Vaginal Patch Research Articles

Results of the RE-DINO multicenter randomized trial on the repeated use of vaginal dinoprostone (Propess®) for labor induction in patients at term

BackgroundLabor is induced in over 25% of women in France. Prostaglandins, especially intravaginal dinoprostone (Propess®), are widely used to initiate cervical ripening. If labor does not start within 24 hours, there is uncertainty about whether to administer a second dinoprostone pessary or to use oxytocin to induce labor in order to achieve a vaginal delivery. ObjectivesOur principal objective was to determine whether placement of a second Propess®, followed by oxytocin (Syntocinon®) if necessary, in pregnant women for whom the first Propess® failed to induce cervical ripening increases the vaginal delivery rate compared to direct oxytocin injection. The vaginal delivery rate was therefore the primary outcome. The secondary outcomes were the cervical ripening failure rate and maternal and fetal morbidity and mortality. Study DesignRE-DINO is a prospective, open-label, multicenter, randomized superiority trial with 2 parallel arms running in 7 French hospitals. Patients at > 37 weeks of gestation who had unfavorable cervical conditions (Bishop score < 6) 24 hours after placement of the first Propess® (vaginal patch featuring progressive continuous diffusion of 10 mg dinoprostone), with fetuses in cephalic presentation, were included. Results160 pregnant women were randomized, 80 patients in each group, from December 2016 through April 2022. Baseline characteristics such as age, BMI, maternal age at induction and Bishop score at induction were similar between both groups. Vaginal delivery occurred in 76.3% of cases in the 2nd Propess® group and 73.8% of cases in the Syntocinon® group (RR=1.03 [0.86; 1.24], p=.715). Although the cesarean section rate was similar in each group, there were significantly more cesarean sections for arrest of dilatation (52.6% vs 19%; p=.0262) in the Propess® group and a larger, borderline-significant difference in patients having operative vaginal delivery (24.6% vs 11.9%; p=.07) for abnormal fetal heart rate (80% vs 29%; p=.05). There was significantly more failure of cervical ripening in the Propess® group (57.1% vs 19%; RR=2.59 ; 95% CI [1.64; 4.11]; p<.0001) and the interval between study treatment and delivery was also significantly longer (28.1h vs 9,7h; p<.0001). There was a higher incidence of postpartum hemorrhage in the Propess® group, although this was not significant (11.3% vs 5% ; p=,15), but also more newborns with acidosis (39.3% vs 27.9% ; p=.18) or severe acidosis (8,6% vs 3.4% ; p=.27), more meconium fluid (11.3% vs 6.3% ; p=.26) and transferred to intensive care (5% vs 2.5% ; p=.68). ConclusionOur data showed no superiority of a second dinoprostone pessary over oxytocin in patients not responding to initial prostaglandins E2 maturation for labor induction. Repeated use of Propess® is not useful for induction of labor.

A comparison between the vaginal patch plastron associated with the anterior sacrospinous fixation and the Uphold™ LITE vaginal support system for the treatment of advanced anterior vaginal wall prolapse

ObjectiveThe aim of the present study was to compare efficacy and safety of the vaginal patch plastron (VPP) associated to the anterior sacrospinous fixation (SSLF-A) with a TVM procedure (Uphold™ LITE support-system) for the treatment of the advanced anterior vaginal wall prolapse.Study design.Single-center retrospective study. Women with symptomatic anterior prolapse ≥ III stage according to the POP-quantification (POP-Q) system and submitted to the VPP associated with the SSLF-A or to the Uphold™ procedure were included. Primary outcome was to compare objective and subjective cystocele relapse and reoperation rate at 6- and 12-month follow-up. Secondary outcome was to describe peri- and postoperative complications. Pearson chi-square test and exact Fisher test were adopted for categorical variables, while intergroup Mann-Whitney U test and intragroup Wilcoxon Rank Sum Test for continuous variables; the statistical analysis was conducted at 95 % confidence level. ResultsFifty-five women in VPP-group and 118 women in Uphold-group were included. At 6-month follow-up, objective anterior relapse in VPP-group (3/55, 5.4 %) was like Uphold-group (5/118, 4.2 %; p = 0.71), as well as objective apical relapse (0/55, 0 % vs 3/118, 2.5 %; p = 0.55); no significant difference emerged in bulge symptoms (1/55, 1.8 % vs 5/118, 4.2 %; p = 0.67). At 12-month follow-up women were telephonically investigated; no significant difference emerged in bulge symptoms (1/55, 1.8 % vs 6/118, 5.1 %; p = 0.43). Reoperation rate for the composite outcome POP relapse, stress urinary incontinence (SUI) and remotion of the TVM resulted lower in the VPP group (1/55, 1.8 % vs 13/118, 11 %; p = 0.03). Post-operative buttock pain (32/55, 58.2 % vs 24/118, 20.3 %; p < 0.0001) and post-operative urinary retention (16/55, 29.1 % vs 6/118, 5.1 %; p < 0.0001) were higher in VPP-group, with a complete resolution between 2 and 3 weeks after treatment. ConclusionVPP associated with SSLF-A was as effective as Uphold™ LITE support-system for both anterior and central compartment prolapse treatment at 6- and 12-month follow-up. VPP-group presented a lower reoperation rate for the composite outcome prolapse relapse repair, SUI, and removal of the mesh.

Mid-Term Results of a New Transobturator Cystocele Repair by Vaginal Patch Plastron without Mesh.

Cystoceles are the most common prolapses. Limitation of the use of synthetic mesh has led to the comeback of native tissue repair procedures. We have developed a new transobturator technique with native tissue based on a mix of a vaginal plastron technique and the transobturator procedure. We present the functional and anatomical mid-term results. In this retrospective study, the vaginal plastron technique and the transobturator procedure were performed in 32 patients. Functional assessment with several validated quality-of-life questionnaires (SF-12, PFIQ-7, PFDI-20, PISQ12) and anatomical evaluation with pelvic examination were performed at 1, 6, and 12 months after surgery. The anatomical success rate was 94.4% at 12 months. There was one Clavien-Dindo grade 2 postoperative complication (one urinary tract infection). All of the quality-of-life scores were statistically significantly improved at one year follow-up. The transobturator technique combined with the vaginal plastron seems to be a promising, effective, innovative, and relevant technique for the repair of high-stage cystoceles.

Cloacal Malformation with Associated Urethral Atresia

Introduction Cloacal malformations comprise a heterogeneous group of anomalies that are considered the most complex anorectal malformations (ARMs) in females. Precise evaluation to identify the unique anatomy prior to reconstruction with collaboration between colorectal surgeons, urologists, and gynecologists is vital. Here, we present a rare anatomical variation in a patient with a cloacal malformation which affected operative and postoperative management. Case description A 6-year-old female with cloaca who underwent colostomy, vaginostomy, and vesicostomy as a newborn presented for reconstruction. Her VACTERL workup was negative except for an atretic right kidney. Her ARM index included the cloaca, a normal spine, and sacrum with a lateral sacral ratio of 0.7, predicting good potential for bowel continence. Cystoscopy through the vesicostomy showed a small bladder with normal ureteral orifices, and a closed bladder neck, with no identifiable urethra. A cloacagram showed an atretic common channel, a single small vagina, and a rectum below the pubococcygeal line. The patient underwent a posterior sagittal anorectovaginourethroplasty, vaginal patch using rectum, rectoplasty, and perineal body reconstruction. The urethra was not amenable to reconstruction, so the vesicostomy was preserved and a future Mitrofanoff was planned. Conclusion Urethral atresia is a rare and challenging finding in cloaca patients, and a vesicostomy is needed to drain urine in the newborn period. Preoperative examination under anesthesia, cystoscopy, vaginoscopy, and cloacagram are crucial to identify the precise anatomy and to plan accordingly.

The Vaginal Patch Plastron Associated to the Anterior Sacrospinous Ligament Fixation for the Treatment of Advanced Anterior Vaginal Wall Prolapse.

this study aims to compare the efficacy and safety of vaginal patch plastron (VPP) associated to anterior sacrospinous ligament fixation (SSLF-A) with SSLF-A associated or not to the anterior colporrhaphy (AC) for cystocele treatment. single-center retrospective study in women with cystocele ≥ III stage submitted to surgery. The primary outcome was to compare objective and subjective cystocele relapse and reoperation rate at follow-up &gt; 6 months. The secondary outcome was to describe peri- and postoperative complications and risk factors for cystocele objective relapse. 75 women were submitted to SSLF-A and 61 women to VPP. VPP objective and subjective relapse (6.5%, 4/61 and 1.1%, 1/61) were lower than SSLF-A (26.7%, 20/75 and 20%, 15/75; p = 0.002 and p = 0.001, respectively). SSLF-A had a higher reintervention rate, but not significantly (6.6%, 5/75 vs. 0%, 0/61; p = 0.06). Previous hysterectomy was a risk factor (HR 4; 1.3-12.1) while VPP was protective factor (HR 0.2; 0.1-0.9) for cystocele anatomical relapse. Postoperative buttock pain was more prevalent in VPP (57.4%, 35/75 vs. 34.7%, 26/61; p = 0.01). VPP is effective and safe for advanced cystocele treatment, with lower objective and subjective relapse rates in comparison to isolated SSLF-A or associated with the AC.

Three new species of Neoechinorhynchus (Acanthocephala: Neoechinorhynchidae) from fresh-water fish collected from Tigris River, Iraq.

Three new species of Neoechinorhynchus are described from freshwater fish of Tigris River, at Salah Al-Din province, mid Iraq, namely Neoechinorhynchus tigrisensis n. sp. from Shilik Leuciscus vorax (Heckel) and Brond-snout Chondrostoma regium (Heckel), N. planilizai n. sp. from Abu mullet Planiliza abu (Heckel) and Tigris catfish Silurus triostegus (Heckel) and N. barbi n. sp. from Mesopotamian barb Capoeta damascina (Valenciennes). The first two new species shared the para-receptacle structure (PRS) with seven nominal valid species of the genus Neoechinorhynchus but they differed in other taxonomic traits, while the third new species shared the vaginal vestibular muscles (para vaginal patch) at the end of female trunk with N. spiramuscularis Amin, Heckmann & Ha, 2014 and N. zabensis Amin, Abdullah & Mhaisen, 2003 but differed for further morphological features. Proboscis hooks of middle and posterior circles in N. barbi n. sp. are remarkably bigger than in the other two new species (N. tigrisensis and N. planilizai) while the hooks in first circle is almost similar in the three species. Furthermore, N. tigrisensis n. sp. and N. planilizai n. sp. differ from some marine species by having smallest hooks size at anterior circle, with different shape and size of hooks. The three new species reported in the present study are compared with other eight species of Neoechinorhynchus reported so far from fish in Iraq. This work contributes to increase the knowledge on the biodiversity of fish parasites all over the world, especially for acanthocephalans.

Vaginal Patch Plastron for cystocele repair at the time of vaginal prosthesis bashing: A technical note (with video)

Native tissue cystocele repair has been the cornerstone of prolapse surgery, especially since the learned societies warned clinicians and patients about serious mesh related complications and recommend a vaginal route without prosthesis in first intention. Surgical techniques mainly consist in anterior colporraphy, vaginal patch plastron and para vaginal repair. However, in case of vaginal patch plastron, the vagina left in contact with the bladder is a material of much better quality than colporraphy alone. The multiplication of native tissues, generating post-operative fibrosis, associated with anchorage on a strong ligamentous structure, allows to expect better outcomes compared to anterior colporraphy. Indeed, vaginal plastron corrects median cystoceles with a vaginal strip as well as lateral cystoceles thanks to bilateral paravaginal suspension. Thereby, vaginal patch plastron appears to be a good compromise between the 3 autologous techniques with median and paralateral repairWe aimed to describe the surgical technique of the vaginal patch plastron for vaginal native tissue repair for cystocele.

Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial

BackgroundNative tissue cystocele repair has been the cornerstone of prolapse surgery, especially since the learned societies warned clinicians and patients about serious mesh-related complications. Surgical techniques mainly consist in anterior colporraphy and vaginal patch plastron. However, success rates of native tissue cystocele repair are heterogeneous, depending on the design of studies and definition of outcomes. To date, high-quality data comparing vaginal native tissue procedures are still lacking.MethodsHerein we aimed to describe the design of the first randomized controlled trial (TAPP) comparing anterior colporraphy (plication of the muscularis and adventitial layers of the vaginal wall) and vaginal patch plastron (bladder support anchored on the tendinous arch of the pelvic fascia by lateral sutures) techniques.Our aim is to assess the effectiveness of vaginal native tissue repair at 1 year for cystocele with a combined definition of success—anatomic and functional. The primary endpoint will be the success rate 1 year after surgery with a composite of objective and subjective measures (Aa and Ba points < 0 from POP-Q (Pelvic Organ Prolapse Quantification System) and a negative answer to question 3 of Pelvic Floor Distress Inventory and no need for additional treatment).DiscussionA prospective study has found a success rate at 35% for anterior colporraphy based on a combined definition, both anatomic and functional, as recently recommended. However, the definition of anatomic was strict (POP-Q< 2), while it seems that the best definition of anatomic success is “no prolapse among the hymen”, that is to say Aa and Ba points from the POP-Q classification < 0. We hypothesize that vaginal patch plastron will have a better anatomic and functional success comparatively to anterior colporraphy because native tissue is added, as it corrects both median and lateral cystoceles thanks to bilateral paravaginal suspension.Trial registrationCHU LIMOGES is the sponsor of this research (n°87RI18_0013).This research is supported by the French Department of Health (PHRC 2018-A03476-49) and will be conducted with the support of DGOS (PHRC interregional – GIRCI SOHO).The study protocol was approved by the Human Subjects Protection Review Board (Comité de Protection des Personnes) on May 16, 2019.The trial is registered in the ClinicalTrials.gov registry (NCT03875989).

Traitement chirurgical du prolapsus génital chez les femmes âgées de plus de 80 ans

The aim of this study was to assess the morbidity and the effectiveness of the vaginal surgical treatment for women over 80 years of age with genital prolapse.All the women over 80 years operated in our institution between 1996 and 2003 were reviewed retrospectively. We examined the risk and the effectiveness of this surgery.Forty-eight women underwent surgery during this period. No colpocleisis was performed. The most frequent surgery was a combination of vaginal patch plastron, Richter's spinous fixation and posterior perineorrhaphy. No major intra- or post-operative complication occurred. One woman required blood transfusion. The most frequent postoperative complication was voiding difficulties (12%), which had disappeared 3 months later. A partial stenosis of a left ureter with ureterohydronephrosis occurred, requiring endoscopic dilatation. At 3 months, anatomic and functional outcome was good in 92% of women. The number of patients lost to follow-up at one year was to large to draw any conclusion.Complete transvaginal surgical treatment is a safe procedure for elderly women which provides good short-term effectiveness.

The vaginal patch plastron for vaginal cure of cystocele: Preliminary results for 47 patients

Objective: We describe a new surgical technique (the vaginal plastron) for the treatment of cystocele by the vaginal route. The technique is based on bladder support by a vaginal strip (6–8 cm in length and 4 cm in width), isolated from the anterior colpocele, left attached to the bladder, associated with a suspension of this strip by its fixation to the tendinous arch of the pelvic fascia by six lateral sutures (three on each side of the plastron). The vaginal plastron is then covered by tucking it under the anterior colporraphy. Study design: We evaluated the short-term functional and anatomical results of the first 47 patients to have undergone this treatment between October 1997 and June 1998. The average age of the patients was 69 years. Cystoceles were associated with urinary stress incontinence in 38.3% of cases, with hysterocele or prolapse of the vaginal dome in 87.2% of cases, with an elytrocele in 19.1% of cases and a rectocele in 70.2% of cases. Of the 45 patients having had a hysterectomy combined with the vaginal plastron or in their past history, 44 (99.77%) had a Richter sacro-spino-fixation and 17 (38%) had a Campbell procedure combined with the vaginal plastron. All patients underwent a posterior perineorraphy with myorraphy of the elevators. Results: Average follow-up was 16.4 months with extremes of 6–26 months and concerned 46 patients (one patient was unavailable). Ninety-three percent of the cystoceles were considered treated. One case of imperfect anatomical outcome was noted (persistence of stage 1 cystocele in one patient) together with two other cases of failure of the treatment of cystocele (relapse to stage 2 cystocele). Conclusion: Proposed as a curative treatment of cystocele and combined with the Richter fixation, the plastron provides a surgical solution to the problem of cystocele relapse arising after vaginal treatment of prolapse by sacro-spino-fixation alone (10–20% according to Richter). Short-term results are encouraging, however, medium- to long-term results (36–60 months) are necessary in order confirm the usefulness of this surgical technique.

Vaginal wall inclusion cyst formation following a modified vaginal wall patch sling technique for patients with genuine stress incontinence

Introduction: The vaginal wall patch sling technique has been reported to have high success rates for the management of patients with genuine stress incontinence (GSI). However, the use of a vaginal patch buried underneath the vaginal wall could theoretically be complicated by inclusion cyst formation. Although the normal vagina does not possess any glands, the potential still exists for exudation and the retention of secretions and subsequent cyst formation. We investigated the long-term effects of burying the vaginal wall as part of the technique of vaginal wall patch sling for patients with GSI.Methods: A modified vaginal wall patch sling was uniformly performed by the same operator (first author) for 44 patients with a clinical and urodynamic diagnosis of GSI. The epithelium covering the vaginal patch was scrapped off using a scalpel. This was designed to minimize the potential risk for cyst formation.Results: Clinical follow-up ranged from 12 months to 5 years. The mean age of the patients was 45 ± 10.2 (range 38–63 years), and the mean parity was 3.4 ± 1.4. Fourteen of 37 patients were postmenopausal and 33 of 37 patients were sexually active. The incidence of cyst formation was 0%.Conclusion: We have not observed any cases of inclusion cyst formation up to 5 years of follow-up. It is conceivable, however, that longer follow-up may reveal cyst development. The present findings suggest that the risk for cyst formation following the vaginal wall patch sling technique appears to be minimal.

The relationship between preoperative abdominal leak point pressure and surgical outcome following retropubic urethropexy for genuine stress incontinence

Introduction: Whereas standard urodynamic measurements examine discrete parts of urethral function, abdominal leak point pressure (ALPP) tends to evaluate the combined effects of the different continence mechanisms. The technique involves the measurement of the amount of intraabdominal pressure required to overcome outlet resistance and produce leakage. The present study investigates the association between preoperative ALPP and clinical outcome following antiincontinence surgery.Methods: Forty-one patients with genuine stress incontinence (GSI) scheduled for vaginal patch sling (n = 17) or retropubic needle suspension (n = 24) were studied. All patients underwent standard urodynamic testing, including cough-induced ALPP. Abdominal leak point pressure was defined as the single lowest pressure that produces leakage.Results: Sixteen of 17 patients (94.1%) who underwent vaginal patch sling and 17 of 24 patients (70.8%) who underwent retropubic needle suspension demonstrated complete clinical and urodynamic improvement of GSI at follow-up with a negative standing stress test and a positive maximum urethral closure pressure on cough profilometry. Thus, a total of 33 of 41 patients had a successful surgical outcome (group I), whereas 8 of 41 patients (group II) had an unsuccessful repair. The mean preoperative ALPP in group I and group II was 107 cm H2O SD ± 10, and 103 cm H2O SD ± 9, respectively. The difference was not statistically significant (P >0.05).Conclusion: While ALPP measurement may be useful in demarcating the severity of incontinence, it appears that preoperative ALPP does not correlate with surgical outcome.

Comparison of preoperative and postoperative pressure transmission ratio and urethral pressure profilometry in patients with successful outcome following vaginal patch sling for genuine stress incontinence

Introduction: Pressure transmission ratio (PTR) determination allows for the quantitative measurement of the relative efficiency with which intraabdominal pressure increases are transmitted to the bladder and urethra. We studied preoperative and postoperative PTR in patients undergoing vaginal patch sling for the primary treatment of genuine stress incontinence (GSI).Methods: Forty-four patients with a clinical and urodynamic diagnosis of GSI were studied. The PTR for each cough was calculated by dividing the amplitude of the urethral pressure spike by the amplitude of the corresponding bladder pressure spike and multiplying the quotient by 100. Cough spikes were assigned locations in the first, second, third, or fourth quartile of the functional urethral length designated Q1 through Q4, respectively.Conclusion: PTR in the two proximal quartiles of the urethra were significantly improved postoperatively, which suggests that the vaginal patch sling technique restores continence by repositioning the proximal urethra into the intraabdominal pressure zone, thus enhancing pressure transmission to the proximal urethra. PreoperativePostoperativeP valuePTR (%)Q170 SD ± 13104 SD ± 12<0.01Q272 SD ± 16102 SD ± 20<0.001Q376 SD ± 1880 SD ± 16NSQ468 SD ± 2272 SD ± 14NS

The triangular vaginal patch sling for stress urinary incontinence and hypermobile urethra

OBJECTIVE: We describe an alternative sling procedure that permits concomitant correction of urethral hypermobility and urinary incontinence through a single surgical exposure. STUDY DESIGN: Fifteen women with severe urinary stress incontinence and urethral hypermobility underwent a sling procedure by creation of a simple triangular patch from the anterior vaginal wall. RESULTS: The mean operative time for the vaginal sling procedure was 38 minutes (range 29 to 65 minutes) in addition to other operations. The mean postoperative hospital stay was 7.7 days (range 5 to 13 days) and all patients were routinely discharged with an indwelling Foley catheter. Spontaneous micturition occurred in 12 patients after a mean period of 25 days (range 13 to 36 days). In three cases long-term catheterization was necessary. By subjective and objective evaluations, all the patients were cured of their stress incontinence. CONCLUSION: The triangular vaginal patch with the single sutures on each side provides an alternative approach for bladder neck stabilization that may permit a more anatomic suspension of a hypermobile urethra.(Am J Obstet Gynecol 1997;177:31)

Simplified Surgical Approach to Bladder Outlet Obstruction Following Pubovaginal Sling

We report a new technique of vaginal patch interposition to relieve bladder outlet obstruction after a suburethral sling procedure when the obstruction is caused by over correction of the urethrovesical angle. In this technique the sling is incised longitudinally in the midline and dissected laterally. A vaginal patch is obtained from the vaginal mucosa, then interposed and sutured between the 2 cut edges of the sling. This method is characterized by simplicity and low morbidity, while preserving the integrity of the suburethral sling to maintain continence.