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.