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1.
Female Pelvic Med Reconstr Surg ; 21(4): 205-10, 2015.
Article in English | MEDLINE | ID: mdl-26052644

ABSTRACT

OBJECTIVE: To evaluate efficacy of the Elevate Anterior and Apical (EAA) in the repair of pelvic organ prolapse (POP) when performed after previous hysterectomy and with or without uterine preservation during POP surgery. MATERIALS AND METHODS: One hundred forty-two women with anterior vaginal prolapse and/or apical descent ≥ stage II were enrolled. The primary outcome was treatment failure defined as > stage II POP-Q during follow-up using the Last observed Failure Carried Forward method. Three sub-groups were analysed: baseline previous hysterectomy (N = 61); concomitant hysterectomy (N = 29), and preserved uterus/no hysterectomy (N = 51). Demographics, primary and secondary outcomes, and extrusion were compared between the groups. A P value less than 0.05 was considered statistically significant. RESULTS: Anatomic success shows significant and durable improvement at 24 months. The success for the apical compartment ranged between 93.8% and 100%. Success was slightly lower for the anterior compartment (70.8-89.1%). No statistically significant difference between the 3 subgroups. Age was the only patient characteristic to be found different between the 3 subgroups. In addition, there was no difference in overall intraoperative complications (P = 0.263). Mesh extrusion was found in all groups: 3 of 61 (4.9%) had previous hysterectomy; 4 of 29 (13.8%) had concomitant hysterectomy; and 1 of 51 (2.0%) had uterus preserved (P = 0.094). There appears to be a trend toward higher extrusion when a hysterectomy was performed with the EAA. CONCLUSIONS: Anatomic success and complications for the EAA do not appear to be significantly impacted when the uterus is removed before or during surgery or preserved. There may be a trend toward increased mesh extrusion when a hysterectomy is performed. However, larger cohort studies are needed to determine if concomitant hysterectomy impact extrusion.


Subject(s)
Gynecologic Surgical Procedures/methods , Pelvic Organ Prolapse/surgery , Adult , Aged , Aged, 80 and over , Female , Humans , Hysterectomy/methods , Middle Aged , Operative Time , Surgical Mesh/adverse effects , Treatment Failure
2.
J Minim Invasive Gynecol ; 21(3): 353-61, 2014.
Article in English | MEDLINE | ID: mdl-24295923

ABSTRACT

The Society of Gynecologic Surgeons Systematic Review Group performed a systematic review of both randomized and observational studies to compare robotic vs nonrobotic surgical approaches (laparoscopic, abdominal, and vaginal) for treatment of both benign and malignant gynecologic indications to compare surgical and patient-centered outcomes, costs, and adverse events associated with the various surgical approaches. MEDLINE and the Cochrane Central Register of Controlled Trials were searched from inception to May 15, 2012, for English-language studies with terms related to robotic surgery and gynecology. Studies of any design that included at least 30 women who had undergone robotic-assisted laparoscopic gynecologic surgery were included for review. The literature yielded 1213 citations, of which 97 full-text articles were reviewed. Forty-four studies (30 comparative and 14 noncomparative) met eligibility criteria. Study data were extracted into structured electronic forms and reconciled by a second, independent reviewer. Our analysis revealed that, compared with open surgery, robotic surgery consistently confers shorter hospital stay. The proficiency plateau seems to be lower for robotic surgery than for conventional laparoscopy. Of the various gynecologic applications, there seems to be evidence that renders robotic techniques advantageous over traditional open surgery for management of endometrial cancer. However, insofar as superiority, conflicting data are obtained when comparing robotics vs laparoscopic techniques. Therefore, the specific method of minimally invasive surgery, whether conventional laparoscopy or robotic surgery, should be tailored to patient selection, surgeon ability, and equipment availability.


Subject(s)
Gynecologic Surgical Procedures/methods , Laparoscopy/statistics & numerical data , Laparotomy/statistics & numerical data , Robotics/statistics & numerical data , Uterine Neoplasms/surgery , Adult , Endometrial Neoplasms/surgery , Female , Gynecologic Surgical Procedures/adverse effects , Gynecologic Surgical Procedures/economics , Gynecologic Surgical Procedures/statistics & numerical data , Gynecology , Humans , Laparoscopy/adverse effects , Laparoscopy/economics , Laparotomy/adverse effects , Laparotomy/economics , Learning Curve , Length of Stay , Minimally Invasive Surgical Procedures , Observational Studies as Topic , Randomized Controlled Trials as Topic , Robotics/economics
3.
Female Pelvic Med Reconstr Surg ; 19(2): 79-83, 2013.
Article in English | MEDLINE | ID: mdl-23442504

ABSTRACT

OBJECTIVE: This study aimed to assess the safety and efficacy of the Elevate Anterior/Apical transvaginal mesh procedure in pelvic organ prolapse (POP) repair at 12-months follow-up. METHODS: This prospective, multicenter, multinational study enrolled 142 patients experiencing anterior vaginal prolapse with or without apical descent (POP-Q ≥ stage II). Each patient received a single-incision transvaginal polypropylene mesh implantation anchored to the sacrospinous ligaments bilaterally. Primary outcome was treatment success defined as POP-Q less than or equal to stage I at 1 year using the Last Failure Carried Forward method. Secondary outcomes included validated quality-of-life measures. Fourteen subjects who received a concomitant posterior apical support procedure were excluded from the analysis. RESULTS: Of the 128 subjects, 112 (87.5%) completed the 12-months follow-up. The mean age was 64.7 years. The anatomic success rate was 87.7% (95% confidence interval, 80.3%-93.1%) for the anterior compartment and 95.9% (95% confidence interval, 88.5%-99.1%) for the apical compartment. POP-Q measurements (Aa, Ba, and C) improved significantly (P < 0.001) with no significant changes to TVL (P = 0.331). Related adverse events reported at greater than 2% were mesh exposure (8; 6.3%), urinary tract infection (7; 5.5%), transient buttock pain (5; 3.9%), de novo stress incontinence (5; 3.9%), retention (5; 3.9%), dyspareunia (3; 3.2%), and hematoma (3; 2.3%). All quality-of-life scores significantly improved from baseline (P < 0.001). CONCLUSIONS: Twelve-month data show that Elevate Anterior/Apical support procedure completed through a single vaginal incision yields favorable objective and subjective outcomes.


Subject(s)
Gynecologic Surgical Procedures/methods , Pelvic Organ Prolapse/surgery , Aged , Female , Follow-Up Studies , Humans , Middle Aged , Prospective Studies , Quality of Life , Surveys and Questionnaires
4.
Int Urogynecol J ; 23(10): 1379-86, 2012 Oct.
Article in English | MEDLINE | ID: mdl-22572917

ABSTRACT

INTRODUCTION AND HYPOTHESIS: The objective of the study was to compare extrusion (vaginal mesh exposure) rates in patients undergoing transvaginal prolapse repair with the trocar-based Apogee and/or Perigee devices (American Medical Systems, Minnetonka, MN, USA) using either the original type I polypropylene mesh (IntePro, American Medical Systems, Minnetonka, MN, USA) or a newer generation lightweight type I mesh (IntePro Lite, American Medical Systems, Minnetonka, MN, USA). METHODS: Data were pooled from three similarly designed prospective multicenter studies evaluating the safety and efficacy of Perigee for correction of the anterior (AC) and/or Apogee to repair the posterior/apical (PC/A) compartments. The first two studies utilized IntePro (mesh density 50 g/m(2)) and the third utilized IntePro Lite (mesh density 25.2 g/m(2)). Data were pooled to form IntePro and IntePro Lite groups for comparison. Patient demographics were recorded. Risk factors for vaginal mesh exposure were also considered. RESULTS: Two hundred and sixty-three patients were implanted with Perigee and/or Apogee with IntePro for a total of 371 heavier mesh implants (174 Perigee, 197 Apogee) compared to 86 patients who underwent Perigee and/or Apogee with IntePro Lite for a total of 116 lightweight mesh implants (60 Perigee, 56 Apogee). Demographics and potential risk factors for extrusion were compared between the two groups. Mean follow-up was 2.0 years and similar between the two groups. In the AC, there were 234 implants, with mesh extrusion occurring in 8.0 % following IntePro compared to 5.0 % following IntePro Lite (p = 0.57). In the PA/C, there were 253 implants, with mesh extrusion occurring in 13.7 % following IntePro compared to 7.1 % following IntePro Lite (p = 0.25). Overall mesh extrusion rates in 487 implants in all compartments were found to be 11.1 % with IntePro versus 6.0 % with IntePro Lite with an estimated odds ratio of 1.93 (95 % confidence interval 0.84-4.44, p = 0.12). CONCLUSIONS: No statistically significant difference in extrusion rates were seen following use of IntePro versus IntePro Lite; however, the 46 % reduction in rate of mesh exposure observed in those receiving the lighter weight mesh may represent clinical importance.


Subject(s)
Equipment Failure/statistics & numerical data , Pelvic Organ Prolapse/surgery , Polypropylenes , Surgical Mesh/adverse effects , Surgical Mesh/classification , Aged , Female , Humans , Middle Aged , Prevalence , Prospective Studies , Retrospective Studies , Risk Factors , Treatment Outcome
5.
Int Urogynecol J ; 23(9): 1285-91, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22527540

ABSTRACT

INTRODUCTION AND HYPOTHESIS: We report 2-year data on the effectiveness and safety of the MiniArc single-incision sling in women with stress urinary incontinence. METHODS: This multi-center, prospective, single-arm, industry-sponsored study measured the effectiveness of the MiniArc sling via quantitative (cough stress test and 1-h pad weight test) and qualitative (Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form) measurements. The objective efficacy rate was defined as the number of patients with a negative cough stress test or 1-h pad weight test ≤ 1 g at 2 years. The subjective efficacy rate was determined by patient responses to the UDI-6 question # 3, "Do you experience, and if so, how much are you bothered by urine leakage related to physical activity, coughing, or sneezing?" Secondary objectives were to evaluate procedural variables of implantation and long-term safety. RESULTS: One hundred and eighty women with a mean age of 51.1 years were implanted in the study. Mean procedure time, blood loss, and length of stay were 11.0 min, 41.7 mL and 9.5 h respectively. At 2 years, 142 patients were available for analysis. The objective efficacy rates for the cough stress test (CST) and pad weight test (PWT) were 84.5 % and 80.1 % respectively and the subjective efficacy rate was 92.9 %. Median Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form scores showed statistically significant improvement (p < .001). The most common adverse events included UTI (4.8 %), constipation (3.7 %), and temporary urinary retention (3.2 %). CONCLUSION: MiniArc is a safe and effective surgical procedure for the treatment of SUI in women with follow-up through 2 years.


Subject(s)
Prosthesis Implantation/methods , Suburethral Slings , Urinary Incontinence, Stress/surgery , Adult , Aged , Blood Loss, Surgical , Constipation/etiology , Female , Follow-Up Studies , Humans , Length of Stay , Middle Aged , Operative Time , Pain, Postoperative/etiology , Prosthesis Implantation/adverse effects , Quality of Life , Statistics, Nonparametric , Suburethral Slings/adverse effects , Surveys and Questionnaires , Treatment Outcome , Urinary Incontinence, Urge/surgery , Urinary Retention/etiology , Urinary Tract Infections/etiology
6.
Int Urogynecol J ; 23(10): 1413-9, 2012 Oct.
Article in English | MEDLINE | ID: mdl-22419354

ABSTRACT

INTRODUCTION AND HYPOTHESIS: The objective of this study was to assess the safety and efficacy of the Elevate Apical and Posterior single-incision mesh system (SIMS) with IntePro Lite for pelvic organ prolapse repair. METHODS: This prospective multicenter study included 139 women with ≥ stage II posterior vaginal prolapse and/or apical descent who underwent placement of type I polypropylene mesh through a single transvaginal incision with no external needle passes. Primary endpoint was the percent of patients with posterior and/or apical stage ≤ I ("cure") at follow-up. Secondary endpoints included, but were not limited to, rate of mesh extrusion and disease-specific quality of life outcomes. RESULTS: At 12 months, objective posterior wall and apical cure rates were 92.5 and 89.2 %, respectively, with an extrusion rate of 6.5 %. CONCLUSIONS: The SIMS appears to be effective and safe in treating patients with posterior vaginal and/or apical prolapse. The risks and benefits of transvaginal synthetic mesh insertion should be considered.


Subject(s)
Gynecologic Surgical Procedures/adverse effects , Gynecologic Surgical Procedures/methods , Pelvic Organ Prolapse/surgery , Surgical Mesh , Aged , Europe , Female , Follow-Up Studies , Humans , Longitudinal Studies , Middle Aged , Patient Satisfaction , Polypropylenes , Prospective Studies , Quality of Life , Risk Assessment , Treatment Outcome , United States
7.
Obstet Gynecol Int ; 2012: 354897, 2012.
Article in English | MEDLINE | ID: mdl-22190952

ABSTRACT

Introduction and Hypothesis. We sought to determine the mesh extrusion (vaginal exposure) rates and subject outcomes following IntePro (Type I polypropylene) mesh "kit" repairs for vaginal prolapse. Methods. Data were pooled from two prospective multicenter studies evaluating the safety and efficacy of the Perigee and Apogee (American Medical Systems, Minnetonka, Minn, USA) to treat anterior and posterior/apical prolapses, respectively. Extrusions involving the anterior compartment (AC) or posterior compartment/apex (PC/A) were recorded. Results. Two hundred sixty women underwent mesh placement, with a total of 368 mesh units inserted (173 in the AC and 195 in the PC/A). Extrusions were noted in 13 (7.5%) of AC implants and 27 (13.8%) of PC/A implants through 12 months. No difference was seen between those with and without extrusion in regard to anatomic cure, postoperative painor quality of life at 1 year. Conclusions. Extrusion had no apparent effect on short-term outcomes. Given the unknown long-term sequellae of vaginal mesh exposure, a thorough assessment of risks and benefits of transvaginal mesh placement should be considered at the time of preoperative planning.

8.
Obstet Gynecol Int ; 2012: 384234, 2012.
Article in English | MEDLINE | ID: mdl-22007230

ABSTRACT

Stress urinary incontinence is a prevalent condition in women with a significant negative effect on quality of life. Intervention includes behavioral modification, intravaginal devices, pelvic floor muscle exercises, biofeedback, functional electrical stimulation, and surgical procedures. We will review a new in-office procedure for the treatment of SUI that may serve as a viable nonsurgical option.

9.
Obstet Gynecol ; 118(5): 1111-1125, 2011 Nov.
Article in English | MEDLINE | ID: mdl-22015880

ABSTRACT

OBJECTIVE: To comprehensively review and critically assess the available gynecologic surgery venous thromboembolism prophylaxis literature and provide clinical practice guidelines. DATA SOURCES: MEDLINE and Cochrane databases from inception to July 2010. We included randomized controlled trials in gynecologic surgery populations. Interventions and comparators included graduated compression stockings, intermittent pneumatic compression, unfractionated heparin, and low molecular weight heparin; placebo and routine postoperative care were allowed as comparators. METHODS OF STUDY SELECTION: One thousand two hundred sixty-six articles were screened, and 14 randomized controlled trials (five benign gynecologic, nine gynecologic oncology) met eligibility criteria. In addition, nine prospective or retrospective studies with at least 150 women were identified and provided data on venous thromboembolism risk stratification, gynecologic laparoscopy, and urogynecologic populations. TABULATION, INTEGRATION, AND RESULTS: Two reviewers independently screened articles with discrepancies adjudicated by a third. Eligible randomized controlled trials were extracted for these characteristics: study, participant, surgery, intervention, comparator, and outcomes data, including venous thromboembolism incidence and bleeding complications. Studies were individually and collectively assessed for methodologic quality and strength of evidence. Overall incidence of clinical venous thromboembolism was 0-2% in the benign gynecologic population. With use of intermittent pneumatic compression for benign major procedures, venous thromboembolism incidence was less than 1%. No venous thromboembolisms were identified in prospective studies of benign laparoscopic procedures. Overall quality of evidence in the benign gynecologic literature was poor. Gynecologic-oncology randomized controlled trials reported venous thromboembolism incidence (including "silent" venous thromboembolisms) of 0-14.8% with prophylaxis and up to 34.6% without prophylaxis. Fair quality of evidence supports that unfractionated heparin and intermittent pneumatic compression are both superior to placebo or no intervention but insufficient to determine whether heparins are superior to intermittent pneumatic compression for venous thromboembolism prevention. Combining two of three risks (aged 60 years or older, cancer, or personal venous thromboembolism history) substantially elevated the risk of venous thromboembolism. CONCLUSION: Intermittent pneumatic compression provides sufficient prophylaxis for the majority of gynecology patients undergoing benign surgery. Additional risk factors warrant the use of combined mechanical and pharmacologic prophylaxis.


Subject(s)
Gynecologic Surgical Procedures , Perioperative Care , Venous Thromboembolism/prevention & control , Female , Humans , Randomized Controlled Trials as Topic
10.
J Urol ; 184(2): 604-9, 2010 Aug.
Article in English | MEDLINE | ID: mdl-20639024

ABSTRACT

PURPOSE: We report 12-month outcomes of the MiniArc single incision sling for stress urinary incontinence in women. MATERIALS AND METHODS: We performed a multicenter, prospective, single arm institutional review board/ethics committee approved study evaluating the effectiveness of the MiniArc sling after implantation via qualitative (Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form) and quantitative (1-hour pad weight test and cough stress test) measurements. Secondary outcome measures included procedural variables (procedure time and estimated blood loss), length of stay, perioperative complications, Wong-Baker Faces Pain Scale and adverse events. RESULTS: A total of 188 women with a mean age of 51.1 +/- 10.6 years (median 50.4, range 25.9 to 79.6) were enrolled in the study. At 1 year 157 patients were available for analysis. Mean procedure time, estimated blood loss and length of hospital stay were 11.0 +/- 6.7 minutes (median 10, range 2 to 55), 41.7 +/- 47.0 ml (median 25, range 0 to 250) and 9.5 +/- 14.1 hours (median 3.2, range 0.5 to 77.2), respectively. At discharge from hospital the mean Wong-Baker pain score was 1.3 +/- 2.0 (range 0.0 to 10.0). Of the patients 90.6% had a negative cough stress test and 84.5% had a 1-hour pad weight test less than 1 gm at 12 months. Median Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form scores showed a statistically significant decrease (p <0.001). Adverse events included urinary tract infection (4.3%), constipation (3.7%), temporary urinary retention (3.2%), dyspareunia (2.1%) and vaginal extrusion (1.6%). CONCLUSIONS: The MiniArc single incision sling is a safe and effective first line surgical procedure for the treatment of female stress urinary incontinence. It demonstrated excellent patient tolerability with minimal pain, early return to normal activity and low morbidity. In addition to sustained efficacy outcomes at 12 months patients treated with the MiniArc experienced a significant improvement in quality of life.


Subject(s)
Suburethral Slings , Urinary Incontinence, Stress/surgery , Adult , Aged , Female , Humans , Middle Aged , Prospective Studies , Prosthesis Design , Urologic Surgical Procedures/methods
11.
Am J Obstet Gynecol ; 201(2): 218.e1-9, 2009 Aug.
Article in English | MEDLINE | ID: mdl-19481728

ABSTRACT

OBJECTIVE: We sought to determine whether mental imagery improves surgical performance of residents novice to cystoscopy. STUDY DESIGN: We performed a multicenter randomized controlled trial. Residents who had performed < or = 3 cystoscopies were randomized to preoperative mental imagery sessions or reading a book chapter describing cystoscopy. The primary outcome was comparison of groups' surgical performance scores. Secondary outcomes were measurements of operative times and resident ratings of helpfulness of their preparation. Scores were compared using 2-factor analysis of variance. RESULTS: In all, 68 residents were randomized; 33 to imagery and 35 to control groups. Groups did not differ in age, cystoscopic experience, residency level, or sex. The imagery group's surgical assessment scores were 15.9% higher than controls (P = .03). Operative times did not differ between groups. Imagery residents rated imagery preparation as more helpful than controls (P < .0001). CONCLUSION: Residents considered mental imagery to be a more useful preoperative preparation. The mental imagery group's surgical performance was superior to controls.


Subject(s)
Cystoscopy/methods , Education, Medical, Graduate/methods , Gynecology/education , Imagination , Internship and Residency/methods , Teaching/methods , Adult , Female , Humans , Male , Textbooks as Topic
12.
Obstet Gynecol ; 112(5): 1131-42, 2008 Nov.
Article in English | MEDLINE | ID: mdl-18978116

ABSTRACT

OBJECTIVE: To estimate the anatomic and symptomatic efficacy of graft use in transvaginal prolapse repair and to estimate the rates and describe the spectrum of adverse events associated with graft use. DATA SOURCES: Eligible studies, published between 1950 and November 27, 2007, were retrieved through Medline and bibliography searches. METHODS OF STUDY SELECTION: To assess anatomic and symptomatic efficacy of graft use, we used transvaginal prolapse repair studies that compared graft use with either native tissue repair or repair with a different graft. To estimate rates of adverse events from graft use, all comparative studies and case series with at least 30 participants were included. For spectrum of adverse events, all study designs were included. TABULATION, INTEGRATION AND RESULTS: Eligible studies were extracted onto standardized forms by one reviewer and confirmed by a second reviewer. Comparative studies were classified by vaginal compartment (anterior, posterior, apical, or multiple), graft type (biologic, synthetic-absorbable, synthetic nonabsorbable) and outcome (anatomic, symptomatic). We found 16 comparative studies, including six randomized trials, 37 noncomparative studies with at least 30 women, 11 case series with fewer than 30 women, and 10 case reports of adverse events. One randomized trial and one prospective comparative study evaluating synthetic, nonabsorbable graft use in the anterior compartment reported favorable anatomic and symptomatic outcomes with graft use. Data regarding graft use for posterior and apical compartments or for biologic or synthetic absorbable graft use in the anterior compartment were insufficient to determine efficacy. Rates and spectrum of adverse events associated with graft use included bleeding (0-3%), visceral injury (1-4%), urinary infection (0-19%), graft erosion (0-30%), and fistula (1%). There were insufficient data regarding dyspareunia, sexual, voiding, or defecatory dysfunction. CONCLUSION: Overall, the existing evidence is limited to guide decisions regarding whether to use graft materials in transvaginal prolapse surgery. Adequately powered randomized trials evaluating anatomic and symptomatic efficacy as well as adverse events are needed.


Subject(s)
Gynecologic Surgical Procedures/methods , Surgical Mesh/adverse effects , Tissue Transplantation/adverse effects , Transplantation, Heterologous/adverse effects , Uterine Prolapse/surgery , Animals , Female , Humans , Practice Guidelines as Topic , Sus scrofa , Tissue Transplantation/methods
13.
Int Urogynecol J Pelvic Floor Dysfunct ; 17(5): 449-54, 2006 Sep.
Article in English | MEDLINE | ID: mdl-16328117

ABSTRACT

Our objective was to determine the safety and effectiveness of Colpexin Sphere in women with advanced genital prolapse. A total of 39 subjects were enrolled in our prospective multicenter clinical trial, and 27 completed the full 16-week assessment. At baseline, subjects were fitted with a sphere, instructed on insertion and removal, and educated on a regimen of pelvic floor muscle exercises performed with the device in place. Efficacy was evaluated by a baseline vs 16-week comparison of pelvic organ prolapse staging and pelvic floor muscle strength assessment. Safety evaluation included, but was not limited to, an assessment of vaginal mucosal integrity. Subjects also completed a patient satisfaction questionnaire at the end of the study. Improvement in the prolapse of at least one vaginal segment was seen in 81.5% of the subjects, while 63% exhibited improved muscle function on digital examination at 16 weeks. Twenty-five (92.6%) would recommend the device to treat prolapse, and most found it easy to insert (96.3%) and remove (100%). In short-term usage, problems with urination (29.6%) and defecation (72%) were reported, primarily due to device displacement. Two subjects developed superficial vaginal mucosal ulceration, which resolved spontaneously. No significant adverse events were reported.


Subject(s)
Intrauterine Devices , Pelvic Floor/pathology , Adult , Aged , Demography , Equipment Safety , Female , Humans , Magnetic Resonance Imaging , Middle Aged , Muscle Strength/physiology , Pelvic Floor/diagnostic imaging , Pelvic Floor/physiology , Pelvic Floor/physiopathology , Prolapse , Radiography , Surveys and Questionnaires
14.
Am J Obstet Gynecol ; 193(6): 2138-43, 2005 Dec.
Article in English | MEDLINE | ID: mdl-16325630

ABSTRACT

OBJECTIVE: The objective of the study was to determine the degree of benefit of a transobturator midurethral polypropylene sling in patients with stress urinary incontinence through a quality-of-life instrument and outcome analysis. STUDY DESIGN: Forty-seven patients completed the validated Individual Incontinence Impact Questionnaire both before and after treatment. Subjects also completed the validated Patient Satisfaction Questionnaire postoperatively to complete outcome analysis. Statistical analyses included a paired Student t test for intrapair comparisons and 2-sample t tests to compare mean differences between groups. RESULTS: Individual Incontinence Impact Questionnaire scores for the entire sample declined from a preoperative mean of 43.0 +/- 27.0% to a postoperative mean of 11.8 +/- 16.4 (P < .0001). On review of Patient Satisfaction Questionnaire responses, 45 patients (95.7%) were completely satisfied or somewhat satisfied, and 42 subjects (89.4%) stated their leakage was much better or better. CONCLUSION: The transobturator midurethral sling provides a significant improvement in quality-of-life and high postoperative patient satisfaction.


Subject(s)
Prostheses and Implants , Quality of Life , Urinary Incontinence, Stress/surgery , Urologic Surgical Procedures , Adult , Aged , Female , Humans , Middle Aged , Outcome Assessment, Health Care , Polypropylenes , Retrospective Studies , Surveys and Questionnaires , Urinary Incontinence, Stress/psychology
15.
Urology ; 64(5): 862-5, 2004 Nov.
Article in English | MEDLINE | ID: mdl-15533464

ABSTRACT

OBJECTIVES: To evaluate the effectiveness of transvaginal manual therapy of the pelvic floor musculature (Thiele massage) in symptomatic female patients with interstitial cystitis and high-tone dysfunction of the pelvic floor. METHODS: A total of 21 women with documented interstitial cystitis and high-tone pelvic floor dysfunction underwent transvaginal massage using the Thiele technique twice a week for 5 weeks. Symptoms were evaluated before massage, at protocol conclusion, and at a mean of 4.5 months after therapy completion (long-term follow-up). The response to treatment was evaluated through the O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes, Likert Visual Analogue Scales for urgency and pain, and Short-Form 12-item (SF-12) Quality-of-Life Scale, and through changes in the physical examination findings using a 5-point modified Oxford Scale to document pelvic floor tenderness. RESULTS: A statistically significant improvement was seen in the Symptom and Problem Indexes of the O'Leary-Sant Questionnaire (P = 0.015 and P = 0.039, respectively), Likert Visual Analogue Scales for urgency and pain (P = 0.001 and P = 0.005, respectively), the Physical and Mental Component Summary from the SF-12 Quality-of-Life Scale (P = 0.049 and P = 0.044, respectively), and the modified Oxford Scale (P <0.05) after protocol completion. At long-term follow-up, the O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes (P = 0.049 and P = 0.02, respectively), Likert Visual Analogue Scales for urgency and pain (P = 0.004 and P = 0.005, respectively), and modified Oxford Scale for three of four muscles in the pelvic floor (P <0.05) remained significantly improved. CONCLUSIONS: Thiele massage appears to be very helpful in improving irritative bladder symptoms in patients with interstitial cystitis and high-tone pelvic floor dysfunction in addition to decreasing pelvic floor muscle tone.


Subject(s)
Cystitis, Interstitial/physiopathology , Cystitis, Interstitial/therapy , Massage/methods , Pelvic Floor/physiopathology , Adult , Female , Humans , Pain Measurement , Physical Examination , Pilot Projects , Prospective Studies , Quality of Life , Spasm/therapy , Surveys and Questionnaires
16.
Article in English | MEDLINE | ID: mdl-15278250

ABSTRACT

Anterior enterocele is an uncommon finding in patients with pelvic organ prolapse. We reviewed 490 consecutive operations for pelvic organ prolapse . Three anterior enteroceles were identified in a series of 193 enterocele repairs (1.6%). The presentation and treatment of each of these patients is reviewed.


Subject(s)
Rectocele/diagnosis , Vaginal Diseases/diagnosis , Aged , Diagnosis, Differential , Female , Gynecologic Surgical Procedures , Humans , Middle Aged , Prolapse , Rectocele/complications , Rectocele/pathology , Rectocele/surgery , Vaginal Diseases/complications , Vaginal Diseases/pathology , Vaginal Diseases/surgery
17.
Int Urogynecol J Pelvic Floor Dysfunct ; 14(5): 305-8; discussion 308-9, 2003 Nov.
Article in English | MEDLINE | ID: mdl-14618305

ABSTRACT

Female patients with interstitial cystitis (IC) unresponsive to standard oral and intravesical therapy were enrolled at three clinical sites for percutaneous sacral nerve root stimulation (PNS) in a prospective, observational pilot study. Evaluation was in the form of a 3-day voiding diary completed both prior to and following the commencement of sacral nerve root stimulation. Symptoms were also assessed by the O'Leary-Sant Interstitial Cystitis Symptom and Problem Indices (ICSI and ICPI). Baseline and test stimulation values for voiding diary parameters and O'Leary-Sant scores were compared to determine treatment efficacy. A total of 33 patients were enrolled. Statistically significant improvements were seen in frequency, pain, average voided volume and maximum voided volume. Significant improvements were also seen in ICSI and ICPI scores. Subacute PNS appears to be effective in reducing symptom severity and increasing voided volumes in patients with IC previously unresponsive to standard therapy.


Subject(s)
Cystitis, Interstitial/therapy , Lumbosacral Plexus , Transcutaneous Electric Nerve Stimulation , Adult , Cystitis, Interstitial/physiopathology , Female , Humans , Pain , Spinal Nerve Roots , Transcutaneous Electric Nerve Stimulation/adverse effects , Urination
18.
Expert Opin Pharmacother ; 4(11): 1967-75, 2003 Nov.
Article in English | MEDLINE | ID: mdl-14596650

ABSTRACT

Interstitial cystitis is a clinical condition occurring predominantly in women characterised by irritative voiding symptoms in the form of urinary frequency, urgency and pain. Patient symptoms have the potential to significantly affect quality of life, posing a challenge to some to perform activities of daily living. Those who reach an eventual diagnosis of interstitial cystitis have typically done so through an emotionally charged and circuitous route, the product of numerous physician encounters and stigmatising experiences. As such, these patients require considerate care. Overall, current pharmacological agents for the treatment of those with interstitial cystitis, provide a measure of symptomatic benefit, however, a universally effective regimen remains to be reported. As a definitive disease aetiopathogenesis is not fully determined, trials of pharmacological therapy are ongoing.


Subject(s)
Cystitis, Interstitial/drug therapy , Administration, Oral , Cystitis, Interstitial/etiology , Cystitis, Interstitial/pathology , Humans , Injections , Urinary Bladder/physiology
19.
Urol Clin North Am ; 29(3): 649-60, 2002 Aug.
Article in English | MEDLINE | ID: mdl-12476528

ABSTRACT

The management of patients with IC remains a challenge because no single agent has proven universally effective. DMSO and PPS have been evaluated through early placebo-controlled trials, and these two agents are FDA approved treatments for IC. BCG is currently undergoing a large placebo-controlled trial, and hyaluronic acid is receiving similar clinical evaluation. Sacral nerve root stimulation shows promise with early favorable results. As with any treatment algorithm, it is reasonable to begin with conservative treatment using time-dependent milestones, allowing adequate trials of successive therapy while ensuring an appropriate pace for timely symptom resolution.


Subject(s)
Cystitis, Interstitial/diagnosis , Cystitis, Interstitial/therapy , Cystitis, Interstitial/physiopathology , Female , Humans
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