Treatment for Sexual Dysfunction in Women with Spinal Cord Injury

NCT05122325 | Enrolling By Invitation

• 1 other identifier: CLirio06
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injuries; Women; Pelvic floor disorders; Sexuality

Outcome Measures

Primary Outcomes (2)

• The "Index of female sexual function (IFSF)"

  This questionnaire showed validity, internal consistency in all its domains, specifically Cronbach's Alpha 0.745 in arousal and 0.753 in orgasm and test-retest reliability of ICC 0.96. This questionnaire consists of 19 questions and is grouped into six domains. The score for each domain is multiplied by a factor and the final result is the arithmetic sum of the domains. The higher the score, the better sexuality.

  5 minutes

• Sexual Quality of Life-Female (SQOL-F)

  SQOL-F showed good validity and reliability. The questionnaire was developed to measure the impact of sexual disorders on quality of life. This questionnaire consists of 18 questions with a response scale of 6 options. The quality of sexual life will be considered poor if the score is between 18-51, moderate between 51-84 and good if it is greater than 84.

  5 minutes

Study Arms (3)

Intervention group 1: Transcutaneous tibial nerve stimulation (TTNS)

EXPERIMENTAL

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.

Device: Transcutaneous tibial nerve stimulation TENS® EMS NMS60 device

Intervention group 2: Genital vibration

EXPERIMENTAL

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.

Device: Genital vibration with Ferticare 2.0® vibrator

Control group

SHAM COMPARATOR

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

Device: TENS® EMS NMS60 device_sham intervention

Interventions

Transcutaneous tibial nerve stimulation TENS® EMS NMS60 device 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).

Also known as: TTNS

Intervention group 1: Transcutaneous tibial nerve stimulation (TTNS)

Genital vibration with Ferticare 2.0® vibrator 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.

Also known as: vibration

Intervention group 2: Genital vibration

TENS® EMS NMS60 device_sham intervention 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.

Also known as: Control

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cristina Lirio: lead

Study Sites (1)

Cristina Lirio-Romero

Toledo, Toledo, 45001, Spain

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Pelvic Floor Disorders; Sexuality

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Sexual Behavior; Behavior

Study Officials

• Cristina Lirio-Romero, PhD

  University of Castilla-La Mancha

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: 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)

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 16, 2021
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)