Treatment for Sexual Dysfunction in Women with Spinal Cord Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-30

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Use of Penile Vibratory Stimulation to Decrease Spasticity Following Spinal Cord Injury

NCT00223873

Spinal Cord Injury Muscle Spasticity

COMPLETED NA

Effect of Peripheral Neuromodulation on Vaginal Blood Flow - Study 2

NCT06999265

Female Sexual Dysfunction Female Sexual Dysfunction Due to Physical Condition

COMPLETED NA

Effects of Spinal Cord Injury on Female Sexual Response

NCT00142714

Female Sexual Dysfunction Multiple Sclerosis Spinal Cord Injury

UNKNOWN NA

Effect of Peripheral Neuromodulation on Vaginal Blood Flow

NCT04384172

Female Sexual Dysfunction Spinal Cord Injuries

COMPLETED NA

Transcutaneous Spinal Cord Electrical Stimulation Combined With Kunming Locomotor Training for the Treatment of Spinal Cord Injury

NCT06802640

Spinal Cord Injuries

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The allocation will be randomly assign to the three groups: an intervention group 1 transcutaneous electrostimulation of tibial nerve (n = 18), an intervention group 2 genital vibration (n = "18) and a control group (n = 18). The treatment time will be 12 weeks. Treatment adherence, as well as treatment effectiveness, will be evaluated through the Female Sexual Function Index, the "Sexual Quality of Life-Female" questionnaire, quantitative sensory tests and the improvement reported by the patient in arousal and orgasm. Evaluations will be carried out before treatment, at the end of the treatment, and at 3 and 6 months after the end of treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will randomize to three groups: an intervention group 1 contracted transcutaneous electrostimulation through the tibial nerve (n = 18), an intervention group 2 that occurred with genital vibration (n = "18) and a control group (n = 18)

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Blind and concealed randomisation will be performed in assessment and data analysis. The assignment to groups will only be known by the main researcher who will be in charge of indicating in a sealed envelope to care providers and each participant the group to which participants have been assigned.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group 1: Transcutaneous tibial nerve stimulation (TTNS)

Transcutaneous application of low frequency electrical current over the tibial nerve TENS® EMS NMS60 for a 30 minutes session, twice a week.

Placing a small electrode 3 fingers up to the internal malleolus and 1 cm posterior (adjusting its placement with a point finder or testing with low frequencies of 2-3 Hz). A large electrode placed in the calcaneus.

Group Type EXPERIMENTAL

Transcutaneous tibial nerve stimulation TENS® EMS NMS60 device

Intervention Type 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).

Intervention group 2: Genital vibration

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

Group Type EXPERIMENTAL

Genital vibration with Ferticare 2.0® vibrator

Intervention Type DEVICE

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.

Control group

A sham of TTNS intervention with the device turned off, twice a week.

Group Type SHAM_COMPARATOR

TENS® EMS NMS60 device_sham intervention

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TTNS vibration Control

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women with incomplete spinal cord injury B, C or D (with preservation of the sacral arch and sensitive assessment of the lower dermatomes not absent, paying special attention to the sensitivity of the genital area) level below T6.
* between 18-60 years
* hormonal analysis. Participants do not present menopausal values of the hormone FSH (follicle stimulating hormone ) (31- 134 U / L)
* present some type of sexual disorder secondary to spinal cord injury with at least 12 months of evolution
* from Spain
* willing to attend the evaluation and treatment center
* seeking to improve in the sexual area.

Exclusion Criteria

* women with active pregnancy
* present pre-existing pathologies in the genital area
* genital malformation, previous neurosurgery that affects the genital response capacity
* sexual disorders before the injury
* pressure ulcers, serious medical illness or any type of pathology in which the use of sick leave is contraindicated frequency
* psychiatric disorder, narcotic dependence, use of specific serotonin reuptake inhibitors, antipsychotics or other drugs that affect sexual response.
* does not sign the informed consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No