The Patient Acceptable Symptom State in Female Urinary Incontinence.

OBJECTIVE: The objective of this study is to characterize an acceptable health state, using the patient acceptable symptom state (PASS) question, in adult women with urinary incontinence. METHODS: This is a prospective multicenter cohort study determining PASS thresholds from condition-specific measures using an electronic research platform in English-speaking women seeking nonsurgical treatment of urinary incontinence between March 2019 and May 2020. Exclusions included pregnancy, isolated overactive bladder, and pelvic organ prolapse greater than stage II. The cohort was described and then grouped based on achievement of PASS. The PASS thresholds were determined using the 75th percentile and univariate regression methods. Multivariable regression modeling was used to understand the influence of covariates on PASS achievement. RESULTS: The study was completed by 100 (80%) of the 125 enrolled subjects. Of these, 45% (n = 45) achieved PASS after a median of 7 weeks of treatment (range, 6-13 weeks). The corresponding questionnaire score for PASS was estimated to be 6 for the Incontinence Severity Index, 3 for the Patient Global Impression of Severity and Improvement, 37.5 using the Urinary Distress Inventory 6, and 33.3 using the Incontinence Impact Questionnaire 7. Increasing age was independently associated with achieving PASS after adjusting for treatment adherence and outcomes scores (adjusted odds ratio, 1.05 [95% confidence interval, 1.01-1.10]; P = 0.02). CONCLUSIONS: PASS was achieved in 45% of women after conservative treatment of urinary incontinence. PASS offers a new perspective for analysis and interpretation of outcome measures used in pelvic floor disorders and can serve as a reference for future research and clinical care pathways.

Do anxiety traits predict subjective short-term outcomes following prolapse repair surgery?

BACKGROUND: Studies conducted in orthopedic surgery have suggested that patients with anxiety have less symptomatic improvement following surgery than those without. We hypothesized for this study that patients with anxiety traits experience less symptomatic improvement following pelvic organ prolapse surgery than patients without. METHODS: All patients presenting for prolapse repair surgery were offered enrollment in this prospective cohort study. Prior to surgery, subjects were asked to complete the Spielberger State-Trait Anxiety Inventory and the Pelvic Floor Distress Inventory 20. Subjects were also asked to list up to five goals related to the outcome of surgery for goal-attainment scaling. At the 6-8-week postoperative visit, subjects were asked to repeat the STAI and PFDI questionnaires and respond to the single question tool assessing Patient Global Impression of Improvement. Subjects were also asked to rate on a Visual Assessment Scale how well preoperative goals were met. All three questionnaires were repeated at >12 weeks following surgery. RESULTS: A total of 32 patients with anxiety trait and 58 without were recruited. Preoperatively, the mean STAI-T was 45.0 (± 7.2.) and 27.7 (± 4.9) for subjects with and without anxiety; PFDI 20 scores were 96.1 (± 48.8) and 94.7 (± 57.5), respectively. At 12+ weeks postoperatively, the mean PFDI-20 for subjects with anxiety was 31.3 (± 20.9) and 30.3 (± 27.9) (p = 0.22) for those without. CONCLUSIONS: We did not find the anxiety trait to be a predictor of subjective outcomes following pelvic organ prolapse surgery.

Sodium fluorescein use during intraoperative cystoscopy.

BACKGROUND: Indigotindisulfonate sodium has been used during cystoscopy to identify the ureteral meatuses and to verify ureteral efflux during pelvic surgery. The U.S. Food and Drug Administration announced the shortage of indigotindisulfonate sodium in June 2014. Surgeons have since been searching for safe alternatives with comparable visualization and an economically favorable profile. METHOD: The recent shortage of indigotindisulfonate sodium prompted our search for alternative options for visualizing ureteral patency during intraoperative cystoscopy. Multiple methods were considered, including instilling the bladder with D50 water, sterile water, or methylene blue-tinged saline and visualizing the contrast in either viscosity or color of the urine against the instilled medium, preoperative oral phenazopyridine, and intravenous methylene blue. Collectively, these methods proved suboptimal. As an alternative, we injected the 10% preparation of sodium fluorescein at 0.25-1 mL intravenously and observed a brilliant yellow ureteral jet minutes after injection (see Video 1). EXPERIENCE: Ten percent sodium fluorescein given intravenously in doses ranging from 0.25 to 1.0 cc results in good visualization of ureteral jets. One patient experienced transient yellowing of the sclera and palms. CONCLUSION: Sodium fluorescein is an effective alternative to indigotindisulfonate sodium for visualization of ureteral jets during intraoperative cystoscopy.

Expectant management of cystotomy at the time of midurethral sling placement: a retrospective case series.

INTRODUCTION AND HYPOTHESIS: Cystotomy is one of the most common complications of retropubic midurethral sling placement. Some centers manage cystotomy with prolonged catheter drainage, and there are few published studies evaluating this practice. The purpose of this study is to review postoperative outcomes of patients who experienced cystotomy at the time of sling placement and did not undergo prolonged catheter drainage. METHODS: This is a retrospective review of all patients undergoing midurethral sling placement complicated by a cystotomy at the University of Rochester between 2004 and 2009. Outpatient and inpatient records were reviewed and data collected include demographics, intraoperative details, voiding trial results, postoperative complications, and voiding function. Descriptive statistics were performed. RESULTS: Between 2004 and 2009, 30 subjects experienced a cystotomy of the 374 subjects that had a midurethral sling placed, all by a suprapubic approach. There were 25 patients who underwent a voiding trial on the day of surgery and 20 (80 %) were discharged home without prolonged drainage. Five subjects (20 %) had urinary retention and were discharged with an indwelling catheter. All five successfully voided within 4 days of discharge. No subject required subsequent catheterization for any reason and at the 6-week postoperative evaluation all subjects denied voiding dysfunction or irritative bladder symptoms. No subject required additional intervention and postoperative complications were rare. CONCLUSIONS: In this study, the majority of subjects experiencing a cystotomy during midurethral sling placement were successfully discharged home the day of surgery without catheter drainage. The results suggest that prolonged catheter drainage after a cystotomy during midurethral sling placement may be unnecessary.

Bowel function after minimally invasive urogynecologic surgery: a prospective randomized controlled trial.

OBJECTIVES: The goals of this study were to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications on (1) time to first bowel movement (BM) and (2) pain level associated with first BM in subjects undergoing minimally invasive urogynecologic surgery. METHODS: Eligible patients scheduled to undergo minimally invasive urogynecologic surgery were offered participation. Enrolled subjects were randomized by computerized schedule. Demographic and perioperative data were collected. Subjects completed a validated questionnaire preoperatively and postoperatively assessing preexisting constipation, frequency and consistency of bowel movements, use of pain medications, mean daily pain level (using visual analog scale), stool consistency, and pain associated with first postoperative bowel movement. The control group was instructed to take docusate sodium twice daily postoperatively. The treatment group took docusate sodium plus Miralax, fiber wafers, and bisacodyl suppositories as directed by protocol. Wilcoxon or t testing was used to compare continuous variables; χ testing was used for categorical relationships, and backward-elimination multiple regression was used to assess independent effects. RESULTS: Seventy-two subjects were enrolled and randomized. Twelve subjects withdrew, leaving 60 (30 per group) completing the study. There were no statistically significant differences between groups in baseline characteristics. Mean (SD) age was 63 (9) years for the control group and 58 (10) for the study group (P = 0.06). Mean pelvic organ prolapse stage was III in each group. The mean (SD) operating room time was 198 (65) minutes for the controls and 216 (74) for the study subjects. Sixty-five percent underwent robot-assisted surgery (50% hysterectomy and 63% sacrocolpopexy). Ninety-eight percent of surgeries were performed under general anesthesia.Before adjustment, the mean (SD) time to first BM was 77 (24) hours in controls versus 64 (21) in the study patients (P = 0.03). Using multiple regression, baseline frequency of defecation (1-2 BMs/wk) was directly associated with the time to first BM (added 25.2 hours; P = 0.009) and being in the study group was inversely associated (first BM, 11.7 hours sooner; P = 0.04). No other variables were retained.There was no difference in pain associated with first postoperative BM (visual analog scale, 3.6 (3.2) vs 3.7 (2.8); P = 0.98), but those with prior complaints of vaginal or rectal splinting had higher pain scores (1.9 and 2.8 points higher, respectively; P = 0.04 for both). There was a trend toward higher pain scores with higher postoperative daily narcotic intake (P = 0.06). No other variables were retained.There was a significant difference in recorded compliance between control versus study regimens (94% vs 81%, respectively; P = 0.002). CONCLUSIONS: Mean time to first postoperative BM after minimally invasive urogynecologic surgery is more than 3.5 days with use of docusate sodium alone and is only slightly shorter when combination therapy is used. First BM after surgery is considered to be painful despite the use of medications. Future studies targeting postoperative discomfort/pain with defecation could target preoperative bowel regimens or more aggressive postoperative interventions. Regimens should remain simple to increase compliance.

Comparison of 2 techniques to predict voiding efficiency after inpatient urogynecologic surgery.

PURPOSE: We compared 2 techniques used to assess adequate postoperative bladder emptying. MATERIALS AND METHODS: We performed a prospective, randomized, crossover study of 2 voiding trial techniques. 1) For back fill the bladder is filled with 300 cc saline before the Foley catheter is removed. 2) For auto fill the catheter is removed and the bladder is allowed to fill spontaneously. Patients were randomized into 2 groups for voiding trials, including group 1-auto fill followed by back fill or group 2-back fill followed by auto fill. Within 15 minutes of each void we measured post-void residual urine by straight catheterization. A void of two-thirds or greater of total bladder volume (voided volume plus post-void residual urine) at void 2 of the 2 voids was considered successful voiding. Patients who voided successfully were discharged home without a urethral catheter. We used the chi-square test with κ to determine successful bladder emptying. RESULTS: We recruited 79 patients, of whom 65 with a mean age of 59.7 years (range 33 to 81) had complete data sets available for analysis. Of the patients 38 (58%) underwent prolapse repair only, 1 (2%) underwent a continence procedure only and 26 (40%) underwent each procedure. The back fill void trial correlated better with a successful voiding trial than the auto fill trial (κ = 0.91, 95% CI 0.81-1.00 vs κ = 0.56, 95% CI 0.39-0.74). Overall 40.5% of patients had an unsuccessful void trial on day 1 postoperatively and were discharged home with a catheter. None subsequently experienced urinary retention. CONCLUSIONS: The back fill technique appears to be a better predictor of adequate postoperative bladder emptying than the auto fill technique for inpatient void trials.

Symptom-based, clinical, and urodynamic diagnoses of urinary incontinence: how well do they correlate in postmenopausal women?

OBJECTIVE: : The objective of this study was to determine the correlation between symptom-based, clinical, and urodynamic (UD) diagnoses of urinary incontinence in postmenopausal women. METHODS: : This is a review of results of UD findings in postmenopausal women with signs and/or symptoms of urinary incontinence. Positive predictive values (PPVs) were calculated for symptom-based and clinically assigned diagnoses by subtype of incontinence and UD diagnosis. RESULTS: : A total of 105 postmenopausal women with signs and/or symptoms of urinary incontinence underwent UD testing. Subjects were predominantly white (95.1%), with average age 61 (SD, ±9). Overall, symptom diagnosis matched UD diagnosis 27% of the time. Similarly, clinical diagnosis matched UD diagnosis 27% of the time. All 3 diagnoses (symptom, clinical, and UD) matched 18% of the time. Report of urine loss with Valsalva had a PPV of 0.57, for UD diagnosis of stress incontinence. For symptoms of urge and mixed incontinence, PPVs were 0.22 and 0.11, respectively. Clinical diagnoses of stress, urge, and mixed incontinence as compared with UD diagnosis showed PPVs of 0.64, 0.30, and 0.09, respectively. PPV for any UD diagnosis of incontinence was 0.69 by symptoms and 0.71 by clinical evaluation. CONCLUSIONS: : The correlation between type of urinary incontinence based on symptoms, clinical evaluation, and UD findings is poor overall in postmenopausal women. It is highest with stress and lowest with mixed incontinence. The voiding diary and cough stress test are valuable tools in predicting type of incontinence by UD testing.

Urodynamic prediction of occult stress urinary incontinence before vaginal surgery for advanced pelvic organ prolapse: evaluation of postoperative outcomes.

OBJECTIVES: : To evaluate the use of urodynamics for assessment of occult stress urinary incontinence (SUI) in women undergoing vaginal surgery for advanced pelvic organ prolapse (POP). METHODS: : Retrospective chart review of women who underwent vaginal surgery for advanced POP at the University of Rochester Medical Center. RESULTS: : The study sample was composed of 41 women (mean age: 65.6 years; range: 42-88 years). Prolapse was stage 3 or 4 in 40 (97.6%) women. Urodynamics identified 17 (41.5%) women with occult SUI. Postoperatively, 3 (7.3%) women reported urinary incontinence: 1 with stress and 2 with urge-related symptoms. The woman with postoperative SUI had been diagnosed with occult SUI, but declined continence repair. None of the women without occult SUI on urodynamics reported postoperative SUI. CONCLUSIONS: : Urodynamic evaluation prior to vaginal surgery for advanced POP can identify women at risk for SUI, who may benefit from concomitant continence repair.

Recovery after robot-assisted laparoscopic sacrocolpopexy: the patients' perspective.

Little information exists about recovery after robot-assisted laparoscopic sacrocolpopexy. We sought to report on subjects' perioperative experience. Subjects were queried about resumption of activities such as work and driving, bowel function, whether recovery went as expected, and whether they would recommend this surgery. Use of pain medications, pain scores, and perioperative data were collected N = 21. All would recommend surgery to a friend. 13/18 (72%) felt their recovery went better than expected, and none responded it was worse than expected. 9/21 (43%) did not use narcotics after the day of surgery, with 15/21 (71%) no longer taking narcotics by postoperative day 4. Fifty-five percent experienced their first postoperative bowel movement as painful. Based on this survey, most patients undergoing robot-assisted laparoscopic sacrocolpopexy will not require narcotics beyond postoperative day 3. Nonsteroidals are the mainstay of pain management. This survey highlights the importance of preventing postoperative constipation/ painful defecation.

Incontinence and pelvic organ prolapse in parous/nulliparous pairs of identical twins.

AIM: To evaluate the role of vaginal delivery in the development of urinary incontinence and pelvic organ prolapse in four sets of identical twins. METHODS: Four sets of identical twins were identified from 101 pairs of parous/nulliparous postmenopausal sister pairs, who completed a comprehensive questionnaire, and underwent clinical evaluation of urinary incontinence and pelvic organ prolapse as part of a study. Findings of identical twin sisters were compared to each other. RESULTS: Ages ranged from 52 to 56 years; the parous sister in each pair had two vaginal deliveries. Two twin pairs reported no incontinence. One pair reported incontinence with activities and stress incontinence was confirmed with VLPP of 120 and 130 cm H(2)O in the nulliparous and parous sister respectively. In one pair only the nulliparous sister reported incontinence, however both sisters were diagnosed with stress incontinence with VLLP of 130 and 120 cm in the nulliparous and parous sister respectively. Using POP-Q staging for relaxation of the pelvic support system, only one twin pair had a greater than 1 stage difference in any compartment. CONCLUSIONS: All four pairs of identical twins were diagnosed with identical continence status. Three pairs were identical with regard to support in all three compartments. Vaginal delivery was not associated with urinary incontinence or clinically relevant differences in relaxation of the pelvic support system within four sets of postmenopausal identical twins with different parity status.

Is parity in the eye of the beholder?

To investigate whether parity status can be predicted by physical examination and which findings are most predictive. A retrospective chart review of 75 postmenopausal nulliparous/parous sister pairs who underwent gynecological examination as part of a study. An examiner, blinded to parity status, predicted parity status based on physical findings recorded on 146 women. Parity status was correctly predicted for 84.9% of the women. Of the 22 women for whom parity prediction was incorrect, 11 were nulliparous and 11 parous. The physical findings most commonly used for prediction were presence or absence of abdominal striae, appearance of the cervical os, and condition of hymen. Absence of the hymen at 6 o'clock alone correctly predicted parity in 11 of 12 parous and 11 of 11 nulliparous women. Parity status can be predicted based on physical exam in the majority of women. Blinding of investigators to parity status may not be feasible.

Outcome of transvaginal radiofrequency for treatment of women with stress urinary incontinence.

The objective of the study was to assess the outcome and patient acceptance of the transvaginal radiofrequency bladder neck suspension procedure. A retrospective chart review of 18 women treated with the transvaginal radiofrequency bladder neck suspension procedure for stress urinary incontinence was conducted. Data on demographics, urodynamics, daily leakage episodes, complications, patient satisfaction, and further intervention were collected. The mean number of leaks per day was 5.7. There were no complications. Postoperatively, two patients were continent, four were improved, and ten were unimproved. The mean number of daily leaks was reduced to 2.7. Five patients reported to be extremely satisfied with the procedure. One patient was satisfied, and ten were not satisfied. Seven patients sought additional treatment within 1 year. Low cure rate, low patient satisfaction, and high rate of additional treatment led us to discontinue transvaginal radiofrequency bladder neck suspension procedure as a treatment option. It is important that long-term outcome data of the initial studies be made public.

Pelvic organ prolapse in nulliparous women and their parous sisters.

OBJECTIVE: To investigate the role of vaginal delivery and familial factors in the development of pelvic organ prolapse by comparing the prevalence of this condition in nulliparous women and their parous sisters. METHODS: Pairs of nulliparous and parous postmenopausal sisters were recruited for assessment of pelvic organ prolapse. One hundred one sister pairs underwent clinical evaluation. Pelvic organ prolapse was recorded using the Pelvic Organ Prolapse Quantification System. RESULTS: The majority of women had no pelvic organ prolapse. By compartment there was a 74.3% to 91.1% concordance in prolapse stage within sister pairs. In discordant sister pairs, the parous sister was found to have the more advanced prolapse 88% of the time. CONCLUSION: High concordance of pelvic organ prolapse in nulliparous and parous sister pairs suggests a familial predisposition toward developing this condition. However, vaginal delivery does appear to confer a risk for more advanced pelvic organ prolapse. LEVEL OF EVIDENCE: II-2.

Local anesthesia with sedation for vaginal reconstructive surgery.

To evaluate local anesthesia with sedation for vaginal reconstructive surgery. All cases of vaginal surgery performed by the primary author for correction of pelvic organ prolapse with and without urinary incontinence between February 2000 and October 2004 were identified. From the medical record, data on age, duration of surgery, amount of local anesthetic used, estimated blood loss, hospital stay, urinary retention, and need for conversion to general anesthesia were recorded. Among 127 potential candidates, 98 (77.2%) opted for local with sedation. These cases included 18 anterior colporrhaphies, 47 posterior colporrhaphies with perineoplasties, 9 enterocele repairs, 32 total colpocleises, and 9 LeFort procedures. Tension-free vaginal tape (TVT) were concomitantly placed in 37 of the cases; 121 TVT-only cases done under local were not included. No cases were converted to general anesthesia. Surgical time ranged from 20 to 195 min (mean 99 min). Most patients were discharged within 24 h of surgery. Traditionally, local anesthesia with sedation has been reserved for superficial vaginal procedures. However, it can be successfully employed for more invasive vaginal reconstructive surgeries. Duration of surgery and patient acceptance have not been limiting factors. The advantages of local anesthesia include minimal interference with homeostasis and rapid recovery with patients often bypassing the recovery unit.

Local anesthesia with sedation for transvaginal correction of advanced genital prolapse.

OBJECTIVE: The purpose of this study was to evaluate local anesthesia with sedation for vaginal surgery for advanced genital prolapse. STUDY DESIGN: Five sacrospinous ligament suspensions and 12 vaginal paravaginal defect repairs performed under local anesthesia in 2004 were identified. Medical records and patient satisfaction questionnaire were reviewed. Patient demographics, degree of prolapse, duration of surgery, hospital stay, and responses to an anesthesia satisfaction questionnaires were recorded. RESULTS: All repairs incorporated placement of dermal allograft. Concomitant procedures included: 6 tension-free vaginal tape (TVTs), 12 posterior and 4 enterocele repairs. Mean patient age was 66.1 years. All patients had prolapse of apex or anterior wall > or = grade 3. Mean OR time was 132 minutes. Average hospital stay was 1.2 days. No patient was converted to general anesthesia. All 17 patients were "very satisfied" with their surgical experience. CONCLUSION: Local anesthesia with sedation can be successfully employed for most vaginal reconstructive surgeries with advanced genital prolapse. Patients report a high level of satisfaction.

Urinary incontinence in nulliparous women and their parous sisters.

OBJECTIVE: To investigate the role of vaginal delivery and familial factors in the development of urinary incontinence by comparing the prevalence of this condition in nulliparous women and their parous sisters. METHODS: A sample of 143 pairs of nulliparous/parous postmenopausal sisters completed a comprehensive questionnaire regarding symptoms of pelvic floor disorders. Of these, 101 pairs underwent clinical evaluation of urinary incontinence and genital prolapse. RESULTS: Among this sample of biological sisters, urinary incontinence was reported by 47.6% of nulliparous women and by 49.7% of parous women (P = .782). We found no difference in the severity or type of urinary incontinence between these 2 groups. There was a high concordance in continence status, however, within biological sisters. CONCLUSION: Vaginal birth does not seem to be associated with urinary incontinence in postmenopausal women. Considering the high concordance in continence status between sister pairs, and considering that the majority of parous women are continent, an underlying familial predisposition toward the development of urinary incontinence may be present.

True occult bladder perforation during placement of tension-free vaginal tape.

Bladder perforation is one of the most common complications of the trans-vaginal tape (TVT) procedure, and is generally identified on routine intra-operative cystoscopy. We present a case of occult bladder perforation occurring during the TVT procedure that could not be identified by cystoscopy. A 57-year-old woman underwent TVT placement for treatment of stress urinary incontinence. A bladder perforation, suspected because of clear fluid at one of the abdominal incision sites, could not be identified with cystoscopy, but was confirmed with bladder installation of sterile infant formula. The tape was removed and the bladder was drained for 48 h. The patient's recovery was uneventful and she subsequently underwent TVT placement without complication. Cystoscopy alone may be inadequate for identification of some bladder perforations during the TVT procedure. Awareness of alternative methods of identification is essential.