A Novel Wearable Transcutaneous Tibial Nerve Stimulation (TTNS) Device in the Treatment of Patients With Overactive Bladder (OAB) and Nocturia
A Novel Wearable Transcutaneous Tibial Nerve Stimulation (TTNS) Device Combined With Behavioral Therapy (BT) Versus Behavioral Therapy in the Treatment of Patients With Overactive Bladder (OAB) and Nocturia: a Prospective, Randomized Controlled Study
Overactive bladder (OAB) is a syndrome with urgency as the main symptom, usually accompanied by frequent urination, nocturia, and sometimes urge urinary incontinence. Globally, the prevalence of OAB in the general population has been reported to be about 20%. Nocturia was defined as the patient waking up at least once during the night to urinate. Among lower urinary tract symptoms, nocturia can significantly affect daily life and quality of life. Reported causes of nocturia include nocturnal polyuria, sleep disorders, circadian rhythm disruption (e.g., circadian rhythm sleep disorders), and reduced bladder capacity. Because overactive bladder (OAB) may be associated with reduced bladder capacity, anticholinergic agents are used as standard therapy in the management of nocturia associated with OAB. However, anticholinergic medications are associated with poor adherence, such as inadequate efficacy and adverse effects (e.g., dry mouth, constipation, and cognitive impairment). Therefore, it is imperative to find alternative therapies for anticholinergic drugs.
Previous studies have shown that transcutaneous tibial nerve stimulation (TNS) can also significantly improve lower urinary tract symptoms, such as frequency, urgency, incontinence, and nocturia, and is also one of the options for the treatment of OAB. A previous study also demonstrated its improvement in sleep quality in women with nocturia. However, the efficacy of tibial nerve stimulation in the treatment of active bladder with nocturia is still a blank, and further studies are needed.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
In strict accordance with the inclusion criteria and exclusion criteria, appropriate research participants were screened to participate in this clinical study. At least 80 cases were completed, with 40 cases in the experimental group and 40 cases in the control group.
Participants in group A were treated with A new wearable transcutaneous tibial nerve stimulation (TTNS) device combined with behavioral therapy (BT), while participants in group B were treated with behavioral therapy alone. Participants were followed up at 4, 8, and 12 weeks after enrollment. The improvement of voiding symptoms (frequent urination, urgency, urge incontinence, etc.) and sleep quality were analyzed at different stages.
Treatment assignments: Group A, participants received tibial nerve stimulation three times a week (30 minutes each time) in combination with daily behavioral therapy. Group B: The study participants received daily behavioral therapy, and the improvement of symptoms was observed in the study participants at all stages.
Baseline data of all participants were collected at the time of enrollment: (1) basic information of patients, including age, gender, height, weight, history of smoking and alcohol, lower urinary tract dysfunction symptoms, previous treatment of OAB and nocturia, and medication history; (2) Pittsburgh sleep Quality index (PSQI); (3) standardized 72-hour voiding diary, sleep onset and awakening time, voiding volume and time, fluid intake and time, and incontinence time; (4) previous treatment of OAB and nocturia, and list of current drugs; (5) Overactive bladder symptom score (OABSS); (6) Nocturia quality of life (NQOL) score.
Study participants were followed up or reexamined at 4, 8, and 12 weeks after enrollment. Data on: (1) Pittsburgh sleep Quality Index (PSQI); (2) Standardized 72-hour voiding diary, sleep onset and awakening time, voiding volume and time, fluid intake and time, and incontinence time; (3) list of currently used drugs; (4) Overactive bladder symptom score (OABSS); (5) Nocturia quality of life (NQOL) score; (6) Urinary tract infection and adverse events.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Yan Li, Doctor
- Puhelinnumero: 18560089113
- Sähköposti: yanli@sdu.edu.cn
Opiskelupaikat
-
-
Shandong
-
Jinan, Shandong, Kiina
- Qilu Hospital of Shandong University
-
Ottaa yhteyttä:
- Yan Li, Doctor
- Puhelinnumero: 18560089113
- Sähköposti: yanli@sdu.edu.cn
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- age ≥20 years old, ≤80 years old, female;
- patients with overactive bladder (OAB) symptoms for more than 8 weeks; The inclusion criteria were as follows: voiding frequency ≥8 times in 24 hours, urgency attack ≥1 time in 24 hours, nocturnal voiding ≥2 times (OABSS score ≥6 points), and nocturnal polyuria index (NPi) ≤0.33.
- the patient's physical condition is stable and can be treated at home;
- All participants volunteered to participate in the study and provided written informed consent before the study began.
Exclusion Criteria:
- Residual urine volume ≥100 mL;
- difficulty walking;
- urethral stricture;
- bladder stones;
- bladder cancer;
- urinary tract infection;
- pregnant, lactating women, women of childbearing age who plan to become pregnant during the study or who do not use safe contraception;
- pelvic organ prolapse;
- neuropsychiatric disorders (including cerebrovascular diseases) associated with neurogenic bladder;
- taking medications for urinary system diseases within 2 weeks before enrollment;
- patients with mental and cognitive impairment who are unable to cooperate with treatment;
- other conditions considered by the investigator to be inappropriate for study participation.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: TTNS+BT (A)
The selected study participants were randomly divided into group A and group B with a ratio of 1:1. Participants in group A were treated with A new wearable transcutaneous tibial nerve stimulation (TTNS) device combined with behavioral therapy (BT), while participants in group B were treated with behavioral therapy alone. Participants were followed up at 4, 8, and 12 weeks after enrollment. The improvement of voiding symptoms (frequent urination, urgency, urge incontinence, etc.) and sleep quality were analyzed at different stages. Treatment assignments: Group A, participants received tibial nerve stimulation three times a week (30 minutes each time) in combination with daily behavioral therapy. Group B: The study participants received daily behavioral therapy, and the improvement of symptoms was observed in the study participants at all stages. |
Group A: participants received tibial nerve stimulation three times a week (30 minutes each time) in combination with daily behavioral therapy.
Group B: The study participants received daily behavioral therapy, and the improvement of symptoms was observed in the study participants at all stages.
Treatment assignments: Group A, participants received tibial nerve stimulation three times a week (30 minutes each time) in combination with daily behavioral therapy.
Group B: The study participants received daily behavioral therapy, and the improvement of symptoms was observed in the study participants at all stages.
|
|
Kokeellinen: BT (B)
The selected study participants were randomly divided into group A and group B with a ratio of 1:1. Participants in group A were treated with A new wearable transcutaneous tibial nerve stimulation (TTNS) device combined with behavioral therapy (BT), while participants in group B were treated with behavioral therapy alone. Participants were followed up at 4, 8, and 12 weeks after enrollment. The improvement of voiding symptoms (frequent urination, urgency, urge incontinence, etc.) and sleep quality were analyzed at different stages. Treatment assignments: Group A, participants received tibial nerve stimulation three times a week (30 minutes each time) in combination with daily behavioral therapy. Group B: The study participants received daily behavioral therapy, and the improvement of symptoms was observed in the study participants at all stages. |
Treatment assignments: Group A, participants received tibial nerve stimulation three times a week (30 minutes each time) in combination with daily behavioral therapy.
Group B: The study participants received daily behavioral therapy, and the improvement of symptoms was observed in the study participants at all stages.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Standardized 72-hour voiding diary
Aikaikkuna: From enrollment to the end of treatment at 12 weeks
|
Standardized 72-hour voiding diary, record the frequency of daily urination over a period of three days
|
From enrollment to the end of treatment at 12 weeks
|
|
Overactive Bladder Symptom Score (OABSS)
Aikaikkuna: From enrollment to the end of treatment at 12 weeks
|
The OABSS score is mainly used for initial severity grading, with total scores ranging from 0 to 15: 0-5 as mild, 6-11 as moderate, and 12-15 as severe.
|
From enrollment to the end of treatment at 12 weeks
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
Aikaikkuna: From enrollment to the end of treatment at 12 weeks
|
PSQI is a self-rating scale that assesses subjective sleep quality, sleep latency, sleep time, sleep efficiency, sleep disorders, sleep medication use, and daytime dysfunction. The scale is divided into two parts: 19 self-rated questions to assess sleep and 5 questions that are assessed by a bed partner (those who do not have a bed partner but have family members who know can also answer). The questions are short, easy to understand, and easy to answer. PSQI questions are scored on a scale ranging from "0 = no difficulty" to "3 = very difficult", resulting in scores that correspond to the various domains of the scale. Scores range from 0 to 21, with scores greater than 5 considered to indicate a sleep disorder |
From enrollment to the end of treatment at 12 weeks
|
|
Nocturia quality of life (NQOL) score
Aikaikkuna: From enrollment to the end of treatment at 12 weeks
|
The questionnaire included 3 dimensions and 13 items.
Sleep/energy (7 items, 0-28 Scores), distress/concern component (5 questions, 0-20 points) and total quality of life score (1 question, 0-4 points).
Each item was selected from "0" to "4" points using Likert5 scale, with a total score of 52 points.
Items 12 and 13 are reverse scoring items, with higher scores indicating higher quality of life.
|
From enrollment to the end of treatment at 12 weeks
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Furtado-Albanezi D, Jurgensen SP, Avila MA, Correia GN, Driusso P. Effects of two nonpharmacological treatments on the sleep quality of women with nocturia: a randomized controlled clinical trial. Int Urogynecol J. 2019 Feb;30(2):279-286. doi: 10.1007/s00192-018-3584-8. Epub 2018 Mar 6.
- Liao L, Li X, Chong T, Chen Q, Xu Z, Huang B, Chen M, Li H, Wei Z, Shao Y, Lu J, Pang R, Li X, Wang Y. Efficacy and safety of tibial nerve stimulation using a wearable device for overactive bladder. BJU Int. 2024 Jun;133(6):760-769. doi: 10.1111/bju.16330. Epub 2024 Mar 11.
- van Balken MR, Vandoninck V, Gisolf KW, Vergunst H, Kiemeney LA, Debruyne FM, Bemelmans BL. Posterior tibial nerve stimulation as neuromodulative treatment of lower urinary tract dysfunction. J Urol. 2001 Sep;166(3):914-8. doi: 10.1097/00005392-200109000-00025.
- Yokoyama O, Yamaguchi O, Kakizaki H, Itoh N, Yokota T, Okada H, Ishizuka O, Ozono S, Gotoh M, Sugiyama T, Seki N, Yoshida M, Yamada S. Efficacy of solifenacin on nocturia in Japanese patients with overactive bladder: impact on sleep evaluated by bladder diary. J Urol. 2011 Jul;186(1):170-4. doi: 10.1016/j.juro.2011.02.2700. Epub 2011 May 14.
- Weiss JP, Jumadilova Z, Johnson TM 2nd, Fitzgerald MP, Carlsson M, Martire DL, Malhotra A. Efficacy and safety of flexible dose fesoterodine in men and women with overactive bladder symptoms including nocturnal urinary urgency. J Urol. 2013 Apr;189(4):1396-401. doi: 10.1016/j.juro.2012.11.067. Epub 2012 Nov 15.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Miesten urogenitaaliset sairaudet
- Urologiset sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet ja raskauden komplikaatiot
- Alempien virtsateiden oireet
- Urologiset ilmenemismuodot
- Virtsarakon sairaudet
- Patologiset tilat, merkit ja oireet
- Merkit ja oireet
- Virtsarakko, yliaktiivinen
- Nocturia
- Psykoterapia
- Käyttäytymistieteet ja toiminnot
- Käyttäytymisterapia
Muut tutkimustunnusnumerot
- KYLL-2026-04-013-1
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .