Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to study whether transcutaneous tibial nerve stimulation (TTNS) is a feasible and satisfactory treatment for overactive bladder in Urogynecology patients who receive their care at a county hospital.
Researchers will compare outcomes with TTNS to patients who undergo percutaneous tibial nerve stimulation (PTNS).
The main questions it aims to answer are:
Participants will:
Patients who consent to this study will be randomly assigned to either receive PTNS in clinic weekly, or TTNS every other day at home. The severity of their overactive bladder symptoms and satisfaction with treatment will be assessed before starting treatment as well as 6 weeks, 12 weeks and 6 months after starting treatment. The results of these surveys will be compared between groups to determine whether TTNS is non-inferior to PTNS in this particular patient population.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous tibial nerve stimulation (PTNS) | Active Comparator | Participants undergo weekly 30-minute percutaneous tibial nerve stimulation in our clinic. The PTNS device is a neuromodulation system comprised of an external signal generator attached to one electrode that is placed on the patient's foot, and the other to an acupuncture needle that is inserted in the patient's inner ankle. It delivers a low electrical signal (20 Hz, 200ms pulse width) to the posterior tibial nerve, adjusted to the participant's perception of stimulation without pain. |
|
| Transcutaneous tibial nerve stimulation (TTNS) | Experimental | Participants receive a TENS unit and are taught how to conduct TTNS therapy at home at their recruitment visit. The TENS unit is a neuromodulation system comprised of an external signal generator attached to one electrode that is placed on the patient's foot, and the other to an electrode patch that is inserted in the patient's inner ankle. It delivers a low electrical signal (20 Hz, 200ms pulse width) to the posterior tibial nerve, adjusted to the participant's perception of stimulation without pain. They will be instructed to conduct this therapy every other day at home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tibial nerve stimulation | Device | neuromodulation therapy for overactive bladder that targets the posterior tibial nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| ICIQ-OAB score | OAB symptom severity | Baseline, 6 weeks, 12 weeks, 6 months post treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Patient satisfaction with the intervention (Y/N; would you recommend it to others?) | 6 weeks, 12 weeks, 6 months post treatment initiation |
| PGI-I | Patient global assessment of overall improvement, graded on a scale of 1-7 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbor UCLA Medical Center | Torrance | California | 90509 | United States |
Not provided
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Randomized control trial
Not provided
Not provided
After randomization, patients and care providers will not be blinded, however investigators will be blinded to the results of the survey instruments.
|
| 6 weeks, 12 weeks, 6 months post treatment initiation |
| Compliance | Number and percentage of PTNS visits (PTNS arm); Patient reported number of self-administered TTNS treatments per week | 6 months post treatment initiation |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |