The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research.
D J Buysse, C F Reynolds, T H Monk...
https://pubmed.ncbi.nlm.nih.gov/2748771/Actively Recruiting
Led by Daniel David Álamo Arce · Updated on 2025-06-13
25
Participants Needed
1
Research Sites
4 weeks
Total Duration
Overactive bladder OAB is a common condition causing urgency, frequent urination, and sometimes urge incontinence. Researchers are evaluating non-invasive neuromodulation techniques as alternative treatments for OAB patients who have not responded well to conventional therapies. This study aims to compare the effects of non-invasive NESA neuromodulation with posterior tibial nerve stimulation on quality of life, symptoms, discomfort, and sleep in adults with OAB. The study involves 24 women aged 38 to 85 years who will undergo ten treatment sessions twice a week. One group will receive NESA neuromodulation using a device that emits very low frequency, intensity, and voltage currents through electrodes on gloves and anklets, combined with pelvic exercises and patient education. The other group will receive transcutaneous posterior tibial nerve stimulation using a TENS device with electrodes placed along the tibial nerve pathway, also combined with pelvic exercises and education. Participants will be assessed before treatment, immediately after the ten sessions, and at two months post-treatment. Researchers will measure quality of life with the SF-36 questionnaire, sleep quality with the Pittsburgh questionnaire, urinary incontinence symptoms with the ICIQ-SF, bladder control with the B-SAQ, and patient satisfaction at follow-up. The study includes monitoring for safety and adherence, with all participants providing informed consent.
CONDITIONS
NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation
R
Raquel I Medina-Ramírez, PhD. Physiotherapist
L
Laura FUENTES-APARICIO, PhD. Physical Therapy
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Daniel David Álamo Arce
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive non-invasive neuromodulation treatment using either the NESA or posterior tibial nerve stimulation devices, combined with pelvic exercises and education.
Daily visits for treatment sessions during the intervention period
Duration - 2 months
Participants complete questionnaires and assessments immediately after treatment ends and again at two months to evaluate outcomes and satisfaction.
2 visits (in-person) for outcome assessments post-treatment
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
D J Buysse, C F Reynolds, T H Monk...
https://pubmed.ncbi.nlm.nih.gov/2748771/Esther Teruel-Hernández, José Antonio López-Pina, Sonia Souto-Camba...
https://pubmed.ncbi.nlm.nih.gov/37947583/Mikolaj Przydacz, Tomasz Golabek, Przemyslaw Dudek...
https://pubmed.ncbi.nlm.nih.gov/33188254/Chi-Wen Lo, Mei-Yi Wu, Stephen Shei-Dei Yang...
https://pubmed.ncbi.nlm.nih.gov/32085542/Daniel David Álamo Arce
Lead Sponsor