Female Sexual Dysfunction (FSD)NCT07764445
Impact of Tibial Nerve Stimulation on Lumbopelvic Mechanics and Sexual Function in Females With Sexual Dysfunctions
A study testing Pelvic floor exercise and transcutaneous tibial nerve stimulation in people with Female Sexual Dysfunction (FSD), run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to examine the effects of Transcutaneous Tibial Nerve Stimulation (TTNS) on lumbopelvic mechanics and sexual function in females with sexual dysfunctions and low back pain Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Female Sexual Dysfunction (FSD)
- What is being tested?
- Pelvic floor exercise and transcutaneous tibial nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females are diagnosed with low back pain combined with female sexual dysfunction.
- Their ages will be ranged from 25 to 35 years.
- Their body mass index (BMI) will be ranged from 23-28 kg/m2.
- Patients with a number of normal deliveries ≤ three times
- They had regular menstruation.
Who cannot join
- Prior history of disc prolapse and sacroiliac joints, symphysis pubic joint as well as lower limb problems.
- Genital prolapse.
- Leg length discrepancy.
- Urinary tract infection.
- Diastasis recti, diabetes, intrauterine device.
- Surgery related to the spine, abdomen or pelvis as well as skin disease that interferes with the usage of TTNS.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo university
Cairo
Doaa Abdel Hady, PHD, 01023600507, Doaaabdlnasser@gmail.com
About this study
Official title: Impact of Transcutaneous Tibial Nerve Stimulation on Lumbopelvic Mechanics and Sexual Function in Females With Sexual Dysfunctions and Low Back Pain: a Randomized Controlled Trial
This study will be conducted to examine the effects of Transcutaneous Tibial Nerve Stimulation (TTNS) on lumbopelvic mechanics and sexual function in females with sexual dysfunctions and low back pain
Read the detailed description
Female sexual dysfunction is a term used to describe various sexual problems, such as low desire or interest, diminished arousal, orgasmic difficulties, and dyspareunia. Female sexual dysfunction is considered common, with a widely quoted prevalence estimate of 43% from the U.S. Low back pain is one of the most common adult musculoskeletal disorders, impacting up to 65% of people per year.
Specifically, low back pain negatively impacts sexual activity due to discomfort during sexual relations that leads to a decrease in the frequency of sexual intercourse and alters feelings in the relationship with the partner, leading to a lack of desire or sexual activity.
Transcutaneous Tibial Nerve Stimulation (TTNS) is a non-invasive, low-risk electrical stimulation technique that modulates the sacral nerve plexus via stimulation of the posterior tibial nerve, with pelvic floor innervation. TTNS has demonstrated promising outcomes in managing overactive bladder, pelvic pain, and pelvic floor dysfunctions by improving neuromuscular activation, enhancing blood flow, and regulating sensory signaling pathways. Despite growing evidence supporting TTNS in pelvic health, its potential influence on spinal mechanics-such as lumbar angle, spinal mobility, and trunk inclination-remains underexplored, particularly in women experiencing low back pain associated with sexual dysfunction.
- Conditions
- Female Sexual Dysfunction (FSD)
- Being tested
- Pelvic floor exercise, transcutaneous tibial nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor exerciseOther
Also called Kegel exercise
The first step in doing Kegel exercises was identifying the muscles and the right muscle contraction, followed by both fast and slow contractions. Slow contractions of Kegel exercises that assist in pelvic floor strengthening were: (1) lifting the pelvic floor muscle for ten seconds and (2) holding the muscles tight while counting to ten, doing three repetitions of ten contractions (hold for 10 seconds and relax for 10 seconds) with a two-minute break in between. All individuals were told to relax their abdominals and gluteal muscles, not to hold their breath, and not to strain during pelvic floor muscle contractions.
transcutaneous tibial nerve stimulationDevice
Transcutaneous tibial nerve stimulation (TTNS), using an electrical stimulation device, model 5200, IOT Japan, was administered for 20 minutes, while the patient was lying supine on the bed with her head resting on a pillow. The electrodes were secured using tape; one was just posterior to the ankle's medial malleolus, and the other was roughly 10 cm above that. To guarantee that the electrodes activate the tibial nerve, a 10 Hz current frequency with a pulse length of 200 μs was delivered initially, with a gradual increase in the intensity to confirm a rhythmic hallux flexion movement.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor exercise group | Active comparator | Kegel exercises will be performed for all participants for six weeks Receives: Other: Pelvic floor exercise |
| Transcutaneous tibial nerve stimulation and pelvic floor exercise group | Experimental | Transcutaneous tibial nerve stimulation will be applied for the participants in the experimental group, for 20 minutes, 3 sessions weekly, along with pelvic floor exercises for 6 weeks Receives: Other: Pelvic floor exercise; Device: transcutaneous tibial nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index (FSFI)
The Female Sexual Function Index (FSFI) is a 19-item, self-report questionnaire used to assess female sexual function over the past 4 weeks. It is widely recognized as the gold standard instrument in both clinical trials and epidemiological studies. The index measures sexual functioning across six distinct areas: Desire: Frequency and level of sexual interest or drive. Arousal: Frequency, level, and confidence in becoming sexually excited. Lubrication: Ease and frequency of vaginal wetness during sexual activity. Orgasm: Frequency, difficulty, and satisfaction with reaching climax, Satisfaction: Level of satisfaction with closeness, partner, and overall sex life. Pain: Level of discomfort or pain during or after vaginal penetration. Total Score Range: The sum of all six weighted domain scores ranges from 2.0 to 36.0.Clinical Cut-off: A total score of 26.55 or lower indicates a risk for female sexual dysfunction (FSD).
Measured: 6 weeks
Pelvic inclination angle
The pelvic inclination angle defines the spatial orientation of the pelvis relative to a vertical line or the horizontal plane. the spinal mouse system will be used to measure it. The device records the raw angle when it passes over the sacral base, specifically between the first sacral vertebra (S1) and the top of the natal cleft. Normal Standing Range: 10 to 25 degrees . More than 25 degrees indicates excessive anterior pelvic tilt. Less than 10 degrees indicates posterior pelvic tilt.
Measured: 6 weeks
lumbar lordotic angle
Spinal Mouse system is a safe, non-invasive electronic device that measures lumbar lordosis and spinal mobility by rolling along the skin over the spinous processes. It provides a radiation-free, quick, and reliable alternative to X-rays for clinical posture assessment. Software uses a mathematical algorithm to calculate the local angle of each vertebral segment. The system sums these local segments to provide the global lumbar lordotic angle in degrees.
Measured: 6 weeks
Spinal mobility
Spinal mobility is calculated by the Spinal Mouse system as the change in angular position between different postural states, specifically measuring the spine's capacity to bend forward and backward.
Measured: 6 weeks
Secondary outcomes (2)
Pelvic floor muscle activity
An Ultrasound imaging unit with a convex transducer will be used at a frequency of 5 MHz for evaluating the thickness and voluntary pelvic floor muscle (PFM) contractions' force (strength) of all patients.
The measurements will be taken with a full bladder while the woman is in crock position, with the lumbar spine neutrally positioned, and the hips and knees bent to 60°. The ultrasound transducer is inserted transversely across the midline of the abdomen directly superior to the symphysis pubis, with an angle of about 60° from vertical. A marker (X) was placed on the image of the bladder at the junction of the hyper- and hypoechoic structures. Another marker was placed at the end of the muscle, and then the measurement will be taken as the distance between the two points. Women will perf three maximal contractions so that displacement of the posterior bladder wall, as a result of PFM contraction, could be measured. The mean of the three measures will be taken and analyzed.
Measured: 6 weeks
Pain intensity
A Visual Analog Scale (VAS) will be used to measure low back pain intensity. It is a horizontal line, usually 10 cm long, whose ends are labeled as the extreme 0 "no pain" and 10 "severe pain" .
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startAug 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual Dysfunction (FSD)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Deraya University
- Responsible party
- Principal investigator, Doaa Abdel Naser Abd El-Hady, Cairo University
- Investigators
- Amel Youssef, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764445
- Sponsor's protocol ID
- P.T.REC/012/003690
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcutaneous Tibial Nerve Stimulation on Lumbopelvic Mechanics and Sexual Function in Females With Sexual Dysfunctions and Low Back Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07764445
- Acronym / sponsor ID
- P.T.REC/012/003690
- Conditions
- Female Sexual Dysfunction (FSD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Deraya University
- Study start
- Aug 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to examine the effects of Transcutaneous Tibial Nerve Stimulation (TTNS) on lumbopelvic mechanics and sexual function in females with sexual dysfunctions and low back pain
Detailed description
Female sexual dysfunction is a term used to describe various sexual problems, such as low desire or interest, diminished arousal, orgasmic difficulties, and dyspareunia. Female sexual dysfunction is considered common, with a widely quoted prevalence estimate of 43% from the U.S. Low back pain is one of the most common adult musculoskeletal disorders, impacting up to 65% of people per year.
Specifically, low back pain negatively impacts sexual activity due to discomfort during sexual relations that leads to a decrease in the frequency of sexual intercourse and alters feelings in the relationship with the partner, leading to a lack of desire or sexual activity.
Transcutaneous Tibial Nerve Stimulation (TTNS) is a non-invasive, low-risk electrical stimulation technique that modulates the sacral nerve plexus via stimulation of the posterior tibial nerve, with pelvic floor innervation. TTNS has demonstrated promising outcomes in managing overactive bladder, pelvic pain, and pelvic floor dysfunctions by improving neuromuscular activation, enhancing blood flow, and regulating sensory signaling pathways. Despite growing evidence supporting TTNS in pelvic health, its potential influence on spinal mechanics-such as lumbar angle, spinal mobility, and trunk inclination-remains underexplored, particularly in women experiencing low back pain associated with sexual dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor exercise group | Active comparator | Other: Pelvic floor exerciseKegel exercises will be performed for all participants for six weeks |
| Transcutaneous tibial nerve stimulation and pelvic floor exercise group | Experimental | Other: Pelvic floor exercise, Device: transcutaneous tibial nerve stimulationTranscutaneous tibial nerve stimulation will be applied for the participants in the experimental group, for 20 minutes, 3 sessions weekly, along with pelvic floor exercises for 6 weeks |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females are diagnosed with low back pain combined with female sexual dysfunction.
- Their ages will be ranged from 25 to 35 years.
- Their body mass index (BMI) will be ranged from 23-28 kg/m2.
- Patients with a number of normal deliveries ≤ three times
- They had regular menstruation.
Key exclusion criteria (6 listed)
- Prior history of disc prolapse and sacroiliac joints, symphysis pubic joint as well as lower limb problems.
- Genital prolapse.
- Leg length discrepancy.
- Urinary tract infection.
- Diastasis recti, diabetes, intrauterine device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor exerciseAlso: Kegel exerciseThe first step in doing Kegel exercises was identifying the muscles and the right muscle contraction, followed by both fast and slow contractions. Slow contractions of Kegel exercises that assist in pelvic floor strengthening were: (1) lifting the pelvic floor muscle for ten seconds and (2) holding the muscles tight while counting to ten, doing three repetitions of ten contractions (hold for 10 seconds and relax for 10 seconds) with a two-minute break in between. All individuals were told to relax their abdominals and gluteal muscles, not to hold their breath, and not to strain during pelvic floor muscle contractions. | Other | Pelvic floor exercise group, Transcutaneous tibial nerve stimulation and pelvic floor exercise group |
| transcutaneous tibial nerve stimulationTranscutaneous tibial nerve stimulation (TTNS), using an electrical stimulation device, model 5200, IOT Japan, was administered for 20 minutes, while the patient was lying supine on the bed with her head resting on a pillow. The electrodes were secured using tape; one was just posterior to the ankle's medial malleolus, and the other was roughly 10 cm above that. To guarantee that the electrodes activate the tibial nerve, a 10 Hz current frequency with a pulse length of 200 μs was delivered initially, with a gradual increase in the intensity to confirm a rhythmic hallux flexion movement. | Device | Transcutaneous tibial nerve stimulation and pelvic floor exercise group |
Primary outcome
Female Sexual Function Index (FSFI)
Time frame: 6 weeks
The Female Sexual Function Index (FSFI) is a 19-item, self-report questionnaire used to assess female sexual function over the past 4 weeks. It is widely recognized as the gold standard instrument in both clinical trials and epidemiological studies. The index measures sexual functioning across six distinct areas: Desire: Frequency and level of sexual interest or drive. Arousal: Frequency, level, and confidence in becoming sexually excited. Lubrication: Ease and frequency of vaginal wetness during sexual activity. Orgasm: Frequency, difficulty, and satisfaction with reaching climax, Satisfaction: Level of satisfaction with closeness, partner, and overall sex life. Pain: Level of discomfort or pain during or after vaginal penetration. Total Score Range: The sum of all six weighted domain scores ranges from 2.0 to 36.0.Clinical Cut-off: A total score of 26.55 or lower indicates a risk for female sexual dysfunction (FSD).
Pelvic inclination angle
Time frame: 6 weeks
The pelvic inclination angle defines the spatial orientation of the pelvis relative to a vertical line or the horizontal plane. the spinal mouse system will be used to measure it. The device records the raw angle when it passes over the sacral base, specifically between the first sacral vertebra (S1) and the top of the natal cleft. Normal Standing Range: 10 to 25 degrees . More than 25 degrees indicates excessive anterior pelvic tilt. Less than 10 degrees indicates posterior pelvic tilt.
lumbar lordotic angle
Time frame: 6 weeks
Spinal Mouse system is a safe, non-invasive electronic device that measures lumbar lordosis and spinal mobility by rolling along the skin over the spinous processes. It provides a radiation-free, quick, and reliable alternative to X-rays for clinical posture assessment. Software uses a mathematical algorithm to calculate the local angle of each vertebral segment. The system sums these local segments to provide the global lumbar lordotic angle in degrees.
Spinal mobility
Time frame: 6 weeks
Spinal mobility is calculated by the Spinal Mouse system as the change in angular position between different postural states, specifically measuring the spine's capacity to bend forward and backward.
2 secondary outcomes
Pelvic floor muscle activity
Time frame: 6 weeks
Pain intensity
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amel Youssef, professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor exercise and transcutaneous tibial nerve stimulation in people with Female Sexual Dysfunction (FSD), run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doaa Abdel Hady, PHD (01023600507, Doaaabdlnaser@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (FSFI) (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.