Long-term follow-up of polypropylene bone anchored slings.

INTRODUCTION: The transvaginal bone anchored polypropylene sling (BAS) has proven to be a successful treatment for patients with SUI. However, there is limited data on long-term outcomes following BAS with polypropylene mesh. We report our series of patients who had at least 3 years of follow-up after placement of BAS. MATERIALS AND METHODS: A retrospective review of prospectively collected data of patients undergoing BAS for stress urinary incontinence (SUI) with minimum 3 year follow-up was performed. Outcomes and complications were determined from annual mailed post-operative questionnaires. RESULTS: 142 patients who had undergone BAS and had answered post-operative questionnaires at a minimum of 3 years were identified. Average follow-up was 58 months (range 36-97 months). The overall success rate was 71 % with a dry rate of 27 %. Complications occurred in 9 % of patients, more commonly in patients without a history of anti-incontinence procedure. CONCLUSIONS: Although less commonly used, BAS with polypropylene mesh is associated with an acceptable success rate at long term follow-up but a low completely dry rate.

Opioid-Limiting Pain Control After Transurethral Resection of the Prostate: A Randomized Controlled Trial.

OBJECTIVE: To assess whether a multimodal opioid-limiting protocol and patient education intervention can reduce postoperative opioid use following transurethral resection of the prostate. METHODS: This prospective, non-blinded, single-institution, randomized controlled trial (NCT04102566) assigned 50 patients undergoing a transurethral resection of the prostate to either a standard of care control (SOC) or multimodal experimental group (MMG). The intervention included adding ibuprofen to the postoperative pain regimen, promoting appropriate opioid use while hospitalized, an educational intervention, and discharging without opioid prescription. Data regarding demographics, operative data, opioid use, pain scores, and patient satisfaction were compared. RESULTS: A total of 47 patients were included, n = 23 (MMG) and n = 24 (SOC). Demographic and operative findings were similar. Statistical analysis for noninferiority demonstrated non-inferior inpatient pain control (mean pain score 2.5 MMG vs 2.4 SOC, P = 0.0003). The multimodal group used significantly fewer morphine milligram equivalents after discharge (0 vs 4.1, P = 0.04). Inpatient use was reduced but did not reach statistical significance (6.0 vs 9.8, P = 0.2). Mean satisfaction scores with pain control were similar (9.6 MMG vs 9.2 SOC, P = 0.32). No opioid prescriptions were requested after discharge. Adverse events and medication side effects were infrequent and largely similar between groups. CONCLUSION: Implementation of an opioid-limiting postoperative pain protocol and patient education resulted in no outpatient opioid use while maintaining patient satisfaction with pain control. Eliminating opioids following a common urologic procedure will decrease risk of opioid-related adverse events and have a positive downstream impact.

Bladder sensation measures and overactive bladder.

PURPOSE: We performed a prospective multicomponent study to determine whether subjective and objective bladder sensation instruments may provide data on sensory dysfunction in patients with overactive bladder. MATERIALS AND METHODS: We evaluated 70 prospectively enrolled patients with urodynamics and questionnaires on validated urgency (Urgency Perception Score), general overactive bladder (Urogenital Distress Inventory) and quality of life (Incontinence Impact Questionnaire). We first sought a correlation between sensory specific (Urgency Perception Score) and quality of life questionnaire scores. We then assessed a correlation between sensory questionnaire scores and urodynamic variables, exploring the hypothesis that certain urodynamic parameters may be bladder sensation measures. We evaluated 2 urodynamic derivatives (first sensation ratio and bladder urgency velocity) to increase sensory finding discrimination. RESULTS: We noted a moderate correlation between the Urgency Perception Score (0.56) and the Urogenital Distress Inventory (0.74) vs the Incontinence Impact Questionnaire (each p <0.01). A weak negative correlation was seen between Urgency Perception Score and bladder capacity (-0.25, p <0.05). No correlation was noted for the other urodynamics parameters. First sensation ratio and bladder urgency velocity statistically significantly correlated with the Urgency Perception Score despite the lesser or absent correlation associated with the individual components of these derivatives. CONCLUSIONS: Bladder sensation questionnaires may be valuable to identify patients with sensory dysfunction and provide additional data not obtained in generalized symptom questionnaires. Urodynamic variables correlated with bladder sensation questionnaire scores and may be an objective method to assess sensory dysfunction.

Outcomes following mid-urethral sling placement in patients with intrinsic sphincteric deficiency: comparison of Sparc and Monarc slings.

PURPOSE: The treatment of patients with intrinsic sphincteric deficiency (ISD) remains difficult. It is theorized that differing vectors of support provided by retropubic versus transobturator mid-urethral sling routes may affect outcomes. We sought to compare outcomes of patients undergoing SPARC versus MONARC sling types in patients with Valsalva leak point pressures (VLPPs) below 60 cm H2O. MATERIALS AND METHODS: A retrospective review of female patients with stress urinary incontinence undergoing SPARC(TM) (n = 97) or MONARC(TM) (n = 39) placement following urodynamic diagnosis of ISD was performed, with minimum 12-month follow-up required. Outcomes were assessed using a questionnaire comprising validated incontinence questionnaires (UDI-6, IIQ-7) and additional items addressing satisfaction. RESULTS: Success rates of 76% and 77% were observed in the SPARC (mean follow-up 36 months) and MONARC (mean follow-up 32 months) cohorts, respectively (p > 0.05). Superior UDI scores were demonstrated in the MONARC cohort (3.8 vs. 5.3, p = 0.04)), in contrast to similar IIQ scores across both groups (3.7 vs. 3.1, p > 0.05). A deterioration in success rates was seen in both cohorts with more extended follow-up and with lower VLPPs. However, this finding was limited by low patient numbers in these cohorts. A complication rate of 7% and 3% was noted in SPARC and MONARC cohorts (p > 0.05). CONCLUSIONS: We observed no significant differences in subjective outcomes when comparing patients undergoing SPARC versus MONARC sling placement in the treatment of SUI with VLPP < 60 cm H2O. A deterioration in continence rates was seen with extended follow-up. These data may be affected by low patient numbers and related study power, in particular with more extended follow-up.

Minimum 24-month followup of the sling for the treatment of stress urinary incontinence.

PURPOSE: The SPARC procedure is a retropubic approach for the placement of a synthetic polypropylene sling for stress urinary incontinence. Although the approach appears to be efficacious, there still exist limited long-term data. We report our experience with SPARC at a minimum followup of 24 months. MATERIALS AND METHODS: Patients with stress urinary incontinence undergoing a SPARC sling procedure were entered into a prospective, institutional review board approved database. Postoperatively patients were asked to complete quality of life questionnaires at 6 months and annually thereafter. Success was defined by questionnaire response of 1 or fewer stress urinary incontinence episode per week or greater than 70% subjective improvement in those with greater than 1 stress urinary incontinence episodes per week. RESULTS: A total of 307 patients were identified during a 5-year period, of whom 280 were more than 24 months from surgery. Of the patients 154 (55%) had questionnaire followup at 24 months or greater from surgery (mean 36, median 36, range 24 to 49). Mean Valsalva leak point pressure in this subset of patients was 66 cm H(2)O (median 63, range 15 to 175). Of the patients 106 (68.8%) reported 1 or greater stress urinary incontinence episodes per week and 11 (7.1%) reported greater than 70% subjective improvement despite greater than 1 stress urinary incontinence episodes per week. Based on these definitions 75.9% of the cases were considered successful. CONCLUSIONS: The antegrade polypropylene mid urethral sling appears effective and most patients are satisfied with the outcome. The ease and minimally invasive nature of this technique does not preclude significant complications. Nevertheless, results in this series are competitive with those of other available surgical options.

Comparison of laparoscopic and abdominal sacrocolpopexy for the treatment of vaginal vault prolapse.

BACKGROUND AND PURPOSE: Laparoscopic sacrocolpopexy (LSCP) offers a minimally invasive treatment for vaginal vault prolapse. We describe the surgical technique and offer insight into the learning curve. In addition, we performed a case series review comparing the laparoscopic procedure with its open surgical counterpart with respect to various demographic and perioperative parameters. PATIENTS AND METHODS: The Institutional Review Board-approved continence database at our institution was queried to identify all patients undergoing sacrocolpopexy between August 1999 and October 2004. The LSCP was performed in 25 patients, and open abdominal sacrocolpopexy (ASCP) was performed in 22 patients. Data were analyzed using Student's t-test and the Fisher exact test. RESULTS: No significant difference was observed in the demographic characteristics of the patients undergoing the two approaches. The mean estimated blood loss (P = 0.0002) and mean length of hospitalization (P < 0.0001) were significantly less for LSCP, whereas the operative time was significantly longer (219.9 minutes v 185.2 minutes; P = 0.045). The success rate for LSCP at 5.9 months was 100%; the ASCP success rate at 11.0 months was 95%. CONCLUSIONS: Laparoscopic sacrocolpopexy led to shorter hospitalization, better hemostasis, and less pain than the open procedure. Early follow-up suggests that LSCP is as effective as ASCP for the treatment of vaginal vault prolapse.

A "Needling" Complication.

Intracavernosal injection therapy with vasoactive agents for treatment of erectile dysfunction has been around for more than 3 decades since its advent in the early 1980s. Common complications include ecchymosis and hematoma at the site of injection, priapism, and fibrosis. We describe a rare but potentially dangerous complication of breakage of needle during administering of injections, and discuss its successful retrieval.

Cadaveric fascial sling with bone anchors: minimum of 24 months of follow-up.

OBJECTIVES: Available published studies to define outcomes using cadaveric fascia for transvaginal urethral sling placement have revealed, in general, disappointing outcomes. However, limited data exist detailing long-term outcomes using this sling type and, more specifically, fascial grafts prepared using solvent-dehydrated techniques. We present our long-term outcomes using non-frozen solvent-dehydrated cadaveric fascia lata for transvaginal urethral sling placement with bone anchors. METHODS: A retrospective review was performed of 354 patients who had undergone non-frozen solvent-dehydrated cadaveric fascia lata for transvaginal urethral sling placement with bone anchors with a minimal follow-up of 24 months. A subjective assessment was performed using validated incontinence and quality-of-life questionnaires performed at 6 and 12 months and annually thereafter. RESULTS: A total of 238 patients (67%) completed follow-up questionnaires with a minimum of 24 months of follow-up. Of the 238 respondents, 71%, 67%, and 65% reported fewer than one episode of stress urinary incontinence per week, and 63%, 58%, and 59% of respondents reported minimal clinical improvement of 70% at a minimal follow-up of 24, 48, and 60 months, respectively. The corresponding rates of dryness were 34%, 27%, and 22% for the same follow-up periods. The Urogenital Distress Inventory, 6-item, and Incontinence Impact Questionnaire, 7-item, scores were not significantly different statistically when compared at each assessed follow-up point. CONCLUSIONS: Our data suggest that non-frozen solvent-dehydrated cadaveric fascia lata for transvaginal urethral sling placement with bone anchors is a safe and efficacious procedure for the treatment of stress urinary incontinence. Mild decreases in subjective satisfaction and improvement were seen during an extended follow-up period, although the validated questionnaire scores remained stable throughout the same period. However, a significant reduction in the dry rate was also observed during extended follow-up.

Transvaginal bone-anchored sling for the treatment of female stress urinary incontinence: effect of Valsalva leak point pressure and prior pelvic surgery on outcomes.

The effect of lower Valsalva leak point pressure (VLPP) and previous pelvic surgery on outcomes following sling surgery is controversial. We assessed outcomes following bone-anchored sling (BAS) placement in patients with intrinsic sphincteric deficiency (ISD) and previous pelvic surgery. A retrospective review of 149 patients undergoing BAS placement was performed. Patients were stratified by VLPP (> or =60, <60, and <30) and by history of previous anti-incontinence/pelvic floor surgery. Outcomes were assessed using a questionnaire comprising validated urogenital distress inventory (UDI)-6, incontinence impact questionnaire (IIQ)-7 questionnaires and additional items addressing satisfaction. In comparing the three VLPP cohorts, the percentage of patients reporting incontinence episodes of <1/week (64%, 68%, and 63%, respectively) and postoperative UDI/IIQ questionnaire scores were similar (p > 0.2, all comparisons). Lower rates of patients achieving <1 episode of incontinence per week (50%; p = 0.07) and worse UDI/IIQ scores (p = 0.02) were associated with patients with > or =2 prior surgeries. Whereas results are similar following BAS in patients with or without varying degrees of ISD, worse outcomes are associated with prior surgery.

High rate of vaginal erosions associated with the mentor ObTape.

PURPOSE: The transobturator tape method is a newer surgical technique for the treatment of stress urinary incontinence. Limited data exist related to complications with this approach or the types of mesh products used. We report our experience with vaginal erosions associated with the Mentor ObTape and American Medical Systems Monarc transobturator slings. MATERIALS AND METHODS: Beginning in December 2003 selected female patients with anatomic urinary incontinence were prospectively followed after placement of the Mentor ObTape. Beginning in January 2004 we also began using the American Medical Systems Monarc in similar patients. Patients were admitted overnight after surgery, discharged on oral antibiotics, and seen in the clinic at 6 weeks postoperatively. RESULTS: A total of 67 patients have undergone placement of the Mentor ObTape and 9 of those patients (13.4%) have had vaginal extrusions of the sling. Eight patients reported a history of persistent vaginal discharge. One patient presented initially to an outside facility with a left thigh abscess tracking to the left inguinal incision site. Each patient was taken back to the operating room for mesh removal. A total of 56 patients have undergone placement of the AMS Monarc and none have had any vaginal erosions. CONCLUSIONS: Our high rate of vaginal extrusion using the ObTape has led us to discontinue the use of this product in our institution. Continued followup of all of these patients will be of critical importance.

Vesicovaginal fistula and mesh erosion after Perigee (transobturator polypropylene mesh anterior repair).

The transobturator polypropylene mesh system is a new approach in the surgical treatment of anterior vaginal wall prolapse. We report the case of a 57-year-old woman who developed a vesicovaginal fistula with erosion of the mesh into the bladder and vagina after Perigee transobturator, polypropylene mesh anterior repair. This is a serious complication associated with this technique. Treatment required an open vesicovaginal fistula repair with excision of the exposed and nearby surrounding mesh.

Suitability of different sling materials for the treatment of female stress urinary incontinence.

Stress urinary incontinence (SUI) is defined as leakage of urine with a sudden increase in intra-abdominal pressure, such as that seen with laughing, lifting, or changing position, without a concomitant rise in detrusor (bladder-generated) pressure. The proposed mechanism of SUI is that an increase in intra-abdominal pressure resulting from various activities causes the bladder pressure to rise above the urethral pressure. The pubovaginal sling remains the standard treatment for female SUI in the US. The market has been flooded with innumerable sling materials. This review discusses the currently available sling materials, surgical approaches, and clinical outcomes data. Long-term data on efficacy is lacking, but early results with new materials and delivery techniques indicate that excellent cure rates with minimal morbidity and high patient satisfaction may be achievable.

Incidence and management of abdominal sacrocolpopexy mesh erosions.

OBJECTIVE: This study was undertaken to evaluate the occurrence and management of mesh erosions in patients undergoing abdominal sacrocolpopexy. STUDY DESIGN: A retrospective chart review of the abdominal sacrocolpopexy procedure (n = 92) between 1997 and 2003 was performed. Patients with mesh erosion were identified. Incidence by graft type and treatment required for erosion resolution was analyzed with chi 2 and Fisher exact test. RESULTS: Erosions occurred in 7.6 % (7/92). Erosions were identified only in patients with Gore-Tex (3/33, 9%) or silicone-coated mesh (4/21, 19%) compared with none of 38 patients with polypropylene mesh (n = 24) or fascia (n = 14) grafts ( P = .068.). Partial excision of exposed graft resolved all 3 Gore-Tex erosions, compared with none of the silicone-coated mesh erosions ( P = .03). Complete graft removal was required to resolve silicone-coated mesh erosions. CONCLUSION: We observed a high rate of erosion with Gore-Tex and silicone-coated mesh. Partial graft excision was adequate for Gore-Tex erosions, but complete graft removal was necessary to resolve erosions associated with silicone-coated mesh.

High complication rate identified in sacrocolpopexy patients attributed to silicone mesh.

OBJECTIVES: To report on our experience using a preconfigured Y-shaped silicone-coated polyester mesh and polypropylene mesh for vaginal vault suspension. A variety of materials have been used for both open and laparoscopic sacrocolpopexy in the management of vaginal vault prolapse. Recently, a preconfigured Y-shaped silicone-coated polyester mesh was introduced to facilitate the vaginal cuff suspension to the sacrum. METHODS: We reviewed the data of 45 consecutive patients who underwent abdominal (n = 28) or laparoscopic (n = 17) sacrocolpopexy. Of the 45 patients, 21 underwent silicone mesh suspension of the vaginal cuff to the anterior sacrum, with a mean follow-up of 23 months (range 16 to 41). A comparative analysis was performed of 24 patients who underwent the same procedure with polypropylene mesh. RESULTS: Of the 21 patients in the silicone group, 5 (23.8%) have had a major complication (four vaginal mesh erosions and one mesh infection) after a median follow-up of 9.5 months (range 4 to 20). The presenting symptoms were persistent or new vaginal discharge and/or nonspecific pelvic pain. One patient underwent successful removal of the mesh transvaginally, but the rest required abdominal exploration. To date, the 24 patients who underwent vaginal cuff suspension with polypropylene mesh have had no vaginal mesh extrusions or infections, with a mean follow-up of 12 months (range 1 to 38). CONCLUSIONS: Silicone-coated polyester mesh has recently been associated with a high rate of vaginal erosion when used as a transvaginal suburethral sling. Our experience specifically with vaginal vault suspension corroborates this. We have abandoned the use of silicone mesh because of the unacceptably high extrusion rate and presently use polypropylene mesh.

Management of vaginal erosion of polypropylene mesh slings.

PURPOSE: The SPARC (American Medical Systems, Minneapolis, Minnesota) polypropylene sling has recently been introduced as an alternative delivery system to TVT (Ethicon, New Brunswick, New Jersey) tension-free vaginal tape for placement of a tension-free mid urethral sling. Erosion must always be considered a risk of synthetic materials. We present 4 cases of vaginal erosion of polypropylene mesh placed with this system and the successful conservative management done. MATERIALS AND METHODS: A total of 90 patients received a SPARC polypropylene pubovaginal sling at our institution between October 1, 2001 and October 1, 2002. During followup 3 of our patients and 1 patient with tension-free vaginal tape who was referred from elsewhere presented with vaginal exposure of the mesh. RESULTS: Two patients described persistent vaginal discharge 6 weeks postoperatively, including 1 who complained primarily of partner discomfort during sexual intercourse. Two patients were completely asymptomatic and mesh erosion was discovered at routine physical examination 6 weeks postoperatively. Pelvic examination demonstrated vaginal exposure of the mesh in all cases. Each patient was observed conservatively and 3 months postoperatively all 4 had complete spontaneous epithelialization over the mesh. None had stress incontinence, urgency or urge incontinence, all emptied the bladder to completion and all patients were completely satisfied with the procedure. CONCLUSIONS: The recent literature suggests that polypropylene mesh erosion should be treated with complete removal of the sling material. We present 4 cases of vaginal erosion of polypropylene slings that were managed conservatively with observation and resulted in complete spontaneous healing. Sling preservation with continued patient continence and satisfaction is a feasible option in those with vaginal exposure of polypropylene mesh.

Perioperative complications: the first 140 polypropylene pubovaginal slings.

PURPOSE: Two widely used tensionless mid urethral slings currently available are the SPARC polypropylene sling (American Medical Systems, Minneapolis, Minnesota) and the TVT (tensionless vaginal tape, Ethicon, New Brunswick, New Jersey). As with the TVT system, the SPARC has been suggested as an outpatient procedure. We present the early complications of our first 140 slings, based on which we recommend that observation of all patients overnight following the SPARC sling be considered. MATERIALS AND METHODS: We retrospectively reviewed the charts of the first 140 patients who received the SPARC polypropylene pubovaginal sling at our institution to evaluate for early complications requiring intervention. Because we wished to evaluate for occult bleeding, we checked the hematocrit on postoperative day 1 in the last 57 patients regardless of blood loss in the operating room. RESULTS: A total of 6 patients required intervention in the early postoperative period, including transfusion in 4 immediately postoperatively for retropubic bleeding. One patient had presented with pelvic pain and vaginal bleeding 1 week postoperatively and was found to have a large retropubic hematoma that required percutaneous drainage. The final patient was discharged home on postoperative day 1 in stable condition but presented on postoperative day 4 with drainage from a suprapubic incision. She had a perforation through a loop of small bowel that required resection of a short segment of the bowel and removal of the sling. The mean decrease in hematocrit from preoperative to postoperative day 1 was 7.1% (range 1% to 14%) despite a mean intraoperative blood loss in this group of 170 cc (range less than 50 to 700). CONCLUSIONS: We recommend caution with any patient who receives a sling that requires passage of needles through the retropubic space, which can result in occult retropubic bleeding, and dilation of the tract. While visceral injury is exceedingly rare, it must be discussed as a possible risk of the surgery. We continue to advocate SPARC as an excellent sling option but we caution surgeons of the potential complications and urge careful postoperative monitoring. We recommend that SPARC not routinely be considered as an outpatient procedure.

Intermediate term failure of pubovaginal slings using cadaveric fascia lata: a case series.

PURPOSE: The pubovaginal sling procedure using autologous fascia has become the gold standard for treating intrinsic sphincter deficiency and stress urinary incontinence in women. A recent modification has been the use of cadaveric fascia as the sling material. We recently reported similar results for cadaveric fascia lata in 121 women and autologous fascia lata in 46 at a mean followup of 12 months. We have now identified 8 patients who experienced intermediate term failure at 4 to 13 months using cadaveric fascia lata. MATERIALS AND METHODS: We retrospectively reviewed the records of 8 of 121 patients who received a pubovaginal sling using cadaveric fascia lata between February 1997 and June 1999 and had recurrent stress incontinence after 4 to 13 months. We reviewed the type of fascia, surgical technique, preoperative and postoperative urodynamics, surgical history and medical co-morbidities. RESULTS: We identified 8 patients who underwent a pubovaginal sling using cadaveric fascia lata and had recurrent stress urinary incontinence at a mean of 6.5 months (range 4 to 13) after the procedure. Fresh frozen fascia from a local tissue bank was used and the surgical technique was identical in all cases. Postoperatively urodynamics confirmed recurrent intrinsic sphincter deficiency. Previous incontinence surgery had been done in 7 of the 8 patients. Patient co-morbidities included neurological disease, diabetes mellitus, previous pelvic irradiation and previous pelvic surgery. CONCLUSIONS: We identified a higher than expected intermediate term failure rate using fresh frozen cadaveric fascia lata. This risk must be weighed against the advantages of decreased operative time and patient morbidity. Longer followup and larger numbers are necessary to determine how much of a problem exists and what patient characteristics are relevant when selecting cadaveric grafts.

Outcomes following mid-urethral sling placement in patients with intrinsic sphincteric deficiency: comparison of Sparc and Monarc slings

Purpose: The treatment of patients with intrinsic sphincteric deficiency (ISD) remains difficult. It is theorized that differing vectors of support provided by retropubic versus transobturator mid-urethral sling routes may affect outcomes. We sought to compare outcomes of patients undergoing SPARC versus MONARC sling types in patients with Valsalva leak point pressures (VLPPs) below 60 cm H2O. Materials and Methods: A retrospective review of female patients with stress urinary incontinence undergoing SPARC™ (n = 97) or MONARC™ (n = 39) placement following urodynamic diagnosis of ISD was performed, with minimum 12-month follow-up required. Outcomes were assessed using a questionnaire comprising validated incontinence questionnaires (UDI-6, IIQ-7) and additional items addressing satisfaction. Results: Success rates of 76 percent and 77 percent were observed in the SPARC (mean follow-up 36 months) and MONARC (mean follow-up 32 months) cohorts, respectively (p > 0.05). Superior UDI scores were demonstrated in the MONARC cohort (3.8 vs. 5.3, p = 0.04)), in contrast to similar IIQ scores across both groups (3.7 vs. 3.1, p > 0.05). A deterioration in success rates was seen in both cohorts with more extended follow-up and with lower VLPPs. However, this finding was limited by low patient numbers in these cohorts. A complication rate of 7 percent and 3 percent was noted in SPARC and MONARC cohorts (p > 0.05). Conclusions: We observed no significant differences in subjective outcomes when comparing patients undergoing SPARC versus MONARC sling placement in the treatment of SUI with VLPP < 60 cm H2O. A deterioration in continence rates was seen with extended follow-up. These data may be affected by low patient numbers and related study power, in particular with more extended follow-up.