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Clinical Studies

A Guide and Resource Directory to Male Fertility Following Spinal Cord Injury/Dysfunction
By Maria J. Amador, B.S.N., CRRNCharles M. Lynne, M.D.Nancy L. Brackett, Ph.D., HCLD
A publication funded by the Paralyzed Veterans of AmericaSpinal Cord Injury Education and Training Foundation  

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Transcutaneous Mechanical Nerve Stimulation Using Perineal Vibration: A Novel Method for the Treatment of Female Stress Urinary Incontinence
JensSønksen,*DanaA.Ohl,†,‡BirtheBonde, Line Læssøe and Edward J. Mc Guire§
From the Department of Urology, Herlev Hospital, University of Copenhagen, and the GYN-OBS Clinic, Copenhagen, Denmark, and the Department of Urology, University of Michigan, Ann Arbor, Michigan

Purpose: We defined basic guidelines for transcutaneous mechanical nerve stimulation in modifying pelvic floor responses in women and determined the efficacy of transcutaneous mechanical nerve stimulation in treating stress urinary incontinence.

Materials and Methods: Perineal and clitoral transcutaneous mechanical nerve stimulation was performed in healthy volunteers while measuring changes in peak urethral pressure to determine optimal vibration amplitude and site of stimulation. Perineal transcutaneous mechanical nerve stimulation was then performed weekly for 6 weeks in a cohort of women with stress urinary incontinence. Reduction in incontinence episodes and pad use on voiding diary were compared from baseline to 6 weeks. Global efficacy was determined at 6 weeks and 3 months after the completion of the program.

Results: In healthy subjects a vibration amplitude of 2.0mm resulted in the highest urethral pressure increase. Although the increase with perineal transcutaneous mechanical nerve stimulation was lower than that seen with clitoral stimulation (80 vs 115 cm H2O), perineal transcutaneous mechanical nerve stimulation was more acceptable to the patient and resulted in a better subjective response. Urethral pressure increases with transcutaneous mechanical nerve stimulation at either site were greater than with voluntary contraction (60 cm H2O). After 6 weeks of transcutaneous mechanical nerve stimulation in the subjects with stress urinary incontinence, there was a significant reduction in daily incontinence episodes (2.60 ± 1.1 vs 0.5 ±1.1, paired t test p <0.001) and pad use (3.5 ± 0.9 vs 0.6 ± 1.3, paired t test p  <0.001). At 6 weeks the cure rate (no incontinence episodes) was73%, with durability through 3 months with 67% still reporting persistent resolution.

Conclusions: Perineal transcutaneous mechanical nerve stimulation has promise as a non invasive and well tolerated method of treating stress urinary incontinence.

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Antispastic Effect of Penile Vibration in Men With Spinal Cord Lesion
LineLjssøe, MD, Jens Bo Nielsen, FinBiering-Sørensen, MD, Jens Sønksen ,MD ABSTRACT. Læssøe L, Nielsen JB, Biering-Sørensen F, Sønksen J.
Antispastic effect of penile vibration in men with spinal cord lesion. Arch Phys Med Rehabil 2004;85:919-24.

Objective: To evaluate the possible antispastic effect penile vibratory stimulation (PVS) in men with spinal cord  lesionDesign:Unblinded, before-after trial.

Setting: Ambulatory care.

Participants: Nine men with SCLs from C2 to T8 were randomly allocated into 2 groups. Intervention: Twenty-four hours of electromyographic recordings from the quadriceps and tibialis anterior muscles were taken, followed by PVS or no treatment and another 24 hours of electromyographic recordings. The presence of electromyographic activity of an amplitude 4 times the baseline, with a duration of more than 5 seconds, was taken to signify a spasm. The number of spasms per hour was calculated before and after PVS and no treatment. Spasticity was evaluated by the Modified Ashworth Scale(MAS).

Main Outcome Measure: Reduction in spasticity and spasms.

Results: The electromyographic data showed a significant reduction in the frequency of leg spasms up to 3 hours (P<.05). Significantly decreased spasticity, as evaluated by MAS, was found immediately after vibration (P<.01).Conclusions: PVS may be useful as an antispastic therapy.

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AN ANALYSIS OF 653 TRIALS OF PENILE VIBRATORY STIMULATION IN MEN WITH SPINAL CORD INJURY
The Journal of Urology Copyright © 1998 by American Urological Association, Inc.
BRACKETT, NANCY L.; FERRELL, SEAN M.; ABALLA, TEODORO C.; AMADOR, MARIA J.; PADRON,OSVALDO F.; SONKSEN, JENS; LYNNE, CHARLES M.

From the Miami Project to Cure Paralysis and Department of Urology, University of Miami School of Medicine, Miami, Florida, and Department of Urology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark Accepted for publication December 12, 1997.

Supported in part by grants from the State of Florida and The Miami Project to Cure Paralysis.(BRACKETT) Requests for reprints: The Miami Project to Cure Paralysis, University of Miami School of Medicine, P.O. Box016960, R-48, Miami, Florida 33136.

Abstract Purpose: We evaluated ejaculatory response and semen quality in 653 trials of penile vibratory stimulation in 211 men with spinal cord injury, and compared results with low versus high amplitude vibratory stimulation.

Materials and Methods: Low and/or high amplitude penile vibratory stimulation was performed 1 to 27 times in each patient, and antegrade and retrograde specimens of those who ejaculated were analyzed.

Results: Significantly more patients ejaculated using high (54.5%) versus low (39.9%) amplitude stimulation. Using either amplitude the ejaculatory success rate was highest in men with injuries at C3 to C7, followed by T1 to T5, T6 to T10 and T11 to L3. While high amplitude stimulation increased the ejaculatory success rate in each group, the highest rate occurred in men with injuries at C3 to C7 (65.6%). Ejaculation was reliable, since most men who ejaculated did so during 100% of the trials and within 2 minutes of stimulation onset. Symptoms of autonomic dysreflexia were safely managed with nifedipine. All patients who ejaculated produced antegrade specimens. With the exception of ejaculate volume, which was significantly higher with high versus low amplitude stimulation, semen parameters were similar using both vibrator amplitudes.

Conclusions: Ejaculatory success is better while semen quality is similar using high versus low amplitude penile vibratory stimulation in men with spinal cord injury. This method may be considered first line treatment for anejaculation in men with spinal cord injury. This method may be relative effectiveness, and relatively low investment of time and money.

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