The impact of sacrospinous ligament fixation on pre-existing nocturia and co-existing pelvic floor dysfunction symptoms.

INTRODUCTION AND HYPOTHESIS: To evaluate whether nocturia and coexisting pelvic floor symptoms in women with pelvic organ prolapse (POP) can be improved by ligamentous fixation of apical vaginal prolapse to the sacrospinous ligament. METHODS: We evaluated the PROPEL study data from 281 women with pelvic organ prolapse stage > 2. Bothersome nocturia and coexisting pelvic floor symptoms were assessed with the Pelvic Floor Disorder Inventory (PFDI) questionnaire preoperatively and at 6, 12 and 24 months after successful vaginal prolapse repair. Women with successful reconstruction (POP-Q stage < 1 at all compartments throughout the 2-year follow-up), defined as anatomical "responders," were compared to the anatomical "non-responders." RESULTS: Among the patients completing all PFDI questions (N = 277), anatomical responders and non-responders were the groups of interest for our analysis. We found the occurrence rates of "moderate" or "quite a bit" of nocturia was significantly reduced after surgery in all subgroups (48.7% at baseline vs. 19.5% after 24 months). The occurrence of nocturia was halved for responders compared to non-responders (45.4% and 48.3% at baseline vs. 14% and 29.5% after 24 months). Anatomical non-responders still had a relevant improvement of POP-Q stages, especially in the apical compartment. Prevalence rates of co-existing over- and underactive bladder, fecal incontinence, defecation disorders and pain symptoms were also significantly reduced postoperatively. CONCLUSION: Nocturia can be associated with symptomatic POP, with improvements seen following vaginal ligamentous prolapse repair. We caution providers, however, when advising patients of the possible resolution of nocturia following POP reconstruction, that all other traditional etiologies of nocturia must first be ruled out.

Treatment of urethral stricture disease in women: A multi-institutional collaborative project from the SUFU research network.

AIM: Female urethral stricture disease is rare and has several surgical approaches including endoscopic dilations (ENDO), urethroplasty with local vaginal tissue flap (ULT) or urethroplasty with free graft (UFG). This study aims to describe the contemporary management of female urethral stricture disease and to evaluate the outcomes of these three surgical approaches. METHODS: This is a multi-institutional, retrospective cohort study evaluating operative treatment for female urethral stricture. Surgeries were grouped into three categories: ENDO, ULT, and UFG. Time from surgery to stricture recurrence by surgery type was analyzed using a Kaplan-Meier time to event analysis. To adjust for confounders, a Cox proportional hazard model was fit for time to stricture recurrence. RESULTS: Two-hundred and ten patients met the inclusion criteria across 23 sites. Overall, 64% (n = 115/180) of women remained recurrence free at median follow-up of 14.6 months (IQR, 3-37). In unadjusted analysis, recurrence-free rates differed between surgery categories with 68% ENDO, 77% UFG and 83% ULT patients being recurrence free at 12 months. In the Cox model, recurrence rates also differed between surgery categories; women undergoing ULT and UFG having had 66% and 49% less risk of recurrence, respectively, compared to those undergoing ENDO. When comparing ULT to UFG directly, there was no significant difference of recurrence. CONCLUSION: This retrospective multi-institutional study of female urethral stricture demonstrates that patients undergoing endoscopic management have a higher risk of recurrence compared to those undergoing either urethroplasty with local flap or free graft.

A longitudinal analysis of urological chronic pelvic pain syndrome flares in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network.

OBJECTIVE: To describe the frequency, intensity and duration of urological chronic pelvic pain syndrome symptom exacerbations ('flares'), as well as risk factors for these features, in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain Epidemiology and Phenotyping longitudinal study. PARTICIPANTS AND METHODS: Current flare status ('urological or pelvic pain symptoms that are much worse than usual') was ascertained at each bi-weekly assessment. Flare characteristics, including start date, and current intensity of pelvic pain, urgency and frequency (scales of 0-10), were assessed for participants' first three flares and at three randomly selected times when they did not report a flare. Generalized linear and mixed effects models were used to investigate flare risk factors. RESULTS: Of the 385 eligible participants, 24.2% reported no flares, 22.9% reported one flare, 28.3% reported 2-3 flares, and 24.6% reported ≥4 flares, up to a maximum of 18 during the 11-month follow-up (median incidence rate = 0.13/bi-weekly assessment, range = 0.00-1.00). Pelvic pain (mean = 2.63-point increase) and urological symptoms (mean = 1.72) were both significantly worse during most flares (60.6%), with considerable within-participant variability (26.2-37.8%). Flare duration varied from 1 to 150 days (94.3% within-participant variability). In adjusted analyses, flares were more common, symptomatic, and/or longer-lasting in women and in those with worse non-flare symptoms, bladder hypersensitivity, and chronic overlapping pain conditions. CONCLUSION: In this foundational flare study, we found that pelvic pain and urological symptom flares were common, but variable in frequency and manifestation. We also identified subgroups of participants with more frequent, symptomatic, and/or longer-lasting flares for targeted flare management/prevention and further study.

Can surgical reconstruction of vaginal and ligamentous laxity cure overactive bladder symptoms in women with pelvic organ prolapse?

OBJECTIVE: To examine the extent and intensity of the coexistence of overactive bladder (OAB) symptoms in women with pelvic organ prolapse (POP) and to evaluate the likelihood of OAB symptom improvement after surgical POP reconstruction over a period of 2 years. PATIENTS AND METHODS: The effectiveness of the transvaginal, single-incision 'Elevate' technique for anatomical cure of anterior/apical and posterior/apical vaginal prolapse has been previously reported in a prospective, multicentre study. This technique uses mesh arms attached to the sacrospinous ligaments to recreate apical ligamentous support. Using the same sample population as that used in the multicentre study (n = 281), we conducted the present sub-analysis focusing on estimating the extent of comorbidity between POP and OAB symptoms, as well as the effects of subsequent pelvic floor reconstruction on OAB symptoms over a long period. Assessments of POP and OAB symptom severity before and after surgery at 6, 12 and 24 months were obtained using the Pelvic Floor Distress Inventory (PFDI) questionnaire. RESULTS: Preoperatively, 70% of all POP patients reported moderate to severe OAB symptoms, with almost half (49.5%) noting severe OAB bother ('quite a bit bothersome') for one or more of the classic OAB symptom domains on the PFDI: 'daytime urinary frequency'; 'urinary urgency'; 'urinary urgency incontinence'; and/or 'nocturia'. In fact, across all four OAB symptom domains evaluated, there were significantly more severe symptoms ('quite a bit bothersome') than moderate ('moderately bothersome') or mild ('somewhat bothersome'): 26-31%, 13-21%, and 17-19% of patients, respectively. In patients with symptomatic POP >stage 2, there was no relationship between further degree of prolapse and presence of severity of OAB symptoms; however, patients with POP stage 2 had significantly more complaints regarding the items 'daytime urinary frequency' and 'urinary urgency incontinence' compared with those with stage 3-4 POP. Pelvic floor reconstructive surgery resulted in significant improvement in all OAB symptoms, which seemed to be stable over time. The cure rate of moderate-to-severe OAB complaints ranged between 60% and 80%, which was a durable improvement noted throughout 24 months. CONCLUSION: Results showed that POP was to a high degree accompanied by moderate-to-severe OAB complaints. Significant long-lasting improvements in bothersome OAB symptoms occurred after adequate surgical reconstruction of anterior/apical and posterior/apical vaginal support.

Elevate and Uterine Preservation: Two-Year Results.

OBJECTIVE: To evaluate efficacy of the Elevate Anterior and Apical (EAA) in the repair of pelvic organ prolapse (POP) when performed after previous hysterectomy and with or without uterine preservation during POP surgery. MATERIALS AND METHODS: One hundred forty-two women with anterior vaginal prolapse and/or apical descent ≥ stage II were enrolled. The primary outcome was treatment failure defined as > stage II POP-Q during follow-up using the Last observed Failure Carried Forward method. Three sub-groups were analysed: baseline previous hysterectomy (N = 61); concomitant hysterectomy (N = 29), and preserved uterus/no hysterectomy (N = 51). Demographics, primary and secondary outcomes, and extrusion were compared between the groups. A P value less than 0.05 was considered statistically significant. RESULTS: Anatomic success shows significant and durable improvement at 24 months. The success for the apical compartment ranged between 93.8% and 100%. Success was slightly lower for the anterior compartment (70.8-89.1%). No statistically significant difference between the 3 subgroups. Age was the only patient characteristic to be found different between the 3 subgroups. In addition, there was no difference in overall intraoperative complications (P = 0.263). Mesh extrusion was found in all groups: 3 of 61 (4.9%) had previous hysterectomy; 4 of 29 (13.8%) had concomitant hysterectomy; and 1 of 51 (2.0%) had uterus preserved (P = 0.094). There appears to be a trend toward higher extrusion when a hysterectomy was performed with the EAA. CONCLUSIONS: Anatomic success and complications for the EAA do not appear to be significantly impacted when the uterus is removed before or during surgery or preserved. There may be a trend toward increased mesh extrusion when a hysterectomy is performed. However, larger cohort studies are needed to determine if concomitant hysterectomy impact extrusion.

Elevate anterior/apical: 12-month data showing safety and efficacy in surgical treatment of pelvic organ prolapse.

OBJECTIVE: This study aimed to assess the safety and efficacy of the Elevate Anterior/Apical transvaginal mesh procedure in pelvic organ prolapse (POP) repair at 12-months follow-up. METHODS: This prospective, multicenter, multinational study enrolled 142 patients experiencing anterior vaginal prolapse with or without apical descent (POP-Q ≥ stage II). Each patient received a single-incision transvaginal polypropylene mesh implantation anchored to the sacrospinous ligaments bilaterally. Primary outcome was treatment success defined as POP-Q less than or equal to stage I at 1 year using the Last Failure Carried Forward method. Secondary outcomes included validated quality-of-life measures. Fourteen subjects who received a concomitant posterior apical support procedure were excluded from the analysis. RESULTS: Of the 128 subjects, 112 (87.5%) completed the 12-months follow-up. The mean age was 64.7 years. The anatomic success rate was 87.7% (95% confidence interval, 80.3%-93.1%) for the anterior compartment and 95.9% (95% confidence interval, 88.5%-99.1%) for the apical compartment. POP-Q measurements (Aa, Ba, and C) improved significantly (P < 0.001) with no significant changes to TVL (P = 0.331). Related adverse events reported at greater than 2% were mesh exposure (8; 6.3%), urinary tract infection (7; 5.5%), transient buttock pain (5; 3.9%), de novo stress incontinence (5; 3.9%), retention (5; 3.9%), dyspareunia (3; 3.2%), and hematoma (3; 2.3%). All quality-of-life scores significantly improved from baseline (P < 0.001). CONCLUSIONS: Twelve-month data show that Elevate Anterior/Apical support procedure completed through a single vaginal incision yields favorable objective and subjective outcomes.

Informed surgical consent for a mesh/graft-augmented vaginal repair of pelvic organ prolapse. Consensus of the 2nd IUGA Grafts Roundtable: optimizing safety and appropriateness of graft use in transvaginal pelvic reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: Complex issues surround informed surgical consent for pelvic reconstructive surgery. METHODS: Vaginally placed mesh/grafts are used with the intent to increase durability of the repair but potentially introduce unique complications, offering new challenges in informed surgical consent counseling. RESULTS: Informed consent is a process that takes place throughout the entire consultation with the patient. A written document often accompanies that process. This paper outlines necessary components of informed surgical consent and the theory behind each component. CONCLUSIONS: We explore elements that should be included in the consent process with regard to expected benefits, alternatives, and material risks that are specific to the use of a mesh/graft-augmented vaginal repair of prolapse. Included is an appendix that may serve as a template for the creation of a surgeon's own written informed consent document.

Treatment of moderate to severe female stress urinary incontinence with the adjustable continence therapy (ACT) device after failed surgical repair.

INTRODUCTION: Treatment of recurrent stress incontinence after a failed surgical procedure is more complicated, and repeat surgeries have higher rates of complications and limited efficacy. We determined the technical feasibility, efficacy, adjustability, and safety of adjustable continence therapy device for treatment of moderate to severe recurrent urinary incontinence after failed surgical procedure. MATERIALS AND METHODS: Female patients with moderate to severe recurrent stress urinary incontinence who had at least one prior surgical procedure for incontinence were enrolled. All patients underwent percutaneous placement of adjustable continence therapy (ACT) device (Uromedica, Plymouth, Minnesota). Baseline and regular follow-up tests to determine subjective and objective improvement were performed. RESULTS: A total of 89 patients have undergone implantation with 1-3 years of follow-up. Data are available on 77 patients at 1 year. Of the patients, 47% were dry at 1 year and 92% improved after 1-year follow-up. Stamey score improved from 2.25 to 0.94 at 1 year (P < 0.001). IQOL questionnaire scores improved from 33.9 to 71.6 at 1 year (P < 0.001). UDI scores reduced from 60.7 to 33.3 (P < 0.001) at 1 year. IIQ scores reduced from 57.0 to 21.6 (P < 0.001) at 1 year. Diary incontinence episodes per day improved from 8.1 to 3.9 (P < 0.001) at 1 year. Diary pads used per day improved from 4.3 to 1.9 (P < 0.001). Explantation was required in 21.7% of patients. CONCLUSION: The ACT device is an effective, simple, safe, and minimally invasive treatment for moderate to severe recurrent female stress urinary incontinence after failed surgical treatment.

Sacral neuromodulation: Therapy evolution.

OBJECTIVES: Sacral neuromodulation has gained increased worldwide acceptance as the standard of care in patients with refractory overactive bladder (OAB) and non-obstructive urinary retention (NOUR). This review will detail the evolution of the technology. MATERIALS AND METHODS: The mechanism of action and advances in treatment, including tined lead, fluoroscopic imaging, and smaller implantable pulse generator (IPG) are reviewed. This discussion also explores expanding indications and future advances including interstitial cystitis, chronic pelvic pain, neurogenic bladder, fecal incontinence, constipation, and dysfunctional elimination syndrome in children. RESULTS: Sacral neuromodulation (SNM) exerts its influence by modulation of sacral afferent inflow on storage and emptying reflexes. The tined lead allows for placement and stimulation to be performed in the outpatient setting under local anesthesia with mild sedation. Lead migration has been minimal and efficacy improved. The use of fluoroscopy has improved accuracy of lead placement and has led to renewed interest in bilateral percutaneous nerve evaluation (PNE). Bilateral PNE can be performed in the office setting under local anesthesia, making a trial of therapy less expensive and more attractive to patients. A smaller IPG has not only improved cosmesis, but decreased local discomfort and need for revision. The role for SNM continues to expand as clinical research identifies other applications for this therapy. CONCLUSIONS: Our understanding of SNM, as well as technological advances in therapy delivery, expands the pool of patients for which this form of therapy may prove beneficial. Less invasive instrumentation may even make this form of therapy appealing to patients without refractory symptoms.

Should asymptomatic anterior pelvic organ prolapse be corrected to treat irritative urinary symptoms?

In clinical practice, women seen with pelvic organ prolapse (POP) often present with a variety of pelvic floor symptoms: urinary incontinence, irritative or overactive bladder symptoms, fecal urgency or incontinence, obstructive voiding, sexual disorders, pelvic and perineal pain, and vaginal bulging. Among these, the only symptom reliably associated with clinically relevant POP that will resolve following vaginal reconstructive surgery is the visualization and/or sensation of a vaginal bulge. Most other symptoms often attributed to POP at best have only weak correlations with worsening pelvic anatomical support. Specifically, with respect to the anterior and/or apical vaginal compartment, there does not appear to be a correlation between irritative overactive bladder symptoms and the presence or degree of anterior vaginal wall prolapse. Furthermore, no other symptoms, urinary or otherwise, are reliably influenced by correction of anatomical defects of pelvic support, especially in the otherwise asymptomatic patient with POP without vaginal bulge. A review of the recent literature underscores the realization that the relationship between pelvic floor symptoms and anatomy is incompletely and poorly understood. With this in mind, there does not seem to be any absolute justification for the surgical correction of otherwise asymptomatic pelvic support defects.

The adjustable continence therapy system for recurrent female stress urinary incontinence: 1-year results of the North America Clinical Study Group.

PURPOSE: We determined the efficacy, safety, adjustability and technical feasibility of the adjustable continence therapy device (Uromedica, Plymouth, Minnesota) for the treatment of recurrent female stress urinary incontinence. MATERIALS AND METHODS: Female patients with recurrent stress urinary incontinence were enrolled in the study and a defined set of exclusionary criteria were followed. Baseline and regular followup tests to determine eligibility, and to measure subjective and objective improvement were performed. A trocar was passed fluoroscopically and with digital vaginal guidance to the urethrovesical junction through small incisions between the labia majora and minora. The adjustable continence therapy device was delivered and the balloons were filled with isotonic contrast. The injection ports for balloon inflation were placed in a subcutaneous pocket in each labia majora. Device adjustments were performed percutaneously in the clinic postoperatively. An approved investigational device exemption Food and Drug Administration protocol was followed to record all adverse events. RESULTS: A total of 162 subjects underwent implantation with 1 year of data available on 140. Mean Stamey score improved by 1 grade or more in 76.4% (107 of 140) of subjects. Improvement in the mean incontinence quality of life questionnaire score was noted at 36.5 to 70.7 (p <0.001). Reductions in mean Urogenital Distress Inventory (60.3 to 33.4) and Incontinence Impact Questionnaire (54.4 to 23.4) scores also occurred (p <0.001). Mean provocative pad weight decreased from 49.6 to 11.2 gm (p <0.001). Of the patients 52% (67 of 130) were dry at 1 year (less than 2 gm on provocative pad weight testing) and 80% (102 of 126) were improved (greater than 50% reduction on provocative pad weight testing). Complications occurred in 24.4% (38 of 156) of patients. Explantation was required in 18.3% (28 of 153) of the patients during 1 year. In terms of the complications 96.0% were considered to be mild or moderate. CONCLUSIONS: The Uromedica adjustable continence therapy device is an effective, simple, safe and minimally invasive treatment for recurrent female stress urinary incontinence. It can be easily adjusted percutaneously to enhance efficacy and complications are usually easily manageable. Explantation does not preclude later repeat implantation.

Evaluating the impact of overactive bladder on sexual health in women: what is relevant?

INTRODUCTION: To assess sexual health, relevant, valid, and reliable questionnaires need to be used. AIM: To assess the relevance and content validity of three sexual health questionnaires in women with overactive bladder (OAB) and urinary incontinence. MAIN OUTCOME MEASURES: Sexual Quality of Life Questionnaire--Female (SQoL-F), Sexual Function Questionnaire (SFQ), and Pelvic Organ Prolapse-Incontinence Sexual Function Questionnaire (PISQ). METHODS: Women with OAB and urinary incontinence were recruited from five urology clinics in the United States; those who were interested in participating were mailed questionnaire packets with instructions. Each questionnaire item was followed by three questions regarding the understandability, relevance, and impact of bladder condition when responding to the question. Patients returned the completed questionnaires by mail; clinical information was obtained from chart review. RESULTS: A total of 129 patients (74% response) returned the questionnaires. The mean age was 56 years; 78% were white; 64% were married. In this sample, 64% had urge incontinence; 32% had mixed incontinence; and 4% had stress incontinence. Participants experienced bladder symptoms for a mean of 12.2 years with the following treatments: surgery (43%), bladder training (26%), exercise/biofeedback (42%), and medications (67%). SQoL-F items were understood by more than 97% of the respondents, more than 89% for SFQ, and more than 82% for PISQ. There were two SQoL-F items, one SFQ item, and 11 PISQ items that less than 60% of the respondents deemed relevant to their bladder condition. Correlations among questionnaire items and relevance to bladder condition ranged from 0.04 to 0.64 for the SQoL-F, 0.04 to 0.47 for the SFQ, and 0.01 to 0.58 for the PISQ. CONCLUSION: Women with OAB found the majority of items on all three questionnaires to be relevant to their bladder condition. Of these questionnaires, the SQoL-F had the highest understandability, fewest questions considered irrelevant, and correlated well with OAB symptoms.

Treatment of stress incontinence with the SPARC sling: intraoperative and early complications of 445 patients.

OBJECTIVES: To review our series of 445 patients to obtain safety and early outcome information regarding use of the SPARC mid-urethral sling. The SPARC mid-urethral sling is commonly used to treat stress urinary incontinence. The SPARC technique involves passage of the trocars from an initial suprapubic approach. METHODS: We retrospectively reviewed the charts of all SPARC slings performed from the first procedure in August 2001 through December 2003. The Urogenital Distress Inventory and Incontinence Impact Questionnaire short-form surveys were mailed to the patients. All SPARC procedures were performed on an outpatient basis unless the patient was undergoing a concurrent procedure. RESULTS: The average patient age was 60 years. Concurrent prolapse repair and/or hysterectomy were performed in 97 patients (22%). The mean time from surgery to questionnaire response was 15 months. Ninety-one percent would undergo the procedure again, and 84% would recommend the SPARC to a friend. One patient was admitted postoperatively for a rectus hematoma. Another presented after 3 days with abdominal pain resulting from a small bowel perforation. Sling release was performed in 19 patients (4.3%) because of large postvoid residual urine volume or obstructive voiding symptoms. CONCLUSIONS: The SPARC mid-urethral sling is an effective outpatient surgical procedure to treat stress urinary incontinence.

Follicular large cell lymphoma localized to the testis in children.

PURPOSE: Primary follicular lymphoma of the testis in childhood is rare with only 6 cases previously reported. We present 3 additional cases. MATERIALS AND METHODS: We extensively analyzed primary follicular lymphoma of the testis in 3 boys. Clinical data were obtained by reviewing patient charts. RESULTS: The patients were 4, 5 and 11 years old, respectively. Two patients presented with painless unilateral testicular enlargement and 1 presented with unilateral hydrocele. Laboratory findings were within normal limits in all patients. Radical orchiectomy was done in all cases. The excised testes were partially or completely replaced by tumor. In all cases the features were those of follicular, large cell-type malignant lymphoma. Tumor cells in all cases were CD20 and CDw75 positive, focally CD23 positive and bcl-2 negative, while in 2 they were CD10 positive and bcl-6 positive. Surface Ig was absent in the 2 cases studied. Karyotyping in 1 case showed a normal karyotype. Staging revealed no evidence of extratesticular disease. All patients underwent combination chemotherapy and were in complete remission 7 to 59 months after therapy. CONCLUSIONS: We present 3 cases of pediatric primary follicular lymphoma of the testis. Pathological findings and clinical features were similar to those in the 6 previously reported cases and suggest that primary pediatric testicular follicular lymphoma may represent unique subset of follicular lymphoma with a particularly good prognosis.

Does the size of the surgical margin in partial nephrectomy for renal cell cancer really matter?

PURPOSE: Although many groups recommend a surgical margin of 1 to 2 cm., to our knowledge the amount of normal renal parenchyma that must be excised during partial nephrectomy for stages T1-2N0M0 renal cell carcinoma to ensure a safe margin has never been critically evaluated. We investigated whether the size of the surgical margin has any effect on recurrence. MATERIALS AND METHODS: All partial nephrectomies performed for localized renal cell carcinoma at our institution from 1988 to 1999 were retrospectively analyzed via a review of hospital records, pathology reports and histological slides. Parenchymal margin status was assessed and quantified by microscopy. Followup data were obtained via patient chart review and telephone interview. Average negative margin size and postoperative followup were determined, and renal cell carcinoma recurrence was assessed. RESULTS: A total of 44 partial nephrectomies were performed with a mean followup of 49 months (range 8 to 153). Mean tumor size was 3.22 cm. (range 1.3 to 10). Surgical margins were negative for malignancy in 41 cases and positive in 3. All patients with negative margins were without local recurrence at followup except 1 with a recurrent mass adjacent to the kidney at a site distant from the original lesion. Mean and median size of the negative margins was 0.25 and 0.2 cm., respectively (range 0.05 to 0.7). In the 3 cases with positive margins there was no evidence of disease at 39 and 62 months of followup in 2, while multiple local and metastatic recurrences developed in 1. CONCLUSIONS: No patient with negative parenchymal margins after nephron sparing surgery for stages T1-2N0M0 renal cell carcinoma had local recurrence at the resection site at a mean followup of 49 months. Margin size was irrelevant. Only a minimal margin of normal renal parenchyma of less than 5 mm. must be removed during partial nephrectomy for localized renal cell carcinoma.