Fractional CO2 laser for treatment of stress urinary incontinence.

OBJECTIVES: To evaluate the impact of trans-vaginal fractional CO2 laser treatment on symptoms of stress urinary incontinence (SUI) in women. STUDY DESIGN: Women clinically diagnosed with SUI preferring non-surgical treatment were recruited to the study. Fractional CO2 laser system (MonaLisa T, DEKA) treatments were administered trans-vaginally every 4-6 weeks for a total of three treatments. Response to treatment was assessed at baseline (T1), at 3 months after treatment completion (T2) and at 12-24-month follow-up (T3) using the Australian Pelvic Floor Questionnaire (APFQ). The primary outcome was changes in reported symptoms of SUI. Secondary outcomes assessed included bladder function, urgency, urge urinary incontinence (UUI), pad usage, impact of urinary incontinence on quality of life (QOL) and degree of bothersome bladder. RESULTS: Fifty-eight women were recruited and received the study treatment protocol. Eighty-two percent of participants reported an improvement in symptoms of SUI at completion of treatment (mild to no SUI) (p = <0.01). Treatment effect waned slightly when assessed at follow-up. Nevertheless, 71% of participants reported ongoing improvement in SUI symptoms at 12-24 months (p < 0.01). All secondary outcome measures were improved after treatment compared to baseline. CONCLUSIONS: This study suggests that fractional CO2 laser is a safe, feasible, and beneficial treatment for SUI and may have a role as a minimally-invasive alternative to surgical management.

Mechanism of action of the Adiana(®) device: a histologic perspective.

BACKGROUND: The study was conducted to confirm the mechanism of action of the Adiana permanent contraception device by means of histologic analysis of long-term specimens. STUDY DESIGN: Fifteen specimens were obtained from eight subjects undergoing hysterectomy 2 to 4 years after the Adiana procedure. Serial sections were stained with hematoxylin and eosin, as well as epithelial membrane antigen immunostain. RESULTS: A normal foreign body reaction with minimal chronic inflammatory changes was observed in all specimens. Immunostaining for epithelial membrane antigen was absent in the interstitial tissue surrounding the matrix. CONCLUSION: Histologic analysis of long-term specimens supports the mechanism of action of the Adiana permanent contraception device.

The Adiana System for permanent contraception: safety and efficacy at 3 years.

STUDY OBJECTIVE: To evaluate the efficacy of the Adiana System for preventing pregnancy in women desiring permanent sterilization. DESIGN: This study is a prospective, single-arm, multicenter, international trial. The primary endpoint was pregnancy prevention rate at 12 months. Pregnancy prevention rates at 24 and 36 months were also calculated (Canadian Task Force classification II-2). SETTING: The study was conducted at 16 sites, 14 in the United States, 1 in Australia, and 1 in Mexico. PATIENTS: A total of 645 women (intent-to-treat group). INTERVENTION: Hysteroscopic placement of polymer matrix was attempted in all patients. Tubal occlusion confirmed by hysterosalpingography at 12 weeks. Ongoing monitoring for pregnancy over 36 months. MEASUREMENTS AND MAIN RESULTS: There was a 95% bilateral matrix placement rate and 88.4% bilateral occlusion by hysterosalpingography, as previously reported. A total of 24 968 person-months of wearing were accrued. Pregnancy prevention rates were summarized with descriptive statistics by use of 95% two-sided confidence interval on the basis of life-table methods. Complete 36-month data were available for 481 subjects. During the first year, 6 pregnancies were reported. Three were determined to be the result of misinterpretation of hysterosalpingography results. The remaining 3 were attributed to method failure, as were the 3 pregnancies during the second year. No additional pregnancies occurred in year 3. The cumulative pregnancy prevention rates at 12, 24, and 36 months compare favorably with data from the Collaborative Review of Sterilization study and other published reports documenting efficacy of established permanent sterilization procedures. CONCLUSIONS: These data demonstrate that the efficacy of the Adiana System for pregnancy prevention is similar to other permanent sterilization methods.

A comparative, single-blind, randomized trial of pain associated with suction or non-suction drains after gynecologic laparoscopy.

STUDY OBJECTIVE: To estimate the difference in pain associated with the wearing or removal of suction or non-suction drains after gynecologic laparoscopic surgery. DESIGN: A randomized controlled trial from August 2006 through October 2007 (Canadian Task Force Classification I). SETTING: Royal Hospital for Women, Department of Endo-Gynaecology and School of Women's and Children's Health University of New South Wales. PATIENTS: A total of 168 women undergoing gynecologic laparoscopy requiring postoperative drainage. INTERVENTIONS: Patients were randomized to receive either a suction or non-suction drain after surgery. MEASUREMENTS AND MAIN RESULTS: Pain was assessed before, during, and after drain removal with a 4-point verbal descriptor scale and 10-cm visual analogue scale. Visual analogue scale and verbal descriptor scale scores for suction versus non-suction groups were 3 versus 3 (p=.654) and 1 versus 1 (p=.686) before removal, 9 versus 7 (p=.016) and 3 versus 2 (p=.029) during removal, and 7 versus 5 (p=.058) and 2 versus 2 (p=.122) after removal. CONCLUSION: There is no significant difference in patient discomfort while wearing or after removal of suction or non-suction drains. However, suction drains are more painful to have removed.

The management of intrauterine synechiae.

PURPOSE OF REVIEW: Intrauterine adhesions are a rare but significant cause of menstrual disturbance and infertility. Most cases are caused by uterine instrumentation. It is important for clinicians to understand the cause, diagnostic tools and rationale behind treatment. RECENT FINDINGS: Hysteroscopy is the gold standard for diagnosis and treatment of intrauterine adhesions. A combination of blunt and sharp dissection or electrosurgery is used by most units. Antibiotics and postoperative administration of estrogen +/- progestogen is important in prevention of recurrence. The use of intrauterine contraceptive devices following synechiolysis is supported by some groups. Restoration of menstruation is highly successful (more than 90%), and pregnancy rates around 50-60% with live birth rates around 40-50% can be achieved. SUMMARY: Clinicians should maintain a level of suspicion of intrauterine adhesions and should investigate by hysteroscopy if necessary. Treatment should follow a protocol that incorporates sound hysteroscopic technique with antibiotic prophylaxis and postoperative hormonal therapy. Consideration should be given to the use of an intrauterine contraceptive device or Foley catheter for a short period.

A 12-month prospective evaluation of transcervical sterilization using implantable polymer matrices.

OBJECTIVE: To evaluate placement efficacy and reliability of a an intratubal occlusion device for permanent contraception and to assess tolerability and overall satisfaction. METHODS: Seven hundred seventy women with known parity were recruited to participate in a prospective, multicenter study. Bipolar, low-level radiofrequency energy delivery and porous silicon inserts were used. Inserts were placed bilaterally in the fallopian tube lumen. Subsequent bilateral occlusion was assessed with hysterosalpingography. RESULTS: Overall, bilateral placement success was achieved in 611 of 645 women (95%). Bilateral occlusion was confirmed in 570 of 645 (88.4%). The 1-year pregnancy prevention rate as derived with life-table methods was 98.9%. CONCLUSION: This transcervical sterilization system offers an effective contraceptive method, which was well tolerated and had a high satisfaction rate. LEVEL OF EVIDENCE: III.

Fluoroscopically guided synechiolysis for patients with Asherman's syndrome: menstrual and fertility outcomes.

OBJECTIVE: To describe a 5-year experience of fluoroscopically guided hysteroscopic synechiolysis for Asherman's syndrome. DESIGN: Retrospective, uncontrolled cohort study. SETTING: Department of Endo-Gynaecology, University of New South Wales, Royal Hospital for Women, Randwick, Sydney, New South Wales, Australia. PATIENT(S): Thirty consecutive patients with confirmed Asherman's syndrome (March 1999-March 2004). INTERVENTION(S): Women had hysteroscopy performed under general anesthetic, with the use of a spinal needle in parallel to the hysteroscope to perform synechiolysis. The progress of the procedure was determined by injecting radiographic contrast medium, and visualized with the use of an image intensifier. Individual procedures were terminated when the endometrial cavity was reconstructed, or at 60 minutes. Cyclic high-dose estrogen therapy was used to stimulate endometrial proliferation. Repeat procedures were performed monthly until the endometrial cavity was reestablished. MAIN OUTCOME MEASURE(S): Menstrual and fertility outcomes were obtained from patient records and by postal questionnaire. RESULT(S): Thirty patients were treated for Asherman's syndrome (13% AFS Grade I, 43% AFS Grade II, and 43% AFS Grade III). Prior to treatment, 60% of patients were amenorrheic. The median number of procedures per patient was 1.5 (range, 1-6), and the mean length of the procedure was 42 minutes (range, 10-70 minutes). After treatment, 96% had regular menses. Seventeen patients attempted to conceive after surgery, and 9 (53%) were successful. CONCLUSION(S): Hysteroscopic synechiolysis under image-intensifier control appears to be an effective treatment for Asherman's syndrome.

Clinical and quality-of-life outcomes after fertility-sparing laparoscopic surgery with bowel resection for severe endometriosis.

STUDY OBJECTIVE: To describe the effect of fertility-sparing laparoscopic excision of endometriosis and bowel resection on clinical and quality-of-life outcomes. DESIGN: Prospective observational cohort study (Canadian Task Force classification II-2). SETTING: Australian tertiary referral center for the surgical treatment of endometriosis. PATIENTS: Seven consecutive patients with known endometriosis involving the bowel. INTERVENTION: Laparoscopic resection of all endometriosis, including laparoscopic bowel resection with end-to-end anastomosis with or without temporary ileostomy. MEASUREMENTS AND MAIN RESULTS: Preoperative and 12-month postoperative data were collected by use of visual analogue scores for dysmenorrhea, nonmenstrual pelvic pain, dyspareunia, and dyschezia. Validated research tools (SF12, EuroQOL, and Sexual Activity Questionnaire) also assessed quality of life. Reduction in median pain scores at baseline was demonstrated and at 12 months after operation for dysmenorrhea 71 (interquartile range 43-85) versus 5 (0-10); p=.028, nonmenstrual pelvic pain 74 (48-85) versus 11 (0-18); p=.046, dyspareunia 66 (0-98) versus 5 (0-8); p=.080, and dyschezia 48 (20-64) versus 20 (0-40); p=.173. All measures of quality of life were improved at 12 months after surgery, although not reaching statistical significance because of the small sample size. All three women wishing to conceive after operation have been successful, resulting in three live births at term. There were few complications associated with this surgery. CONCLUSION: Fertility-sparing laparoscopic excision of endometriosis with bowel resection results in improvements in all aspects of pain and quality of life. Results appear to parallel published data for conservative resection of endometriosis not involving bowel. For women with severe endometriosis involving bowel, this surgical treatment provides a viable alternative to pelvic clearance and successfully maintains fertility.

Peri-operative physiotherapy improves outcomes for women undergoing incontinence and or prolapse surgery: results of a randomised controlled trial.

BACKGROUND: Urinary incontinence and pelvic organ prolapse are common complaints in women. Physiotherapy and surgery to correct these conditions are often seen as mutually exclusive. No study has yet investigated their synergistic potential. AIM: This study aimed to investigate the role of peri-operative physiotherapy in women undergoing corrective surgery for pelvic organ prolapse and/or incontinence. METHODS: In this randomised controlled trial, 30 women underwent preoperative physiotherapy and 30 others had no physiotherapy prior to their incontinence and or prolapse surgeries. Comparison was performed on the basis of the following tests: paper towel test, urinary symptom specific health and quality of life questionnaire, frequency/volume chart and pelvic floor muscle manometry. Women were followed up for 3 months. RESULTS: Both groups showed improvement in urinary continence. Significant group differences were noted in the quality of life questionnaire (P= 0.004), urinary symptoms (P= 0.017) and maximum pelvic floor muscle squeeze on manometry (P= 0.022). Diurnal frequency analysis indicates that there is a significant difference in favour of the treatment group (P= 0.024). CONCLUSION: Routine pre and post operative physiotherapy interventions improve physical outcomes and quality of life in women undergoing corrective surgery for urinary incontinence and or pelvic organ prolapse.

Assessment of a method to expel intraperitoneal gas after gynecologic laparoscopy.

STUDY OBJECTIVE: To assess a method using instillation of saline to expel all residual intraperitoneal CO2 after laparoscopy. If successful, this would enable clinicians to use radiography as a simple diagnostic test to detect bowel perforation following laparoscopic surgery. DESIGN: Cohort study (Canadian Task Force classification II-2). SETTING: Department of Endo-Gynecology, Royal Hospital for Women, Sydney, Australia. PATIENTS: Thirty women undergoing elective gynecologic laparoscopic surgery. INTERVENTIONS: At completion of surgery, the patient remained in maximum head- down position as the abdomen was filled with up to 1 L of normal saline. The suprapubic port remained open to allow the CO2 to escape as it was displaced by the saline. Closure of abdominal ports was completed in routine manner. Erect upper abdominal radiographs were taken 24 hours after surgery, and measurements of any subdiaphragmatic gas were recorded. If gas was evident at 24 hours, a repeat radiograph was performed at 48 hours. MEASUREMENTS AND MAIN RESULTS: Of the 30 patients recruited, four did not complete the study protocol. There was evidence of subdiaphragmatic gas in 25 (96%) of 26 patients on the radiograph taken 24 hours postsurgery. The median volume of gas was 12.9 mL (range 0-2003 mL; IQ range 2.0-144 mL). Of the patients that had a second radiograph, 76% still had subdiaphragmatic gas present. CONCLUSION: This method for displacement of residual intraperitoneal gas at the end of laparoscopy does not appear to be effective.

Pilot study of botulinum toxin type A in the treatment of chronic pelvic pain associated with spasm of the levator ani muscles.

OBJECTIVE: To investigate whether botulinum toxin type A (BOTOX) injected into the levator ani muscles of women with objective pelvic floor muscle spasm decreases pain symptoms and improves quality of life. DESIGN: A prospective cohort study. SETTING: Outpatient clinic in a tertiary referral centre, Sydney, Australia. SAMPLE: Twelve women, aged 18-55 years, with objective pelvic floor muscle hypertonicity and a minimum 2-year history of chronic pelvic pain were recruited. METHODS: All women completed visual analog scale pain assessments; questionnaires relating to bladder and bowel symptoms and quality of life; and specific examinations. Forty units of BOTOX at three different dilutions were given bilaterally into the puborectalis and pubococcygeus muscles under conscious sedation. RESULTS: Median visual analog scale scores were significantly improved for dyspareunia (80 vs 28; P=0.01) and dysmenorrhea (67 vs 28; P=0.03), with non-significant reductions in non-menstrual pelvic pain (64 vs 37) and dyschesia (47 vs 29). Pelvic floor muscles manometry showed a 37% reduction in resting pressure at week 4 and a 25% reduction was maintained at week 12 (P <0.0001). Quality of life scores (EQ-5D and SF-12) were improved from baseline at week 12, but did not reach statistical significance. Sexual activity scores were markedly improved, with a significant reduction in discomfort (4.8 vs 2.2; P=0.02) and improvement in habit (0.2 vs 1.9; P=0.03). These results were not influenced by dilution. CONCLUSION: There is evidence from the present pilot study suggesting that women with pelvic floor muscles hypertonicity and pelvic pain may respond to BOTOX injections into the pelvic floor muscles. Further research into this novel treatment of chronic pelvic pain is strongly recommended.

MycroMesh is not a suitable soft tissue prosthesis for repair of the defective vaginal wall.

Thirty-one women had recurrent vaginal wall prolapse repaired with insertion of a soft tissue prosthesis-MycroMesh in 22 (group B) and other materials in 9 (group A). Rejection rates were 18% and zero percent, respectively. Given these data, MycroMesh is not recommended to repair a defective vaginal wall.