TVT versus laparoscopic mesh colposuspension: 5-year follow-up results of a randomized clinical trial.

INTRODUCTION AND HYPOTHESIS: Before the introduction of the tension-free vaginal tape (TVT) procedure for the treatment of female stress urinary incontinence, the colposuspension operation was regarded as the "gold standard" procedure. The laparoscopic variant of the colposuspension was introduced as a less invasive operation. The aim of the present trial was to compare the new minimally invasive TVT procedure with laparoscopic mesh colposuspension (LCM). METHODS: A multicenter randomized clinical trial conducted in six public hospitals in Finland including primary cases of stress incontinence. Objective treatment success criteria were a negative stress test and no retreatment for stress incontinence. Patient satisfaction was assessed by Patients Global Impression of Improvement, a visual analog scale, and the Urinary Incontinence Severity Score. RESULTS: Of 128 randomized patients, 121 underwent the allocated operation. At the 5-year follow-up 77 % in the TVT group and 84 % in the LCM group could be assessed according to the protocol. The objective cure rate was significantly higher in the TVT group (94 %) than in the LCM group (78 %). Subjective treatment satisfaction (completely satisfied with the procedure) was significantly higher in the TVT group (64 %) than in the LCM group (51 %). CONCLUSIONS: By per protocol analysis both objective and subjective cure rates were significantly higher in the TVT group than in the LCM group. If cases that were lost to follow-up were regarded as failures, the intension-to-treat analysis found no difference between the groups.

Seventeen years' follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The minimally invasive tension-free vaginal tape (TVT) operation has become the "gold standard" of incontinence surgery. The aim of the present study was to evaluate the long-term effect of the tape material and to assess the continence status 17 years after surgery METHODS: A cohort of 90 women operated upon with the TVT procedure at three Nordic centers has been prospectively followed for 17 years. All of the women alive according to national registries were contacted and invited to visit the clinics for evaluation. Pelvic examination was performed to reveal any adverse effects of the tape material. Objective and subjective continence status were assessed by a cough stress test and the patients' global impression of improvement as well as by condition-specific quality of life questionnaires. RESULTS: Seventy-eight percent of the potentially assessable women were evaluated either by a clinic visit or by a telephone interview. One case of a minimal, symptom-free tape extrusion was seen. No other tape complications occurred. Over 90 % of the women were objectively continent. Eighty-seven per cent were subjectively cured or significantly improved. CONCLUSION: The TVT operation is durable for 17 years, with a high satisfaction rate and no serious long-term tape-induced adverse effects.

Effectiveness of the TVT procedure as a repeat mid-urethra operation for treatment of stress incontinence.

UNLABELLED: INTRODUCTION AND HYPOTHESES: The aim was to evaluate the long-term (5 years) effect of performing a retropubic tension-free vaginal tape (TVT) operation after a prior failed mid-urethra sling procedure and try to identify reasons for failure of the primary operation. METHODS: We identified 26 women to whom a repeat mid-urethra sling procedure (using the TVT Gynecare device) had been performed. Both the primary and repeat operations were retropubic procedures. Four different tape materials had been utilized in the primary procedure. RESULTS: Twenty women (77%) of the identified 26 women participated in the study. Seventy-five percent of the women were cured or significantly improved after the repeat TVT procedure. Reasons for failure of the primary procedure were grouped as follows: inadequate tape material (four out of 20), inadequate surgical technique (six out of 20), patients' medical condition (four out of 20), and unrecognized reasons (six out of 20). CONCLUSIONS: A retropubic mid-urethra sling operation can be considered after failed mid-urethra sling surgery.

Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence.

The aim of this study was to evaluate the long-term effectiveness and safety of the tension-free vaginal tape (TVT) procedure. In a Nordic three-center prospective observational cohort study, 90 women with primary stress incontinence had a TVT operation performed in local anesthesia. Assessment included a 24-h pad test, a stress test, physical examination, and a visual analog scale for assessing the degree of bother. Patient's global impression of cure was obtained, and condition specific quality of life questionnaires were used. Seventy-seven percent of the initial cohort of 90 women and 89% of those alive and capable of cooperating were assessed 11.5 years after the TVT operation. Ninety percent of the women had both a negative stress test and a negative pad test being objectively cured. Subjective cure by patients global impression was found in 77%, 20% being improved and only 3% regarded the operation as a failure. No late-onset adverse effects of the operation were found, and no case of tape erosion was seen. The TVT procedure is safe and effective for more than 10 years.

Nicotinamide does not influence cytokines or exhaled NO in human experimental endotoxaemia.

This study examined the hypothesis that nicotinamide could attenuate endotoxin-induced inflammatory responses in humans as indicated by levels of cytokines and nitric oxide. Ten healthy male volunteers participated in a randomised, double-blind, cross-over design with regard to the effects of nicotinamide. The volunteers received orally 4 g nicotinamide or placebo at 14 h and at 2 h preceding the experiment (total dose of 8 g). Endotoxin (E. coli, 2 ng/kg), was administered intravenously. Blood samples and haemodynamic data were collected prior to and up to 6 h after the endotoxin infusion. Orally exhaled NO was measured hourly. Following endotoxin, body temperature increased from baseline 36.3 +/- 0.09 degrees C to a maximum of 38.0 +/- 0.1 degrees C for all (mean +/- SEM, P < 0.001) and heart rate increased from 59 +/- 1.9 to 87.0 +/- 2.6 beats/min after 3 h (mean +/- SEM, P < 0.001). Endotoxin challenge also markedly elevated the TNF-alpha, IL-6, IL-8 and IL-10 concentrations (P < 0.001 versus baseline for all) during the study period. Orally exhaled NO also increased (P < 0.01) compared to baseline. Nicotinamide treatment did not influence the patterns of cytokine and NO response to endotoxin. In conclusion, there was no effect on the inflammatory parameters by oral nicotinamide at a dose of 8 g, limiting the potential use of this agent for anti-inflammatory purpose in man.

A double-blind placebo-controlled study of the effects of amphetamine and physiotherapy after stroke.

Major therapeutic advances in the rehabilitation of subacute stroke are lacking. One promising approach is treatment with amphetamine in combination with physiotherapy so as to promote motor function. In a randomized, double-blind, placebo-controlled clinical trial, the effect of 10 sessions with 10 mg of amphetamine combined with physiotherapy during a 5-week period was investigated in 39 geriatric patients who had been admitted to a stroke rehabilitation unit. Motor function (Fugl-Meyer motor performance score) and activities of daily living (ADL; Barthel's index) were assessed at baseline and at the end of treatment. All patients improved significantly over the intervention period. Amphetamine-treated patients did not show any increase in motor function or ADL as compared to the control group. Rehabilitation with amphetamine at this dosage and interval, combined with physiotherapy, did not promote motor recovery or functional capacity in patients suffering from stroke.

Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence.

In a prospective long-term Nordic multicenter study, 90 consecutive patients who had a tension-free vaginal tape (TVT) operation performed because of stress urinary incontinence were evaluated according to a strict protocol after approximately 5 years (range 48-70 months). Eighty-five patients could be evaluated according to the protocol. Another 5 elderly patients had to be interviewed by telephone at the final check-up after 5 years. The study protocol involved pre- and postoperative objective and subjective evaluation. The median follow-up time was 56 months. Seventy-two of the 85 patients who were fully evaluated (84.7%) were both objectively and subjectively completely cured. Another 9 patients (10.6%) were significantly improved and 4 (4.7%) were regarded as failures. No patient complained of long-term voiding difficulties and there were no signs of defective healing or rejection of the tape material. All patients had suffered from primary stress incontinence, and 25 also had preoperative complaints of urge. In 14 of these (56%) the urge symptoms were relieved postoperatively. We conclude that the TVT procedure seems to fulfil the expectations of high long-term cure rates, as suggested in previous short-term reports.

Transdermal oestrogen therapy protects postmenopausal liver transplant women from osteoporosis. A 2-year follow-up study.

BACKGROUND/AIMS: Hormone replacement therapy (HRT) prevents osteoporosis in postmenopausal women by inhibiting bone resorption, but the benefits of oestrogen therapy in liver transplant patients have not been studied. METHODS: The effect of transdermal HRT was studied in 33 postmenopausal liver transplant women. The main outcome measure was the change in bone mineral density (BMD) which was measured annually for 2 years. The effect on bone turnover was studied by assessment of the serum aminoterminal propeptide of type I procollagen (PINP). RESULTS: The mean lumbar BMD increased from 0.816 at baseline to 0.858 and to 0.878 g/cm2 (P < 0.001) after 1 and 2 years of therapy, respectively. The BMD of the femoral neck increased from 0.665 to 0.690 g/cm2 (P < 0.006). During the first and second years, the mean BMD of the lumbar spine increased by 5.3 and 1.2%, while that of the femoral neck increased by 3.3 and 1.2%. After 2 years of HRT, only one-fifth of the patients had osteoporosis, whereas over half of the women had osteoporosis at baseline. The median serum PINP decreased by 47% at 1 year and remained decreased at 2 years compared with baseline levels. CONCLUSION: Transdermal HRT decreased the turnover rate of mineralized bone matrix. Transplant women responded with increased BMD, just like healthy postmenopausal women.

The tension-free vaginal tape procedure is successful in the majority of women with indications for surgical treatment of urinary stress incontinence.

OBJECTIVES: To evaluate the effectiveness and safety of the ambulatory, minimally invasive tension-free vaginal tape procedure in women scheduled for incontinence surgery. DESIGN: A prospective open study with a standardised protocol for pre- and post-operative evaluation. PARTICIPANTS: One hundred and sixty-one consecutive women with urodynamically proven stress incontinence. The mean age was 56 years; 45 women (28%) had recurrent incontinence, 59 women (37%) had mixed incontinence and 18 women (11%) had a low pressure urethra. MAIN OUTCOME MEASURES: Subjective and objective cure rates, complications and length of hospital stay. RESULTS: The average follow up time was 16 months. Ninety-four percent of the treated women were completely cured or significantly improved. Eighty percent of the women were released from hospital on the afternoon of the day of surgery. There were no major complications and 80.2% of the women had no complication at all. Seven women (4.3%) had no more than four days of urinary retention problems, five women (3.1%) developed de novo urge symptoms, ten women (6.1%) had urinary tract infection, six cases (3.7%) of intraoperative bladder perforation occurred and less than 3% had bleeding or infection problems. There was no difference in the cure rate between women suffering from primary, recurrent or mixed incontinence. CONCLUSIONS: The tension-free vaginal tape operation is an effective and safe procedure for treatment of most cases of female urinary stress incontinence. The operation can be performed as an ambulatory procedure because of the low risk of post-operative morbidity.

Effectiveness of the conveen continence guard (a disposable vaginal device) in the treatment of complicated female stress incontinence.

BACKGROUND: Treatment alternatives for women with stress urinary incontinence, complicated by prior unsuccessful surgery or concomitant diseases that prevent surgical intervention are limited. The aim of this study was to investigate the usefulness and effectiveness of a disposable vaginal device, the Conveen Continence Guard, in cases where surgery was not recommended for treatment of stress urinary incontinence. METHODS: Twenty-eight women, with a urodynamically proven stress urinary incontinence, were offered the use of a vaginal device during a prospective three-week treatment period. Objective and subjective prevention of urinary leakage was assessed by a 24-h pad-weighing test, by a visual analog scale and a quality of life questionnaire. At the end of the treatment period the women answered a questionnaire on the ease and comfort of use of the device. RESULTS: Of the nineteen women who completed the study, 89.5% were cured or improved according to subjective assessments, the respective figure being 84.2% according to objective assessment. CONCLUSION: The Conveen Continence Guard seems to be a promising treatment alternative for women for whom other treatment methods have failed. The device was well tolerated by the women and was regarded easy to use.

Serum and follicular fluid leptin during in vitro fertilization: relationship among leptin increase, body fat mass, and reduced ovarian response.

The satiety factor leptin is expressed in several reproductive tissues, but its role in the control of reproductive physiology is not well understood. We studied leptin concentrations in the sera and follicle fluids of 52 women [body fat mass percentage (BFM%) range, 19.6-38.8%] undergoing pituitary down-regulation and ovarian hyperstimulation for in vitro fertilization (IVF) treatment. Fasting serum samples were collected 1) at maximal suppression before the initiation of gonadotropin treatment, 2) at maximal ovarian hyperstimulation, 3) at the time of oocyte retrieval, and 4) 16 days later when all subjects were under exogenous luteal support using 600 mg progesterone daily. Follicular fluid (FF) was obtained at oocyte retrieval from two representative preovulatory follicles in both ovaries. During ovarian hyperstimulation there was a significant 60% increase in serum leptin concentrations from 10.9 +/- 1.1 (SEM) to 15.7 +/- 1.5 ng/mL (P < 0.01) between suppression and maximal hyperstimulation, demonstrating that the ovarian functional state can affect serum leptin concentrations. A serum leptin increase of 22-198% during ovarian hyperstimulation was evident in 43 subjects, whereas in 9, leptin concentrations remained unchanged. A positive correlation between leptin change and BFM% (r = 0.55; P < 0.0005) was observed in the 43 leptin responders. The follicular fluid leptin level was similar to that in serum. In separate linear regression analysis, BFM% contributed to 59-64%, body mass index to 46-56%, and weight to 46-55% (all P < 0.001) of the variability in leptin concentrations at the 4 time points. The 20-fold increase in serum estradiol concentrations during IVF was not significantly correlated with changes in leptin concentrations. On the contrary, the relative serum leptin increase was negatively associated with the ovarian response to hyperstimulation, as revealed by the numbers of follicles (b = -0.28; r2 = 8.1%; P < 0.05) and oocytes retrieved (b = -0.39; r2 = 15.2%; P < 0.01). This relationship was further reflected in a positive correlation between the percent increases in leptin and FSH concentrations (r = 0.39; P < 0.01). The significant relationship of high leptin and reduced ovarian response was also maintained when the cumulative dose of FSH was used as a covariable. Reduced ovarian response was not a function of body mass index, BFM%, basal leptin levels, or insulin concentrations. Fasting serum insulin concentrations remained unchanged in response to IVF, but were positively correlated to serum leptin concentrations at all four time points. Our data suggest that leptin production may be influenced by the ovarian functional state. During IVF a high relative leptin increase is associated with adiposity and a reduced ovarian response. These observations support the possibility that high leptin concentrations might reduce ovarian responsiveness to gonadotropins. Hence, leptin might explain in part why obese individuals require higher amounts of gonadotropins than lean subjects to achieve ovarian hyperstimulation.

Chronic fatigue syndrome differs from fibromyalgia. No evidence for elevated substance P levels in cerebrospinal fluid of patients with chronic fatigue syndrome.

Levels of substance P were determined in the cerebrospinal fluid (CSF) in 15 patients with chronic fatigue syndrome (CFS). All values were within normal range. This is in contrast to fibromyalgia (FM). The majority of patients with FM have increased substance P values in the CSF. The results support the notion that FM and CFS are different disorders in spite of overlapping symptomatology.

A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence.

The aim of the study was to evaluate the safety and efficacy of TVT (tension-free vaginal tape) for the surgical treatment of stress urinary incontinence. The design was a prospective open multicenter study including six centers, each operating an approximately 20 patients. In total 131 patients suffering from genuine stress incontinence were included. They were followed for at least 1 year using a specific protocol for objective and subjective evaluation of the outcome. All patients underwent the operation under local anesthesia. Mean operation time was 28 minutes (range 19-41 minutes); 119 (91%) of the patients were cured according to the protocol and another 9 (7%) were significantly improved. There were 3 (2%) failures. The majority of the patients (about 90%) were operated upon on a day-care basis, which implied that they were released from the hospital within 24 hours, with no postoperative catheterization. No defect healing and no tape rejection occurred. Three patients needed an indwelling catheter for 3 days. In 1 patient catheterization was necessary for more than 10 days. Two uncomplicated hematomas and one uncomplicated bladder perforation occurred. Based on the results, we conclude that TVT is a safe and effective ambulatory procedure for surgical treatment of genuine stress urinary incontinence.

Aspects on the actual practice of surgical management of urinary incontinence in Norway and Finland.

OBJECTIVE: To elucidate aspects of the actual practice of surgical management of urinary incontinence in Norway and Finland. METHOD: A questionnaire about preoperative diagnostic procedures, type of surgery, follow-up procedure and number of operations per center and per surgeon per year (1995) was sent to all departments of Gynecology and Obstetrics in Norway and Finland. RESULT: Thirty-one (86%) of the Norwegian and 26 (90%) of the Finnish departments returned the questionnaire. More than 90% of the departments performed preoperative urodynamic evaluation. Burch colposuspension was used by more than 90% of the departments in the two countries. Generally the number of procedures per center and per department was low. Twenty-nine and 12% of the departments respectively did not perform any follow-up after surgery. Only 16% of the Norwegian and 23% of the Finnish centers had controlled results of surgery. CONCLUSION: There seems to be a need for criteria of good clinical practice or a reference program for all steps of surgical management of stress incontinence in order to stimulate the process of quality development of this treatment.

The tensionfree vaginal tape procedure (TVT) for treatment of female urinary incontinence. A minimal invasive surgical procedure.

BACKGROUND: To test the suitability of a new surgical procedure for treatment of female urinary incontinence to be used as an ambulatory and minimal invasive operation. METHODS: Thirty-one consecutive patients with urodynamically proven stress incontinence had a tensionfree vaginal tape procedure performed. Operation time, the amount of anesthetics and analgetics used, postoperative mobilization, voiding patterns, residual urine volumes, per- and postoperative complications, hospital stay and need for sick leave were prospectively recorded. RESULTS: All 31 patients were cured from stress incontinence. Local anesthesia was used in all cases and additional analgetics were needed in only small doses. Seventy per cent of the patients were released from the hospital on the same day of the operation. By medical criteria 90% could have been released on the same day. No significant per- or postoperative complications occurred. Three patients needed postoperative catheterization. All but one patient was able to empty her bladder within 24 hours from the operation. An average of 15 days sick leave was prescribed. CONCLUSION: The tensionfree vaginal tape procedure seems to fulfil the criteria for being regarded as a minimal invasive surgical procedure for treatment of female urinary stress incontinence. It is highly effective and is associated with very few intra and postoperative side effects.

Safety and efficacy of transdermal estradiol replacement therapy in postmenopausal liver transplanted women. A preliminary report.

OBJECTIVE: To determine the safety and efficacy of transdermal estrogen replacement therapy in liver transplanted menopausal women. SUBJECTS: Thirty-two menopausal women who had at least 6 months earlier undergone liver transplantation, ages from 46-70 years old receiving hormone replacement therapy. METHODS: The study was an open prospective. The subjects received transdermal estradiol replacement therapy in combination with progestin (EstracombR-Ciba, 50 microg/24 h, 250 microg/24 h) if the uterus was intact, and estradiol alone (EstradermR-Ciba, 50 microg) if the uterus had been removed. The follow-up time was 6 months. Liver function parameters and hemostatic parameters were measured at 0, 3 and 6 months. Gynecological transvaginal ultrasound (TVS) was performed at 0 and 6 months. The efficacy of the hormonal treatment was assessed by measuring serum concentrations of estradiol, estrone, FSH, LH and SHBG, by measuring endometrial thickness with TVS and by recording changes in subjective climacteric symptoms at 0 and 6 months. Safety was assessed by measuring liver enzyme activity, liver synthesis functions and coagulation factors. RESULTS: Estrogen replacement therapy did not impair any of the liver parameters measured and no thrombotic effect could be detected. Hormonal effects of the regimen prescribed could be verified both biochemically, clinically and by TVS. CONCLUSION: A clinically desired hormonal effect was achieved by the dose of 50 microg estradiol-17beta. Liver function and hemostatic balance were unaffected by the transdermal hormonal treatment. Immunosuppressive drugs and transdermal estrogen may well be combined.