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A Novel Wearable Transcutaneous Tibial Nerve Stimulation (TTNS) Device in the Treatment of Patients With Overactive Bladder (OAB) and Nocturia

3. juni 2026 opdateret af: Qilu Hospital of Shandong University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Shandong
      • Jinan, Shandong, Kina
        • Qilu Hospital of Shandong University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. age ≥20 years old, ≤80 years old, female;
  2. 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.
  3. the patient's physical condition is stable and can be treated at home;
  4. All participants volunteered to participate in the study and provided written informed consent before the study began.

Exclusion Criteria:

  1. Residual urine volume ≥100 mL;
  2. difficulty walking;
  3. urethral stricture;
  4. bladder stones;
  5. bladder cancer;
  6. urinary tract infection;
  7. pregnant, lactating women, women of childbearing age who plan to become pregnant during the study or who do not use safe contraception;
  8. pelvic organ prolapse;
  9. neuropsychiatric disorders (including cerebrovascular diseases) associated with neurogenic bladder;
  10. taking medications for urinary system diseases within 2 weeks before enrollment;
  11. patients with mental and cognitive impairment who are unable to cooperate with treatment;
  12. other conditions considered by the investigator to be inappropriate for study participation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: A new wearable transcutaneous tibial nerve stimulation (TTNS) device
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.
Adfærdsmæssigt: behavioral therapy
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.
Eksperimentel: 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.
Adfærdsmæssigt: behavioral therapy
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Standardized 72-hour voiding diary
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Qilu Hospital of Shandong University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

10. juni 2026

Primær færdiggørelse (Anslået)

10. juni 2027

Studieafslutning (Anslået)

10. juni 2027

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KYLL-2026-04-013-1

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