Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT05122325
NA

Treatment for Sexual Dysfunction in Women with Spinal Cord Injury

Sponsor: Cristina Lirio

View on ClinicalTrials.gov

Summary

Women with spinal cord injury frequently experience sexual dysfunction such as disturbances during arousal and an increased time to orgasm. However, little evidence has been found on its therapeutic approach and low adherence. To verify the effectiveness of two interventions: the application of genital vibration and transcutaneous stimulation of the tibial nerve. This is a randomized clinical trial. 54 women will be recruited who suffer from sexual dysfunction.

Official title: Vibration and Transcutaneous Tibial Nerve Stimulation As a Treatment for Sexual Dysfunction in Women with Spinal Cord Injury: a Randomized Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2026-06

Completion Date

2027-01

Last Updated

2025-02-19

Healthy Volunteers

No

Interventions

DEVICE

Transcutaneous tibial nerve stimulation TENS® EMS NMS60 device

Stimulation sessions with a TENS® EMS NMS60 device. These will be carried out for 30 minutes, once a week at 10 Hz, with a pulse width of 200 μs and an intensity between 0 and 100 mA, which will be individually adjusted to each participant. Inicially, frequency between 2-3 Hz, so that when the current passes, a contraction-relaxation will cause the first toe movement visually evident (excitomotor threshold). Once verified, the frequency is raised to what has been established between 10Hz and there the intensity is increased without having to now reach the excitomotor threshold, as long as the physiotherapist notice it is enough (it must be tolerable).

DEVICE

Genital vibration with Ferticare 2.0® vibrator

Women will be instructed in the use of the Ferticare 2.0® vibrator. Initially, a practice will be carried out , indicating that the frequency of use will be 70 Hz with an amplitude of 1.5 mm. It will be recommended to gradually increase its use over time, with a limit of 30 minutes a day.

DEVICE

TENS® EMS NMS60 device_sham intervention

Sham of TTNS intervention with Stimulation sessions with a TENS® EMS NMS60 device. These will be carried out for 30 minutes, once a week. Inicially, frequency between 2-3 Hz, so that when the current passes, a contraction-relaxation will cause the first toe movement visually evident (excitomotor threshold). Once verified, the intensity is decreased to lower the sensitive threshold of treatment.

Locations (1)

Cristina Lirio-Romero

Toledo, Toledo, Spain