The effect of skeletal muscle-derived cells implantation on stress urinary incontinence and functional urethral properties in female patients.

OBJECTIVE: To evaluate improvement of stress urinary incontinence (SUI) and functional status of the urethra after autologous skeletal-muscle derived cell (aSMDC) implantation. METHODS: Phase I-II, open, non-randomized, single-center study of ultrasound guided aSMDC implantation (dosed at 0.2 × 106  cells/2 mL) into the external urethral sphincter to treat SUI. RESULTS: A total of 38 patients were treated and followed for 2 years. SUI measured by Incontinence Episode Frequency score, short pad test, quality of life, patient's and clinician's perception significantly improved and remained improved after 2 years. However, urodynamic urethral properties in general did not improve at 1-year after treatment. Subgroup analysis revealed that addition of an adjuvant functional electrical stimulation therapy discontinued 4 weeks after injection in the compliant group, gave better urodynamic values and maintained the long-term SUI improvement at 2 years. CONCLUSION: The aSMDC injection was safe and well-tolerated by patients. The status of SUI improved and with it the quality of life of patients, even if this was not necessarily reflected in the urodynamic urethral properties. Electrical stimulation, as an adjuvant therapy, could have an essential role in the success of the therapy. CLINICAL REGISTRATION: Clinical study was registered under Eudra-CT number: 2010-021867-34 at European Clinical Trial Database (EudraCT), accessible at: EudraCT (europa.eu).

Single-Incision Mini-Sling for the Treatment of Female Stress Urinary Incontinence: Is it Actually Inferior to Transobturator Vaginal Tape and Tension-Free Vaginal Tape?

OBJECTIVES: The aim of the study was to report the extended long-term results of the use of single-incision mini-sling (SIMS), tension-free vaginal tape (TVT), and transobturator tape (TOT) for the treatment of female stress urinary incontinence (SUI) at the Department of Gynecology and Obstetrics of the University Medical Center Ljubljana. MATERIALS AND METHODS: Enrolled women were evaluated by Patient Global Impression of Severity (PGI-S), Patient Global Impression of Improvement (PGI-I), Sandvik severity scale, Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7), and Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI) Short Form and data about diagnosis, procedures, complications, reoperations, postoperative results, and satisfaction with procedure were recorded. RESULTS: In analyzed group of patients (n = 357), 116 (32%) underwent SIMS procedure, 189 (53%) TOT, and 52 (15%) TVT. The SIMS, TOT, and TVT groups did not differ significantly from each other in PGI-S, PGI-I, Sandvik severity scale, UDI-6, IIQ-7, and ICIQ-UI Short Form or in postoperative complication rate. Repeat surgery was needed in 9.5% after SIMS, in 13.2% of TOT patients and in 23.1% of TVT patients (P = 0.194). Urinary retention occurred in 9.5% of the SIMS patients, in 9.5% of the TOT patients, and in 13.5% of the TVT patients (P = 0.682). Mesh erosion/inflammation occurred in 3.4% of the SIMS patients, in 6.3% of the TOT patients, and in 3.8% of the TVT patients (P = 0.485). CONCLUSION: The efficacy and safety of SIMS, TOT, and TVT in the surgical treatment of SUI are comparable. The choice of the technique should be based on the relative pros and cons of techniques and the surgeon's experience.

Efficacy of Non-ablative Laser Therapy for Lichen Sclerosus: A Randomized Controlled Trial.

OBJECTIVE: The aim of this randomized controlled trial was to evaluate the safety and efficacy of neodymium: yttrium aluminum garnet laser treatment of lichen sclerosus (LS) by comparing it with topical corticosteroid treatment. METHODS: A total of 40 female patients with vulvar LS were randomized 1:1 into a study (laser) group and a control (topical corticosteroids) group. The laser group received three laser treatments. Blinded evaluators evaluated biopsies and graded improvement on clinical photographs at baseline and at 3 months. Patients graded the intensity of symptoms on a 0 to 10 visual analogue scale at baseline and 1-, 3-, and 6-month follow-up. Patients also rated the tolerability of laser treatments, and side effects were monitored. (Canadian Task Force classification I) RESULTS: Laser treatment discomfort was on average 1.5 of 10 on the visual analogue scale. At 1- and 3-month follow-up, patients in the laser group had significantly greater improvement in LS symptoms (burning, itching, pain, and dyspareunia), better patient satisfaction, and greater reduction of sclerosis than patients in the topical corticosteroid group. At 6-month follow-up, the improvement of symptoms in the laser group was still significant. The correct order of photographs (before and after treatment) was assigned significantly more often in the laser-treated patients compared with the control group. CONCLUSION: Laser therapy for LS caused minimal patient discomfort during the treatment, with no adverse effects, and demonstrated better efficacy than in the control group, with significant improvement lasting up to 6 months. Laser therapy is a promising option for patients not responding to topical corticosteroid therapy or patients wishing to reduce long-term corticosteroid maintenance use.

Non-ablative Er:YAG laser therapy effect on stress urinary incontinence related to quality of life and sexual function: A randomized controlled trial.

OBJECTIVE: Stress urinary incontinence (SUI) is a common complaint in women after childbirth. It affects their quality of life and sexual satisfaction and is one of the major reasons for gynaecological surgery. There is a need for effective non-invasive treatment alternatives. The aim of this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy in the treatment of SUI and improvement of sexual gratification in parous women. STUDY DESIGN: 114 premenopausal parous women with SUI were randomized in two groups of 57 women; a laser intervention group and sham group. Both groups were treated according to the IncontiLase® clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG laser, except that there was no energy output when treating the sham group. Patients were blinded to the allocation. At baseline and 3 months after treatment patients were clinically examined, answered questionnaires for SUI severity and sexual function assessment and their pelvic floor muscle (PFM) function was assessed with perineometry. Validated International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) was used as the primary outcome measure. The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire short form (PISQ-12) and The Female Sexual Function Index (FSFI) were used to assess the sexual function. Patients were monitored for discomfort and side-effects during treatment and follow-up period. RESULTS: 3 months after treatment the ICIQ-UI SF (p < 0.001), PISQ-12 (p = 0.014) and FSFI (p = 0.025) scores were significantly more improved in the laser group than in the sham control group. All perineometry variables improved in the laser group after treatment; duration and maximum pressure had statistically significantly better improvement than the sham group, whereas average pressure did not. 21% of laser treated patients were dry (ICIQ-UI SF = 0) at follow up compared to only 4% of the sham control patients. No serious adverse effects were observed or reported. The treatment was well tolerated by patients. CONCLUSIONS: The non-ablative Er:YAG laser therapy improves the impact of SUI symptoms on quality of life and sexual function in premenopausal parous women significantly better than placebo. It provides a promising minimally-invasive safe treatment alternative for SUI.

A prospective, case-control study on the lipid profile and the cardiovascular risk of menopausal women on oestrogen plus progestogen therapy in a northern Italy province.

PURPOSE: To evaluate the effects of oestrogen plus progestogen therapy (EPT) on the lipid metabolism of menopausal patients. METHODS: We conducted a prospective study on 223 patients with clinical and blood chemistry diagnosis of menopause, who were eligible for hormone therapy and a follow-up period lasting at least 5 years. We selected a control group. Patients attended annual or 6-monthly visits for the duration of the 5-year follow-up period. For each patient, total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglyceride values were considered at the first visit and after 5 years. We compared these values of the above parameters in relation to time and EPT and the repercussions that the presence/absence of replacement therapy had in terms of lipid profile alteration between the groups studied. RESULTS: Of the 223 patients eligible for enrolment, 178 made up the study group (EPT Group) and 45 made up the control cohort (N-EPT-Group). At the first visit, median value was (EPT-Group vs. N-EPT-Group): cholesterol was 240 versus 226 mg/dL, LDL-cholesterol 169 versus 174 mg/dL, HDL-cholesterol 60 mg/dL in both groups, triglyceride 125 versus 92 mg/dL (p:n.s). Five years later, median value was (EPT-Group versus N-EPT-Group): cholesterol 225 versus 236 mg/dL (p < 0.001), LDL-cholesterol 125 versus 184 mg/dL (p < 0.001), HDL-cholesterol 64 versus 68 mg/dL (p:n.s.), triglyceride 72 versus 94 mg/dL (p:n.s.). No adverse effects of EPT were observed. CONCLUSIONS: Thorough risk/benefit assessment, associated with initially low doses and without rigid cutoffs, particularly when started early, EPT can be made a valid means of cardiovascular prevention, specifically because it positively alters the lipid profile of menopausal women.

Ultrasound-guided autologous myoblast injections into the extrinsic urethral sphincter: tissue engineering for the treatment of stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Limitations of the existing treatment methods for stress urinary incontinence (SUI) have encouraged investigation of new therapeutic approaches in the field of regenerative medicine. Enabled by tissue engineering technology safety, feasibility and efficacy of ultrasound-guided intrasphincteric autologous myoblast implantation to treat SUI presented in the accompanying video were assessed in a pilot study of 38 women. METHODS: Following upper arm muscle biopsy, autologous myoblast suspension was injected into the extrinsic urethral sphincter under transurethral ultrasound visualization. Functional electrical stimulation (FES) was used postoperatively to possibly enhance cell integration. Objective and subjective parameters were compared at 6 weeks, 3 months, and 6 months postoperatively. RESULTS: The tissue harvest, laboratory tissue processing, and myoblast implantation were successful in all 38 patients. No serious adverse events were reported through the course of the study. Objective and subjective measurements collected at baseline were significantly improved at 6 weeks postoperatively. Additional improvement or a plateau was observed at 3 and 6 months postoperatively, not being negatively influenced by discontinuation of FES. Of the patients, 23.7 % considered their SUI cured, and 52.6 % reported improvement at 6 months; 95 % would recommend this treatment to others. CONCLUSIONS: Intrasphincteric ultrasound-guided autologous myoblast injection for SUI is feasible. This simple to perform and well-tolerated minimally invasive procedure safely produced promising initial results.

Extragenital Müllerian adenosarcoma with pouch of Douglas location.

BACKGROUND: Of all female genital tract tumors, 1-3% are stromal malignancies. In 8-10% of cases, these are represented by Müllerian adenosarcoma an extremely rare tumor characterized by a stromal component of usually low-grade malignancy and by a benign glandular epithelial component. Variant that arises in the pouch of Douglas is scarcely mentioned in the medical literature. CASE PRESENTATION: A 49-year-old para-0 woman, was seen at our OB/GYN-UNIT because she complained vaguely of pelvic pain. She had a mass of undefined nature in the pouch of Douglas. A simple excision of the mass showed low-grade Müllerian adenosarcoma with areas of stromal overgrowth. One and a half year after surgery, at another hospital, a mass was detected in the patient's posterior vaginal fornix and removed surgically. Six months later she came back to our observation with vaginal bleeding and mass in the vaginal fornix. We performed radical surgery. The pathological examination showed recurrent adenosarcoma. Surgical treatment was supplemented by radiation therapy. CONCLUSIONS: The case of Müllerian adenosarcoma reported here is the third known so far in the literature that was located in the pouch of Douglas. To date, only two other such cases have been reported, including one resulting from neoplastic degeneration of an endometriotic cyst.

CA 125 serum values in surgically treated endometriosis patients and its relationships with anatomic sites of endometriosis and pregnancy rate.

Endometriosis is a benign gynecologic disease defined as the presence of functional endometrial glands and stroma outside the uterine cavity, causing dysmenorrhea, dyspareunia, menstrual irregularities, and infertility. Serum CA-125 measurement is now a consolidated method for diagnosing this condition, and its interpretation has posed a number of problems, particularly regarding utility in diagnosing minimal-mild endometriosis, whereas its value as a diagnostic aid in moderate-severe stages is well recognized. In our cohort, serum CA-125 values were significantly elevated in patients with ovarian and mixed endometriosis lesions (median levels 48 U/mL), compared with those who had exclusively extraovarian foci (median levels 27 U/mL), and so the correlation between this marker and the surgical and pathologic finding of ovarian and deep endometriosis was found to be statistically significant; however, the location did not affect the fertility rate.

Risk factors for vaginal prolapse after hysterectomy.

OBJECTIVE: To identify risk factors for pelvic organ prolapse (POP) and their influence on the occurrence of vaginal prolapse after hysterectomy. METHODS: Medical records from 2 groups of women who had undergone hysterectomy were reviewed retrospectively. The study group was 82 women who had undergone surgery for vaginal prolapse after hysterectomy; the control group was 124 women who had undergone hysterectomy with no diagnosis of vaginal prolapse by the time of the study. All hysterectomy procedures had been performed for benign gynecological disease, including POP. Both groups of women completed a self-administered questionnaire to obtain additional information on the occurrence of POP. RESULTS: The incidence of vaginal prolapse after hysterectomy was significantly higher in women with a higher number of vaginal deliveries, more difficult deliveries, fewer cesareans, complications after hysterectomy, heavy physical work, neurological disease, hysterectomy for pelvic organ prolapse, and/or a family history of pelvic organ prolapse. Premenopausal women had vaginal prolapse corrected an average of 16 years after hysterectomy, and postmenopausal women 7 years post hysterectomy. CONCLUSION: Before deciding on hysterectomy as the approach to treat a woman with pelvic floor dysfunction, the surgeon should evaluate these risk factors and discuss them with the patient.