Impact of Tibial Nerve Stimulation on Lumbopelvic Mechanics and Sexual Function in Females With Sexual Dysfunctions

NCT07764445 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/003690
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Female Sexual Dysfunction (FSD)

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  6 weeks

Secondary Outcomes (2)

• Pelvic floor muscle activity

  6 weeks

• Pain intensity

  6 weeks

Study Arms (2)

Pelvic floor exercise group

ACTIVE COMPARATOR

Kegel exercises will be performed for all participants for six weeks

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

Other: Pelvic floor exercise; Device: transcutaneous tibial nerve stimulation

Interventions

Pelvic floor exercise OTHER

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.

Also known as: Kegel exercise

Pelvic floor exercise group; Transcutaneous tibial nerve stimulation and pelvic floor exercise group

transcutaneous tibial nerve stimulation DEVICE

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.

Transcutaneous tibial nerve stimulation and pelvic floor exercise group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Deraya University: collaborator

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Study Officials

• Amel Youssef, professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Doaa Abdel Hady, PHD

CONTACT

01023600507; Doaaabdlnaser@gmail.com

Mahitab Yosri, PHD

CONTACT

01222606996; mahitab.yosri@pt.cu.edu.eg

Study Design

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

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

EG (1)