Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study.

BACKGROUND/AIMS: In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone. METHODS: Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student's t-test (continuous) and chi-square or Fisher's exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p < 0.05. RESULTS: Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being "very satisfied" overall with study information (97.7% vs 88.5%, p = 0.01); "strong agreement" for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being "very important" (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group. CONCLUSION: The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.

Gaining the patient perspective on pelvic floor disorders' surgical adverse events.

BACKGROUND: The Institute for Healthcare Improvement defines an adverse event as an unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment, or hospitalization or that results in death. The majority of research has focused on adverse events from the provider's perspective. OBJECTIVE: The objective of this qualitative study was to describe patient perceptions on adverse events following surgery for pelvic floor disorders. STUDY DESIGN: Women representing the following 3 separate surgical populations participated in focus groups: (1) preoperative (women <12 weeks prior to surgery); (2) short-term postoperative (women up to 12 weeks after surgery); and (3) long-term postoperative (women 1-5 years after surgery). Deidentified transcripts of audio recordings were coded and analyzed with NVivo 10 software to identify themes, concepts, and adverse events. Women were asked to rank patient-identified and surgeon-identified adverse events in order of perceived severity. RESULTS: Eighty-one women participated in 12 focus groups. Group demographics were similar between groups, and all groups shared similar perspectives regarding surgical expectations. Women commonly reported an unclear understanding of their surgery and categorized adverse events such as incontinence, constipation, nocturia, and lack of improvement in sexual function as very severe, ranking these comparably with intensive care unit admissions or other major surgical complications. Women also expressed a sense of personal failure and shame if symptoms recurred. CONCLUSION: Women consider functional outcomes such as incontinence, sexual dysfunction, and recurrence of symptoms as severe adverse events and rate them as similar in severity to intensive care unit admissions and death.

Models for Predicting Recurrence, Complications, and Health Status in Women After Pelvic Organ Prolapse Surgery.

OBJECTIVE: To develop statistical models predicting recurrent pelvic organ prolapse, surgical complications, and change in health status 12 months after apical prolapse surgery. METHODS: Logistic regression models were developed using a combined cohort from three randomized trials and two prospective cohort studies from 1,301 participants enrolled in surgical studies conducted by the Pelvic Floor Disorders Network. Composite recurrent prolapse was defined as prolapse beyond the hymen; the presence of bothersome bulge symptoms; or prolapse reoperation or retreatment within 12 months after surgery. Complications were defined as any serious adverse event or Dindo grade III complication within 12 months of surgery. Significant change in health status was defined as a minimum important change of SF-6D utility score (±0.035 points) from baseline. Thirty-two candidate risk factors were considered for each model and model accuracy was measured using concordance indices. All indices were internally validated using 1,000 bootstrap resamples to correct for bias. RESULTS: The models accurately predicted composite recurrent prolapse (concordance index=0.72, 95% CI 0.69-0.76), bothersome vaginal bulge (concordance index=0.73, 95% CI 0.68-0.77), prolapse beyond the hymen (concordance index=0.74, 95% CI 0.70-0.77), serious adverse event (concordance index=0.60, 95% CI 0.56-0.64), Dindo grade III or greater complication (concordance index=0.62, 95% CI 0.58-0.66), and health status improvement (concordance index=0.64, 95% CI 0.62-0.67) or worsening (concordance index=0.63, 95% CI 0.60-0.67). Calibration curves demonstrated all models were accurate through clinically useful predicted probabilities. CONCLUSION: These prediction models are able to provide accurate and discriminating estimates of prolapse recurrence, complications, and health status 12 months after prolapse surgery.

Modified Beef Tongue Model for Fourth-Degree Laceration Repair Simulation.

BACKGROUND: An existing model for fourth-degree laceration repair uses beef tongue with plastic or vinyl tubing. This modified model substitutes beef tripe for the anal mucosa and chicken leg muscles for the anal sphincter muscle analogs to create a realistic model. METHOD: Tripe is tunneled through the body of the trimmed beef tongue and sutured like an ostomy to simulate the anal canal. The tongue is incised toward the tripe "anal canal." Chicken leg muscles are tunneled from the incision out to the cut edges of the beef tongue to create anal sphincter muscle analogs. Procedures can be repeated on the opposite side. Two double-sided models can be made per tongue. EXPERIENCE: The model can be refrigerated or frozen and thawed before use. A fourth-degree laceration can be cut immediately before use. Materials were obtained at a local supermarket for $5-7 per half-tongue, double-sided model. Residents responded positively to the model and stated that animal tissue provided realistic haptic simulation. CONCLUSION: The modified beef tongue model utilizing tripe and chicken leg muscles as anal mucosa and anal sphincter muscle analogs, respectively, provided excellent perceived haptic fidelity. Moreover, it is an innovative, inexpensive, and well-received teaching tool to augment resident education.

Achilles tendoscopy.

Endoscopic surgery provides a minimally invasive approach to visualize and treat several pathologic conditions of the Achilles tendon. Open surgery on the Achilles tendon is notorious for wound complications, whereas endoscopic procedures have been recognized for less scaring, less perioperative pain, fewer wound complications, and faster recovery. This article reviews various endoscopic techniques for the treatment of equinus contracture, Achilles rupture, Haglund's deformity, and noninsertional Achilles tendinopathy.

Postoperative bowel function, symptoms, and habits in women after vaginal reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: The objective was to characterize postoperative bowel symptoms in women undergoing vaginal prolapse reconstructive surgery randomized to preoperative bowel preparation vs a regular diet. METHODS: Subjects (N = 121) completed two bowel diaries: a 7-day bowel diary immediately before surgery and a 14-day diary postoperatively. Self-reported bowel diary data and symptoms included the time to first bowel movement (BM), daily number of BMs, Bristol Stool Form Scale score, pain, and urgency associated with BM, episodes of fecal incontinence, and use of laxatives. Antiemetic use was abstracted from medical records. Outcomes of groups were compared using Chi-squared/Fisher's exact test or Student's t test as appropriate. RESULTS: Mean time to first postoperative BM was similar in the bowel preparation (n = 60) and control groups (n = 61), 81.2 ± 28.9 vs 78.6 ± 28.2 h, p = 0.85. With the first BM, there were no significant differences between bowel preparation and control groups regarding pain (17.2 vs 27.9 %, p = 0.17), fecal urgency with defecation (56.9 vs 52.5 %, p = 0.63), fecal incontinence (14.0 vs 15.0 %, p = 0.88) and >1 use of laxatives (93.3 vs 96.7 % p = 0.44) respectively. Antiemetic use was similar in both groups (48.3 vs 55.7 % respectively, p = 0.42). CONCLUSIONS: There were no differences in the return of bowel function and other bowel symptoms postoperatively between the randomized groups. Lack of bowel preparation does not have an impact on the risk of painful defecation postoperatively. This information may be used to inform patients regarding expectations for bowel function after vaginal reconstructive surgery.

Outcomes of midurethral sling procedures in women with mixed urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The objective was to compare midurethral sling (MUS) urinary outcomes in women with stress urinary incontinence (SUI) only versus mixed UI (MUI). METHODS: This was a retrospective cohort study of women who underwent primary MUS surgery for SUI. MUI was defined as at least "moderately" bothersome urgency and stress incontinence on the Urinary Distress Inventory (UDI-6) subscale of the Pelvic Floor Distress Inventory-20 (PFDI-20). The primary outcome was SUI cure defined by a response of "no," "not at all," or "somewhat" bothersome SUI on both of the two UDI-6 stress subscale items. Symptom impact was assessed using the Urinary Impact Questionnaire (UIQ-7). Multivariable models assessed the effect of MUI on SUI outcomes. RESULTS: One thousand one hundred and ninety-one primary MUS procedures were reviewed. Seven hundred and fifteen out of 1,191 (60%) questionnaires were returned and 534 out of 715 (75%) had completed baseline and follow-up questionnaires. Mean (± SD) follow-up time was 35 ± 15 months. Women with MUI had a higher (worse) baseline total score on the UDI-6 (p ≤ 0.001). A lower proportion of women with MUI had SUI success compared with the SUI only group (64 vs 84.5%, p < 0.001). On multivariable analyses, women in the MUI group were at an increased risk of SUI failure (OR 2.5, 95% CI 1.6, 4.0), but greater improvements in UDI-6 (-31.6 ± 30.6 vs -15.5 ± 25.1), and UIQ-7 scores (-21.7 ± 35.3 vs -15.1 ± 28.2) compared with women with SUI only (all p < 0.02). CONCLUSIONS: Women with MUI are at an increased risk of SUI failure after MUS compared with women with SUI only, but experience greater overall improvement in the impact of urinary symptoms on the quality of life.

Bowel preparation before vaginal prolapse surgery: a randomized controlled trial.

OBJECTIVE: To compare surgeons' intraoperative surgeon acceptability or assessment of the operative field regarding bowel contents and patients' satisfaction with or without a mechanical bowel preparation before reconstructive vaginal prolapse surgery. METHODS: In this single-blind, randomized trial, women scheduled to undergo vaginal prolapse surgery with a planned apical suspension and posterior colporrhaphy were allocated using block randomization to an intervention or control group. Surgeons were blinded to patient allocation. One day before surgery, mechanical bowel preparation instructions consisted of a clear liquid diet and two self-administered saline enemas; the participants in the control group sustained a regular diet and nothing by mouth after midnight. The primary outcome was surgeons' intraoperative assessment of the surgical field regarding bowel content as measured on a 4-point Likert scale (1, excellent; 4, poor). Secondary outcomes included participant satisfaction and bowel symptoms. The primary outcome was determined by intention-to-treat analysis and other analyses were per protocol. RESULTS: Of the 150 women randomized (75 women to intervention and control group), 145 completed the study. No differences existed in the demographic, clinical, and intraoperative characteristics between groups (P>.05). Surgeons' intraoperative assessment rating was 85% "excellent or good" with bowel preparation compared with 90% for participants in the control group (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.21-1.61; P=.30). The bowel preparation group was less likely to report "complete" satisfaction compared with the participants in the control group (OR 0.11, 95% CI 0.04-0.35; P<.001). Abdominal fullness and cramping, fatigue, anal irritation, and hunger pains were greater in the bowel preparation group (all P<.01). CONCLUSION: Before reconstructive vaginal surgery, mechanical bowel preparation conferred no benefit regarding surgeons' intraoperative assessment of the operative field, reflected decreased patient satisfaction, and had increased abdominal symptoms. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01431040. LEVEL OF EVIDENCE: I.

Incontinence outcomes in women undergoing primary and repeat midurethral sling procedures.

OBJECTIVE: To assess stress urinary incontinence (SUI) and other lower urinary tract symptom outcomes in women undergoing repeat midurethral sling procedures compared with those undergoing primary midurethral sling procedures. METHODS: Cure was defined as responses of "not at all" or "somewhat" to both questions of the SUI subscale of the Urogenital Distress Inventory-6; symptom effect was assessed using the Incontinence Impact Questionnaire-7. Multivariable models were created controlling for baseline Medical Epidemiologic and Social Aspects of Aging questionnaire urge score and Urogenital Distress Inventory-6 stress subscale score. RESULTS: One thousand three hundred sixteen patients had charts available for review: 135 of 1,316 (10.2%) had undergone prior midurethral sling procedures; 799 of 1,316 (61%) questionnaires were returned, with 92 from those having undergone prior midurethral sling procedures. Median follow-up time was 36.4 months with a range of 11.4-71.5 months. Cure rates were 71% (95% confidence interval [CI] 67.7-74.3%) in the primary midurethral sling group and 54% (95% CI 43.8-64.2%) in the repeat midurethral sling group (P<.001). Women undergoing repeat midurethral sling procedures experienced significantly greater improvement in symptom-specific quality of life (QOL) compared with those undergoing primary midurethral sling procedures (-28.87±37.6 compared with -18.42±32.73, P=.01). Multivariable analyses revealed that women in the repeat midurethral sling group had increased risk of SUI failure (odds ratio 1.7, 95% CI 1.1-2.8). CONCLUSION: Women undergoing repeat midurethral sling procedures had almost two times the odds of SUI treatment failure but greater improvement in symptom effect on QOL than did those undergoing a primary midurethral sling procedure. This information can help counsel patients regarding their expectations of repeat midurethral sling surgery for recurrent SUI . LEVEL OF EVIDENCE: II.

Vitamin D status in women with pelvic floor disorder symptoms.

INTRODUCTION AND HYPOTHESIS: Our aim was to characterize the relationship between 25-hydroxyvitamin D [25(OH)D] status with pelvic floor symptom distress and impact on quality of life. METHODS: A retrospective chart review was performed in women with a 25(OH)D level drawn within 1 year of their gynecology/urogynecology visit. Validated questionnaires including the Colorectal-Anal Distress Inventory (CRADI)-8 and Incontinence Impact Questionnaire (IIQ-7) were used. Multivariate analyses characterized pelvic floor disorder (PFD) symptom differences among women by vitamin D status. RESULTS: We studied 394 women. Mean ± standard deviation (SD) 25(OH)D levels were higher in women without than with PFD symptoms (35.0 ± 14.1 and 29.3 ± 11.5 ng/ml, respectively (p < 0.001)]. The prevalence of vitamin D insufficiency was 51% (136/268). CRADI-8 and IIQ-7 scores were higher among women with vitamin D insufficiency (p = 0.03 and p = 0.001, respectively). Higher IIQ-7 scores were independently associated with vitamin D insufficiency (p < 0.001). CONCLUSIONS: Insufficient vitamin D is associated with increased colorectal symptom distress and greater impact of urinary incontinence on quality of life.