Trial Outcomes & Findings for Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction (NCT NCT04122703)
NCT ID: NCT04122703
Last Updated: 2026-05-14
Results Overview
Female Sexual Function Index (FSFI) is a 19-item questionnaire used to assess female sexual function. Minimum score is 1.2 and maximum score is 36. A score of 26.55 or lower is classified as sexual dysfunction
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
Baseline, at week 6 and at week 12
Results posted on
2026-05-14
Participant Flow
recruitment goal not met due to covid
Participant milestones
| Measure |
Percutaneous Tibial Nerve Stimulation (PTNS)
The patients in the PTNS group will receive 1 PTNS treatments per week for 12 weeks.
percutaneous tibial nerve stimulation (PTNS): The PTNS treatments will be given in 30 min sessions. The PTNS treatment consists of inserting a 34-gauge needle electrode approximately 5 cm cephalad to the medial malleolus and, as well as placing a PTNS surface electrode on the ipsilateral calcaneus. To keep the electrode placement consistent with the sham treatment, 2 inactive transcutaneous electrical nerve stimulation (TENS) surface electrodes are also added, 1 placed under the little toe and 1 on the top of the foot. The PTNS lead set is connected to the Urgent PC stimulator, and a current level of 0.5 to 10 mA at 20 Hz is delivered until the flexion of the big toe is observed or the patient reports a radiating sensation at the sole of the foot.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
The patients in the Sham group will receive one sham (TENS) treatment per week for 12 weeks
Sham procedure: The sham treatment, involves simulating the sensation of the PTNS needle insertion at the same location using a Steritberger placebo needle. This is a blunt tip needle which simulates the sensation of a needle prick when touched to the skin, however, the blunt tip retracts into the handle when pressed into the skin. This creates the illusion of the needle entering the skin, without breaking the skin's surface. An inactive PTNS surface electrode is also placed on the ipsilateral calcaneus. The two TENS surface electrodes, placed in the same location as the PTNS treatment, are active and deliver stimulation mimicking the sensory effects of the PTNS. However, since no electrode needles were inserted near the tibial nerve, there will be no tibial nerve stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
40
|
|
Overall Study
COMPLETED
|
34
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Percutaneous Tibial Nerve Stimulation (PTNS)
n=39 Participants
The patients in the PTNS group will receive 1 PTNS treatments per week for 12 weeks.
percutaneous tibial nerve stimulation (PTNS): The PTNS treatments will be given in 30 min sessions. The PTNS treatment consists of inserting a 34-gauge needle electrode approximately 5 cm cephalad to the medial malleolus and, as well as placing a PTNS surface electrode on the ipsilateral calcaneus. To keep the electrode placement consistent with the sham treatment, 2 inactive transcutaneous electrical nerve stimulation (TENS) surface electrodes are also added, 1 placed under the little toe and 1 on the top of the foot. The PTNS lead set is connected to the Urgent PC stimulator, and a current level of 0.5 to 10 mA at 20 Hz is delivered until the flexion of the big toe is observed or the patient reports a radiating sensation at the sole of the foot.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=40 Participants
The patients in the Sham group will receive one sham (TENS) treatment per week for 12 weeks
Sham procedure: The sham treatment, involves simulating the sensation of the PTNS needle insertion at the same location using a Steritberger placebo needle. This is a blunt tip needle which simulates the sensation of a needle prick when touched to the skin, however, the blunt tip retracts into the handle when pressed into the skin. This creates the illusion of the needle entering the skin, without breaking the skin's surface. An inactive PTNS surface electrode is also placed on the ipsilateral calcaneus. The two TENS surface electrodes, placed in the same location as the PTNS treatment, are active and deliver stimulation mimicking the sensory effects of the PTNS. However, since no electrode needles were inserted near the tibial nerve, there will be no tibial nerve stimulation
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=79 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=39 Participants
|
30 Participants
n=40 Participants
|
58 Participants
n=79 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=39 Participants
|
10 Participants
n=40 Participants
|
21 Participants
n=79 Participants
|
|
Age, Continuous
|
41 years
n=39 Participants
|
41 years
n=40 Participants
|
41 years
n=79 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=39 Participants
|
40 Participants
n=40 Participants
|
79 Participants
n=79 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=79 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
39 participants
n=39 Participants
|
40 participants
n=40 Participants
|
79 participants
n=79 Participants
|
PRIMARY outcome
Timeframe: Baseline, at week 6 and at week 12Female Sexual Function Index (FSFI) is a 19-item questionnaire used to assess female sexual function. Minimum score is 1.2 and maximum score is 36. A score of 26.55 or lower is classified as sexual dysfunction
Outcome measures
| Measure |
Percutaneous Tibial Nerve Stimulation (PTNS)
n=34 Participants
The patients in the PTNS group will receive 1 PTNS treatments per week for 12 weeks.
percutaneous tibial nerve stimulation (PTNS): The PTNS treatments will be given in 30 min sessions. The PTNS treatment consists of inserting a 34-gauge needle electrode approximately 5 cm cephalad to the medial malleolus and, as well as placing a PTNS surface electrode on the ipsilateral calcaneus. To keep the electrode placement consistent with the sham treatment, 2 inactive transcutaneous electrical nerve stimulation (TENS) surface electrodes are also added, 1 placed under the little toe and 1 on the top of the foot. The PTNS lead set is connected to the Urgent PC stimulator, and a current level of 0.5 to 10 mA at 20 Hz is delivered until the flexion of the big toe is observed or the patient reports a radiating sensation at the sole of the foot.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=30 Participants
The patients in the Sham group will receive one sham (TENS) treatment per week for 12 weeks
Sham procedure: The sham treatment, involves simulating the sensation of the PTNS needle insertion at the same location using a Steritberger placebo needle. This is a blunt tip needle which simulates the sensation of a needle prick when touched to the skin, however, the blunt tip retracts into the handle when pressed into the skin. This creates the illusion of the needle entering the skin, without breaking the skin's surface. An inactive PTNS surface electrode is also placed on the ipsilateral calcaneus. The two TENS surface electrodes, placed in the same location as the PTNS treatment, are active and deliver stimulation mimicking the sensory effects of the PTNS. However, since no electrode needles were inserted near the tibial nerve, there will be no tibial nerve stimulation
|
|---|---|---|
|
Female Sexual Function Index (FSFI)
Baseline
|
16.72 score on a scale
Interval 16.23 to 17.22
|
16.88 score on a scale
Interval 16.36 to 17.42
|
|
Female Sexual Function Index (FSFI)
Week6
|
22.02 score on a scale
Interval 20.15 to 24.08
|
21.22 score on a scale
Interval 19.28 to 23.34
|
|
Female Sexual Function Index (FSFI)
Week12
|
24.29 score on a scale
Interval 22.03 to 26.79
|
22.42 score on a scale
Interval 20.2 to 24.89
|
Adverse Events
PTNS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place