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1.

Objectives

Previous studies have indicated that the urethra may provide an effective route for administering vasoactive medication for the treatment of erectile dysfunction. We evaluated the safety and efficacy of alprostadil administered intraurethrally at home for the treatment of this disorder.

Methods

This prospective, multicenter, double-blind, placebo-controlled study evaluated the erectile response to randomly assigned doses of transurethral alprostadil at home in 68 men with long-standing (mean 41 months) erectile dysfunction of primarily organic etiology. Patients completing the study each administered a random sequence of four different doses ( 125, 250, 500, and 1000 μg) and placebo over a 2 to 4 week period. Assessments included the couples' ability to have intercourse, patient ratings of erectile response by both categorical and visual analogue scales, penile volume measurements, and overall assessments of comfort and ease of administration.

Results

Overall, 75.4% (49 of 65) of study patients achieved full enlargement of the penis and 49.2% (32 of 65) achieved an erection judged by the patient to be sufficient for intercourse. In addition, 63.6% (42 of 66) of patients reported intercourse. Efficacy was similar across etiologies. The most common side effect was penile pain, which occurred in association with 9.1 % to 18.3% of alprostadil administrations, depending on dose. Mean comfort ratings ranged from 79 to 87, depending on dose, where 0 = severe discomfort and 100 = comfortable; ease of administration scores were above 90 for each dose, where 0 = difficult and 100 = easy. There were no episodes of priapism in this study.

Conclusions

Short-term treatment with transurethral alprostadil produced erections resulting in sexual intercourse in most patients with chronic erectile dysfunction. This therapy may be a useful treatment option for patients with erectile dysfunction.  相似文献   

2.

Purpose

Transurethral alprostadil has been shown to be efficacious in many men with erectile dysfunction. We compared transurethral alprostadil and prazosin alone, and in combination to treat this disorder.

Materials and Methods

In this double-blind, placebo controlled study the erectile responses to transurethral alprostadil, prazosin and alprostadil-prazosin combinations were assessed in 234 men 26.8 to 8.15 years old with complete organic erectile dysfunction. Patients self-administered a random sequence of 7 doses in the clinic in 4 weeks. The erectile response was assessed using categorical and visual analog scales.

Results

Full penile enlargement or rigidity was achieved by 165 of the 234 men (70.5%) after at least 1 active dose of medication. The most effective alprostadil dose (500 micro g.) resulted in full penile enlargement or rigidity in 51.8% of administrations, whereas the most effective prazosin dose (2,000 micro g.) and placebo resulted in a similar response in 12.7 and 2.7%, respectively (p <0.001). The 500/2,000 micro g. alprostadil/prazosin combination, which resulted in full enlargement or rigidity in 58.9% of doses, was only slightly better than the most effective dose of alprostadil alone (500 micro g.). However, combinations of 125/500 and 250/500 micro g. alprostadil/prazosin were more effective (p <0.01) than 125 and 250 micro g. alprostadil given alone, respectively. The most common side effect of therapy was penile pain, which rarely led to study discontinuation. Hypotension most commonly developed at the higher alprostadil-prazosin combination.

Conclusions

Transurethral alprostadil and alprostadil-prazosin combinations produced erections in men with complete organic erectile dysfunction. This combination therapy may be an option in patients who do not respond to transurethral alprostadil alone.  相似文献   

3.

Purpose

We evaluated the hemodynamic effects of transurethral alprostadil in 21 patients with erectile dysfunction using color duplex ultrasonography.

Materials and Methods

Penile arterial diameter, peak flow velocity and end diastolic velocity were compared following intraurethral administration of 500 micro g. alprostadil and intracavernosal injection of 10 micro g. alprostadil.

Results

A dose of 500 micro g. transurethral alprostadil resulted in significant increases in corporeal blood flow comparable to those achieved with intracavernosal injection of 10 micro g. alprostadil as measured by duplex ultrasonography in men with erectile dysfunction. Transurethral alprostadil resulted in statistically significant increases in arterial diameter and peak flow velocity comparable to those achieved with intracavernosal injection. End diastolic velocities were higher after transurethral alprostadil than intracavernosal injections. Color ultrasonography following transurethral alprostadil showed arterial and venous hyperemia of the corpus spongiosum and corpora cavernosa. Furthermore, color ultrasonography revealed communicating vessels between the corpus spongiosum and corpora cavernosa following administration of transurethral alprostadil.

Conclusions

The visualization of communicating vessels between the corpus spongiosum and corpora cavernosa after transurethral alprostadil suggests local mechanisms of drug transfer from one to the other. In addition to potential clinical benefits, transurethral alprostadil may be useful to visualize the vascular anatomy of the penis and to test for patient responsiveness to local vasoactive agents.  相似文献   

4.
Aim: To evaluate the efficacy and safety of transurethral application of alprostadil (MUSE.) for the treatment of erectile dysfunction in Indonesians. Methods: Twenty erectile dysfunction patients aged between 32 - 74 years old were recruited in this study. The inclusion criteria were as follows: 1 ) adult males 18 years or older with a subjective complaint or erectile dysfunction, 2) to provide written informed consent, 3) to agree not to use other forms of treatment for erectile dysfunction, 4) fulfill the screening laboratory values. Part 1, eligible patients were titrated in the clinic starting with a dose of 250 μg and proceed in a stepwise manner to 500μg and 1000μg on separate clinic visits until they identified a dose that produced a satisfactory response. The interval between each in-clinic titration was 2-3 days. Each in-clinic titration dose was evaluated at 15 min intervals over a one hour period for erection assessment, blood pressure and pulse. Part 2, patients used MUSE at home for three months at the dose identified during the inclinic titration. Monthly interim visits were required for patient follow-up and drug distribution. At the end of the study, patients had another laboratory (except testosterone, only assayed in screening procedure) and physical examination. Results: The etiology of erectile dysfunction was psychological in 5 patients and organic in 15 patients. The 65% of the patients achieved the erection scale of 4 or 5 either in the clinic or at home, 10% achieved the scale of 4 at home, but not in the clinic, and 25 % only achieved the scale of 2 or 3 with the highest dose of 1000μg either in the clinic or at home. No significant differences were found in biochemical examination before and after the study. The 60 % of the patients who achieved erection scale 4 or 5 continued to use MUSE until the end of the study, while 40 % of them complained of pain at the time of MUSE application, during erection and/or during intercourse. They withdrew from the study. Conclusion: Transurethral application of alprostadil (MUSE) is effective and safe to produce erection sufficient for intercourse in erectile dysfunction of various etiologies. Pain during application, erection and intercourse is a common side effect and a cause of withdrawal.  相似文献   

5.

Purpose

We objectively measured the incidence of erectile dysfunction following transurethral resection of the prostate.

Materials and Methods

A total of 56 men completed a questionnaire detailing perceived sexual dysfunction, and underwent nocturnal penile tumescence testing for 3 nights before transurethral resection of the prostate and again at 3 months postoperatively.

Results

Complete data were available for 40 men. No significant difference was found in penile tumescence, number of erectile events and duration of events before and after surgery. Preoperative and postoperative rigidity was statistically different, with a slight improvement after transurethral resection of the prostate (p less than 0.05). A subjective decrease in quality of erection after transurethral resection of the prostate was reported in 27.5 percent of the patients. However, on further questioning, 63.6 percent of these patients equated retrograde ejaculation with decreased potency.

Conclusions

We demonstrated no decrease in objective parameters of erectile function studies following transurethral resection of the prostate. Previous estimates of impotence after transurethral prostatectomy may have been tainted by subjective patient reports equating retrograde ejaculation with erectile dysfunction.  相似文献   

6.

Purpose

We evaluated the effects of alprostadil, prazosin hydrochloride, and alprostadil/prazosin hydrochloride, agents used in the clinical treatment of male erectile dysfunction, on the motility, viability and membrane integrity of human sperm.

Materials and Methods

Ten healthy volunteers provided semen samples that were incubated with 0.4 mg./ml. alprostadil, 0.1 and 0.2 mg./ml. prazosin hydrochloride and 0.4 mg./ml. alprostadil plus 0.1 mg./ml. prazosin hydrochloride for 2 hours. Control incubations included polyethylene glycol 1450, the formulation vehicle for the clinical use of alprostadil and prazosin, and Ham's F-10 buffer. Serial evaluations of percent sperm motility, percent viability, membrane function (by hypo-osmotic swelling test) and several computer generated measurements of sperm motion, including straight line velocity, curvilinear velocity, linearity and amplitude of lateral head displacement, were made.

Results

None of the agents had a significant impact on the percentage of motile or viable sperm or on sperm membrane function. Incubation with 0.2 mg./ml. prazosin reduced straight line velocity and curvilinear velocity significantly compared with the other agents. These changes were most likely a direct result of the viscosity of the 0.2 mg./ml. prazosin solution and not a cellular or metabolic effect on the sperm.

Conclusions

Alprostadil and prazosin hydrochloride at doses used in transurethral therapy for erectile dysfunction have no effect on the motility, viability and membrane integrity of human sperm.  相似文献   

7.

Background and Objective:

Studies are limited regarding the impact of obesity on early erectile functional outcomes after robotic radical prostatectomy. Our goal was to determine this impact using patient-reported validated questionnaires.

Methods:

International Index of Erectile Function (IIEF-6) scores were prospectively collected with institutional review board approval, for patients who underwent robotic radical prostatectomy with bilateral nerve sparing from February 2007 to October 2009. The data were categorized into nonobese and obese groups and subsequently into 2 subgroups based on risk for postprostatectomy erectile dysfunction. Low risk is preoperative IIEF-6 ≥19 and high risk is IIEF-6 <19. The groups and subgroups were compared using chi-square analysis.

Results:

Of 190 consecutive patients, 67 were excluded for preoperative severe erectile dysfunction (IIEF-6 <7), or lack of IIEF-6 scores, or both. There were 69 nonobese patients of which 88% were potent preoperatively and 20% regained potency at 12 months postoperatively. Of 54 obese patients, 85% were potent preoperatively and 25% at 12 months. There was no difference in erectile function recovery rates between the groups (P=0.755). In both groups, patients with low risk of postoperative erectile dysfunction had statistically similar postoperative mean IIEF-6 scores at 6 and 12 months (P=0.580 and P=0.389, respectively), and no difference in erectile function recovery rates existed at 12 months (P=0.735).

Conclusion:

Obesity has no major contribution to the rate of early erectile function recovery after robotic radical prostatectomy. Preoperative erectile function remains the determining factor in postradical prostatectomy erectile dysfunction.  相似文献   

8.
A Korean multicenter study was conducted to assess the effectiveness of transurethral alprostadil with MUSE in 334 subjects with chronic erectile dysfunction (ED) who were enrolled in 21 clinical centers. Patients with psychogenic impotence comprised about 30% of subjects. Intraurethral alprostadil was titrated in a stepwise fashion in the clinics from 250 to 500 or 1000 mcg based on erectile response and tolerability. The erectile responses were evaluated using an erection assessment scale (score of 1-5). The dose that produced a maximal penile response of score 5 (full rigid erection) or 4 (full tumescence, partial rigidity) was selected for home treatment. Patients who showed partial erection (score of 3) with 1000 mcg were also included in the home-treatment group. In-clinic phase: 198 men (59.3%) had maximal penile responses of score 4 or 5. The rate of maximal responses was not related to patient age, etiology or duration of the ED. A total of 228 (68.3%) men progressed to home treatment. The overall level of comfort of the transurethral alprostadil was rated as uncomfortable or very uncomfortable in 12%. Home phase: During the two-month period of home treatment, 178 (78.1%) men had successful sexual intercourse at least once, and 78.2% of administrations (1976) resulted in successful intercourse. The main causes of drop-out were insufficient erectile response in 27 men (11.8%), adverse reactions (mostly penile or urethral pain) in 7 (3.1%) or both in 7 (3.1%). In conclusion, transurethral alprostadil could be a suitable treatment option for patients with ED regardless of age and etiology of ED. Efficacy in an Asian population (Korea) is comparable to that reported previously in Caucasians.  相似文献   

9.
10.
11.

Objective

The purpose of this study was to evaluate the effect of low-dose sildenafil (25 mg) for rehabilitation of erectile function after nerve-sparing radical prostatectomy.

Patients and methods

In a prospective study, 43 sexually active patients underwent nerve-sparing retropubic radical prostatectomy. Rigiscan® measurement of nocturnal penile tumescence and rigidity (NPTR) was carried out 7–14 days after surgery. A group of 23 patients with preserved nocturnal erections received sildenafil 25 mg/day at night to support recovery of erectile function. A control group of 18 patients underwent follow-up without PDE-5 inhibitors. Evaluation using the IIEF-5 questionnaire was performed 6, 12, 24, 36, 52 and 78 weeks after the operation.

Results

Of 43 patients, 41 (95%) showed 1–5 erections during the first night after catheter removal. In the group receiving daily sildenafil, the mean IIEF-5 score decreased or increased from 20.8 preoperatively to 3.6 at 6 weeks, 3.8 at 12 weeks, 5.9 at 24 weeks, 9.6 at 36 weeks, 14.1 at 52 weeks and 19.3 at 78 weeks after prostatectomy. In the control group, the mean preoperative IIEF-5 score of 21.2 decreased or increased to 2.4 at 6 weeks, 3.8 at 12 weeks, 5.3 at 24 weeks, 6.4 at 36 weeks, 9.3 at 52 weeks and 13.2 at 78 weeks. Statistical evaluation showed significant differences regarding the IIEF-5 score and recovery period of erectile function between the groups (p<0.001), with potency rates of 92 vs 68%.

Conclusion

The measurement of NPTR after nerve-sparing radical prostatectomy showed erectile function as early as the first night after catheter removal. In cases of early penile erections, daily low-dose PDE-5 inhibitors lead to a significant improvement/acceleration of erectile function recovery.  相似文献   

12.

Purpose

We evaluated the quality of life effects of self-administered intracavernosal injection of alprostadil sterile powder for erectile dysfunction when used by patients for up to 18 months.

Materials and Methods

Clinical and self-reported measurements were used to assess physiological and psychological status at baseline, and at 3, 6, 12 and 18 months for 579 patients who entered the self-injection phase of an open label, flexible dose clinical. Quality of life was measured using the Center for Marital and Sexual Health Sexual Functioning Questionnaire, which focuses on the psychosocial and physical dimensions of erectile dysfunction; the Brief Symptom Inventory, which measures mental health, and the Duke Health Profile, which measures general of life. The primary evaluations were quality of life changes from baseline to post-initiation periods and reasons for treatment discontinuation.

Results

The Center for Marital and Sexual Health Sexual Functioning Questionnaire displayed improvements at all post-initiation periods in 10 questions (p <0.001, Student's paired t tests) grouped into scales representing frequency of sexual activity, erection, orgasm and satisfaction domains. On the Brief Symptom Inventory interpersonal sensitivity, anxiety and depression as well as global scores improved (p <0.001). Overall mental health as measured by the Duke Health Profile also improved (p <0.01) between baseline and 6 months. The reasons most frequently cited for treatment discontinuation were nonfirm erections and injection site pain.

Conclusions

Clinical improvements in erectile function due to alprostadil therapy were associated with improvements in sexual activity, sexual satisfaction and overall mental health.  相似文献   

13.

Purpose

Management of prostate cancer following radiation therapy remains challenging, especially for younger men or those with life expectancy greater than 10 years. We outline the efficacy, safety and adequacy of radical prostatectomy for the treatment of radiorecurrent localized prostate cancer.

Methods

A systematic review was performed in September 2012 searching MEDLINE articles from 1980 to 2012 on salvage radical prostatectomy. We excluded unpublished data and non-English-language articles.

Results

The ideal candidate for salvage radical prostatectomy (SRP) has a life expectancy greater than 10 years, a PSA < 10 ng/ml and whose initial clinical staging was T1 or T2. A prostate biopsy and imaging studies to rule out metastatic disease should be performed prior to SRP. Salvage RP has a high complication rate, but this appears to be decreasing over time. Urinary continence rates range from 36 to 81 %, whereas erectile function following SRP was generally poor with less than 30 % of men regaining adequate erectile function. Men with good erectile function prior to SRP fared better than those with pre-operative erectile dysfunction. Biochemical recurrence-free probability at 5 years ranged from 37 to 55 % and the estimated cancer-specific survival at 10 years ranged from 70 to 83 %. Minimally invasive SRP is feasible and early outcomes suggest that this approach is not inferior to open surgery.

Conclusion

SRP offers a potentially curative option with proven long-term disease-free survival in appropriately selected patients. Given the morbidity of this procedure, judicious patient selection and referral to providers experienced with salvage surgery may optimize patient outcomes.  相似文献   

14.
Study Type – Harm (individual cohort) Level of Evidence 2b What's known on the subject? and What does the study add? Measuring erectile function after radical prostatectomy is challenging: While lengthy questionnaires may be more comprehensive and accurate, a single question tool may be more easily administered, for clinical and research purpose. The present study compares the performance of a single question and the widely used International Index of Erectile Function (TIEF) in assessment of post radical prostatectomy erectile function.

OBJECTIVE

  • ? To present a single‐question institutional erectile function scale, which was developed at Memorial Sloan‐Kettering Cancer Center (MSKCC) before the availability of the International Index of Erectile Function (IIEF), and to compare its performance with the IIEF. Erectile function status assessment after radical prostatectomy is a significant challenge both for research purposes and in clinical practice. Recently, there has been a shift away from complex questionnaire use such as the IIEF and regression to single‐item assessment of erectile function.

PATIENTS AND METHODS

  • ? Our erectile function score, a single question 5‐point score based on physician–patient interview, was applied to 276 patients with prostate cancer after radical prostatectomy. Based on the erectile function score, patients were grouped into five groups. The mean IIEF score and the mean score of questions 3 and 4 of the IIEF were calculated and compared across the groups.
  • ? Each score group was compared with the preceding group and tested for significant difference. The erectile function domain of the IIEF and the institutional score were tested for correlation.

RESULTS

  • ? The complete erectile function domain score from the IIEF was available for 170 patients and scores from questions 3 and 4 were available for 220 patients. The institutional erectile function score categorized the subjects into distinct groups based on erectile function status.
  • ? The institutional erectile function score was highly correlated with the IIEF erectile function domain score (r=?0.692, P < 0.001) and with the questions 3 and 4 combined score (r=?0.678, P < 0.001).

CONCLUSIONS

  • ? The MSKCC erectile function scale is a practical, readily administered method to assess erectile function in patients with prostate cancer after radical prostatectomy.
  • ? The erectile function score, as determined by this scale, is highly correlated with the IIEF erectile function domain score.
  相似文献   

15.

Purpose

Results of retrograde transurethral collagen injection for treatment of stress urinary incontinence have been generally disappointing for men with intrinsic sphinchter deficiency following radical prostatectomy. We described a new technique of antegrade transvesical collagen injection using suprapublic percutaneous bladder access.

Materials and Methods

Between October 1994 and January 1996, 20 patients underwent antegrade collagen injection for post-radical prostatectomy stress urinary incontinence. Evaluation by pad test, urodynamics and subjective scores was performed before and after injections.

Results

At a mean followup of 8.5 months 9 of 20 patients (45 percent) had significant subjective improvement and 5 (25 percent) were totally dry.

Conclusions

Antegrade collagen injection is a promising and simple method of correcting post-radical prostatectomy stress urinary incontinence. Further study and longer followup are necessary to determine its precise role in the treatment of this condition.  相似文献   

16.
What's known on the subject? and What does the study add? Over the last decade, the surgical treatment of prostate cancer has evolved towards minimal access surgery, particularly via a robot‐assisted technique. However, there is still debate regarding the true benefit for patients with respect to a functional outcome such as erectile function. The present prediction model provides a reliable estimation of the likelihood of regaining erectile function after prostatectomy.

OBJECTIVE

  • ? To identify the reported rates of potency after prostatectomy in the recent literature for men without preoperative erectile dysfunction (ED) and to develop a statistical model for predicting the expected potency after prostatectomy.

MATERIALS AND METHODS

  • ? A Medline search was conducted with the keywords ‘potency’ and ‘prostatectomy’ from 2003 to 2009.
  • ? In total, 33 studies in the English language reporting pre‐ and postoperative erectile function were identified.
  • ? Data from studies reporting outcome after open, laparoscopic and robot‐assisted prostatectomy were analyzed separately.
  • ? Only data obtained from potent men before surgery were included in the analysis.

RESULTS

  • ? In potent men before surgery, the main predictors of post‐treatment erectile function are age and time after treatment.
  • ? The cumulative range of potency rates at 48 months for all ages (45–75 years) was 49–74% for open, 58–74% for laparoscopic and 60–100% for robotic prostatectomy.
  • ? The predicted outcome differs by type of operation and patient age.

CONCLUSIONS

  • ? Men aged <60 years have a significant likelihood of regaining erectile function after radical prostatectomy.
  • ? The reported statistical model provides a reliable estimation of erectile function outcome after prostatectomy for men with localized prostate cancer and intact erectile function.
  相似文献   

17.

Objective

To investigate the behavior of Chinese erectile dysfunction (ED) patients after radical prostatectomy (RP) who were offered the penile rehabilitation and to assess their attitude and feasibility of rehabilitation after RP in China.

Materials and methods

Comprehensive medical and sexual histories of 187 evaluable PCa patients for RP were obtained together with their attitude towards penile rehabilitation. The rehabilitation data was compared between patients who accepted this treatment or not. The successful intercourse rate six months after treatment was also compared among three rehabilitation interventions, including phosphodiesterase type 5 inhibitor (PDE-5i), vacuum erection device (VED) and combination of both.

Results

141 (75.4%) patients reported being sexually active in the six months before RP.122 (65.2%) patients wished to preserve sexual activity and 80 (42.8%) had interest in penile rehabilitation after RP. Penile rehabilitation rate was 30.5%. The patients with younger age (P<0.001), higher IIEF-5 score preoperatively (P=0.03) and no adjuvant therapy post-RP (P=0.01) were more acceptable for rehabilitation. Main reasons for refusal of rehabilitation included lack of sexual interest followed by high cost of treatment. The successful intercourse rate was not significantly different among three rehabilitation interventions (P=0.32).

Conclusions

Less than one-third of Chinese RP patients accepted penile rehabilitation postoperatively. Patients’ attitude towards rehabilitation was conservative because of many reasons from traditional Chinese culture, doctors and patients themselves. Penile rehabilitation was feasible and effective in Chinese RP patients.  相似文献   

18.

Objectives

To compare monopolar and bipolar transurethral resection of the prostate (M-TURP and B-TURP, respectively) focusing on erectile and ejaculatory functions in a randomized trial.

Methods

Between January 2013 and December 2014, all consecutive TURP candidates with benign prostatic hyperplasia (BPH) were prospectively randomized 1:1 into M-TURP/B-TURP arms and followed up at 2, and 4 weeks, 6 and 12 months after surgery. All patients were assessed using IIEF-15 (International index of erectile function-15) and Ej-MSHQ (ejaculatory domain-male sexual-health inventory). Changes in IIEF-15, its subdomains and Ej-MSHQ scores were compared between both intervention groups.

Results

Following M.TURP and B.TURP; 122 and 124 patients were included respectively and were considered for analysis at 1 year. Sexual function did not differ significantly between arms during follow-up (erectile function, P?=?0.82; orgasmic function, P?=?0.46; sexual desire, P?=?0.29; intercourse satisfaction, P?=?0.18; overall satisfaction, P?=?0.92). There were no differences between arms in the distribution of EF evolution at any time compared with base line (at 12 months: M-TURP vs. B-TURP?=?improved, 24.5 vs. 26.6%; stable, 66.4 vs. 64.5%; deteriorated, 9.1 vs. 8.9%; P?=?0.41). Newly developed erectile dysfunction (ED) was present in 8.2 and 7.3% of patients following M.TURP and B.TURP respectively and was related to presence of DM and obesity. Orgasm perception significantly reduced following M.TURP and B.TURP (P?<?0.001). Newly reported ejaculatory dysfunction (Ej-MSHQ?<?22) was significantly associated with low orgasm perception.

Conclusions

There were no differences between M-TURP/B-TURP in any aspect of sexual function.
  相似文献   

19.
The Repair study contains many data regarding the incidence of erectile dysfunction following radical prostatectomy, and the point of view of patients who undergo sexual disorders. First, it appears that 80% of patients are given information by their urologist before surgery about sexual consequences of radical prostatectomy. During the three months before surgery, 92% and 75% of patients who completed the questionnaires have had erections and sexual intercourse, respectively. Using the laparoscopic approach or the open technique for radical prostatectomy appears not to influence the incidence of erectile dysfunction following surgery that is 92%. Contrary to what the urologists report in the questionnaires, the patients consider erectile dysfunction more important than urinary disorders. In addition, 61% of patients report that they would like to be treated for erectile dysfunction during the first three months following surgery, which is earlier than the urologists consider. Finally, it appears in the Repair study that erectile function recovery is easier when patients are managed early after surgery for their sexual disorders.  相似文献   

20.
The efficacy and safety of intracavernosal alprostadil was evaluated for the treatment of erectile dysfunction in men with type I or type II diabetes mellitus. This was an open-label, flexible dose-escalating study involving 336 men (77% of whom were Asian/Oriental) enrolled by 15 centres in Australia, Canada and seven countries in Asia. The effective alprostadil dose, ie the dose producing penile rigidity adequate for intercourse and lasting up to 60 min, was established by titration at the clinic prior to entry into the 6 month self-treatment home phase. All men were fully trained in the self-injection technique before entry into the home phase. Efficacy and safety were assessed using patient and partner diaries and by interview at clinic visits during the titration phase and after 1, 3 and 6 months of treatment. An effective home dose was established by titration for 94% of the 336 men (median dose 20 microg, range 2.5-60 microg). Of 278 (83%) men who entered the home phase, 277 men (247 with type II diabetes and 30 with type I diabetes) had evaluable data for alprostadil dosage and clinical response. During the home phase, a satisfactory erectile response was achieved after 99% of injections, and the median alprostadil dose remained unchanged. The initial home dose and clinical response were similar in type I and type II diabetic men. Treatment was generally well tolerated with a low incidence of penile pain (24%) In conclusion, intracavernosal alprostadil was effective and well tolerated in type I and type II diabetic men with erectile dysfunction of mixed aetiology.  相似文献   

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