Back to resultsTreatment for Sexual Dysfunction in Women With Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries
Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Transcutaneous tibial nerve stimulation TENS® EMS NMS60 device
Genital vibration with Ferticare 2.0® vibrator
TENS® EMS NMS60 device_sham intervention
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal cord injuries, Women, Pelvic floor disorders, Sexuality
Eligibility Criteria
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.
Sites / Locations
- Cristina Lirio-Romero
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Intervention group 1: Transcutaneous tibial nerve stimulation (TTNS)
Intervention group 2: Genital vibration
Control group
Arm Description
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.
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.
A sham of TTNS intervention with the device turned off, twice a week.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05122325
Brief Title
Treatment for Sexual Dysfunction in Women With Spinal Cord Injury
Official Title
Vibration and Transcutaneous Tibial Nerve Stimulation as a Treatment for Sexual Dysfunction in Women With Spinal Cord Injury: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2024 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cristina Lirio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal cord injuries, Women, Pelvic floor disorders, Sexuality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group 1: Transcutaneous tibial nerve stimulation (TTNS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention group 2: Genital vibration
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
A sham of TTNS intervention with the device turned off, twice a week.
Intervention Type
Device
Intervention Name(s)
Transcutaneous tibial nerve stimulation TENS® EMS NMS60 device
Other Intervention Name(s)
TTNS
Intervention Description
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
Intervention Name(s)
Genital vibration with Ferticare 2.0® vibrator
Other Intervention Name(s)
vibration
Intervention Description
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
Intervention Name(s)
TENS® EMS NMS60 device_sham intervention
Other Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
The "Index of female sexual function (IFSF)"
Description
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.
Time Frame
5 minutes
Title
Sexual Quality of Life-Female (SQOL-F)
Description
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.
Time Frame
5 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Lirio-Romero, PhD
Phone
+34600320518
Email
cristina.lirio@uclm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Lirio-Romero, PhD
Organizational Affiliation
University of Castilla-La Mancha
Official's Role
Study Director
Facility Information:
Facility Name
Cristina Lirio-Romero
City
Toledo
ZIP/Postal Code
45001
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment for Sexual Dysfunction in Women With Spinal Cord Injury
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