Pudendal Neuromodulation is Feasible and Effective After Pudendal Nerve Entrapment Surgery.

BACKGROUND: Patients with intractable pain in the pudendal nerve distribution may benefit from pudendal neuromodulation; however, some may have previously undergone pudendal nerve entrapment surgery (PNES), potentially altering nerve anatomy and function. AIM: We examined pudendal neuromodulation outcomes in patients with prior PNES. METHODS: Patients with a history of PNES and quadripolar, tined pudendal lead placement for urogenital pain were reviewed. Symptoms and outcomes were collected from existing medical records. OUTCOMES: Patients with pudendal neuromodulation and prior PNES were compared to patients with no prior PNES who had pudendal lead placement. RESULTS: Fifteen patients with a history of 1, 2, or 3 prior PNES (n = 13, 1, and 1, respectively) were evaluated. Most (10; 67%) were female, with bilateral pain (9; 60%), and symptoms of 5-26 years. After trialing the lead, bladder symptoms and pain were improved in 8 of 12 and 9 of 14 patients, respectively, and 80% of patients (12/15) underwent permanent generator implantation. When prior PNES patients were compared to those with no prior PNES (n = 43), gender (67% vs 77% female; P = .50) and age (median 63 vs 58 years; P = .80), were similar; however, BMI differed (mean 24 vs 29; P = .008) and a lower proportion (12/15; 80% vs 42/43; 98%; P = .049) had generator implantation. Importantly, median lead implant time (48 vs 50 minutes; P = .65) did not differ between the 2 groups. CLINICAL IMPLICATIONS: Pudendal neuromodulation has the potential to provide pain relief for a very difficult-to-treat population; furthermore, it does not appear that prior PNES surgery made lead placement significantly more challenging. STRENGTHS & LIMITATIONS: Study strengths include being a tertiary referral center for urogenital pain and having a single surgeon perform all procedures in a regimented way. Limitations include the retrospective study design, small sample size and various approaches to PN CONCLUSION: Chronic pudendal neuromodulation can be a viable option even after prior PNES. Kristen M. Meier, Patrick M. Vecellio, Kim A. Killinger, Judith A. Boura, Kenneth M. Peters. Pudendal Neuromodulation is Feasible and Effective After Pudendal Nerve Entrapment Surgery. J Sex Med 2022;19:995-1001.

Coexisting depressive symptoms do not limit the benefits of chronic neuromodulation: A study of over 200 patients.

AIMS: To examine the relationship between coexisting depressive symptoms and outcomes after staged neuromodulation procedures for refractory urological symptoms. METHODS: Adults who enrolled in a prospective database and completed a Personal Health Questionnaire Depression Scale (PHQ-8) at baseline were reviewed. The PHQ-8 and Generalized Anxiety Disorder (GAD-7) assessed depressive/anxiety symptoms pre and 6 months post device implant. Urological symptoms were assessed with The Interstitial Cystitis Symptom Index/Problem Index (ICSI-PI) and Overactive Bladder Questionnaire (OAB-q) at baseline, 3 and 6 months, and Global Response Assessments (GRA) post implant. Subjects, grouped by PHQ <10 and PHQ ≥10, were compared with Pearson's Chi-square, Fisher's Exact or Wilcoxon rank test, and Spearman's correlations. RESULTS: In 117 PHQ <10 and 84 PHQ ≥10 patients, age differed (mean 59 vs 52 years; P = 0.001), and PHQ <10 had lower GAD-7, ICSI-PI, and OAB-q scores at baseline (P < 0.0001, P = 0.0003, and P < 0.0008, respectively). Implantation rates were similar between groups. Reoperation and complication rates within the first 6 months did not differ, similar proportions (majority) were improved on the GRA at each time point, and ICSI-PI and OAB-q scores improved significantly. PHQ scores only improved significantly for those with baseline PHQ ≥10. Baseline PHQ strongly correlated with GAD-7 at baseline and 6 months, and baseline ICSI-PI. Change in PHQ positively correlated with the change in GAD-7, 6 month ICSI-PI, and change in ICSI-PI from baseline to 6 months. CONCLUSIONS: Coexisting depressive symptoms do not limit the efficacy of neuromodulation and PHQ improvements correlate with improved anxiety and bladder symptoms.

The impact of prior back surgery on neuromodulation outcomes: A review of over 500 patients.

AIMS: To evaluate neuromodulation outcomes in patients with prior back surgery. METHODS: Adults in our prospective observational sacral/pudendal neuromodulation study were retrospectively evaluated. History and operative details were reviewed, and outcomes were measured at 3, 6, 12, and 24 months with overactive bladder questionnaire (OAB q) symptom severity (SS)/health related quality of life (HRQOL), interstitial cystitis symptom/problem indices (ICSI - PI), voiding diaries, and global response assessments (GRA). Data were examined with Pearson's χ2 , Fisher's exact, Wilcoxon rank sum tests, and logistic regression multivariate analysis. RESULTS: Five hundred and sixty patients were evaluated (mean age 58.8 ± 17 years; 83% female; 79% had a sacral lead placed), 109 (19%) had history of back surgery; 66 surgeries were lumbar. Back surgery patients were older (mean 63 ± 15 vs. 58 ± 17 years; P = 0.003) and a higher proportion had urge urinary incontinence (UUI) (64% vs. 50% P = 0.008). Generator implant rates were similar (94% vs. 91%; P = 0.34). OABq-SS and HRQOL and ICSI - PI composite scores did not differ between groups at any time point. On bladder diaries, median incontinence episodes daily at baseline and between stages were worse in the prior back surgery group but all bladder diary parameters improved significantly in both groups with the exception of mean voided volume which only improved significantly in the non-back surgery group. Most patients in both groups reported moderate/marked improvement in overall bladder symptoms. CONCLUSIONS: This study suggests that prior back surgery does not appear to impact clinical outcomes; therefore, neuromodulation may be offered in this patient population.

Predictors of reoperation after sacral neuromodulation: A single institution evaluation of over 400 patients.

AIMS: To explore factors that may predispose patients to reoperation after sacral neuromodulation (SNM). METHODS: Patients enrolled in our longitudinal neuromodulation database were reviewed. Medical records data, and voiding diaries, Interstitial Cystitis Symptom-Problem Indices (ICSI-PI), and Overactive Bladder Questionnaires (OAB-q) at baseline and 3 months were analyzed with Pearson's χ2 , Fisher's Exact test, Wilcoxon rank tests, and multivariable logistic regression. RESULTS: Of 407 patients, 134 (33%) had at least one reoperation over median 28.9 months follow-up (range 1.6-121.7); 78/407 (19%) were revised, and 56/407 (14%) were explanted. The most common reason for reoperation was lack of efficacy/worsening symptoms (n = 87). The reoperations group had a higher proportion of women (P = 0.049), lower mean body mass index (BMI; P = 0.010), more reprogramming events (P < 0.0001), longer median follow-up (P = 0.0008), and higher proportions with interstitial cystitis (P = 0.013), using hormone replacement therapy (P = 0.0004), and complications (P < 0.0001). Both reoperations/no reoperations groups had similar improvements in ICSI-PI (P < 0.0001 for both), OAB-q severity (P < 0.0001 for both) and quality of life (P < 0.0001 for both). On multivariate analysis, only longer follow-up (P = 0.0011; OR 1.048; CI 1.019, 1.078) and having a complication (P < 0.0001; OR 23.2; CI 11.47, 46.75) were significant predictors of reoperations. In women only, using HRT at time of implant was also predictive of reoperation (P = 0.0027; OR 3.09; CI 1.48, 6.46). CONCLUSIONS: In this largest known series to date, one third of the patients required reoperation and the most common reason was lack of efficacy/worsening symptoms. Ongoing study is needed as the technology continues to evolve. Neurourol. Urodynam. 36:354-359, 2017. © 2015 Wiley Periodicals, Inc.

Analysis of changes in sexual function in women undergoing pelvic organ prolapse repair with abdominal or vaginal approaches.

INTRODUCTION AND HYPOTHESIS: To examine changes in sexual function after abdominal and transvaginal pelvic organ prolapse repair. METHODS: Women enrolled in our prospective, longitudinal prolapse database with abdominal sacrocolpopexy (ASC) or transvaginal (TVR) pelvic organ prolapse (POP) repair with or without mesh, between 19 December 2008 through 4 June 2014. The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and the Pelvic Floor Distress Inventory (PFDI -20) were mailed preoperatively, and at 6 and 12 months postoperatively. Patients completed Global Response Assessments to rate their overall satisfaction. RESULTS: Two hundred and four of the 300 women met the inclusion criteria: 74 out of 204 (36 %) had ASC and 130 out of 204 (64 %) had TVR. Seventy-two out of seventy-four ASCs were performed robotically and 2 were open. Baseline demographics were similar except that the ASC patients were significantly younger (60 vs 63, P = 0.019) and had a higher rate of apical repair (77 % vs 55 %). Thirty-six out of seventy-four ASC (48.7 %) and 63 out of 128 TVR patients (49.2 %) were sexually active at baseline (P = 0.94). Sixteen out of thirty-eight ASC (42.1 %) and 18 out 63 TVR patients (28.6 %; P = 0.16) reported dyspareunia at baseline. Seventy-two out of seventy-four ASC (97 %) and 86 out of 130 TVR patients (66 %) had mesh-augmented repairs. There was no difference in sexual activity or dyspareunia between the groups at the 6- or 12-month follow-up. PISQ and PFDI scores improved significantly in both the ASC and TVR groups over time compared with the baseline (p < 0.0001). Most women in the ASC (77.5 %) and TVR (64.8 %) groups were satisfied with the results of prolapse surgery at 12 months. CONCLUSIONS: Sexual function and pelvic floor symptoms improved in a similar manner in patients after abdominal and transvaginal POP surgery.

Changes in sexual functioning in women after neuromodulation for voiding dysfunction.

INTRODUCTION: Sacral neuromodulation is a well-established treatment for urinary and bowel disorders with potential use for other disorders such as sexual dysfunction. AIM: To evaluate changes in sexual functioning in women undergoing neuromodulation for voiding symptoms. METHODS: Patients enrolled in our prospective, observational neuromodulation database study were evaluated. Data were collected from medical records, and patient-completed Female Sexual Function Index (FSFI) and Interstitial Cystitis Symptom-Problem Indices (ICSI-PI) at baseline, 3, 6, and 12 months post-implant. Patients rated overall change in sexual functioning on scaled global response assessments (GRA) at 3, 6, and 12 months post-implant. We grouped women by baseline FSFI scores: less (score<26) and more sexually functional (score≥26). Data were analyzed with Pearson's Chi-square or Fisher's Exact test and repeated measures. MAIN OUTCOMES MEASURES: Changes in FSFI and ICSI-PI scores in women grouped by baseline FSFI score<26 and ≥26. RESULTS: Of 167 women evaluated, FSFI scores improved overall from preimplant (mean 13.5±8.5) to 12 months (N=72; mean 15.9±8.9, P=0.004). At baseline and each follow-up point, ICSI-PI scores were similar between groups and improved through time. For patients in the FSFI<26 group there was improvement from baseline to 12-month scores (N=63; 11.9±6.9 to 14.8±8.7; P=0.0006). Improved FSFI domains included desire, orgasm, satisfaction, and pain. Furthermore, of the 74 subjects in this group not sexually active at baseline, 10 became sexually active during follow-up. In the FSFI≥26 group there was slight but statistically significant decline in mean scores between baseline and 12 months (N=9; 27.4±1.1 to 24.5±3.4; P=0.0302); however one had become sexually inactive. A significant decrease was seen in the satisfaction domain. CONCLUSIONS: Many factors affect sexual functioning in women; however sexual function may improve along with urinary symptoms after neuromodulation.

Does patient age impact outcomes of neuromodulation?

AIMS: We evaluated whether patients stratified by age have the same level of risks/benefits after a staged neuromodulation procedure for refractory voiding symptoms. METHODS: Urologic diagnosis, complications, and revisions were collected from medical records of adults enrolled in our prospective observational study. Symptoms were assessed over 2 years with diaries, Interstitial Symptom-Problem Indices (ICSI-PI), and the Overactive Bladder Questionnaire-SF (OAB-q SF). 12-item Short-Form Health Survey (SF-12v2®) mental (MCS) and physical (PCS) component summaries evaluated quality of life. Data were examined with Pearson Chi-square or Fisher's Exact test, Kruskal-Wallis tests, and repeated measures analyses. RESULTS: Patients (83% female) were grouped by age (years): <40 (n = 46), 40-64 (n = 146), and ≥65 (n = 136). Urge incontinence was predominant in the older groups and more patients <40 had interstitial cystitis/painful bladder syndrome (IC/PBS). In the <40, 40-64, and ≥65 groups, respectively, generator implant (91%, 88%, and 89%) and explant (15%, 12%, and 10%) rates were similar. Complications (24%, 14%, and 9%; P = 0.031) and revisions (20%, 5%, and 6%; P = 0.0025) differed. For the three respective groups, urinary frequency (P < 0.0001 for all), nocturia (P < 0.0001 for all), incontinence episodes (P < 0.0001 for all), urgency (P = 0.0474, P < 0.0001, P = 0.0020), ICSI-PI (P = 0.0015, P < 0.0001, P < 0.0001), and OAB-q scores improved over time. Incontinence severity improved in those >65 (P = 0.0015). SF-12 PCS improved in those 40-64 (P = 0.0482) and MCS scores improved in the <40 and 40-64 age groups (P = 0.013 and P = 0.0440, respectively). CONCLUSIONS: These data suggest that neuromodulation success is not age dependent, however continued study is needed to confirm findings.

Pain in interstitial cystitis/bladder pain syndrome: do characteristics differ in ulcerative and non-ulcerative subtypes?

INTRODUCTION AND HYPOTHESIS: Key differences between interstitial cystitis/bladder pain syndrome (IC/BPS) subtypes (with and without Hunner's ulcer) have been noted. We hypothesized that pain characteristics in women grouped by IC/BPS subtype would differ. METHODS: A survey was mailed to 749 women to assess IC/BPS pain and other characteristics. Cystoscopy/hydrodistention reports were reviewed for presence/absence of Hunner's ulcer. The McGill Pain Questionnaire Short Form© (MPQ-SF), Brief Pain Inventory (BPI), and Interstitial Cystitis Symptom and Problem Indices (ICSI-PI) assessed symptoms. Data were analyzed with Pearson's chi-square, Fisher's exact, t tests, and Wilcoxon rank tests. RESULTS: Of the 214 women that returned a survey (36 ulcerative and 178 non-ulcerative IC/BPS), similar proportions in each group reported that certain foods, exercise, and/or stress triggered symptoms. Fewer ulcerative patients reported pain with vaginal penetration than non-ulcerative (5/33, 15.2 % vs 76/160, 47.5 %; p = 0.0006). On the BPI, the ulcerative and non-ulcerative groups reported similar numbers of painful areas (mean 4.1 ± 6.1 and 4.1 ± 3.8; p = 0.33), and lower abdominal/pelvic pain was reported most (13/35, 37 % vs 79/172, 46 %; p = 0.34) followed by lower back pain (12/35, 34 % vs 69/172, 40 %; p = 0.52). Even though ICSI-PI, MPQ-SF, and BPI scores/responses did not differ, on the MPQ-SF the three words most frequently used by ulcerative patients to describe their pain were sharp, stabbing, and hot burning, and in non-ulcerative were aching, cramping, and tender. CONCLUSIONS: These measures did not reveal any significant differences in pain between subtypes. More research is needed in larger samples to determine whether differences exist.

Perioperative experience of pelvic organ prolapse repair with the Prolift and Elevate vaginal mesh procedures.

INTRODUCTION AND HYPOTHESIS: We compared the operative and immediate postoperative experience of the trocar-based Prolift and non-trocar-based Elevate techniques used to repair vaginal prolapse. METHODS: A retrospective review of Prolift and Elevate repairs was performed. Baseline characteristics and operative and postoperative variables evaluated included compartment(s) repaired, adjacent organ injury, operative time (OT), change in hemoglobin (ΔH), pain score, narcotic use, length of stay (LOS), and short-term complications. Categorical variables were assessed as counts and percent frequency. Data were compared using chi-squared analysis and paired t test. RESULTS: Prolift (n = 143) and Elevate (n = 77) patients were similar in age (p = 0.19). Concurrent hysterectomy was done in 22 (15.4 %) and 24 (31.2 %), respectively, and concurrent midurethral sling placed in 100 (70 %) and 50 (65 %), respectively. LOS (median, 25th,75th) after anterior/apical compartment repairs was shorter with Elevate, whether with (1.0; 1.0,1.5 vs. 2.0 days;1.0, 2.0; p = 0.003) or without (2.0; 1.0, 2.0 vs. 2.0 days; 2.0, 3.0; p = 0.024) hysterectomy, but no differences in OT, ΔH, pain score, or narcotic use occurred. Posterior compartment mean pain scores were lower with Prolift (3.6 ± 2.2 vs. 1.7 ± 1.5, p = 0.035), and three-compartment-repair pain scores were lower with Elevate (0.6 ± 1.3 vs 2.5 ± 1.9; p = 0.013). Three bladder injuries occurred with Prolift but none with Elevate. CONCLUSIONS: Operative and postoperative experiences were similar between groups; however, Elevate anterior/apical repairs had shorter LOS, which might reflect more aggressive discharge planning. There were no bowel or major vascular injuries, and the Prolift trocar bladder injuries did not alter the surgical procedure.

Is sensory testing during lead placement crucial for achieving positive outcomes after sacral neuromodulation?

AIMS: Motor and sensory responses help guide lead placement during staged neuromodulation procedures. However, eliciting sensory responses requires lighter anesthesia. We evaluated the impact of assessing sensory responses during quadripolar tined lead placement on outcomes in subjects with refractory voiding symptoms. METHODS: Adults who had a sacral lead placed were identified from our prospective neuromodulation database and grouped by whether they had intraoperative sensory testing or not. History, operative data, and implantable permanent generator (IPG) implant, lead revision and device explant rates were collected from medical records. Symptoms were evaluated with the Interstitial Cystitis Symptom Index/Problem Index (ICSI-PI) and scaled global response assessments (GRA) for the first 24 months post IPG placement. Data were analyzed using Pearson's Chi-square, Fisher's Exact, or Wilcoxon rank test. RESULTS: Of 141 subjects (82% female), 86 (61%) had sensory testing and 55 (39%) did not. Sensory and no sensory testing groups were not significantly different on demographics, urologic diagnosis, IPG implant rates (76/84; 90% and 48/55; 87% respectively) or mean operative time (37.9 ± 13.9 minutes vs. 35.5 ± 11.6). Within 4 years, 19/141 (13.5%) were revised and/or explanted. For explant alone, 11/86 (13%) in the sensory and only 3/55 (5.5%) in the no sensory group (P = 0.16) were explanted. Overall, ICSI-PI scores improved over time (P < 0.0001) and most reported improvement on the GRA at each time point, but no differences were seen between groups. CONCLUSIONS: Intraoperative sensory testing during sacral lead placement does not necessarily improve IPG implantation rates or clinical outcomes of neuromodulation.

Secondary changes in bowel function after successful treatment of voiding symptoms with neuromodulation.

AIMS: Expanded indications for neuromodulation are continually being explored. We evaluated secondary changes in bowel function after successful neuromodulation for voiding symptoms. METHODS: Patients in our prospective neuromodulation database study with comorbid irritable bowel syndrome (IBS), constipation and/or diarrhea, or fecal incontinence (FI) at baseline were evaluated. Pre- and 3, 6, and 12 months post-operative measures included Interstitial Cystitis Symptom Index and Problem Index (ICSI-PI), bowel diaries (assessing bowel movement frequency; constipation, diarrhea, and FI episodes), and scaled global response assessments (GRA) ("markedly worse" to "markedly improved" bowel function). RESULTS: Most patients reporting secondary bowel problems (128/199; 64.3%) were female (89%; mean age 56 ± 15.4 years). Primary voiding complaints were urgency/frequency (U/F) with or without urinary incontinence (n=74), interstitial cystitis/painful bladder syndrome (IC/PBS; n=43), and urinary retention (n=11). Secondary bowel complaints included constipation and/or diarrhea (49%), IBS (27%), and FI (23%). Urinary (ICSI-PI) scores improved after treatment (P<0.0001 for IBS and constipation/diarrhea; P=0.0021 for FI). Bowel diary data only indicated that mean FI episodes/day increased over time (P = 0.0100) in the FI group. Only the 12-month value (1.4 ± 2.2; n=8) was significantly different from baseline (0.3 ± 0.5; n = 18). On the GRA, only the IBS group consistently reported bowel function improvement versus worsening at each time point. Many reported no change. CONCLUSIONS: Studies have indicated that neuromodulation improves FI in carefully selected patients. The impact on other bowel conditions, including IBS, is unclear. Since voiding and bowel symptoms often coexist, it is crucial to fully evaluate all potential treatment benefits.

Small Fiber Polyneuropathy in Hunner Lesion and Non-Hunner Lesion Interstitial Cystitis/Bladder Pain Syndrome.

OBJECTIVE: This study aimed to determine whether small fiber polyneuropathy (SFPN) diagnosis differs between Hunner lesion interstitial cystitis/bladder pain syndrome (HL IC/BPS) and non-Hunner lesion IC/BPS (NHL IC/BPS). METHODS: This was a pilot study of 20 women with IC/BPS. Results from baseline questionnaires, such as Genitourinary Pain Index, Interstitial Cystitis Symptom Index/Interstitial Cystitis Problem Index (ICSI/ICPI), Patient Health Questionnaire-2, were collected.Two punch biopsies were performed on each patient: distal leg and thigh. The samples were evaluated for intraepidermal nerve fiber density. One intraepidermal nerve fiber density less than the fifth percentile, regardless of site, indicated a positive SPFN diagnosis. RESULTS: Twenty patients were enrolled; 10 HL IC/BPS and 10 NHL IC/BPS. The HL IC/BPS group was found to be significantly older than the NHL IC/BPS group (63 vs 48 years, P = 0.007). No significant differences were found in employment or relationship statuses, or in levels of education or comorbidities between the 2 groups.Sixty percent (6/10) of patients had SFPN in the NHL IC/BPS group compared with 40% (4/10) in the HL IC/BPS group. No significant differences were seen in SFPN positivity (P = 0.3) or Genitourinary Pain Index, Patient Health Questionnaire-2, or Interstitial Cystitis Symptom Index/Interstitial Cystitis Problem Index scores between the NHL and HL IC/BPS groups. CONCLUSIONS: Similar to previously published studies, 60% of NHL IC/BPS patients in this cohort were positive for SFPN compared with only 40% of the HL IC/BPS patients. Larger studies may be needed to realize the full impact of SFPN in IC/BPS.

Symptom and Quality of Life Improvements After Pelvic Floor Physical Therapy in a Clinical Population of Women With Pelvic Pain and Other Symptoms.

OBJECTIVES: This study aimed to evaluate changes in validated symptom scores at intake and discharge in women undergoing pelvic floor physical therapy (PFPT) for pain and other pelvic floor symptoms. METHODS: Consecutive women starting PFPT during 1 year were reviewed. History, demographics, and Pelvic Floor Distress Inventory Questionnaire - Short Form 20 (PFDI) total and domain scores (Pelvic Organ Prolapse Distress Inventory-6, Urogenital Distress Inventory-6, Colorectal-Anal Distress Inventory-8), Pelvic Floor Impact Questionnaire (PFIQ-7), and pain levels on a numeric rating scale (NRS) were collected at intake and discharge. Data were analyzed with descriptive statistics and sign tests. RESULTS: Of 474 women, mean age was 50.3 ± 16.7 years (range, 18-87 years) and the most common indication for PFPT was pelvic pain (208/474; 43.9%). In women with complete data, pretreatment to posttreatment median scores improved on the PFDI (77.3 vs 41.8; P < 0.0001), Urogenital Distress Inventory (37.5 vs 16.0; P < 0.0001), and PFIQ (58.0 vs 19.0; P < 0.0001), and the minimal clinically important difference was met for the PFDI, PFIQ, and Colorectal-Anal Distress Inventory. Women with primarily pelvic pain (n = 208) achieved significant improvements in PFDI, PFIQ, and NRS scores (P < 0.0001 for all) as well as the minimal clinically important difference for these measures. Pain patients with a history of pelvic surgery (n = 50) also had significant improvements in PFIQ and NRS but not PFDI scores. CONCLUSIONS: Most women referred to PFPT demonstrated symptom improvements as measured by validated instruments.

Chronic pudendal neuromodulation: expanding available treatment options for refractory urologic symptoms.

AIMS: Chronic pudendal nerve stimulation (CPNS) is a logical alternative particularly in those who fail sacral stimulation. We evaluated symptoms, complications, and satisfaction after CPNS. METHODS: We retrospectively reviewed patients having a tined lead placed at the pudendal nerve via the ischial-rectal approach. Demographics, history, complications, and pre-implant voiding diary data were collected. In those responding to CPNS, post-implant symptom changes were measured with the Interstitial Cystitis Symptom and Problem indices (ICSI-PI) and voiding diaries at 3, 6, and 12 months, and a mailed survey. RESULTS: The majority of 84 patients (78.6% female; age 51.8 ± 16.9 years) had interstitial cystitis/painful bladder syndrome, or overactive bladder. Pudendal response (≥ 50% improvement) occurred in 60/84 (71.4%), however 5 of these chose sacral neuromodulation. Almost all (93.2%) who had previously failed sacral neuromodulation responded to pudendal stimulation. Outcomes were evaluated in 55 continuing on CPNS (median follow up 24.1 months). Seven complications requiring 5 revisions, and 4 other re-operations occurred. Five were explanted. Over time, significant improvements in frequency (P < 0.0001), voided volume (P < 0.0001), incontinence (P < 0.0001), and urgency (P = 0.0019) occurred. ICSI-PI scores significantly improved over 12 months (P < 0.0001). Survey responses indicated that most still had a device (35/40; 87.5%) continuously in use (24/29; 82.8%), and overall bladder, pelvic pain, incontinence, urgency, and frequency symptoms had improved. CONCLUSIONS: CPNS is a reasonable alternative in complex patients refractory to other therapies including sacral neuromodulation. Continued research is needed to fully assess long-term outcomes and identify predictors of success.

Pelvic Floor Distress Inventory Scores Improve After Prolapse Surgery Regardless of Surgical Approach but Not After Observation Alone.

OBJECTIVE: To evaluate the effect of different surgical procedures on Pelvic Floor Distress Inventory (PFDI) scores in women with pelvic organ prolapse. MATERIALS AND METHODS: Women with prolapse were enrolled from 2008 to 2014. Baseline data and outcomes at 1 year were collected including subscales of the PFDI. Patients who had surgery (SGY) within the first year were compared to those who did not (N-SGY). Subanalyses of SGY included vaginal vs abdominal, with or without concurrent hysterectomy (HYST, N-HYST), placement of mesh (MESH, N-MESH), and concurrent posterior repair/perineorrhaphy (POST, N-POST). RESULTS: A total of 233/239 patients underwent surgery in the first year. For SGY vs N-SGY, SGY had significant improvements in PFDI and all subscale scores at 1 year while N-SGY did not. When comparing vaginal to abdominal approach, MESH to N-MESH and HYST to N-HYST, there were no differences between any scores at baseline or 1 year between the groups. However, all within group symptom scores improved from baseline to 1 year (P <.0001 for all). In comparing POST to N-POST, there were no differences between groups at 1 year in PFDI and Urogenital Distress Inventory and Pelvic Organ Prolapse Distress Inventory subscale scores. Colorectal-Anal Distress Inventory scores were significantly higher at baseline for POST (P <.0001) but not at 1 year (P = 0.37). All within group scores statistically significant improved at 1 year. CONCLUSION: Women who underwent surgical repair for prolapse had significantly improved overall PFDI and subscale scores regardless of surgical approach and concurrent procedures.

Transvaginal Trigger Point Injections Improve Pain Scores in Women with Pelvic Floor Hypertonicity and Pelvic Pain Conditions.

OBJECTIVES: Chronic pelvic pain in women often requires multimodal treatment regimens. We describe our method of transvaginal trigger point injections (TPIs) and report outcomes using change in pain scores. METHODS: This was a retrospective review of women treated with in-office pelvic floor muscle injections from January 2012 to August 2015. Lidocaine 1% and 2%, bupivacaine 0.5%, or ropivacaine 0.5% with or without the addition of triamcinolone 40 mg was used for the injections. Pain was reported on a 0- to 10-point numerical rating scale before and after injection. Differences in pretreatment and posttreatment pain scores were analyzed after the first injection and after subsequent injections. Repeated-measures analysis was used to determine if any variable affected treatment response. RESULTS: One hundred one women with a mean age of 44 years had a total of 257 separate visits for pelvic floor muscle injections. Triamcinolone was used at 90.2% (230/255) of the TPI visits. After the initial TPI visit, there was significant decrease in total levator numerical rating scale score (maximum score, 20; mean, -6.21 ± 4.7; P < 0.0001), and 77% (70/91) of patients had improved. These significant improvements were noted at all visits 1 through 4 and whether bilateral or unilateral injections were done. Only the total amount of local anesthestic used had a significant effect on the change in total levator pain scores (P = 0.002). Minor adverse effects including leg numbness, dizziness, nausea, bleeding, and headache occurred at 10% of visits. CONCLUSIONS: Pelvic floor muscle injections decrease pain levels in women with pelvic floor dysfunction.

The relationship between subjective and objective assessments of sacral neuromodulation effectiveness in patients with urgency-frequency.

AIMS: Global response assessment (GRA) has been used to evaluate patients' perceptions of treatment effectiveness. However, few studies have scrutinized the relationship between GRAs and objective voiding diary outcomes data. This study explores the relationship between self-reported symptom-specific GRA responses and objective changes in frequency, urgency and pelvic pain in patients with urgency-frequency with or without pelvic pain after implantation of a prosthetic sacral nerve stimulation device. METHODS: Patients scheduled for a staged procedure were enrolled in a prospective, observational, longitudinal study. Post implantation, patietns were grouped into "responders" or "non-responders" based on their answers to symptom-specific GRAs at three and six months. Treatment responders were defined as those reporting "moderately" or "markedly improved" on a 7-point scale, and all others were considered non-responders. Pre- and post-implant changes in mean 24-hour voiding frequency, voided volume, urgency and pelvic pain scores as recorded on voiding diaries were compared between groups using paired t-test. RESULTS: At three months, responders demonstrated corresponding statistically significant improvement in voiding frequency (P < 0.001), average voided volume (P = 0.003), urgency (P = 0.022) and pelvic pain (P = 0.039). At six months, responders demonstrated statistically significant improvements in frequency (P = 0.025) and urgency (P = 0.006). None of the symptom changes were statistically significant in treatment non-responders. CONCLUSIONS: The GRA non-responders groups' perceptions of treatment response agreed with their objective changes in bothersome symptoms and responders' changes agreed with their perception of improvement in the majority of symptoms. Further study is needed to standardize the GRA, and explore its potential for use in clinical practice.

Exploring Racial Differences Surrounding Prostate Cancer Screening: Beliefs and Attitudes in Community Dwelling Men Attending an Urban Men's Health Event.

The purpose of the study was to explore attitudes/beliefs in men attending an urban health fair to explore barriers to prostate cancer (PCa) screening. Five hundred and forty-four men attending the PCa booth at the fair in 2014 or 2015 completed questionnaires about PCa. Data were examined using Pearson's χ2, Fisher's Exact, and Wilcoxon rank tests after grouping men by African American (AA) and non-African American ethnicity. Three hundred and twenty-six (60%) men were AA and two hundred and eighteen (40%) were non-AA (89% white). Median age (54 vs. 56 years) and prior PCa screening were similar between AA and non-AA; income ( p = .044) and education ( p = .0002) differed. AA men were less likely to have researched prostate-specific antigen (PSA) on the internet ( p = .003), but more used TV ( p = .003) and media ( p = .0014) as information sources. Family members had a stronger influence over screening decisions for AA men ( p = .005). After reading PSA information, AA men were more likely to still be confused ( p = .008). A higher proportion of AA men were less worried about dying from PCa ( p = .0006), but would want treatment immediately instead of watchful waiting ( p < .0001). Interestingly, a higher proportion of AA men indicated that they would prefer not to know if they had PCa ( p = .001). Ultimately, more AA men had a PSA done (98.4% vs. 95.1%; p = .031). When considering screening eligible men, a higher proportion of AA men had an abnormal PSA (13.1% vs. 5.3%; p = .037). AA men's beliefs surrounding PCa differ from non-AA men, and should be considered when developing culturally appropriate education, screening, and treatment strategies for this group.

Percutaneous Tibial Nerve Stimulation in the Office Setting: Real-world Experience of Over 100 Patients.

OBJECTIVE: To examine the outcomes and compliance with percutaneous tibial nerve stimulation (PTNS) for overactive bladder (OAB) symptoms. METHODS: Adults who had PTNS from June 30, 2011, to October 8, 2015, were retrospectively reviewed for demographics, copay, travel distance, employment status, history, symptoms, and treatments used before, during, and after PTNS. Pearson chi-square test, Fisher exact test, Wilcoxon rank and paired t test were performed. RESULTS: Of 113 patients (mean age 75 ± 12 years), most were women (65.5%), married (78.1%), and retired or unemployed (80.2%). The median distance to the clinic was 8.1 mi, and the median copay was $0. The most common indication for PTNS was nocturia (92.9%) followed by OAB with urgency urinary incontinence (75.2%) and urinary urgency and/or frequency (24.8%). Prior treatments included anticholinergics (75.2%), mirabegron (36.6%), behavioral modification (29.2%), pelvic floor physical therapy (18.6%), and others (19.5%). Patients completed a mean of 10.5 ± 3 of 12 planned weekly PTNS treatments. Of 105 patients, 40 (38.1%) used concomitant treatments (most commonly anticholinergics). Of 87 patients, 62 (71.3%) had decreased symptoms at 6 weeks, and of 85 patients, 60 (70.6%) had decreased symptoms at 12 weeks. The majority (82; 75.6%) completed all 12 weekly treatments and 45 (54.9%) completed 3 (median) monthly maintenance treatments. The most common reason for noncompliance was lack of efficacy. Visit copay, employment status, and distance to the clinic were not associated with failure to complete weekly treatments or progression to monthly maintenance. CONCLUSION: Although most patients' symptoms decreased after weekly PTNS, nonadherence to maintenance and lack of efficacy may limit long-term feasibility. Copay and distance traveled were not associated with noncompliance.

Pudendal Neuromodulation as a Treatment for Persistent Genital Arousal Disorder-A Case Series.

BACKGROUND: Persistent genital arousal disorder (PGAD) is a rare life-altering condition characterized by unwanted, uncomfortable genital sensations or spontaneous orgasms without physical or emotional stimulation. Its etiology remains unclear, and a variety of treatments have been attempted with incomplete resolution. We propose that chronic pudendal neuromodulation (CPN) may be a useful treatment for PGAD symptoms. METHODS: A retrospective chart review was performed for women older than 18 years with a diagnosis of PGAD that had staged neuromodulation with placement of a tined lead at the pudendal nerve. Demographic, operative, and postoperative data were collected. A survey was then sent to these women to assess additional demographic data, preoperative and postoperative symptoms, and patient satisfaction. Descriptive statistics were performed. RESULTS: Six women underwent CPN for PGAD. Mean age was 52 (SD, 9) years. Five (83%) of 6 were still implanted at time of survey, at a mean of 38 months after implantation; 1 device was removed for nonuse. Four of 6 completed surveys and were still using their device. Three of 4 had met their treatment goals and were satisfied with CPN; 3 of 4 felt CPN was the most useful treatment modality they had used overall. Chronic pudendal neuromodulation also improved chronic pelvic pain (4/4), bowel function (3/4), and bladder function (3/4). CONCLUSIONS: Chronic pudendal neuromodulation can be an effective treatment for decreasing frequency of PGAD symptoms and providing symptom relief.