10 results on '"Melendez-Munoz J"'
Search Results
2. Modified transobturator (TVT Abbrevo) and single incision (MiniArc) suburethral sling in women with stress urinary incontinence-A randomised controlled trial: 3 year follow up.
- Author
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Lee J.K., Ryan G., Rosamilia A., Nikpoor P., Karjalainen P.K., Ow L.L., Melendez-Munoz J., Leitch A., Lee J.K., Ryan G., Rosamilia A., Nikpoor P., Karjalainen P.K., Ow L.L., Melendez-Munoz J., and Leitch A.
- Abstract
Objective: To evaluate 3-year objective and subjective outcomes of single incision and modified transobturator sling in women with stress urinary incontinence. Method(s): Women assessed for stress urinary incontinence surgery were eligible to participate. Exclusion criteria included intrinsic sphincter deficiency, previous failed midurethral or fascial sling, untreated detrusor overactivity or significant voiding dysfunction. Randomization was performed with computer-generated blocks of 4-8, with concealed allocation. Assuming an objective cure rate of 90% for TVT Abbrevo with a power of 80%, a sample size of 79 in each arm was required to detect a clinical difference of 15%, using a 1-sided alpha of 0.05. Allowing for 15% attrition rate, target recruitment was 220. Institution ethics approval (11261B) was obtained. Three year follow up consisted of patient-reported outcome measures utilizing ICIQ UI SF, ICIQ OAB, IIQ7, PISQ12 & PGII and objective outcomes included POP-Q, cough stress test, assessment of mesh complications and uroflowmetry. Objective cure was defined as a negative cough stress test with a comfortably full bladder. Subjective cure was defined as "no" leakage on section 3 and 5 of ICIQ UI SF Question 6. Result(s): At 3 years data was available for 207 women (MiniArc: 100 and TVT Abbrevo:107) from the original 246 women. Those who were excluded after randomization were described in the 12 month follow up publication. Baseline characteristics of the two groups were comparable. There was no statistically significant difference in subjective (59% vs 69.5%; P: 0.14) or objective (92.6% vs 98.7%; P: 0.12) cure rates between MiniArc and TVT Abbrevo at 3 years, respectively. A sensitivity analysis taking into account all missing data also showed this. No statistically significant differences were found in functional outcomes and incontinence impact scores significantly improved and were greater than the minimally important difference in both groups. Conclusio
- Published
- 2020
3. A fiber-optic sensor-based device for the measurement of vaginal integrity in women.
- Author
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Parkinson L.A., Werkmeister J.A., Gargett C.E., Arkwright J.W., Melendez-Munoz J., Rosamilia A., Papageorgiou A.W., Mukherjee S., Parkinson L.A., Werkmeister J.A., Gargett C.E., Arkwright J.W., Melendez-Munoz J., Rosamilia A., Papageorgiou A.W., and Mukherjee S.
- Abstract
Aims: Pelvic floor disorders (PFDs) in women are a major public health concern. Current clinical methods for assessing PFDs are either subjective or confounded by interference from intra-abdominal pressure (IAP). This study introduces an intravaginal probe that can determine distributed vaginal pressure during voluntary exercises and measures the degree of vaginal tissue support independent of IAP fluctuations. Method(s): An intravaginal probe was fabricated with 18 independent fiber-optic pressure transducers positioned along its upper and lower blades. Continuous pressure measurement along the anterior and posterior vaginal walls during the automated expansion of the probe enabled the resistance of the tissue to be evaluated as a function of displacement, in a manner reflecting the elastic modulus of the tissue. After validation in a simulated vaginal phantom, in vivo measurements were conducted in the relaxed state and during a series of voluntary exercises to gauge the utility of the device in women. Result(s): The probe reliably detected variations in the composition of sub-surface material in the vaginal phantom. During in-vivo measurements the probe detected distributed tissue elasticity in the absence of IAP change. In addition, the distribution of pressure along both anterior and posterior vaginal walls during cough, Valsalva and pelvic floor contraction was clearly resolved with a large variation observed between subjects. Conclusion(s): Our data highlight the potential for the probe to assess the integrity of the vagina wall and support structures as an integrated functional unit. Further in vivo trials are needed to correlate data with clinical findings to assist in the assessment of PFDs.Copyright © 2019 Wiley Periodicals, Inc.
- Published
- 2019
4. Anal incontinence: The role of the levator ani muscle in the absence of anal sphincter injury.
- Author
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Subramanian N., Dietz H.P., Friedman T., Melendez Munoz J., Subramanian N., Dietz H.P., Friedman T., and Melendez Munoz J.
- Abstract
Introduction: The puborectalis muscle, the most substantial part of the levator ani complex, is considered an important structure in anal continence. It is responsible for maintenance of the ano-rectal angle and opening or occluding the anal canal when relaxing or contracting respectively. (1) To date, there is however little evidence on the role of avulsion as a risk factor for anal incontinence, and the few studies performed on this issue do not control for anal sphincter trauma. Objective(s): To determine any association between levator ani trauma and anal incontinence, while controlling for sonographic evidence of past anal sphincter injury. Method(s): The records of 1273 patients attending a tertiary urogynaecological unit with a complaint of pelvic floor dysfunction between January 2014 and December 2016 were retrospectively analysed. Patients had had a physician-directed interview including a St Marks score for anal incontinence (AI) and VAS (visual analogue scale) assessment of AI bother, and 4D translabial ultrasound for levator and sphincter imaging on pelvic floor muscle contraction (PFMC), as described previously.( 2) Stored 4D pelvic floor ultrasound volume data sets were analysed offline with the help of proprietary software (4D VIEW V 10.0, GE Medical Systems), at a later date and blinded against all clinical data A complete avulsion was diagnosed if at least three central tomographic slices showed an abnormal muscle insertion, rated separately for each side. Significant external anal sphincter (EAS) defects were diagnosed if at least 4/6 slices had defects of 30 degrees or more of the EAS circumference.(3) We used logistic regression modelling to analyse any association between levator avulsion and measures of anal incontinence, controlling for anal sphincter trauma, age, body mass index and Forceps delivery. (Figure Presented) Results: Mean age at presentation was 54 +/- 13 years. Mean BMI was 29 +/- 7. Median vaginal parity was 2 (2-3). 1142 (90%)
- Published
- 2019
5. Modified transobturator (tvtabbrevo) and single incision (miniarc) suburethral sling in women with stress urinary incontinence-a randomised controlled trial: 3 year follow up.
- Author
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Leitch A., Rosamilia A., Lee J.K., Nikpoor P., Karjalainen P.K., Ow L.L., Melendez-Munoz J., Ryan G., Leitch A., Rosamilia A., Lee J.K., Nikpoor P., Karjalainen P.K., Ow L.L., Melendez-Munoz J., and Ryan G.
- Abstract
Objective: To evaluate 3-year objective and subjective outcomes of single incision and modified transobturator sling in women with stress urinary incontinence. Method(s): Women assessed for stress urinary incontinence surgery were eligible to participate. Exclusion criteria included intrinsic sphincter deficiency, previous failed midurethral or fascial sling, untreated detrusor overactivity or significant voiding dysfunction. Randomization was performed with computer-generated blocks of 4-8, with concealed allocation. Assuming an objective cure rate of 90% for TVT Abbrevo with a power of 80%, a sample size of 79 in each arm was required to detect a clinical difference of 15%, using a 1-sided alpha of 0.05. Allowing for 15% attrition rate, target recruitment was 220. Institution ethics approval (11261B) was obtained. Three year follow up consisted of patient-reported outcomemeasures utilizing ICIQ UI SF, ICIQ OAB, IIQ7, PISQ12& PGII and objective outcomes included POP-Q, cough stress test, assessment of mesh complications and uroflowmetry. Objective cure was defined as a negative cough stress test with a comfortably full bladder. Subjective cure was defined as "no" leakage on section 3 and 5 of ICIQ UI SF Question 6. Result(s): At 3 years data was available for 207 women (MiniArc: 100 and TVT Abbrevo:107) from the original 246 women. Those who were excluded after randomization were described in the 12 month follow up publication. Baseline characteristics of the two groups were comparable. There was no statistically significant difference in subjective (59% vs 69.5%; P: 0.14) or objective (92.6% vs 98.7%; P: 0.12) cure rates between MiniArc and TVTAbbrevo at 3 years, respectively. A sensitivity analysis taking into account all missing data also showed this. No statistically significant differences were found in functional outcomes and incontinence impact scores significantly improved and were greater than theminimally important difference in both groups. Conclusion(s)
- Published
- 2019
6. Long termchanges in urine flow among women with retropubic sling for more than 5 years.
- Author
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Leitch A., Lee J., Ryan G., Melendez Munoz J., Rosamilia A., Edwards G., Leitch A., Lee J., Ryan G., Melendez Munoz J., Rosamilia A., and Edwards G.
- Abstract
Introduction: Although long term outcomes for mid-urethral retropubic slings (RMS) have already been published (1), reviewing the literature, no data is available regarding long term urine flow parameters of women who had RMUS in the past. Objective(s): To assess long term voiding changes in patients with RMUS for more than 5 years. Method(s): Patients who had a RMS inserted before August 2011 were eligible to participate in the study. Women with chronic voiding dysfunction, neurological disease, failed retropubic sling after August 2011 but before follow up appointment and those who had non-retropubic sling were excluded. Those who fit the inclusion criteria were contacted and asked to participate in the study. They were invited to attend for a follow up consultation. All patients would be asked to fill in Patient Reported Outcome tools including: ICIQ UI SF, ICIQ OAB, PGII, and W-IPSS voiding questionnaire. Those who did not want or could not attend were sent the questionnaires by mail. Consultation included a vaginal examination to assess pelvic organ prolapse (POP) and mesh exposure. A cough stress test would be performed with a comfortable full bladder. A uroflowmetry test to assess their urine flow followed and then a bladder US scan to measure post void residual. All Data was collected on a standardized proforma including patient characteristics and statistical analysis was performed. Result(s): 103 female patients accepted to participate in the study. Mean age was 70 +/- 10 years old.Mean age at the time of surgery of 63 +/- 11 years old. The mean follow up was 86.6 +/- 17.6 months. 10 patients had had previous incontinence surgery, 6 had a midurethral sling and 4 had a Burch colposuspension. Only 10 patients had concomitant surgery at the time. Preoperative urodynamics confirmed SUI in all patients. Median (IQR, 25%-75%) maximal urethral closure pressure (MUCP) was 20 (14 - 27) and Median (IQR, 25%-75%) abdominal leak point pressure (ALPP) was 60 (40 - 76).
- Published
- 2019
7. Composite mesh design for delivery of autologous mesenchymal stem cells influences mesh integration, exposure and biocompatibility in an ovine model of pelvic organ prolapse.
- Author
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Tan K.S., Gargett C.E., Werkmeister J.A., Ng M., Darzi S., Rosamilia A., Bhakoo K., Emmerson S., Mukherjee S., Melendez-Munoz J., Cousins F., Edwards S.L., Karjalainen P., Tan K.S., Gargett C.E., Werkmeister J.A., Ng M., Darzi S., Rosamilia A., Bhakoo K., Emmerson S., Mukherjee S., Melendez-Munoz J., Cousins F., Edwards S.L., and Karjalainen P.
- Abstract
The widespread use of synthetic transvaginal polypropylene mesh for treating Pelvic Organ Prolapse (POP) has been curtailed due to serious adverse effects highlighted in 2008 and 2011 FDA warnings and subsequent legal action. We are developing new synthetic mesh to deliver endometrial mesenchymal stem cells (eMSC) to improve mesh biocompatibility and restore strength to prolapsed vaginal tissue. Here we evaluated knitted polyamide (PA) mesh in an ovine multiparous model using transvaginal implantation and matched for the degree of POP. Polyamide mesh dip-coated in gelatin and stabilised with 0.5% glutaraldehyde (PA/G) were used either alone or seeded with autologous ovine eMSC (eMSC/PA/G), which resulted in substantial mesh folding, poor tissue integration and 42% mesh exposure in the ovine model. In contrast, a two-step insertion protocol, whereby the uncoated PA mesh was inserted transvaginally followed by application of autologous eMSC in a gelatin hydrogel onto the mesh and crosslinked with blue light (PA + eMSC/G), integrated well with little folding and no mesh exposure. The autologous ovine eMSC survived 30 days in vivo but had no effect on mesh integration. The stiff PA/G constructs provoked greater myofibroblast and inflammatory responses in the vaginal wall, disrupted the muscularis layer and reduced elastin fibres compared to PA + eMSC/G constructs. This study identified the superiority of a two-step protocol for implanting synthetic mesh in cellular compatible composite constructs and simpler surgical application, providing additional translational value.Copyright © 2019 Elsevier Ltd
- Published
- 2019
8. TVT Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence - A randomised controlled trial.
- Author
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Leitch A., Lee J.K.-S., Melendez-Munoz J., Braverman M., Rosamilia A., Young N., Leitch A., Lee J.K.-S., Melendez-Munoz J., Braverman M., Rosamilia A., and Young N.
- Abstract
Introduction: Single incision slings (SIS) were introduced in an attempt to decrease the complications associated with retropubic and transobturator slings. The TVT Abbrevo is a modification of the TVT-O with a reduced length and less immediate postoperative pain. The Miniarc SIS has been shown to be equivalent to outside-in transobturator sling, Monarc at 12 month follow-up. Objective(s): To evaluate objective and subjective outcomes of MiniArc SIS and TVT Abbrevo midurethral sling (MUS) in women with stress urinary incontinence. Method(s): Female subjects who were assessed and referred for stress urinary incontinence surgery were eligible to participate in this study. Exclusion criteria included women with intrinsic sphincter deficiency previous failed midurethral or fascial sling, untreated detrusor overactivity or significant voiding dysfunction. Patients' randomisation was performed with computer-generated blocks of 4-8, with concealed allocation. Assuming an objective cure rate of 90% for TVT AbbrevoTMwith a power of 80%, a sample size of 79 in each arm was required to detect a clinical difference of 15%, using a one sided alpha of 0.05. The target recruitment number was 220 allowing for an attrition rate of 15%. Institution ethics approval (11261B) was obtained and the trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611001151921). Routine preoperative assessment was conducted for objective data, whilst patient reported outcome tools (PRO) were utilised for subjective outcomes. These include ICIQ UI SF, ICIQ OAB, IIQ7, EQ5D, PISQ12, PGIs & PGII. TVT AbbrevoTM or MiniarcTMwere performed in a standardized fashion, together with any concomitant prolapse surgery. Review was conducted at 6 weeks and at 6 and 12 months. Objective cure was defined as a negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with physical exertion. All Data was collected and outcomes were ana
- Published
- 2018
9. Long term voiding function following retropubic sling.
- Author
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Edwards G., Rosamilia A., Leitch A., Lee J., Ryan G., Melendez Munoz J., Edwards G., Rosamilia A., Leitch A., Lee J., Ryan G., and Melendez Munoz J.
- Abstract
Hypothesis/aims of study The retropubic midurethral sling (RMUS) decribed by Ulmsten et al has become the gold standard for the treatment of Stress Urinary Incontinence since 1996. (1) Although long term outcomes for retropubic slings have already been published (2), reviewing the literature, no data is available regarding long term urine flow parameters of women who had RMUS in the past. Objective and subjective outcomes related to urine flow of patients who had a retropubic sling for more than five years will give us a better understanding of the impact of retropubic slings and we will be able to advice better regarding operation's long term implications. Study design, materials and methods Patients who had a retropubic sling inserted before August 2011 were eligible to participate in the study. Women with chronic voiding dysfunction, neurological disease, failed retropubic sling after August 2011 but before follow up appointment and those who had non-retropubic sling were excluded. Those who fit the inclusion criteria were contacted and asked to participate in the study. They were invited to attend for a follow up consultation. All patients would be asked to fill in Patient Reported Outcome tools including: ICIQ UI SF, ICIQ OAB, PGIS, and W-IPSS voiding questionnaire. Those who did not want or could not attend were sent the questionnaires by mail. At the consultation they were offered a vaginal examination to assess pelvic organ prolapse (POPQ) and to check for mesh exposure. A cough stress test would also be performed with a comfortable full bladder. A uroflowmetry test to assess their urine flow followed and then a bladder US scan to measure post void residual. All Data was collected on a standardized proforma including patient characteristics. Outcomes were compared with Pearson 2 test for categorical data and Student t test or Wilcoxon rank-sum for continuous data as appropriate. ICIQ UI SF, ICIQ OAB ,PGI-I and W-IPSS voiding questionnaire were analysed using
- Published
- 2017
10. Miniarc vs TVT abbrevo midurethral sling in women with stress urinary incontinence-an RCT-6 and 12month follow up.
- Author
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Melendez Munoz J., Lee J., Leitch A., Young N., Rosamilia A., Braverman M., Melendez Munoz J., Lee J., Leitch A., Young N., Rosamilia A., and Braverman M.
- Abstract
Hypothesis/aims of study Single incision slings (SIS) were introduced in an attempt to decrease the complications associated with retropubic and transobturator slings. The FDA has requested ongoing studies to determine the efficacy of single incision slings. The TVT Abbrevo is a modification of the TVT-O with a reduced length and less immediate postoperative pain1. The Miniarc SIS has been shown to be equivalent to outside-in transobturator sling, Monarc at 12 month follow-up2. OBJECTIVE(S): To evaluate objective and subjective outcomes of MiniArc SIS and TVT Abbrevo midurethral sling (MUS) in women with stress urinary incontinence METHODS: Female subjects who were assessed and referred for stress urinary incontinence surgery were eligible to participate in this study. Women with intrinsic sphincter deficiency (maximum urethral closure pressure (MUCP) of 20 cmH2O or less and/or abdominal leak point of 60 cm H2O or less), previous failed midurethral or fascial sling, untreated detrusor overactivity or significant voiding dysfunction (maximum flow rate < 15 mL/s or < 10% Liverpool nomogram and/or postvoid residual > 100 mL) were excluded. Patients had equal probability of allocation to TVT Abbrevo or MiniArc sling; randomisation was performed with computergenerated blocks of 4-8, with concealed allocation. Surgeons or patients were not blinded once allocation was revealed. Assuming an objective cure rate of 90% for TVT AbbrevoTM with a power of 80%, a sample size of 79 in each arm was required to detect a clinical difference of 15%, using a one sided of 0.05. The target recruitment number was 220 allowing for an attrition rate of 15%. Institution ethics approval (11261B) was obtained and the trial was registered with the national clinical trial registry. Routine preoperative assessment (symptom evaluation, clinical examination, urodynamics and perineal ultrasound, urinary diary) was conducted for objective data, whilst patient reported outcome tools (PRO) were utilise
- Published
- 2017
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