Characteristics of storage and voiding symptoms in adult patients with type 2 diabetes with lower urinary tract symptoms.

AIMS: We aimed to assess the relationships between lower urinary tract symptoms (LUTS) and various parameters including diabetes complications in patients with type 2 diabetes. METHODS: In this single-center cross-sectional study, we enrolled 404 patients hospitalized for diabetes. We ultimately analyzed data from 160 patients. To evaluate LUTS, the International Prostate Symptom Score and overactive bladder symptom score were used. The identified relationships were then analyzed considering parameters such as age, sex, body mass index (BMI), HbA1c, creatinine, and urinary albumin excretion. RESULTS: The prevalences of overactive bladder (OAB), storage symptoms and voiding symptoms were 21.9%, 63.8%, and 39.4%, respectively. In multivariate logistic regression analysis, the coefficient of variation of the R-R interval, indicating autonomic neuropathy, correlated negatively with OAB, while BMI and duration of diabetes correlated positively with storage symptoms. A history of cerebrovascular disease correlated significantly with voiding symptoms in multivariate logistic analysis. CONCLUSIONS: Our analysis of diabetic patients with LUTS revealed differences in the characteristics of storage and voiding symptoms. These findings provide evidence that the features of LUTS associated with diabetes may have different pathogenic origins. J. Med. Invest. 71 : 237-245, August, 2024.

Deep Learning Models for Cystoscopic Recognition of Hunner Lesion in Interstitial Cystitis.

Background: Accurate cystoscopic recognition of Hunner lesions (HLs) is indispensable for better treatment prognosis in managing patients with Hunner-type interstitial cystitis (HIC), but frequently challenging due to its varying appearance. Objective: To develop a deep learning (DL) system for cystoscopic recognition of a HL using artificial intelligence (AI). Design setting and participants: A total of 626 cystoscopic images collected from January 8, 2019 to December 24, 2020, consisting of 360 images of HLs from 41 patients with HIC and 266 images of flat reddish mucosal lesions resembling HLs from 41 control patients including those with bladder cancer and other chronic cystitis, were used to create a dataset with an 8:2 ratio of training images and test images for transfer learning and external validation, respectively. AI-based five DL models were constructed, using a pretrained convolutional neural network model that was retrained to output 1 for a HL and 0 for control. A five-fold cross-validation method was applied for internal validation. Outcome measurements and statistical analysis: True- and false-positive rates were plotted as a receiver operating curve when the threshold changed from 0 to 1. Accuracy, sensitivity, and specificity were evaluated at a threshold of 0.5. Diagnostic performance of the models was compared with that of urologists as a reader study. Results and limitations: The mean area under the curve of the models reached 0.919, with mean sensitivity of 81.9% and specificity of 85.2% in the test dataset. In the reader study, the mean accuracy, sensitivity, and specificity were, respectively, 83.0%, 80.4%, and 85.6% for the models, and 62.4%, 79.6%, and 45.2% for expert urologists. Limitations include the diagnostic nature of a HL as warranted assertibility. Conclusions: We constructed the first DL system that recognizes HLs with accuracy exceeding that of humans. This AI-driven system assists physicians with proper cystoscopic recognition of a HL. Patient summary: In this diagnostic study, we developed a deep learning system for cystoscopic recognition of Hunner lesions in patients with interstitial cystitis. The mean area under the curve of the constructed system reached 0.919 with mean sensitivity of 81.9% and specificity of 85.2%, demonstrating diagnostic accuracy exceeding that of human expert urologists in detecting Hunner lesions. This deep learning system assists physicians with proper diagnosis of a Hunner lesion.

Comparison of Mirabegron and Vibegron in Women With Treatment-Naive Overactive Bladder: A Randomized Controlled Study.

OBJECTIVE: To compare the efficacy and safety of mirabegron versus vibegron in postmenopausal women with treatment-naïve overactive bladder (OAB). METHODS: We conducted a prospective randomized controlled study of women with treatment-naïve OAB. The patients received mirabegron or vibegron at 50 mg daily for 12 weeks by a stratified randomized method. The OAB symptom score (OABSS) and quality of life (QOL) index were evaluated before and 4 and 12 weeks after the treatment. The patients' 3-day voiding diary and postvoided residual urine volumes were evaluated before and 12 weeks after the treatment. RESULTS: Of 213 patients initially enrolled in this study, 199 patients were randomized to the mirabegron group (n = 97) or vibegron group (n = 102). Twelve weeks after the treatment, OABSS, QOL index, the numbers of micturition, urgency episodes, incontinence episodes, and voided volume per 24 hours were significantly improved compared with the baseline in both groups, and there was no significant difference in the rate of change in both groups. The postvoid residual urine volume was not significantly different in the 2 groups at 12 weeks. Discontinuation because of adverse effects was observed in 6.2% of patients in the mirabegron group and 6.8% in the vibegron group, with no significant difference between 2 groups. CONCLUSION: Both mirabegron at 50 mg and vibegron at 50 mg improved OAB symptoms and the parameters of voiding diary equally in postmenopausal women with treatment naïve OAB.

Does metabolic syndrome influence the efficacy of mirabegron treatment in female patients with overactive bladder?

INTRODUCTION AND HYPOTHESIS: We aimed to determine whether the presence of metabolic syndrome (MS) affects the efficacy of mirabegron in treatment-naïve women with overactive bladder (OAB). METHODS: Women being treated with mirabegron 50 mg were allocated to MS and non-MS groups, and the efficacy of treatment of OAB was compared using the OAB symptom score (OABSS) and a 3-day voiding diary before and 12 weeks after starting treatment. The Wilcoxon signed-rank and Mann-Whitney U tests and multivariate logistic regression were used for statistical analyses, and a p-value < 0.05 was considered to represent statistical significance. RESULTS: Of the 197 patients who completed the trial, 43 (23.9%) had MS. After 12 weeks of mirabegron treatment, both the MS and non-MS groups showed significant improvements in OABSS score, the number of incontinence episodes/24 h, the number of micturition episodes/24 h, and the number of episodes of urgency/24 h. The factors associated with clinically important differences in OABSS were the presence of hyperglycemia (odds ratio 2.43, 95% confidence interval [CI] 1.05-5.60) and OABSS score at baseline (odds ratio 1.23, 95% CI 1.09-1.39). CONCLUSIONS: Mirabegron is effective in patients with and without MS, and comorbid hyperglycemia and severe OAB symptoms before treatment are predictors of the efficacy of mirabegron treatment.

Comparison of full-dose gemcitabine/cisplatin, dose-reduced gemcitabine/cisplatin, and gemcitabine/carboplatin in real-world patients with advanced urothelial carcinoma.

BACKGROUND: While gemcitabine/cisplatin (GC) is the gold standard regimen for patients with advanced urothelial carcinoma (aUC), either dose-reduced GC or gemcitabine/carboplatin (GCa) is an alternative option for "cisplatin-unfit" patients. However, few studies have compared outcomes with these commonly used regimens in the real-world setting. METHODS: We retrospectively reviewed patients with aUC who received full-dose GC, dose-reduced GC, or GCa as first-line salvage chemotherapy at two university hospitals between 2016 and 2020. Progression-free survival, cancer-specific survival, and overall survival, as well as best overall response and adverse event profiles, were compared among these three regimens. RESULTS: Of 105 patients, 41, 27, and 37 patients received full-dose GC, dose-reduced GC, and GCa, respectively. Significant differences were noted in the patients' baseline age, primary site, and renal function among the three regimens. Sixty-nine (65.7%) patients died during a median follow-up period of 14 months. There was no significant difference among the three regimens for all survival outcomes and best overall response. However, the complete response rate of dose-reduced GC (2/27, 7.4%) appeared inferior to that of full-dose GC (9/41, 22.0%) or GCa (6/37, 16.2%). Regarding adverse event profiles, no significant difference was observed among the three regimens, except for significantly fewer cases with elevated alanine aminotransferase in the GCa group compared with the other groups. CONCLUSIONS: This study compared the oncological and toxicological outcomes of full-dose GC, dose-reduced GC, and GCa in real-world patients with aUC. Unlike in the clinical trial setting, there were almost no significant differences among the three regimens.

Comparison of effectiveness between modified transvaginal mesh surgery and vaginal pessary treatment in patients with symptomatic pelvic organ prolapse.

OBJECTIVES: This study aimed to compare the efficacy of modified transvaginal mesh (TVM) surgery and vaginal pessary in patients with symptomatic pelvic organ prolapse (POP). METHODS: We retrospectively analyzed 130 patients with symptomatic POP treated with either modified TVM (n = 62) or vaginal pessary (n = 68). To evaluate the prolapse, lower urinary tract, bowel, and sexual symptoms and prolapse-related quality of life (QOL) were assessed using the prolapse QOL questionnaire. All questionnaires were completed before treatment and 1 year after the treatment. RESULTS: One year after the treatment, the prolapse and voiding symptoms and all prolapse-related QOL domains, except for the personal relationships and sleep/energy, were significantly improved in the pessary group. The prolapse, urinary storage, voiding, bowel, and sexual symptoms and all QOL domains significantly improved in the modified-TVM group. CONCLUSIONS: Both the modified TVM surgery and vaginal pessary effectively treated prolapse and voiding symptoms and improved most of the prolapse-related QOL domains. Modified TVM surgery was more effective in improving urinary storage, bowel, and sexual symptoms than the pessary treatment. Modified TVM seemed to position the organs more correctly to improve bladder, bowel, and sexual function than pessary insertion.

Genomic analysis of circulating tumor cells in adenosquamous carcinoma of the prostate: a case report.

BACKGROUND: Adenosquamous carcinoma of the prostate (ASCP) is an extremely rare and aggressive prostate cancer variant, whose genomic characteristics have not been elucidated. Although liquid biopsy of circulating tumor cells (CTCs) is an emerging topic in oncology, no study has assessed CTCs in patients with ASCP. CASE PRESENTATION: A 76-year-old man presented with discomfort in his urethra. His prostate-specific antigen (PSA) level was 13.37 ng/mL. A computed tomography (CT) scan indicated a prostate mass with multiple lymph node and lung metastases. The patient underwent transurethral resection of the prostate and prostatic needle biopsy; both specimens demonstrated Gleason grade group 5 acinar adenocarcinoma of the prostate. Bone scintigraphy indicated bone metastasis in the ischium. Combined androgen blockade was implemented, and his serum PSA level rapidly decreased to 0.01 ng/mL. However, a CT scan 6 months after the initial diagnosis revealed worsening of the disease. The patient therefore underwent repeated prostatic needle biopsy; its specimen demonstrated prostatic adenocarcinoma together with squamous carcinoma components. As immunohistochemical analyses showed the tumor cells to be negative for CD56, chromogranin A, synaptophysin, and PSA, the definitive diagnosis was ASCP. Although the patient underwent chemotherapy (docetaxel and cabazitaxel), he died of the disease 3 months after the diagnosis of ASCP, or 13 months after the initial diagnosis of prostatic adenocarcinoma. His PSA values remained ≤ 0.2 ng/mL. CTCs from the patient's blood (collected before starting docetaxel) were analyzed and genomically assessed. It showed 5 cytokeratin (CK)+ CTCs, 14 CK- CTCs, and 8 CTC clusters, per 10 mL. Next-generation sequencing identified a total of 14 mutations in 8 oncogenes or tumor suppressor genes: PIK3CB, APC, CDKN2A, PTEN, BRCA2, RB1, TP53, and CDK12. Of 14 mutations, 9 (64%) were detected on CK- CTCs and 5 (36%) were detected on CK+ CTCs. CONCLUSIONS: This is the first report of CTC analysis and genomic assessment in ASCP. Although the prognosis of ASCP is dismal due to lack of effective treatment, genomic analysis of CTCs might lead to effective treatment options and improved survival.

Pigmented median raphe cyst of the penis that developed after middle age without infection or trauma history.

INTRODUCTION: Median raphe cysts are rare benign lesions of the male genitalia that can develop anywhere along the midline from meatus to anus. They are believed to be caused by a defect in closure of median raphe during embryonic development. These cysts commonly appear in childhood or adolescence, although some are diagnosed after middle age, typically triggered by infection or trauma. Pigmented median raphe cysts, or those containing melanin pigment and/or melanocytes, are extremely rare. CASE PRESENTATION: A 78-year-old man visited our hospital with a complaint of a penile mass that he first noticed in his 50s which slowly grew, eventually causing voiding difficulty. He had no history of infection or trauma. The lesion was excised, and the pathological diagnosis was pigmented median raphe cyst. CONCLUSION: We successfully treated a rare case of pigmented median raphe cyst of the penis that developed after middle age without infection or trauma history.

Sex Differences in Prevalence and Patient Behavior Regarding Lower Urinary Tract Symptoms Among Japanese Medical Checkup Examinees.

OBJECTIVES: To evaluate the prevalence of lower urinary tract symptoms (LUTS) and patient behavior regarding LUTS and to reveal sex differences among medical checkup examinees. METHODS: This cross-sectional, community-based study included participants age 40 years and above in Japan who presented for a medical checkup. The study parameters included the International Prostate Symptom Score, International Consultation on Incontinence Questionnaire-Short Form, overactive bladder symptom score, and an original questionnaire regarding patients' distress and behavior with respect to LUTS. RESULTS: Of 1934 residents who presented for a medical checkup, 1582 (81.8%) individuals agreed to participants. Finally, the data of 1256 participants (808 men, 448 women) were analyzed in this study. The overall prevalence of LUTS was similar in both sexes (men 46.8%, women 44.5%; P = .156). Men had a significantly higher prevalence of LUTS than women for voiding and postmicturition symptoms, and a similar prevalence of storage symptoms and overactive bladder. Women had a significantly higher prevalence of urinary incontinence. The rate of distress regarding LUTS and the need to consult a physician were similar in both sexes. However, the consultation rate for LUTS was significantly lower in women than in men (men 38.5%, women 5.3%; P < .001), and women were more likely to restrict their activities owing to LUTS than men (men 13.0%, women 43.6%; P < .001). CONCLUSION: Sufficient education regarding LUTS and providing appropriate medical facilities for consultation are warranted to encourage patients, particularly women, to treat their LUTS.

Effects on Depression and Anxiety After Mid-Urethral Sling Surgery for Female Stress Urinary Incontinence.

PURPOSE: Urinary incontinence (UI) is a common health-related problem in the female population and has a negative impact on many aspects of patients' quality of life including mental problems. This study evaluated the mental effects of mid-urethral sling (MUS) surgery in female patients with stress UI or stress UI-dominant mixed UI. PATIENTS AND METHODS: Women with stress UI or stress UI-dominant mixed UI who underwent MUS surgery and were enrolled in this study and followed up for 12 months. The International Consultation of Incontinence Questionnaire-Short Form (ICIQ-SF) and the Hospital Anxiety and Depression Scale (HADS) at baseline and 12 months after the MUS to evaluate the efficacy of the surgery. RESULTS: At baseline, proportions of the patients with anxiety (HADS-Anxiety score of ≥8) and depression (HADS-Depression score of ≥8) were 21.6% (22/102) and 24.5% (25/102), respectively. At 12 months postoperatively, the median ICIQ-SF score, HADS-Anxiety score, and HADS-Depression score were significantly improved compared with their baseline values (p<0.001 for ICIQ-SF and HADS-Depression, p=0.011 for HADS-Anxiety). At 12 months postoperatively, changes in the ICIQ-SF and HADS-A scores showed a moderate correlation (r = 0.578, p < 0.001), and changes in the ICIQ-SF and HADS-D scores had a strong correlation (r = 0.838, p <0.001). CONCLUSION: This study demonstrated that MUS surgery significantly improved UI, anxiety, and depression with significant correlations in their symptoms. This suggests that improvement of the patients' UI helped to relieve their symptoms of anxiety and depression.

Prognostic significance of the albumin-to-globulin ratio for upper tract urothelial carcinoma.

BACKGROUND: Although the albumin-to-globulin ratio (AGR) is a promising biomarker for various malignancies, few studies have investigated its prognostic significance for upper tract urothelial carcinoma (UTUC). METHODS: This retrospective study conformed to the REporting recommendations for tumour MARKer prognostic studies (REMARK) guideline. We reviewed 179 patients with UTUC who underwent radical nephroureterectomy at our institution between 2008 and 2018. Associations of preoperative clinicopathological factors, including the AGR, with cancer-specific survival (CSS) and overall survival (OS) were assessed. The Cox proportional hazards model was used for univariate and multivariable analyses. AGR was dichotomized as < 1.25 and ≥ 1.25, according to the most discriminatory cutoff determined from the receiver operating characteristic curve analysis. RESULTS: During a median follow-up of 34 months after surgery, 37 patients died from UTUC and 13 died of other causes. The preoperative AGR significantly correlated with pathological T stage, pathological N stage, and adjuvant chemotherapy. Multivariate analyses demonstrated that a decreased (< 1.25) preoperative AGR was an independent poor prognostic factor for both CSS (hazard ratio [HR] = 2.81, P <  0.01) and OS (HR = 2.09, P <  0.05). CONCLUSIONS: Preoperative AGR < 1.25 might serve as a useful prognostic marker for patients with UTUC undergoing radical nephroureterectomy.

An evaluation of the impact of post-hysterectomy vesicovaginal fistula repair on the mental health of patients in a developed country.

INTRODUCTION AND HYPOTHESIS: Obstetric vesicovaginal fistulae (VVFs) occur frequently as a result of childbirth in developing countries, but occurrence of VVFs in developed countries is rare and is generally observed after hysterectomy. Moreover, there are no reports regarding the effect of post-hysterectomy VVF repair on the patients' mental health in developed countries. Our study aimed to confirm the effect of post-hysterectomy VVF repair on Japanese iatrogenic VVF patients' mental health. METHODS: A retrospective chart review was performed for 31 patients who underwent post-hysterectomy VVF repair. Each patient's urinary incontinence and mental state were evaluated using two questionnaires, the International Consultation on Incontinence Questionnaire-Short Form and the Hospital Anxiety and Depression Scale questionnaires, respectively, at baseline and at 3 or 6 months post-surgery. The Wilcoxon signed-rank test was used to compare the pre- and post-repair scores of each questionnaire, while McNemar's test was used to compare the pre- and post-repair proportions of patients with anxiety and depression. RESULTS: Of the 31 patients, 13 (41.9%) underwent hysterectomy because of malignancies. All questionnaire scores showed significant improvement after VVF repair. The prevalence of clinical anxiety and depression decreased from 51.6% to 16.1% (P < 0.01) and from 51.6% to 12.9% (P < 0.01), respectively, after VVF repair, and urine leakage through fistulae was not observed in any patient after VVF repair. CONCLUSIONS: Our results suggest that iatrogenic VVF can have severe impacts on patients' mental health, but VVF repair can significantly improve it.

Effects of Mirabegron on Anxiety and Depression in Female Patients with Overactive Bladder.

BACKGROUND: Treatment of overactive bladder (OAB) with antimuscarinic agents has been shown to improve depression and/or anxiety symptoms. OBJECTIVES: The aim of this study was to evaluate the efficacy of mirabegron on OAB symptoms and its effects on depression and/or anxiety of treatment-naïve women with OAB. METHODS: Women treated with mirabegron were prospectively evaluated by the OAB symptom score and hospital anxiety and depression Scale before and at 4 and 8 weeks after treatment. Wilcoxon signed-rank and Spearman rank correlation coefficient were used for statistical analyses, and a p value of < 0.05 was considered as significant. RESULTS: Of the 112 patients who were enrolled, 25.0% had been previously diagnosed as having clinical anxiety and 22.3% as having clinical depression. The OAB, anxiety, and depression symptom scores were significantly improved at both 4 and 8 weeks (p < 0.05). Anxiety, but not depression, symptoms were significantly correlated with OAB symptoms. CONCLUSION: Improvement of OAB symptoms helps relieve anxiety, but not depression.

Acute hypotension induced by suction of cystic fluid containing extremely high concentrations of catecholamines during resection of giant pheochromocytoma.

INTRODUCTION: Since pheochromocytomas present with various complications due to catecholamine hypersecretion, their perioperative management needs special attention. CASE PRESENTATION: A 45-year-old man visited our hospital with a complaint of abdominal swelling. Radiological and endocrinological assessments determined the tumor as a giant (>20 cm) cystic pheochromocytoma. After administration of doxazosin, the patient underwent radical surgery. Since the tumor was extremely large and fixed to surrounding structures, we punctured it and aspirated cystic fluid to improve the tumor's mobility. However, during the aspiration, the patient developed acute hypotension, which could be reversed by suction withdrawal and vasopressor administration. A similar event occurred during a second aspiration. Eventually, the tumor was successfully excised with negative surgical margin. The cystic fluid proved to contain extremely high concentrations of catecholamines, which might result in the hypotension. CONCLUSION: We report the first case who developed acute hypotension due to aspiration of cystic fluid from giant pheochromocytoma.

Sexual activity and quality of life in Japanese pelvic organ prolapse patients after transvaginal mesh surgery.

AIM: This study aimed to evaluate sexual activity and quality of life (QOL) after transvaginal mesh (TVM) surgery in Japanese patients with pelvic organ prolapse (POP). The objective cure rate and associated complications were also investigated. METHODS: The cases of patients who underwent TVM surgery were retrospectively analyzed. QOL was assessed using the Prolapse Quality of Life Questionnaire (P-QOL), and sexual function was evaluated using the Female Sexual Function Index (FSFI) before surgery and 12 months after surgery. RESULTS: A total of 237 patients completed the planned follow-up examinations. All P-QOL domains were significantly improved after surgery. In total, 6 (2.5%), 5 (2.1%), 13 (5.5%), 4 (1.7%) and 1 (0.4%) patients developed recurrent POP, mesh extrusion, de novo stress urinary incontinence, inguinal pain and de novo dyspareunia, respectively. Before surgery, 124 of the 237 patients (52.3%) refused to complete the FSFI because they had not engaged in any sexual activity. Among the 113 patients who completed the FSFI, 13 (11.5%) were sexually active. After surgery, 79 patients completed the FSFI, and 14 (17.7%) were sexually active. The overall scores for sexual function and arousal were significantly improved after surgery. CONCLUSION: Patients who underwent TVM surgery at our institution exhibited quite low sexual activity levels both before and after the operation. But TVM surgery achieved good QOL outcomes, a high success rate and a low complications rate at 12 months in Japanese POP patients. TVM implantation for POP is safe and effective in sexually inactive patients.

Long-term Persistence with Mirabegron versus Solifenacin in Women with Overactive Bladder: Prospective, Randomized Trial.

OBJECTIVES: To compare persistence with medication and the reasons for discontinuation of mirabegron or solifenacin therapy up to12 months in women with overactive bladder (OAB). METHODS: Female OAB patients who presented to women's urology clinics were enrolled in a prospective, randomized, two-arm study. Patients were randomized to receive mirabegron at 25-50 mg (n = 76) or solifenacin at 2.5-5 mg (n = 72). The persistence rate and the reasons for discontinuation were investigated up to 12 months. RESULTS: The 12-month persistence rate was 12.2% in the mirabegron group versus 20.1% in the solifenacin group and there were no significant differences of the persistence rates during the study (n.s). Patients discontinued treatment because of lack of efficacy (21.6%), spontaneous improvement (18.2%), and side-effects (17.6%), while 19.6% were lost to follow up. Discontinuation due to side-effects was significantly more frequent in the solifenacin group than the mirabegron group (27.3 vs. 7.9%, P < 0.05). In contrast, discontinuation due to lack of efficacy was significantly more frequent in the mirabegron group than the solifenacin group (36.8 vs. 5.6%, P < 0.05). CONCLUSIONS: This study demonstrated low persistence rates over 12 months for both mirabegron and solifenacin, although the reasons for discontinuation were somewhat different.

[The User Fact-Finding on the Electric Warm-Water Lavage Toilet Seats in the Women Consulting Our Urological Outpatient Clinic].

We conducted our original self-completed questionnaire survey on a total of 305 women who came to our urology department as an outpatient from March 2014 to September 2014. They were asked to fill in the questionnaire on their experience of usage as well as how and where they were using the washing function of the toilet seat. The effective response rate was 95.4%. Seventy-nine (230) individuals were using the warm-water washing toilet seat. There was no significant difference in age between the usage group and the non-use group. The purposes of use after defection, for defecation induction, and after urination were 90.4, 41.3, and 40.4%, respectively. Regarding the kinds of washing, a strong tendency for the use of the anal washing function to induce defection and after defection was observed, whereas a tendency was observed for the use of the bidet function after urination and for washing the vagina. Since many individuals were using the washing function for the purpose of inducing defection and after urination, which were not functions assumed appropriate by the manufacturer, it was considered necessary to discuss the appropriate usage from the standpoint of an urologist.

Reinforcement of suspensory ligaments under local anesthesia cures pelvic organ prolapse: 12-month results.

INTRODUCTION AND HYPOTHESIS: In 2005, a new minimally invasive procedure, the tissue fixation system (TFS) was reported. Like TVT (tension-free vaginal tape), the TFS works by creating a foreign body collagenous tissue reaction that reinforces a weakened pelvic ligament. The objective was to assess the effectiveness and perioperative safety of TFS in a day surgery clinic for the treatment of pelvic organ prolapse (POP). METHODS: The TFS tape was applied in a tunnel adjacent to natural ligaments to repair the anterior cervical ring and cardinal ligament, paravaginal tissues and uterosacral ligaments under local anesthesia/sedation. We prospectively studied 60 patients, mean age 67, between October 2008 and February 2010 at Women's Clinic LUNA. Levels of POP were grade 2 (n = 20; 7 %), grade 3 (n = 30; 55 %), and grade 4 (n = 4; 7 %) according to the ICS POPQ classification. Fifty-four patients (90 %) who underwent a total of 162 POP operations presented for review. Follow-up was performed at 12 months. We defined surgical failure according to the ICS POPQ classification. We used prolapse quality of life (P-QOL) questions for QOL measurement. RESULTS: Ninety-eight percent of patients were discharged on the day of surgery. Of the 162 TFS operations reviewed, 157 were successful and 5 failed. The 5 failed operations comprised 4 cystoceles and 1 rectocele. Two patients developed cervical protrusions at the introitus at 6 months with no prolapse of the uterine body. We found 5 cases of erosion in 162 tape insertions. The total number of patients who had no complications, no surgical failures, no erosions, no sensation of bulging, and no cervical protrusions was 47 (87 %). CONCLUSIONS: The TFS uses the same surgical principle for repair as the TVT; this principle vastly minimizes the volume of mesh used, erosions, and other complications.

Laxity of the vaginal introitus after childbirth: nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-energy radiofrequency thermal therapy.

INTRODUCTION: Vaginal childbirth may result in vaginal introital laxity, altered genital sensation during sexual intercourse, and reduced sexual satisfaction. We report the long-term effectiveness of a single nonsurgical procedure with radiofrequency (RF) energy for laxity at the vaginal introitus. MATERIALS AND METHODS: Prospective single-arm study of 30 premenopausal women (21-52 year) with one 30-minute office procedure using RF applied to the vaginal introitus; 12-month outcome assessments included the linguistic validated Japanese versions of the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) and the Vaginal Laxity and Sexual Satisfaction Questionnaires. RESULTS: Sexual function improved significantly throughout 6 months (30 subjects); mean FSFI total score was 22.4±6.7 before treatment and then improved to mean 26.0±5.8 at month 6 (P=0.002), inclusive of improved scores in five of six FSFI domains except desire (P<0.001 -<0.01). In the 22 of 30 subjects remaining evaluable at 12 months, the mean was 26.0±5.2 (P=0.08). Distress related to sexual activity decreased significantly; baseline FSDS-R mean score of 15.8±11.7 improved to 9.8±8.0 at one month and was sustained throughout 12 months (P<0.001 - 0.002). Subjects reported decreased vaginal laxity within the first month after the procedure (P<0.001); responses peaked, and effectiveness was sustained through 12 months (P<0.001). CONCLUSIONS: A single nonsurgical office-based RF procedure for vaginal introital laxity achieved significant and sustainable 12-month effectiveness with respect to improved integrity at the vaginal introitus and improved sexual satisfaction. Treatment was well-tolerated with no adverse events.