MECHANISM OF EJECTION DURING EJACULATION: IDENTIFICATION OF A URETHROCAVERNOSUS REFLEX

The ejaculatory mechanism involves 2 reflexes: the "glans-vasal", which seems to bring the semen to the posterior urethra (emission phase of ejaculation), and the "urethromuscular" which ejects it to the exterior (ejection phase). This study investigated the mechanism of bulbocavernosus muscle (BCM) contraction, once the seminal fluid reaches the bulbous urethra. The study included 14 healthy male volunteers (mean age 37 +/- 10.2 SD years). To test the response of the BCM to urethral distension, a 10F balloon-tipped catheter was introduced into the prostatic urethra and filled with saline in increments of 0.25 mL; a needle electrode recorded the response. The balloon was then withdrawn to lie in the membranous, bulbous, and pendulous urethra and the test was repeated at each site. The latency of the muscle response was calculated. The BCM response to each of the anesthetized bulbous urethra and anesthetized BCM was recorded. Distension of the prostatic, membraneous, or pendulous urethra effected no BCM EMG response. Bulbous urethral distension with 0.25 mL of saline also produced no muscle response, whereas distension with 0.5 mL and up to 1.5 mL caused increased EMG activity of the BCM. The muscle response augmented with the increase of the distending volume. The mean latency was 10 +/- 1.3 ms and showed no significant change (p >. 05) with the different distending volumes. Neither the anesthetized bulbous urethra nor the anesthetized BCM responded to bulbous urethral distension. The BCM contraction upon distension of the bulbous urethra is probably reflex and mediated through the urethrocavernosus reflex. Small-volume distension did not effect BCM contraction. The latter presumably propels the semen from the posterior to the pendulous urethra. It is suggested that the urethrocavernosus reflex be included in current andrologic investigations for patients with ejaculatory disorders.     

男性尿道损伤早期手术方式的选择

目的探索男性尿道损伤早期最佳治疗方法。方法回顾性分析60例男性尿道损伤早期处理,球部尿道部分损伤15例,留置尿管3w治愈。球部尿道完全断裂45例,20例行Ⅰ期尿道吻合术,10例膀胱造瘘,15例行尿道会师术。结果球部尿道部分损伤患者20.0%(3/15)有轻度尿道狭窄,无阳痿发生。单纯膀胱造瘘术后尿道狭窄的发生率为100.0%,阳萎的发生率为40.0%(4/10);尿道会师及牵引术后尿道狭窄的发生率为80.0%(12/15),阳萎的发生率为26.7%(4/15);早期经会阴部Ⅰ期尿道吻合术后尿道狭窄的发生率为15.0%(3/20),阳萎的发生率为35.0%(7/20)。结论尿道部分损伤患者停留尿管效果满意;球部尿道断裂Ⅰ期尿道吻合术疗效良好,尿道会师术创伤小,如病情重则可先行单纯膀胱造瘘术。     

A comparison of Nocturnal Penile Tumescence and penile response to erotic stimulation during waking states in comprehensively diagnosed groups of males experiencing erectile difficulties

The erectile responses of 13 nondysfunctional males and 48 dysfunctional males were compared during Nocturnal Penile Tumescence (NPT) and during exposure to erotic videotapes. The results showed distinct patterns of NPT and daytime responding that could differentiate the various subgroups: those displaying (i) no dysfunction; (ii) vasculogenic erectile dysfunction; (iii) high risk for erectile dysfunction (organic and psychogenic); (iv) psychogenic dysfunction; reactive to erotica; and (v) psychogenic dysfunction; nonreactive to erotica. Subjects participating in this study underwent a comprehensive medical and psychological screening to place them in each subgroup. The penile circumference response to erotic stimuli used in conjunction with NPT response appeared useful in differentiating subgroups of erectile dysfunction and suggested the need for further diagnostic refinement in this area. The majority of vasculogenic dysfunctional subjects experienced greater erection responses during exposure to erotic stimulation than during NPT; several of these subjects achieved almost full erections in waking states but were practically flaccid at night. The discussion covers diagnostic and therapeutic implications.     

Nd:YAG激光治疗尿道狭窄

目的探讨激光治疗尿道狭窄的方法及疗效。方法对不完全性尿道闭锁者先导入输尿管导管,用Nd:YAG接触式激光汽化切割尿道瘢痕组织,对于闭锁段<1cm尿道完全闭锁者,用接触式激光沿尿道正道同一轴线方向打通尿道,再切割瘢痕组织;若闭锁段>1cm,则沿造瘘口下缘切开2 cm,左手食指伸入直肠内引导尿道探子紧贴耻骨下缘钻通闭锁段尿道,助手以手指经瘘口伸入后尿道协助引导尿道探子尖端进入膀胱,依次扩张尿道至24F,再用接触式激光汽化切除瘢痕组织,术后定期尿道扩张,分别于术后3、6、12个月随访。结果全部病例排尿顺畅,术后1 年IPSS评分平均减少20．5分,生活质量评分减少3．8分,最大尿流率增加10.6 ml／s,剩余尿量减少 258．8 ml。与术前比较,差异有统计学意义(P<0．01)。结论经尿道Nd:YAG激光切除尿道瘢痕结合术后尿道扩张治疗尿道狭窄,是治疗尿道狭窄较好的方法。     

产后压力性尿失禁的腹压漏尿点压及对应的超声参数研究

目的探讨产后压力性尿失禁(SUI)女性的前盆腔结构改变及不同腹压漏尿点压(ALPP)对应的前盆腔超声参数特点。方法选取2015年1月至2017年12月于韶关市粤北人民医院就诊的86例产后6周~6个月的女性进行经会阴超声检查,其中产后未合并SUI者为对照组(25例),产后合并SUI者为实验组(61例)。经会阴超声分别于静息期(R)及张力期(V)测量膀胱尿道后角(RA)、尿道倾斜角(UI)、膀胱颈位置(BSD),计算尿道旋转角度(UR)、膀胱尿道后角变化[RA(V-A)]、膀胱颈移动度(BND);测量实验组患者的ALPP,根据测量ALPP的结果分两组,实验组1:ALPP为> 60~<150cm H2O(40例);实验组2:ALPP≤60cmH2O(21例),对测量数据进行分析。结果实验组的V-RA、RA(V-R)、V-UI、UR、BND均高于对照组(t=2.23~7.01,均P <0.05),实验组的BSD较对照组下移(t=-4.77,P <0.05)、漏斗形尿道内口发生率较对照组增加(χ2=10.10,P=0.00)。实验组1的V-UI、UR、V-BSD、BND均低于实验组2(t=-5.58~5.42,均P <0.05),实验组1与实验组2的漏斗形尿道内口发生率比较差异无统计学意义(χ2=1.25,P=0.40)。结论 SUI女性张力期前腔室结构不稳定性增加:膀胱和尿道位置下移、膀胱及尿道过度运动、尿道内口开放呈漏斗形改变导致关闭障碍;ALPP越低提示尿道关闭功能越差,超声下表现为张力期的UR增加及膀胱颈的过度位移。     

The role of nocturnal penile tumescence in differentiating between organic and psychogenic impotence: The first stage of validation

A study was conducted to assess the validity of nocturnal penile tumescence (NPT) as a means of distinguishing between psychogenic and organic erectile failure (impotence). On the basis of independent clinical criteria, patients were assigned to one of four diagnostic categories—organic impotence, psychogenic impotence, mixed etiology, and uncertain etiology. The NPT characteristics of the patients in the organic and psychogenic groups were compared and decision rules formulated in order to provide optimal discrimination between the two diagnostic categories. A decision rule based on the maximum erectile response observed for each patient led to the correct diagnosis in 80% of cases. Accuracy was increased to 95% when a decision rule based on the maximum frequency of nocturnal erections was employed. The clinical value and limitations of NPT as a diagnostic procedure are discussed.Parts of this paper were presented at the Annual Meeting of the Ontario Psychiatric Association, Toronto, January 24–27, 1979.     

Psychogenic erectile dysfunction: comparative study of three therapeutic approaches

We administered the International Index of Erectile Function (IIEF; Rosen et al., 1997) questionnaire to 30 patients with psychogenic erectile dysfunction (ED) at baseline, immediately after treatment, and 3 months after treatment. We randomized patients into three groups: group I, who had weekly sessions of time-limited theme-based group psychotherapy for 6 months and 50 mg sildenafil citrate orally on demand; group II, who had an intake of 50 mg sildenafil citrate orally on demand for 6 months only; and group III, who had weekly sessions of time-limited theme-based group psychotherapy for 6 months. We analyzed data (15-item IIEF) for each group at three times during the study and compared by the data using analysis of variance (ANOVA), followed by the Bonferroni multiple comparison test. We used Cochran's Q-test for analysis between baseline and posttreatment stages of patients with remission of symptoms (EF equal to or higher than 26 points). Group III had a mean score higher than group II, with the difference being statistically significant (immediately after treatment, p = 0.033; at 3 months after treatment, p = 0.049; p < 0.05). All three therapeutic alternatives resulted in an improvement of erectile function domain score. However, significant differences from baseline were observed in groups I (p = 0.0009) and III (p = 0.0002) but not in group II (p = 0.135). The psychotherapy groups, I and III, had significantly higher scores compared with group II, in which patients were exclusively treated with sildenafil citrate. These findings suggest that time-limited theme-based group psychotherapy is an effective treatment for psychogenic ED.     

IMPROVEMENT OF SEXUAL ACTIVITY,PREGNANCY RATE,AND LOW PLASMA TESTOSTERONE AFTER BILATERAL VARICOCELECTOMY IN IMPOTENCE AND MALE INFERTILITY PATIENTS

To evaluate the effects of bilateral varicocelectomy on sexual activity, testicular volumes, semen quality, and serum hormone levels in impotence and male infertility patients, 48 patients were studied from an outpatient clinic from May 1998 to March 2001. The mean age was 37 &#45 5.9; 16 patients were complaining of erectile dysfunction and 32 patients were complaining of male infertility. The mean duration of impotence was 3.3 &#45 2.4 years and for male infertility was 3.8 &#45 3.2 years. Sexual and reproductive history was taken for erectile dysfunction and male infertility patients. General, local examination, and laboratory investigations were done for all patients. Preoperative and postoperative testicular volumes; semen parameters, including semen volume, sperm count, and motility; and morphology and hormonal parameters, including LH and FSH, and testosterone levels were measured. All patients were followed up for 3-36 months after varicocele repair. Left and right testicular volume was improved in impotence and male infertility patients and fertility groups, but this improvement was not statistically significant ( p >.25). The semen volume was significantly increased in male infertility patients and fertility group ( p <.05), but there was no statistical significant difference in impotent patients ( p >.25). The sperm count was improved in male infertility patients and fertility group, but this improvement was not statistically significant ( p >.25), and in impotent patients there was no significant difference ( p >.40). The sperm motility was very significantly increased in male infertility patients and the fertility group ( p <.0005), and highly significantly increased in impotent patients ( p <.005). The abnormal forms were not statistically significant in impotence and male infertility patients ( p >.40), but significantly decreased in the fertility group ( p <.05). Serum testosterone was very significantly increased in impotence and male infertility patients ( p <.0005) and was highly significantly increased in fertility groups ( p <.005). Serum FSH was improved in impotence and male infertility patients, but this improvement was not statistically significant ( p >.10), and in fertility groups of male infertility patients, the results showed a statistically significant increase ( p <.05). Serum LH was not statistically significant in impotence and male infertility patients ( p >.10), and was significantly increased in fertility groups ( p <.05). The improvement of sexual activity was 50-75%, the pregnancy rate for their partners was 37% and increased plasma testosterone levels over a period of 3 years of follow-up after varicocele repair.     

Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials

OBJECTIVE: To compare the feasibility of blinding and the perceived risk of unblinding in trials evaluating pharmacologic (PT) and nonpharmacologic treatments (NPT) of hip or knee osteoarthritis. STUDY DESIGN AND SETTING: Two independent reviewers assessed the feasibility of blinding patients, care providers, and outcome assessors, the perceived risk of unblinding, and whether blinding was reported in 110 reports of randomized controlled trials (RCTs) evaluating PT and NPT in patients with hip or knee osteoarthritis. RESULTS: Blinding was considered to be possible less often in NPT trials than in PT trials for patients (42 vs. 96%; P <.001), care providers (12 vs. 96%; P <.001), and outcome assessors (34 vs. 98%; P <.001). When blinding was judged feasible, the perceived risk of unblinding was more often considered moderate or important in NPT than PT trials for patients (35 vs. 14%, P=.02) and outcome assessors (44 vs. 10%, P=.0004). When blinding was judged feasible, it was reported less often in NPT reports than in PT reports for patients (46 vs. 98%, P <.001), care providers (43 vs. 83%, P=.03), and outcome assessors (72 vs. 98%, P=.0006). CONCLUSION: Blinding appears to be more difficult to achieve and unblinding may occur more often in NPT than PT trials.     

An examination of pain,disability, and the psychological correlates of Chiari Malformation pre- and post-surgical correction

Background50% of patients with Chiari Malformation (CM) report a history of depression; however, rates of other psychological symptoms are unknown. Further, it is unclear whether surgical correction impacts pain, disability, and psychological symptoms.Objective/Hypothesis: We examined rates of symptoms in a nationwide sample of CM patients who had (n = 639) and had not (n = 551) undergone surgical correction. We hypothesized lower symptom severity in the latter group.MethodsParticipants completed assessments and submitted pre-surgical MRI scans online (n = 286). Informed by the Fear-Avoidance Model of pain, we controlled for psychological symptoms when assessing pain/disability, and pain/disability when assessing psychological symptoms.ResultsOverall, high rates of depression (44% moderate-severe) and anxiety (60% moderate-severe) were reported. Groups (surgery vs. no-surgery) did not differ in the proportion of patients meeting cutoff scores for current disability; however, the no-surgery group was more likely to meet cutoffs for anxiety (χ2 = 11.26, p < .05), stress (χ2 = 14.63, p < .01) and health anxiety (χ2 = 4.63, p < .05). The surgery group reported lower levels of continuous affective pain F(1, 1065) = 10.28, p < .001), anxiety F(1,1026) = 4.96, p < .05) and stress F(1, 978) = 5.67, p < .05) although effect sizes were small (η²s ranging from 0.010 to 0.006, Cohen's D ranging from 0.17 to 0.25).ConclusionCM patients experience high rates of psychological symptomatology regardless of surgical status, suggesting that all CM patients may benefit from evidence-based interventions to address anxiety and depression.     

Penile tumescence monitoring during morning naps to assess male erectile functioning: An initial study of healthy men of varied ages

Whether sleep erections occurred during morning naps (preceded by modest sleep deprivation) in healthy men whose ages were representative of clients in sexual health clinics was assessed. Subjects (N = 30) reduced their normal sleep time to increase the likelihood that they would experience rapid eye movement (REM) sleep [closely associated with nocturnal penile tumescence (NPT)]. They then reported to an outpatient psychophysiological laboratory for an early morning nap, during which sleep and penile tumescence measures were recorded continuously. All subjects were able to sleep during at least 1 of their 2 recording sessions, 24 (80%) experienced REM sleep, and 22 (73%) experienced tumescence episodes consistent with previous NPT studies. The magnitude of these erections could reduce concerns about the presence of organic pathology, and obviate the need for an NPT study. Results suggest that monitoring tumescence during naps may be useful as an inexpensive and convenient screening approach in the assessment of male erectile functioning.Supported in part by grants from Syracuse University to Christopher M. Gordon, and from the National Institute of Mental Health Grant 1-K21-MH01101 to Michael P. Carey.     

Nocturnal penile tumescence and penile responses in the waking state in diabetic and nondiabetic sexual dysfunctionals

This study compared diabetics with sexual dysfunction, nondiabetics with sexual dysfunction, and a group of controls on nocturnal penile tumescence (NPT) during three nights in a sleep laboratory, and penile response to erotic stimulation in the waking state on one of the nights. Both diabetic and nondiabetic dysfunctionals showed less erectile response to erotic films and tape than controls but did not differ from each other. In contrast, the diabetic dysfunctionals showed significantly weaker NPT response than both the nondiabetic dysfunctionals and the controls, and 58% of them (contrasted with 23% of nondiabetic dysfunctionals and 0% of controls) would be classified as organic using minimal NPT (less than 11.5 mm maximal increase in penile circumference during any nocturnal erection) as the sole criterion. There was a significant relationship between NPT and waking erections in response to erotic stimuli, especially in the diabetic dysfunctionals and the controls.The research on which this report is based was supported in part by NIMH Grant No. 1-R01-MH31908. Parts of this report were presented at the Seventh Annual Meeting of the Society for Sex Therapy and Research, March 20–22, 1981, New York, N.Y., and at the International Congress Therapy in Andrology: Pharmacological, Surgical and Psychological Aspects, June 21–24, 1982, Pisa, Italy.     

Pulmonary function in Sardinian fire fighters

Our study examined the respiratory function of 92 firemen whose main activity is fire fighting in forests and open country. Such fire fighting activities are to be considered a risk to the respiratory tract, taking into account studies already in the literature that have evaluated the nature and quantity of inhalable toxins present in activities of this kind. The control group was composed of 51 Carabinieri (policemen), who were asked to fill in a questionnaire about their work activities. Forced expiratory volume and flow, total lung capacity, respiratory volume, and the permeability of the alveolar-capillary barrier were measured. Firemen and Carabinieri (policemen) showed FVC rates higher than the European Community for Coal and Steel standards. The firemen showed a significant reduction in forced expiratory volume in 1 second (FEV₁) [3.90 (0.50) vs. 4.04 (0.44); p < 0.05] and forced expiratory flow at 75% of forced vital capacity (FVC) (FEF₇₅) [8.37 (4.11) vs. 8.38 (1.67) p < 0.05] and more markedly in the FEV₁/FVC relationship [80.07 (5.89) vs. 83.89 (1.67) p < 0.001] and in FEF₅₀ [4.73 (1.34) vs. 5.54 (1.44) p < 0.01] and FEF₂₅ [1.58 (.47) vs. 1.99 (.69) p < 0.001]. There were no marked differences in air-blood exchanges. No correlation was found between respiratory function data and years of service or the number of fires extinguished during work experience. © 1996 Wiley-Liss, Inc.     

Yohimbine, Erectile Capacity, and Sexual Response in Men

In a double-blind, placebo-controlled crossover study on a group of men with erectile problems and a sexually functional comparison group, the effect of yohimbine (up to 30 mg/day) was assessed on a number of objective and subjective measures of erectile response through the use of daily logs and psychophysiological laboratory procedures involving response to visual sexual stimulation (VSS). Sexual desire, arousal, and ejaculatory response were also assessed. Results indicated no effect of yohimbine on most aspects of sexual response in sexually functional men. Mixed effects were found on measures of sexual function in men with erectile dysfunction, with 3 of 11 men reporting strong positive effects. Under yohimbine, frequency of sexual activities increased, as did self-assessed genital response to VSS. Daily diaries indicated increased sexual arousal and erectile response during masturbation but not intercourse. A number of other measures, including NPT and retrospective summaries of erectile functioning at the end of drug phases, showed no effect. Results are discussed in terms of possible yohimbic effects on psychological factors that modulate overall sexual response, and consequently, erectile response.     

Low-income young adults report increased variety in fruit and vegetable intake after a stage-tailored intervention

The objective of this study was to determine if a fruit and vegetable (FV) intervention, previously demonstrated to increase amount of FV per day, also increased the variety consumed. Variety in FV intake was assessed using a 26-item FV (12 fruit and 14 vegetable) food frequency questionnaire on 1255 low-income adults, with ages from 18 to 24 years (control = 684 vs experimental = 571), after completion of a stage-tailored intervention to increase FV intakes. The food frequency questionnaire was administered at 12 months to assess how often and how much participants ate of each item over the previous year. Variety was defined as the number of different types of fruits and vegetables consumed. At completion, the experimental group vs the control group had significantly greater variety in number of fruit items (9.5 ± 0.1 vs 9.1 ± 0.1, P ≤ .001) and vegetable items (11.5 ± 0.1 vs 11.2 ± 0.1, P < .01) as well as greater total intake of fruits (2.73 ± 0.09 vs 2.33 ± 0.11 cups, P < .01) and vegetables (1.87 ± 0.10 vs 1.62 ± 0.01 cups, P ≤ .001) and a greater consumption of the categories of seasonal fruits (P < .05), juices (P < .01), and high-β-carotene vegetables (P ≤ .001). This is one of the first studies to document an increase in FV variety as a result of an educational intervention for low-income young adults.     

INHIBIN B LEVELS IN PERIPHERAL VEIN DO NOT CORRELATE WITH INHIBIN B LEVELS IN THE SPERMATIC VEIN IN ADOLESCENTS WITH VARICOCELE

This study was conducted to evaluate the inhibin B with FSH and LH levels on spermatogenesis in varicocele patients. The study group consisted of 10 adolescent with left idiopathic varicocele of grade II and III. Blood specimens were obtained from dilated spermatic vein and peripheral vein simultaneously. Peripheral samples were also collected from 7 healthy children as controls. Inhibin B was measured with ELISA inhibin B kits. FSH and LH were analyzed by radioimmunoassay techniques. The results were analyzed using Mann-Whitney U and Spearman's rank tests. A value of p < 0.05 was considered significant. Peripheral FSH, LH and inhibin B levels were the same in the study and control group (p > 0.05). Mean inbibin B levels of spermatic vein were significantly higher than the control and peripheral blood of the study groups (p < 0.05). FSH, LH, and inhibin B levels correlated poorly each other (p > 0.05). Preoperative serum inhibin B concentration could not reliably predict a response to varicocelectomy, but the increase in inhibin B levels after treatment might suggest an improvement in testicular function.     

Predicted Effects of a New Combination Vaccine on Childhood Immunization Coverage Rates and Vaccination Activities

Introduction

A new combination vaccine, diphtheria-tetanus-acellular pertussis (DTaP)-hepatitis B (HepB)-inactivated poliovirus vaccine (IPV) [DTaP-HepB-IPV], recently became available for use in the US primary infant-vaccination series. Our objectives were to estimate its effects on immunization-coverage rates, vaccination activities, and health-system costs in US dollars (2003 values).

Methods

A model was developed and applied to medical records of 775 children born in mid-2001 who received primary care at 32 private pediatrics centers. DTaP-HepB-IPV use was predicted by applying decision rules to selectively substitute it for component vaccines, in compliance with the Advisory Committee on Immunization Practices’ minimum age and time interval criteria. The model considered effects of DTaP-HepB-IPV on use of HepB at age <6 weeks, and HepB, HepB-Haemophilus influenzae type B (Hib), Hib, DTaP, and IPV at age 6 weeks to 2 years.

Results

At 2 years of age, DTaP-HepB-IPV would increase the proportion of children receiving three or more doses of DTaP (95.6% vs 96.4%; p = 0.02), HepB (91.7% vs 95.2%; p < 0.001), IPV (90.7% vs 96.3%; p < 0.001), and each of these vaccines (86.2% vs 94.6%; p < 0.001), compared with those receiving each component in singular or combination vaccinations other than DTaP-HepB-IPV. Coverage rates would also be increased for recommended doses of all three component vaccines at ages 1 and 1½ years. At 2 years of age, the use of DTaP-HepB-IPV would also reduce the number of injections (17.3 vs 14.6; p < 0.001), vaccination visits (6.8 vs 6.6; p = 0.006), and administration costs ($US240 vs $US203; p = 0.004), compared with those receiving each component in singular or combination vaccinations other than DTaP-HepB-IPV.

Conclusion

DTaP-HepB-IPV use is estimated to improve immunization coverage rates while reducing the number of vaccine injections, vaccination visits, and costs.

     

Long term effect of spa therapy combined with patient education program on subjects with overweight and obesity — A controlled study

The aim of this single center prospective controlled study in volunteers with obesity and overweight was to evaluate the effect of a patient therapeutic education program (PTE group) combined with spa therapy on weight, physical activity, eating habits and quality of life versus spa therapy alone (control group). The main endpoint was weight change at 5 months after the end of the program.The PTE group of 151 subjects with obesity or overweight followed a 3-week program combining patient education with spa therapy and 189 attended a course of spa therapy alone. At 5 months significant loss was observed in the PTE group compared to controls (?2.69 kg vs ?1.24 kg, p = 0.008), a relative weight loss of ?2.8% vs ?1.3%. At 11 months after spa therapy, only the PTE group maintained a weight loss in addition to the weight loss obtained during spa therapy. The control group returned to the weight they had at the end of spa therapy. In both groups, a significant increase in physical activity was observed at 5 (p < 0.001) and 11 months (p < 0.001) with a significant better improvement in the PTE group. In addition, while in both groups some quality of life parameters and dietary choices were improved, the improvement (more fruit, vegetables, fish and water) was significantly higher in the PTE group, at both 5 and 11 months after spa therapy.In conclusion, while spa therapy alone initiated positive changes in weight loss, physical activity and some quality of life parameters, the PTE program enhanced this effect.     

Levonorgestrel-releasing intrauterine system compared to low dose combined oral contraceptive pills for idiopathic menorrhagia: a randomized clinical trial

Background

This study compared the efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) to low dose combined oral contraceptive pills (COC) in the management of idiopathic menorrhagia.

Study Design

A single-center, open, randomized clinical trial. One hundred twelve women complaining of excessive menstruation who desired contraception were randomized to receive LNG-IUS or COC. Treatment failure was defined as the need for medical or surgical treatment during the follow-up. Other outcomes included: menstrual blood loss (MBL) by alkaline hematin and by pictorial blood assessment chart (PBLAC), hemoglobin levels and assessment of lost days in which physical or mental health prevented participating women from performing usual activities.

Results

At baseline, LNG-IUS (n=56) and COC (n=56) groups were comparable in age (mean±S.D.) (39.3±6.7 vs. 38.7±5.2 years, p=.637), parity (median and range) [3(1-6.4) vs.3(2-6), p=.802] and BMI (mean±S.D.) (29.6±5.9 vs. 31.1±5.7 kg/m², p=.175). Time to treatment failure was longer in LNG compared to COC group with a total of 6 (11%) patients who had treatment failure in the LNG-IUS compared to 18 (32%) in COC group with a hazard ratio of 0.30 (95% CI, 0.15-0.73, p=.007). Using alkaline hematin, the reduction in MBL (mean±S.D.) was significantly more in the LNG-IUS group (87.4±11.3%) compared to the COC group (34.9±76.9%) (p=.013). Utilizing PBLAC scores, the reduction in the LNG-IUS (86.6±17.0%) group was significantly more compared to the COC group (2.5±93.2%) (p<.001). In the LNG-IUS group, increase in the hemoglobin and ferritin levels (mean±S.D.) were noted (from 10.2±1.3 to 11.4±1.0 g/dL; p<.001; with reduction of the number of lost days (from 6.8±2.6 to 1.6±2.4 days, p=.003).

Conclusion

The LNG-IUS is a more effective therapy for idiopathic menorrhagia compared to COC.