Surgical treatment of advanced anterior wall and apical vaginal prolapse using the anchorless self-retaining support implant: long-term follow-up.

INTRODUCTION AND HYPOTHESIS: Following health notification by the FDA in 2008 of serious complications with transvaginal mesh for anterior pelvic organ prolapse, there has been a return to native tissue repairs. Earlier work with a self-retaining support (SRS) implant showed a high anatomical success rate with minimal implant-related complications over a medium-term follow-up. It is proposed that post-implant complications are more a consequence of the method of mesh anchoring rather than the implant itself. Our system incorporates an ultralight mesh with a frame that provides level I, II, and III support without the need for fixation. The first long-term outcomes of SRS implantation are presented. METHODS: A prospective multicenter trial was conducted using two consecutive identical protocols of the use of the SRS implant in women with symptomatic anterior compartment prolapse extending their follow-up to 36 months. Anatomical success (Pelvic Organ Prolapse Quantification stage 0 or 1 or a Ba ≤ -2) was recorded along with subjective success as defined by regular quality-of-life (PFDI-20 and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) assessments. RESULTS: Sixty-seven patients completed 36 months of follow-up. Mean Ba measurements improved from 3.1 (-1 to 6) cm to -2.8 (-1 to -3) cm and C point from 0.4 (-8 to 6) cm to -6.9 (-10 cm to 1) cm. accumulating to a significant anatomical success rate of 94.3%. Subjective success based on question #3 of the PFDI-20, analyzed for the index surgical compartment, reached 95.7%. Post-operative complications included 2 cases of urinary retention, 1 minor frame exposure, 1 case of delayed voiding dysfunction, and 2 cases of de novo stress urinary incontinence. Untreated pre-operative second-degree Bp measurements had increased in 27% at follow-up. CONCLUSION: The long-term outcome of the SRS implant shows an excellent subjective and objective success with minimal risk of complications or need for reintervention.

[ANCHORLESS VAGINAL IMPLANT FOR THE TREATMENT OF ADVANCED PELVIC ORGAN PROLAPSE].

INTRODUCTION: The use of vaginal mesh in pelvic surgery has previously demonstrated anatomical advantage combined with surgical complications that have called its effectiveness into question. OBJECTIVES: To evaluate the safety and efficacy of an anchorless implant for the repair of pelvic organ prolapse (POP) in women with risk factors for recurrence. METHODS: Retrospective evaluation of the self-retaining support (SRS) implant in women with a ≥2 degree vaginal anterior and apical prolapse with an increased risk of prolapse recurrence. Demographic and clinical data were collected, and women suspected of recurrence, based on a telephone questionnaire, were re-examined. RESULTS: Sixty women were evaluated. Four (6.6%) underwent reoperation due to prolapse recurrence of the posterior and vaginal apex. No intra-operative complications were documented; 4 (6.6%) women had surgical field hematoma treated conservatively. No chronic pelvic pain or dyspareunia were documented. Six (10%) women who reported bulging sensation in the telephone questionnaire were examined and found to have prolapse of the posterior compartment and not of the anterior or apical compartment treated by the SRS. CONCLUSIONS: Use of the SRS demonstrated 93.3% success rate at a mean follow-up of 14 months postoperatively without intra-operative complications and mild post-op complications at follow-up. DISCUSSION: Short term data on the use of the SRS demonstrate that anchorless mesh technique may preserve the benefits of vaginal mesh while eliminating surgical complications. The SRS is a safe and effective surgical alternative for the repair of anterior and apical vaginal prolapse in women with advanced pelvic organ prolapse and risk factors for relapse.

Anchorless implant for the treatment of advanced anterior and apical vaginal prolapse - Medium term follow up.

OBJECTIVE: to evaluate the mid-term safety and efficacy of a surgical technique using an anchorless implant. STUDY DESIGN: This is a prospective study. Women with symptomatic POP were recruited. The technique involved placement of an open trapezoid-shaped frame which retains a polypropylene mesh stretched within its parameter. No fixation techniques used. Demographic data and pre-operative quality of life (QoL) questionnaires were collected. Peri-operative data were documented. Patients were followed at 2, 6, 12, 24 and 36 months. Follow-up included repeated QoL questionnaires, Pelvic Organ Prolapse- Quantification (POP-Q) measurements and assessment for possible complications. RESULTS: Seventy women were recruited. Mean age was 63.1 years, mean parity was 4.6 deliveries. Mean pre-operative POP-Q were Ba = 3.1 (-1 to 6) cm and C = 0.4 (-8 to 6) cm. No intra-operative complications were observed. Surgical time averaged 24.7 min. Estimated blood loss averaged 155 cc. Mean follow up at last visit was 27.7 months. Two patients (2.8 %) underwent partial frame resection and two patients (2.8 %) underwent a TVT-O for de-novo stress urinary incontinence (SUI). At follow-up, the mean POP-Q were Ba= -2.8 (-3 to -1) cm and C = -6.8 (-10 to 1) cm. Two patients (2.8 %) had recurrent prolapse. One was symptomatic and received treatment. No mesh erosion or chronic pelvic pain were documented. Pelvic Function Distress Inventory (PFDI20) scores showed significant improvement. Thirty-eight (54 %) patients completed the Pelvic organ prolapse/Urinary Incontinence Sexual Questionnaire (PISQ12) showing no chronic dyspareunia. CONCLUSION: The Self Retaining Support (SRS) implant provides 97 % subjective and 94.3 % objective cure. Two patients (2.8 %) had the implant's frame removed surgically. The SRS is a safe and effective treatment for pelvic organ prolapse.

Self-retaining support implant: an anchorless system for the treatment of pelvic organ prolapse-2-year follow-up.

INTRODUCTION AND HYPOTHESIS: The search for an improved vaginal mesh prompted the development of a new anchorless implant. The objective was to report on outcome after 2 years of a technique using a self-retaining support (SRS) implant. METHODS: Patients with anterior vaginal wall prolapse, with/without apical prolapse, were recruited. Participants underwent surgical repair using the SRS device. Demographic data, pre-surgical Pelvic Organ Prolapse Quantification (POP-Q) scoring, quality of life (QoL) questionnaires (Pelvic Floor Distress Inventory Short Form 20 [PFDI-20], Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 [PISQ-12]), and surgical data were collected. Patients were followed at 2 weeks, 2, 6, 12, and 24 months after surgery. Objective anatomical success was defined using the NIH criteria. RESULTS: Twenty women were recruited for the study with an average age of 62.1 years and an average parity of 4.0 deliveries. Average BMI was 28. Pre-operative mean POP-Q measurements were Aa =1.40 (-1 to 3) cm, Ba = 2.3 (-1 to 6) cm and C = 0.4 (-7 to 6) cm. Surgical time averaged 31.2 min. Estimated blood loss averaged 165 ml. No intra-operative complications were observed. One case (5%) of frame erosion was documented 8 months after surgery. At 2 years' follow-up, mean POP-Q measurements were: Aa = -2.95 (-3 to -2) cm, Ba = -2.85 (-3 to -2) cm, and C point -6.90 (-10 to -3) cm. Seventeen (85%) patients had stage 0 and 3 patients (15%) had stage 1. No mesh erosions or chronic pelvic pain were documented at follow-up. The total PFDI score at follow-up was decreased by 92.8 points (p < 0.0001). CONCLUSIONS: At 2 years' follow-up, the SRS implant was found to be safe, showing no intra-operative or immediate post-operative complications. All women presented with POP-Q measurements of the anterior and apical compartment at normal value (Ba ≤ -2 cm) and statistically significant subjective improvement.

Outcome of vaginal mesh reconstructive surgery in multiparous compared with grand multiparous women: Retrospective long-term follow-up.

We aimed to compare the long-term surgical outcome and complications of multiparous and grand multiparous women undergoing reconstructive surgery with vaginal mesh implants for repair of pelvic organ prolapse. This retrospective, long-term follow-up (28.17±20.7 months) comprised 113 women who underwent surgical reconstructive surgery with vaginal polypropylene mesh in a high parity rate population medical center. The women were divided into 2 groups (multiparous and grand multiparous) and each group was evaluated for objective and subjective surgical outcome. Patient demographics and surgical data were retrieved from electronic medical records. Outcome measure included POP-Q exam as objective outcome and validated Pelvic Floor Distress Inventory questionnaire (PFDI) to assess subjective outcome. Average age of patients was 62±7.9 (range 42-83) years. Average parity was 5.6±3.1 (range 1-14). There were 54 (47.7%) multiparous women and 59 (52.3%) grand multiparous women. The grand multiparous women were younger than the multiparous women and had a significantly higher degree of prolapse. At the last follow-up, the only significant difference was related to symptoms of an overactive bladder. In conclusion, long-term follow-up demonstrates that vaginal mesh surgery in grand multiparous women offers anatomical and subjective cure rates comparable to multiparous women.

Cadaver study of anchorless implant for the treatment of anterior and apical vaginal wall prolapse.

OBJECTIVE: This cadaver study was performed in order to evaluate the feasibility and the anatomical landmarks of a Self-Retaining device, a new unanchored mesh, for the treatment of anterior and apical vaginal prolapse. STUDY DESIGN: The Self-retaining device was implanted transvaginally in two cadavers. One cadaver underwent a detailed trans-abdominal dissection of the pelvis and the other cadaver, frozen after the implant placement, underwent a cross section dissection of the pelvis. RESULTS: The location of the device was confirmed to be in appropriate anatomical position and in safe distance from any major neurovascular structures in the pelvis. CONCLUSION: The self-retaining implant, in its planned location, can be a safe procedure with respect to neighboring neurovascular and muscular pelvic structures. Brief summery: A cadaver study of anchorless implant for safety evaluation of the distance from vital structures. The implant found anatomically safe for use.

[Urogynecology: from past to future].

Over the last decade, the field of urogynecologic surgery has been subject to deep changes. A thorough understanding of the injury mechanisms responsible for pelvic organ prolapse (POP) and urinary incontinence in women, greatly contributed to the development of innovative surgical techniques and changing therapeutic approaches. The variety of treatment options to correct POP and incontinence has greatly expanded, partly thanks to the development of several advanced surgical kits by biotechnology companies. This review describes the evolution of surgical techniques in the field of pelvic floor reconstruction during the last century and raises questions regarding the safety and efficacy of the various techniques available in this field. This paper summarizes the "state of the art" for POP and the incontinence surgery approach in Western countries. It also provides a number of general recommendations based on the authors personal experience [expert opinion]. Such recommendations with slight variations appear in position statements of professional societies worldwide.

Validation of Hebrew versions of the Pelvic Floor Distress Inventory, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire, and the Urgency, Severity and Impact Questionnaire.

OBJECTIVE: Validated objective tools in the native languages of investigated populations are important for evaluating effects of medical disorders and treatments. The aim of our study was to validate a Hebrew version of the validated questionnaires commonly used in the field of urogynecology. METHODS: This is a 2-step, prospective, multicenter study. Using a back-translation method, Hebrew-language versions of the following questionnaires were developed: Pelvic Floor Distress Inventory, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire, and the Urgency, Severity and Impact Questionnaire. The questionnaires were administered in both Hebrew and English to 56 bilingual patients with pelvic organ prolapse and/or urinary incontinence. To test reliability, the participants were asked to refill the questionnaires in Hebrew 2 weeks later. Scores from the Hebrew and English versions were compared, using the Wilcoxon signed rank test. Correlations between versions were assessed by the Spearman test. P < 0.05 or less was considered significant. RESULTS: Scores from the Hebrew and English versions were found to be highly correlated, ρ = 0.61-0.96; P < 0.001. No differences in total scores were detected between the 2 versions of the 3 questionnaires and their subcategories (P > 0.05). Cronbach alpha values were good (0.65-096) for all questionnaires. Scores were highly correlated when the patients refilled the questionnaires in Hebrew (ρ = 0.81-0.98; P < 0.001). CONCLUSIONS: This study provides validated Hebrew versions of 3 well-accepted pelvic floor questionnaires. These questionnaires will enable standardization when assessing women with pelvic floor dysfunction.

Age as a risk factor for perioperative complications in women undergoing pelvic reconstructive surgery.

OBJECTIVE: : The purpose of this study is to determine whether the age of a patient undergoing pelvic reconstructive and/or anti-incontinence pelvic surgery is a risk factor for perioperative complications. STUDY DESIGN: : A retrospective chart review was conducted of women who underwent pelvic reconstructive and anti-incontinence pelvic surgery between the years 2000 and 2006. The women underwent surgery by 1 urogynecologist, at 2 city hospitals. Patients with incomplete medical documentation were excluded from the study. The variables investigated included demographics, smoking history, prior surgical history, comorbidities, length of surgery, estimated blood loss, deep venous thrombosis prophylaxis, perioperative antibiotics, type of anesthesia, and the American Society of Anesthesia classification. The outcome variables included change in hematocrit, length of hospitalization, intraoperative injury, and prevalent postoperative complications. Postoperative complications included, febrile morbidity (T ≥ 101, ≥24 hours following surgery), documented infection (acute cystitis, wound or pelvic infection, and pneumonia), cardiovascular compromise (myocardial infarction, cerebral vascular accident, congestive heart failure, hypotension, arrhythmia), renal failure, graft erosion, dyspareunia, urinary retention, anemia (hematocrit ≤24%), ileus, hematoma, seroma, and ICU admission. A point system was created for each complication to limit the variation in data collection. Morbidity and mortality were determined for women aged ≤55 years old (group I), 56 to 69 years old (group II), and ≥70 years old (group III). One-way analysis of variance was used to determine whether a difference exist between the age groups, and exact χ tests were used to identify the association between age and the aforementioned outcome variables. An alpha level of 0.05 was predetermined as the level of statistical significance. RESULTS: : A total of 411 patients underwent pelvic reconstructive surgery, 404 surgical procedures met the inclusion criteria, group I (n = 168), group II (n = 152), and group III (n = 84). Most surgeries were done vaginally. The women were followed up for an average of 185 days (group I), 243 days (group II), and 248 days (group III). There was no significant difference in the operative time, length of hospitalization, or follow-up period between the groups. Demographically, the groups had a similar composition. There are minor differences in prior medical and surgical histories between the age groups. Older women were more likely to have a history of cardiovascular disease. Patients in group II were more likely to have a prior history of a midurethral sling (P = 0.02). Patients in group III, were more likely to have a prior history of an abdominal hysterectomy (P = 0.01) and anterior colporrhaphy with graft (P = 0.01). In this study, group II underwent more salpingectomies (P = 0.01) and group III underwent more hysterectomies (P = 0.01), oophorectomies (P = 0.05), and posterior colporrhaphies (P = 0.001). Overall, the rate of intraoperative complications was 1.0%. There was no statistical difference in the postoperative complication rate among the 3 age groups (P = 0.27) and no fatalities. CONCLUSION: : The age of a patient undergoing vaginal reconstructive and/or anti-incontinence pelvic surgery does not appear to be a risk factor for perioperative complications.