (−17 to 23) | 0.82 |
| Skin Patch Estrogen, n/N (%) | 2/45 (4) | 0/43 (0) | 4 (−4 to 15) | 0.49 |
| Smoker, n/N (%) | 9/45 (20) | 10/43 (23) | −3 (−22 to 15) | 0.80 |
| Diabetes, n/N (%) | 7/45 (16) | 4/43 (9) | 6 (−9 to 22) | 0.52 |
| Pulmonary Diseaseb, n/N (%) | 4/45 (9) | 4/43 (9) | 0 (−15 to 13) | >0.99 |
| Cardiovascular Diseasec, n/N (%) | 4/45 (9) | 3/43 (7) | 2 (−11 to 15) | >0.99 |
| Prior Prolapse Surgery, n/N (%) | 0/45 (0) | 3/43 (7) | −7 (−19 to 2) | 0.11 |
| Pelvic Floor Measurements and Symptoms | ||||
| POPQ Measurements (cm), Median (P25, P75) | ||||
| POPQ Ba | 3.0 (2.0, 4.0) | 2.0 (1.0, 4.0) | 0.0 (−1.0 to 1.0) | 0.74 |
| POPQ Bp | 0.0 (−2.0, 2.0) | 0.5 (−1.0, 3.0) | −0.5 (−2.0 to 1.0) | 0.39 |
| POPQ C | 0.0 (−3.0, 2.0) | 0.0 (−2.0, 3.0) | 0.0 (−2.0 to 1.0) | 0.56 |
| POPQ GH Strain | 4.5 (4.0, 5.0) | 4.0 (4.0, 5.0) | 0.0 (−0.5 to 0.5) | 0.70 |
| POPQ PB Strain | 3.0 (2.5, 4.0) | 3.0 (2.5, 4.0) | 0.0 (0.0 to 0.0) | 0.97 |
| POPQ TVL | 9.0 (8.0, 10.0) | 9.0 (8.0, 10.0) | 0.0 (0.0 to 0.5) | 0.86 |
| POPQ Staged, n/N (%) | 0.38 | |||
| Stage 2 | 9/45 (20) | 11/43 (26) | −6 (−24 to 13) | |
| Stage 3 | 33/45 (73) | 26/43 (60) | 13 (−7 to 33) | |
| Stage 4 | 3/45 (7) | 6/43 (14) | −7 (−22 to 6) | |
| Apical Prolapse (POPQ C > 0), n/N (%) | 43/45 (96) | 42/43 (98) | 0 (−21 to 22) | >0.99 |
| Anterior Prolapse (POPQ Aa or Ba > 0), n/N (%) | 20/45 (44) | 22/43 (51) | −2 (−13 to 8) | >0.99 |
| Posterior Prolapse (POPQ Ap or Bp > 0), n/N (%) | 21/45 (47) | 20/43 (47) | −7 (−28 to 15) | 0.67 |
| Any Vaginal Bulge, n/N (%) | 45/45 (100) | 43/43 (100) | ||
| Bothersome Vaginal Bulge, n/N (%) | 43/44 (98) | 43/43 (100) | −2 (−12 to 6) | >0.99 |
| Patient Reported Outcomes | ||||
| PFDI Score, Median (P25, P75) | 127.1 (79.2, 162.5) | 91.7 (70.8, 161.5) | 17.7 (−7.3 to 43.8) | 0.17 |
| UDI Score, Median (P25, P75) | 18.8 (6.3, 40.6) | 18.8 (6.3, 31.3) | 3.1 (−6.3 to 12.5) | 0.45 |
| CRADI Score, Median (P25, P75) | 45.8 (25.0, 66.7) | 33.3 (16.7, 54.2) | 8.3 (−4.2 to 20.8) | 0.16 |
| POPDI Score, Median (P25, P75) | 50.0 (33.3, 66.7) | 45.8 (29.2, 66.7) | 4.2 (−4.2 to 16.7) | 0.33 |
| PFIQ Score, Median (P25, P75) | 47.6 (14.3, 71.4) | 28.6 (9.5, 61.9) | 9.5 (−4.8 to 28.6) | 0.17 |
| UIQ Score, Median (P25, P75) | 23.8 (0.0, 42.9) | 9.5 (0.0, 33.3) | 4.8 (0.0 to 19.0) | 0.19 |
| CRAIQ Score, Median (P25, P75) | 0.0 (0.0, 23.8) | 0.0 (0.0, 14.3) | 0.0 (0.0 to 4.8) | 0.17 |
| POPIQ Score, Median (P25, P75) | 4.8 (0.0, 28.6) | 9.5 (0.0, 28.6) | 0.0 (−4.8 to 4.8) | 0.89 |
| ISI Score, Median (P25, P75) | 4.0 (1.0, 8.0) | 3.0 (1.0, 6.0) | 0.0 (−1.0 to 2.0) | 0.59 |
| FAS Score Median (P25, P75) | 96.2 (84.6, 100.0) | 98.1 (87.5, 100.0) | 0.0 (−3.0 to 0.0) | 0.37 |
| SPS Pain at Rest Score, Median (P25, P75) | 0.0 (0.0, 3.0) | 0.0 (0.0, 1.0) | 0.0 (0.0 to 0.0) | 0.40 |
| SPS Pain during Normal Activities Score, Median (P25, P75) | 1.0 (0.0, 3.0) | 1.0 (0.0, 3.0) | 0.0 (0.0 to 1.0) | 0.64 |
| SPS Pain during Exercise Score, Median (P25, P75) | 2.0 (0.0, 4.0) | 0.0 (0.0, 2.5) | 0.5 (0.0 to 2.0) | 0.13 |
| SPS Worst Pain Score, Median (P25, P75) | 1.0 (0.0, 3.0) | 0.0 (0.0, 3.0) | 0.0 (0.0 to 0.0) | 0.47 |
| BPPS Score, Median (P25, P75) | 0.4 (0.0, 1.1) | 0.1 (0.0, 0.7) | 0.1 (0.0 to 0.4) | 0.11 |
| BIS Score, Median (P25, P75) | 5.0 (2.0, 10.0) | 4.0 (0.0, 8.0) | 1.0 (0.0 to 3.0) | 0.16 |
| PISQ-IR Score among Sexually Active, Median (P25, P75) | 3.5 (3.0, 3.9) | 3.5 (2.9, 3.8) | 0.0 (−0.3 to 0.5) | 0.76 |
| Concomitant Surgical Procedures | ||||
| Anterior Prolapse Repair, n/N (%) | 39/45 (87) | 32/43 (74) | 12 (−5 to 30) | 0.18 |
| Posterior Prolapse Repair, n/N (%) | 26/45 (58) | 26/43 (60) | −3 (−24 to 18) | 0.83 |
| Urinary Incontinence Repair (TVT/TOT), n/N (%) | 24/45 (53) | 24/43 (56) | −2 (−24 to 19) | 0.83 |
BIS, Body Image Scale; BMI, body mass index; BPPS, Body Part Pain Scale; CI, confidence interval; CRADI, Colorectal Anal Distress Inventory; CRAIQ, Colorectal Anal Impact Questionnaire; FAS, Functional Activity Scale; ISI, Incontinence Severity Index; PFDI, Pelvic Floor Distress Inventory; PFIQ, Pelvic Floor Impact Questionnaire; PISQ-IR, Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire-IUGA Revised; POPDI, Pelvic Organ Prolapse Distress Inventory; POPIQ, Pelvic Organ Prolapse Impact Questionnaire; POPQ, Pelvic Organ Prolapse Quantification; SPS, Surgical Pain Scale; TOT, transobturator tape; TVT, transvaginal tape; UDI, Urogenital Distress Inventory; UIQ, Urinary Impact Questionnaire.
Risk difference, 95% confidence intervals, and p-values were obtained using Fisher’s exact test for categorical measures. Location shift, 95% confidence intervals, and p-values were obtained using Wilcoxon Rank-Sum test for continuous measures with a Hodges-Lehmann estimation of location shift (i.e., estimate of the difference in two distributions, calculated as the median of all paired differences between observations in the two samples). All tests were conducted at a significance level of 0.05.
Pulmonary disease includes any the following: asthma, chronic obstructive pulmonary disease, acute respiratory distress syndrome, and emphysema.
Cardiovascular disease includes any the following: angina, congenital heart failure/heart disease, heart attack, stroke/TIA, peripheral vascular disease.
Pelvic Organ Prolapse Quantification (POPQ) Stages: Stage 2-The vagina is prolapsed between 1 cm above the hymen and 1 cm below the hymen; Stage 3-The vagina is prolapsed more than 1 cm beyond the hymen but is not everted within 2 cm of its length; Stage 4-The vagina is everted to within 2 cm of its length.