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A two-part pilot study of sildenafil (VIAGRA) in men with erectile dysfunction caused by spinal cord injury.
Spinal Cord. 1999 Feb; 37(2):110-6.SC

Abstract

STUDY DESIGN

This was a two-part pilot study in men with erectile dysfunction (ED) due to spinal cord injury (SCI: cord level range T6-L5). Part I was a randomised, double-blind, two-way cross-over study comparing a single dose of sildenafil 50 mg or placebo. Part II was a randomised, double-blind, parallel-group evaluation of sildenafil 50 mg or placebo, taken as required (not more than once daily) approximately 1 h prior to sexual activity, over a period of 28 days.

OBJECTIVES

To assay the efficacy and safety of sildenafil 50 mg and placebo.

SETTING

Clinic- and home-based assessments in the United Kingdom.

METHODS

A total of 27 subjects who were able to achieve at least a grade 2 erection (hard, but not hard enough for penetration) in response to penile vibratory stimulation (PVS) were recruited. In Part I, the reflexogenic response of the penis to PVS was evaluated in the clinic while in Part II, the response to treatment was assessed in the home (global efficacy. questionniare, diary).

RESULTS

In Part I, 17/26 (65%) subjects had erections of >60% rigidity at the penile base (median duration 3.5 min) after sildenafil compared with 2/26 (8%) (median duration 0 min) alter placebo (P=0.0003). In Part II, 9/12 (75%) subjects on sildenafil and 1/14 (7%) subjects on placebo reported that the treatment had improved their erections (P<0.005), and 8/12 (67%) and 2/13 (15%) men, respectively, indicated that they wished to continue treatment (P<0.02). An analysis of diary data showed no difference between the groups with respect to the mean number of erections hard enough for penetration (P = 0.08). The mean proportion of attempts at sexual intercourse that were successful was 30 and 15%, respectively (P=0.21). Similarly, responses to the end-of-treatment questionnaire indicated that there were no significant differences between the groups with respect to the frequency of erections hard enough for sexual intercourse (P=0.47) or that lasted as long as the subject would have liked (P=0.11). No subject discontinued sildenafil due to adverse events.

CONCLUSION

Sildenafil is an effective, well-tolerated oral treatment for ED in SCI subjects.

Authors+Show Affiliations

Pfizer Central Research, Sandwich, UK.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10065749

Citation

Maytom, M C., et al. "A Two-part Pilot Study of Sildenafil (VIAGRA) in Men With Erectile Dysfunction Caused By Spinal Cord Injury." Spinal Cord, vol. 37, no. 2, 1999, pp. 110-6.
Maytom MC, Derry FA, Dinsmore WW, et al. A two-part pilot study of sildenafil (VIAGRA) in men with erectile dysfunction caused by spinal cord injury. Spinal Cord. 1999;37(2):110-6.
Maytom, M. C., Derry, F. A., Dinsmore, W. W., Glass, C. A., Smith, M. D., Orr, M., & Osterloh, I. H. (1999). A two-part pilot study of sildenafil (VIAGRA) in men with erectile dysfunction caused by spinal cord injury. Spinal Cord, 37(2), 110-6.
Maytom MC, et al. A Two-part Pilot Study of Sildenafil (VIAGRA) in Men With Erectile Dysfunction Caused By Spinal Cord Injury. Spinal Cord. 1999;37(2):110-6. PubMed PMID: 10065749.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A two-part pilot study of sildenafil (VIAGRA) in men with erectile dysfunction caused by spinal cord injury. AU - Maytom,M C, AU - Derry,F A, AU - Dinsmore,W W, AU - Glass,C A, AU - Smith,M D, AU - Orr,M, AU - Osterloh,I H, PY - 1999/3/5/pubmed PY - 1999/3/5/medline PY - 1999/3/5/entrez SP - 110 EP - 6 JF - Spinal cord JO - Spinal Cord VL - 37 IS - 2 N2 - STUDY DESIGN: This was a two-part pilot study in men with erectile dysfunction (ED) due to spinal cord injury (SCI: cord level range T6-L5). Part I was a randomised, double-blind, two-way cross-over study comparing a single dose of sildenafil 50 mg or placebo. Part II was a randomised, double-blind, parallel-group evaluation of sildenafil 50 mg or placebo, taken as required (not more than once daily) approximately 1 h prior to sexual activity, over a period of 28 days. OBJECTIVES: To assay the efficacy and safety of sildenafil 50 mg and placebo. SETTING: Clinic- and home-based assessments in the United Kingdom. METHODS: A total of 27 subjects who were able to achieve at least a grade 2 erection (hard, but not hard enough for penetration) in response to penile vibratory stimulation (PVS) were recruited. In Part I, the reflexogenic response of the penis to PVS was evaluated in the clinic while in Part II, the response to treatment was assessed in the home (global efficacy. questionniare, diary). RESULTS: In Part I, 17/26 (65%) subjects had erections of >60% rigidity at the penile base (median duration 3.5 min) after sildenafil compared with 2/26 (8%) (median duration 0 min) alter placebo (P=0.0003). In Part II, 9/12 (75%) subjects on sildenafil and 1/14 (7%) subjects on placebo reported that the treatment had improved their erections (P<0.005), and 8/12 (67%) and 2/13 (15%) men, respectively, indicated that they wished to continue treatment (P<0.02). An analysis of diary data showed no difference between the groups with respect to the mean number of erections hard enough for penetration (P = 0.08). The mean proportion of attempts at sexual intercourse that were successful was 30 and 15%, respectively (P=0.21). Similarly, responses to the end-of-treatment questionnaire indicated that there were no significant differences between the groups with respect to the frequency of erections hard enough for sexual intercourse (P=0.47) or that lasted as long as the subject would have liked (P=0.11). No subject discontinued sildenafil due to adverse events. CONCLUSION: Sildenafil is an effective, well-tolerated oral treatment for ED in SCI subjects. SN - 1362-4393 UR - https://www.unboundmedicine.com/medline/citation/10065749/A_two_part_pilot_study_of_sildenafil__VIAGRA__in_men_with_erectile_dysfunction_caused_by_spinal_cord_injury_ L2 - https://doi.org/10.1038/sj.sc.3100803 DB - PRIME DP - Unbound Medicine ER -