Small intestinal submucosa xenograft to manage lower urinary tract prostheses perforation: a new path?

INTRODUCTION AND HYPOTHESIS: Tapes for stress urinary incontinence (SUI) and meshes for pelvic organ prolapse can result in postoperative complications, such as urethral (UP) or bladder (BP) perforations. Martius fat pad (MFP) is an historic procedure, widely used to treat lower urinary tract (LUT) fistulae. We report our experience with the insertion of the biological small intestinal submucosa (SIS) xenograft as an alternative to MFP in these prosthetic complications. METHODS: We conducted a retrospective, monocentric study which included all patients who underwent SIS insertion during surgical removal of tape/vaginal mesh for UP or BP from 2011 to 2019. Preoperative assessment was based on history, symptoms, physical examination and urethrocystoscopy. Primary outcome was successful repair defined as absence of any LUT defect. Secondary outcomes were complications, LUT symptoms, pain and additional SUI surgical procedures. RESULTS: Thirty-eight patients were included. Twenty-six had a UP and eight a BP. In four cases, perforation involved both the bladder neck and urethra. All LUT defects were cured. Six postoperative complications were reported (five of grade ≤ 2 and one of grade 3b according to the Clavien-Dindo classification). At the mean follow-up of 37.2 (range 6-98) months, 14 patients (36.8%) presenting a postoperative SUI underwent a SUI surgical procedure and 1 patient had a laparoscopic sacrocolpopexy for cystocele recurrence. CONCLUSION: Absorbable SIS xenograft is an effective and safe graft for the management of lower urinary tract tape and mesh perforations. The cost has to be balanced with the good results, short operative time and no fat pad complications as in MFP.

Back to the future: vaginal hysterectomy and Campbell uterosacral ligaments suspension for urogenital prolapse.

INTRODUCTION AND HYPOTHESIS: To evaluate vaginal hysterectomy (VH) associated with vaginal native tissue repair (VNTR) using Campbell uterosacral ligament suspension (C-USLS) for the treatment of predominant uterine prolapse associated with cystocele. METHODS: We conducted a retrospective monocentric study including patients who underwent VH and C-USLS, without concomitant mesh, for primary urogenital prolapse between January 2011 and June 2018. We evaluated the anterior and apical prolapse recurrence rate, using a composite criterion (symptomatic, asymptomatic recurrence, POP-Q stage ≥ 2). We analyzed 2-year recurrence-free survival using the Kaplan-Meier method. Univariate and multivariate analyses were performed to identify variables associated with recurrence. Secondary outcomes included postoperative complications, lower urinary tract symptoms (LUTS) and sexual satisfaction. RESULTS: Ninety-four patients were included. Eighty-three (88.3%) and 65 (69.1%) patients had stage ≥ 3 uterine prolapse and cystocele, respectively. Mean follow-up was 36 months. Prolapse recurrence rate was 21.3% including 3.2% of cystocele. Two-year recurrence-free survival was 80%. Age, body mass index, POP-Q stage and associated surgical procedure were not significantly associated with recurrence. Early complications were reported for 20 patients (21.2%), mostly grade ≤ 2 (95%). De novo LUTS were reported in 11 cases (11.7%). Preoperative stress urinary incontinence and urgency were cured for 12 (80%) and 29 (80.6%) patients, respectively. Sexual satisfaction rate for patients with preoperative sexual activity was 95.8%. CONCLUSION: C-USLS following VH as primary treatment for predominant uterine prolapse with associated cystocele is a safe procedure with satisfying mid-term functional results. This VNTR could be an alternative in light of the worldwide market withdrawal of actual vaginal mesh.

French validation of the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-IUGA revised (PISQ-IR).

INTRODUCTION AND HYPOTHESIS: The aim of this study was to clinically validate the French-translated PISQ-IR in a French-speaking population of women with pelvic floor disorders. METHODS: We aimed to recruit 300 women to account for potential attrition secondary to failure to respond or loss to follow-up. Women were enrolled as part of an RCT and from a separate specific study. Both studies included surgically managed patients. Data were collected at recruitment, visit 1 (V1), V2 (9-12 months postoperatively) and V3 (V2 + 5-15 days). Participants also completed a PFDI 20, ICI-Q and FSFI and were assessed by POP-Q. RESULTS: A total of 297 women were recruited between 18 January 2013 and 18 January 2016. Data were available for 291, 148 and 110 participants at V1, V2 and V3, respectively. The non-response rate for the NSA items varied from 5% to 30%, while for SA women, the non-response rate for the items varied from 0% to 15%. The tool was deemed reliable for five domains of the summary score. We also identified that several sections demonstrated acceptable to good temporal stability. A statistically significant score change was identified in different domains in the participants categorized as improved on either PGI-I or POP-Q. We also identified moderate to strong correlations between PISQ-IR and FSFI. CONCLUSIONS: The French translated PISQ-IR has several strengths in support of its validity. Our findings confirm the validity of the summary scores in addition to the item-based initial scoring system.

Long-term women-reported quality of life after radical cystectomy and orthotopic ileal neobladder reconstruction.

BACKGROUND: The purpose of this study was to determine health-related quality of life (HRQoL) among long-term disease-free survivors in women who underwent radical cystectomy (RC) for urothelial carcinoma and orthotopic ileal neobladder (ONB) reconstruction, using validated patient-reported outcome instruments. METHODS: From 2000 to 2011, a total of 46 women with urothelial bladder carcinoma had RC and ONB at our institution; 31 (67 %) eligible women completed 3 validated questionnaires: the medical outcome study short form 12 (SF-12), the urinary symptom profile, and the Contilife, respectively evaluating general HRQoL, voiding function, and urinary incontinence specific HRQoL. Unadjusted analyses were performed to analyze standardized measures of HRQoL and voiding symptoms; p < 0.05 was considered significant. RESULTS: The mean follow-up was 5.7 years; 24 women (77 %) considered their health as good, very good, or excellent. The SF-12 physical and mental scores were not significantly different between the population study and the general population (p > 0.05). A total of 20 women (65 %) declared to be fully continent. Daytime incontinence, nighttime incontinence, and hypercontinence were reported by 26, 29, and 31 % of women, respectively. On unadjusted analysis, incontinence was associated with age > 65 years at the time of surgery (p < 0.001). Hypercontinence was not associated with any variable. CONCLUSIONS: This study suggests that in the setting of radical cystectomy in women, ileal neobladder reconstruction provides long-term satisfaction with maintained HRQoL. For properly selected women, orthotopic neobladder can be considered an appropriate diversion choice.

Identification of Key Factors Influencing the Choice of the Type of Vaginal Pessary for Women Presenting with Pelvic Organ Prolapse: Semi-Directive Interviews and Development of an Algorithm.

(1) Background: Pelvic organ prolapse (POP) can be managed using a vaginal pessary. However, the decision-making process whereby health professionals choose the right pessary is unclear. The objective of this study was to focus on the experience of experts in pessary use and to propose an algorithm. (2) Methods: A prospective study, based on face-to-face semi-directive interviews and group discussions, was conducted on a multidisciplinary panel of professional experts specialized in pessary prescriptions. A consensual algorithm was established, and its accuracy was assessed by expert and non-expert panels. The Consolidated Criteria for Reporting Qualitative Studies (COREQ) were used. (3) Results: 17 semi-directive interviews were conducted. The parameters involved in the decision-making process regarding the choice of vaginal pessaries were: desire for self-management (65%), associated urinary stress incontinence (47%), POP type (41%), and POP stage (29%). The algorithm was developed step by step (4 iterations) using the Delphi technique. Most of the expert panel (76%) rated the relevance of the algorithm as 7 or more out of 10 on a visual analog scale according to their own experience (reference activity). Finally, most (81%) of the non-expert panel (n = 230) rated the usefulness of this algorithm as 7 or more out of 10 on a visual analog scale. (4) Conclusions: This study provides an expert panel-based algorithm that may help in the prescription of pessaries for POP.

Management of female pelvic organ prolapse-Summary of the 2021 HAS guidelines.

When a patient presents with symptoms suggestive of pelvic organ prolapse (POP), clinical evaluation should include an assessment of symptoms, their impact on daily life and rule out other pelvic pathologies. The prolapse should be described compartment by compartment, indicating the extent of the externalization for each. The diagnosis of POP is clinical. Additional exams may be requested to explore the symptoms associated or not explained by the observed prolapse. Pelvic floor muscle training and pessaries are non-surgical conservative treatment options recommended as first-line therapy for pelvic organ prolapse. They can be offered in combination and be associated with the management of modifiable risk factors for prolapse. If the conservative therapeutic options do not meet the patient's expectations, surgery should be proposed if the symptoms are disabling, related to pelvic organ prolapse, detected on clinical examination and significant (stage 2 or more of the POP-Q classification). Surgical routes for POP repair can be abdominal with mesh placement, or vaginal with autologous tissue. Laparoscopic sacrocolpopexy is recommended for cases of apical and anterior prolapse. Autologous vaginal surgery (including colpocleisis) is a recommended option for elderly and fragile patients. For cases of isolated rectocele, the posterior vaginal route with autologous tissue should be preferentially performed over the transanal route. The decision to place a mesh must be made in consultation with a multidisciplinary team. After the surgery, the patient should be reassessed by the surgeon, even in the absence of symptoms or complications, and in the long term by a primary care or specialist doctor.

Management of stress urinary incontinence following prostate surgery with minimally invasive adjustable continence balloon implants: functional results from a single center prospective study.

PURPOSE: We determined the functional results and morbidity of balloon (ProACT™) implants for the treatment of male stress urinary incontinence after prostate surgery. MATERIALS AND METHODS: Between 2002 and 2008 a prospective, noncontrolled study was conducted. The ProACT implant consists of 2 adjustable balloons placed on either side of the native striated sphincter. The implants are adjusted by inflation during followup visits. The primary efficacy end point was postoperative continence as defined by the use of 0 to 1 pad daily. RESULTS: A total of 128 consecutive patients underwent implantation. Mean ± SD patient age was 71 ± 42.3 years (range 52 to 87). The severity of incontinence before ProACT was moderate (71), mild (40) and severe (17). Overall 25% of patients previously underwent pelvic radiotherapy. The mean number of daily pads per patient was 1.46 (vs 4.2 at baseline). Mean followup was 56.3 months (range 24 to 95). The functional result was success in 68% of patients with moderate/mild incontinence and the explantation rate was 18%. Among the 30 patients treated with radiotherapy before ProACT the success rate was only 46% and the incidence of urethral erosion was significantly higher (p = 0.005). CONCLUSIONS: The ProACT implant appears to be an option for the treatment of moderate male stress urinary incontinence, especially given the minimally invasive modalities of insertion, the capacity to adjust the inflation of the balloons to achieve postoperative continence and the relative reversibility.

Clinical relevance of urethral stents (Urospiral 2™) placement in patients with prostatic obstacle and concomitant high-risk surgical status or neurological diseases: a feasibility and safety study.

AIMS: To review the indications and to assess the functional outcomes after placement of a new temporary urethral stent (TUS) in men with lower urinary tract dysfunction. METHODS: We retrospectively reviewed the data of men with prostate obstruction and concomitant high-risk surgical status or neurological diseases between 2006 and 2008. TUS placement was performed with Urospiral 2™ which is a temporary, non-expanding, transprostatic stent. Success was defined as follows: when TUS placement allowed patients to void spontaneously and/or when surgery was made feasible after the period of relative contraindication (therapeutic group) or when TUS placement allowed physicians to define the role of prostate obstruction in the patients' voiding disorders and therefore to make an appropriate therapeutic decision (diagnosis group). RESULTS: We included 94 men with a mean age of 73.3 ± 9 years (48-99) and 5 of them were lost to follow-up. The mean follow-up was 148 ± 100 days (2-1,046) and the mean duration of TUS placement was 155 ± 90 days (2-1,045). After a mean hospital stay of 4.8 ± 3 days (1-31), 84 patients (89%) had recovered spontaneous micturition. In the therapeutic group and the diagnosis group, 23 patients (92%) and 45 patients (70%) voided spontaneously, respectively. CONCLUSIONS: TUS placement may be proposed temporarily in selected patients with static bladder outlet obstruction due to an enlarged prostate as it allows patients to avoid the use of an indwelling catheter.

Is the implantation of an artificial urinary sphincter with a large cuff in women with severe urinary incontinence associated with worse perioperative complications and functional outcomes than usual?

INTRODUCTION AND HYPOTHESIS: As the subsequent risks of complications and explantation increase with the size of the cuff, we aimed to assess functional outcomes after the implantation of an artificial urinary sphincter (AUS) with a large cuff (≥8 cm) in women with severe urinary incontinence. METHODS: Fifty women underwent an AUS placement with a large cuff between 1984 and 2007. Forty-three (86%) had previously undergone anti-incontinence procedures. The AUS was implanted with an open surgical technique using a transverse abdominal approach. The cuff was placed around the bladder neck between the periurethral fascia and the vagina. Perioperative complications were reviewed. To assess the resolution of urinary incontinence, all patients were seen at 1, 3, 6 and 12 months and yearly thereafter. RESULTS: The mean age was 59 ± 12.4 years (26-81). The mean BMI was 27.3 ± 5.1 (19-37). The mean pre-operative closure pressure was 19.1 ± 9.4 cmH(2)O (3-46). The mean hospital stay was 14.1 ± 5 days (5-28). The mean follow-up was 8 ± 5.6 years. Incontinence was completely resolved in 34 women (68%). The protective factors to avoid explantation were a number of gestations less than two (p = 0.04), a closure pressure higher than 19 cmH(2)O (p = 0.04) and a cuff size equivalent to 8 cm (p = 0.005). CONCLUSIONS: Specific anatomical conditions can sometimes lead to AUS implantation with a large cuff with encouraging outcomes. Thus, surgeons should not be reluctant to place a large cuff when the situation requires it.

Surgical resection for suburethral sling complications after treatment for stress urinary incontinence.

PURPOSE: Suburethral tapes have been widely adopted to treat stress urinary incontinence. Further resection of such tapes may be necessary in certain cases. We review our experience and assess urinary functional outcomes. MATERIALS AND METHODS: We retrospectively reviewed the data on all women referred to our institution between 2001 and 2007 for suburethral tape related complications and on those who had the tape surgically removed. Complete or partial resection was achieved after assessment, including endoscopic and urodynamic assessment. RESULTS: A total of 75 women with a mean age of 60.7 years (range 28 to 78) were included in the study. The tape used was transvaginal in 58 cases (77.3%) and transobturator in 17 (22.7%). There were different complications, such as erosion in 16% of cases, vaginal extrusion in 24%, bladder outlet obstruction in 45%, chronic pelvic pain in 21%, and de novo urinary incontinence and urgency in 12%. Resection was done a mean +/- SD of 33 +/- 22 months (range 6 to 80) after tape placement. Of the 58 women with transvaginal tape the tape was completely removed by laparoscopy in 30 (51%). Four of the 17 transobturator slings (23%) were completely removed by laparoscopy (1) and via a low gynecological approach (3). The remaining slings were partially resected via a gynecological approach. At a mean followup of 38.4 months (range 12 to 72) incontinence recurred in 39 women (52%) after partial (18) and complete (21) resection. CONCLUSIONS: In rare women who experience crippling symptoms after suburethral sling implantation urologists must be aware that the decision to completely or partially resect the tape can help resolve symptoms.

De novo urinary stress incontinence after laparoscopic sacral colpopexy.

OBJECTIVE: To analyse the incidence and the risk of developing de novo stress urinary incontinence (SUI) after laparoscopic sacral colpopexy (LSCP). PATIENTS AND METHODS: In all, 53 women wit no concomitant or occult SUI before surgery had a LSCP with no anti-incontinence procedure. All their medical charts were reviewed retrospectively and analysed statistically to assess the association between clinical data before LSCP (age, body mass index, maximum urethral closure pressure, medical history of UI and prolapse surgery, bladder neck hypermobility) and de novo SUI after LSCP. RESULTS: With a mean (sd) follow up of 20.4 (9.1) months, seven patients (13%) developed de novo SUI, within a median (range) of 2.1 (1-3) months after surgery. There was no statistical association between factors before LSCP and de novo SUI afterward on a univariate analysis (P > 0.05). The 5-year SUI-free survival rate after LSCP was 86%. CONCLUSION: Despite the risk of de novo SUI remaining low after LSCP patients should always be informed before surgery, as it cannot be predicted. Moreover, it can directly affect the functional outcome and lead to a second procedure in a few cases.

[French multicentre prospective study of the use of ACT balloons (Uromedica, Inc., Plymouth, Min, U.S.A.; Medtronic, Minneapolis, U.S.A.) for the treatment of female stress urinary incontinence]. / Etude française prospective multicentrique de l'utilisation des ballons ACT pour le traitement de l'incontinence urinaire d'effort chez la femme.

OBJECTIVE: French multicentre prospective study to evaluate the efficacy and feasibility of ACT (Adjustable Continence Therapy) balloons for the management of female stress urinary incontinence (SUI). MATERIALS AND METHODS: The ACT system comprises two adjustable balloons implanted on either side of the bladder neck in order to restore continence. The feasibility of this technique was evaluated perioperatively. Adverse events were recorded to evaluate the acceptability of the technique. Evaluation of efficacy was based on individual interviews to determine the severity of incontinence (use of pads and quality of life questionnaire (I-QoL)) and by Direct Visual Stress Testing (DVST). RESULTS: 68 patients with SUI were included. The mean operating time was 31.8 +/- 11.7 minutes. The ACT was implanted with no particular difficulties in 91% of cases. Evaluation of patients (mean follow-up: 2 years) after implantation revealed a marked improvement of incontinence (87%), DVST (85%) and I-Qol (score: 75/100). The ACT was removed in 18 patients for various reasons and was reimplanted in 6 cases. The ACTI was removed in 8 patients at their request due to complete absence of efficacy. CONCLUSION: ACT balloon implantation is a new, reversible and promising minimally invasive technique for the management of female stress urinary incontinence. The possibility of percutaneous adjustment of the size of the balloons according to clinical efficacy appears to be an essential advantage of this technique.

Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review.

OBJECTIVES: The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items. STUDY DESIGN AND SETTING: A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting. Finally, we screened these reporting guidelines to find those using our set of reporting items. RESULTS: Seven relevant reporting items were selected that related to four topics: randomization, learning curve, surgical setting, and device information. A total of 348 reporting guidelines were identified, among which 26 met our inclusion criteria. However, none of the 26 reporting guidelines presented all seven items together. The most frequently reported item was timing of randomization (65%). On the contrary, device information and learning curve effects were poorly specified. CONCLUSION: To our knowledge, this study is the first to identify specific items related to IMDs in reporting guidelines for clinical trials. We have shown that no existing reporting guideline is totally suitable for these devices.

[Surgical management of chronic refractory pain after TVT treatment for stress urinary incontinence]. / Prise en charge chirurgicale des douleurs chroniques rebelles survenues après cure d'incontinence urinaire d'effort selon la technique TVT.

OBJECTIVE: To evaluate the results of surgical treatment of iatrogenic pelviperineal pain following TVT treatment for stress urinary incontinence (SUI). MATERIAL AND METHODS: Eight patients developed chronic pain after TVT that was refractory to symptomatic medical treatment. Pain was characterized by clinical interview and clinical examination and an aetiological assessment demonstrated the role of TVT in pathogenesis of the pain. TVT was removed by open surgery or by laparoscopy. Pain and continence were evaluated postoperatively. RESULTS: TVT was completely (n = 3) or partially (n = 5) removed. With a mean follow-up of 31 months, no patient has experienced pain recurrence. Five patients have remained continent and 3 patients were treated for recurrent urinary incontinence. CONCLUSION: Although medical treatment may be disappointing, surgical resection provides good results on refractory pain, but preservation of continence is inconstant.

Evaluating single-incision slings in female stress urinary incontinence: the usefulness of the CONSORT statement criteria.

OBJECTIVE: To evaluate the usefulness and applicability of the Consolidated Standards of Reporting Trials (CONSORT) for journal articles reporting randomized, controlled trials evaluating single-incision slings in the treatment of female stress urinary incontinence. METHODS: Original articles reporting randomized, controlled trials assessing single-incision slings in the treatment of female stress urinary incontinence were searched for in the PubMed and Embase databases in 2011. Reporting quality was studied by 2 hospital pharmacists and 2 urologic surgeons. Primary outcome was the score out of 20 in the abstract CONSORT checklist. Secondary outcomes were the scores in the standard CONSORT checklist and the extension CONSORT additional items for trials assessing nonpharmacologic treatments. RESULTS: Among 135 articles retrieved, 8 met the inclusion criteria and were assessed. Abstract scores ranged from 4.7-14.1. Standard scores were >10.0 out of 20 for most articles; the extension scores did not exceed 5.0 out of 10. Four reported trials were not identified as randomized in the title. The interventions were incompletely reported. Four articles reported whether blinding was achieved but lack of blinding was never discussed as a potential source of bias. Few articles reported the operators and centers characteristics and their impact on statistical analysis. The combination of the 3 checklists was considered a useful guideline to enhance and assess the reporting quality of a surgical trial. CONCLUSION: Our results support the further use of CONSORT criteria as a basic standardized tool in all stages of clinical evaluation for any prosthetic device in female pelvic surgery.

Laparoscopic approach for artificial urinary sphincter implantation in women with intrinsic sphincter deficiency incontinence: a single-centre preliminary experience.

BACKGROUND: Implantation of an artificial urinary sphincter (AUS) is used as a last resort in women with stress urinary incontinence (SUI). OBJECTIVE: To assess the early functional outcome after laparoscopic placement of an AUS in women. DESIGN, SETTING, AND PARTICIPANTS: Twelve women with type 3 SUI underwent a laparoscopic AUS placement between 2006 and 2008. Eleven (92%) had previously undergone anti-incontinence procedures. INTERVENTION: The AUS was implanted with laparoscopic access either preperitoneally or intraperitoneally. The cuff was placed around the bladder neck between the periurethral fascia and the vagina. MEASUREMENTS: Perioperative complications were reviewed. To assess resolution of urinary incontinence, all patients were seen at 1, 3, 6, and 12 mo after the surgery and yearly thereafter. RESULTS AND LIMITATIONS: The mean age of subjects was 56.7+/-12 yr (33-78). The mean body mass index was 24+/-2.3 (20-25). The mean preoperative closure pressure was 22+/-10.9 cmH(2)O (4-35). The mean operative time was 181+/-39 min [110-240]. Intraoperative complications occurred in three women (25%), with bladder (n=2) and vaginal (n=2) injuries. These complications required open conversion. AUS implantation was postponed in one case. The mean hospital stay was 7+/-2.3 d (3-11). The bladder catheter was removed after a mean time of 10+/-8 d (2-30). Urinary retention was observed in five cases (45%) after bladder catheter removal. AUS activation was done 4-14 wk after implantation. Mean follow-up was 12.1+/-8 mo (5.2-27). Incontinence was completely resolved in eight women (88%) who underwent complete laparoscopic procedure. The main limitation of the study was the limited length of follow-up. CONCLUSIONS: AUS implantation can be successfully achieved by laparoscopy. It appears to be technically feasible. These results are still preliminary, and further studies of larger populations with longer follow-up are needed to make any statement regarding surgical strategy.

Laparoscopic surgical complete sling resection for tension-free vaginal tape-related complications refractory to first-line conservative management: a single-centre experience.

BACKGROUND: Tension-free vaginal tape (TVT) has been largely used for the management of stress urinary incontinence. In certain cases, however, this procedure results in bothersome complications that lead to a complete resection. OBJECTIVE: We assessed the technical feasibility and functional outcome after complete laparoscopic resection of TVT. DESIGN, SETTING, AND PARTICIPANTS: Thirty-eight women with TVT-related complications refractory to first-line management underwent a complete laparoscopic tape resection between 2001 and 2009. SURGICAL PROCEDURE: Complete laparoscopic resection was achieved with either an intra- or extraperitoneal laparoscopic approach. Laparoscopy was performed with four ports: a 10-mm umbilical telescope port, two 5-mm ports placed medially to the anterior superior iliac spines, and a 10-mm port placed at the midpoint between the pubis and umbilicus. The two half-tapes were dissected towards the urethra and removed. MEASUREMENTS: All data referring to patient demographics, surgery, tape-related complication, and perioperative outcomes were recorded. RESULTS AND LIMITATIONS: The mean age of the patients was 66.2 yr (range: 45-79 yr). TVT-related complications included bladder erosion, vaginal extrusion, and bladder outlet obstruction or groin pain. The resection took place at a mean time of 25 mo (range: 6-80 mo) after TVT placement. Resection was complete in all patients, within a mean operative time of 110 min (range: 50-240 min). All women reported a total decrease of symptom-related complications within a mean follow-up period of 37.9 mo (range: 2-80 mo). However, recurrent incontinence occurred in 65.7% (n=25) of the patients. The main limitation of the study was the lack of a validated questionnaire to assess the evolution of functional disorders. CONCLUSIONS: Complete laparoscopic resection of TVT is safe and technically feasible. In the limited number of women who have persisting disabling symptoms after conservative management, urologists must be aware that a complete resection can help resolve the symptoms.

Treatment of postprostatectomy stress urinary incontinence using a minimally invasive adjustable continence balloon device, ProACT: results of a preliminary, multicenter, pilot study.

OBJECTIVES: To evaluate the safety and efficacy of a new minimally invasive device, Adjustable Continence Therapy (ProACT) for patients with postprostatectomy stress urinary incontinence (SUI). METHODS: Sixty-two patients with urodynamic SUI after prostate surgery were evaluated according to daily pad count and a specific validated evaluation for persons with urinary incontinence. RESULTS: All patients were successfully implanted in a single procedure using general or spinal anaesthesia. Procedural time was 37 minutes (range, 18 to 80 minutes). Daily pad usage decreased from 4.6 pads per day to 1.06 pads per day at 12 months. Mean quality-of-life index score increased from 48 to 67 at 12 months.Fifty-nine percent of patients without adjuvant radiation were improved (greater than 50% reduction in pad use), and 30% were cured (no pads), whereas 83% of postirradiated patients failed intervention. Fifty-five patients (88%) required percutaneous balloon adjustments. The mean optimal volume after adjustments for all 45 improved patients was 3.8 mL per balloon. Complications necessitating removal occurred in 19 patients and included erosion, infection, migration, and failure to respond. Of these, 4 were successfully reimplanted. All complications occurred in the first postoperative month. CONCLUSIONS: Implantation of postoperatively adjustable balloons in postprostatecomy men is technically feasible, with an improvement in continence particularly in patients with nonirradiated periurethral tissues. Optimal urethral resistance is achieved, with easy postoperative adjustment. Implantation of ProACT balloons may represent a promising development in the treatment of postprostatectomy SUI.