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Recruiting NCT07598227

Moxibustion for Nocturia

No phase Interventional Nocturia Acupoint Moxibustion Traditional Chinese Medicine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Moxibustion.
Who it may be relevant to
Registry conditions: Nocturia, Acupoint, Moxibustion, Traditional Chinese Medicine. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of the Efficacy and Safety of Acupoint Moxibustion for Nocturia: A Pilot Study

Overview

Nocturia, the interruption of sleep due to nighttime voiding, severely compromises quality of life, emotional health, and overall well-being when occurring twice or more per night. Given that some patients experience inadequate responses to conventional Western therapies or harbor concerns about the long-term side effects of pharmaceuticals, many are turning to Traditional Chinese Medicine (TCM) for alternative solutions. This study utilized a randomized clinical trial design to investigate the efficacy and safety of acupoint moxibustion for nocturia.

Detailed description

Nocturia, the interruption of sleep due to nighttime voiding, severely compromises quality of life, emotional health, and overall well-being when occurring twice or more per night. Given that some patients experience inadequate responses to conventional Western therapies or harbor concerns about the long-term side effects of pharmaceuticals, many are turning to Traditional Chinese Medicine (TCM) for alternative solutions. This study utilized a randomized clinical trial design to investigate the efficacy and safety of acupoint moxibustion for nocturia. Using voiding diaries, the International Prostate Symptom Score (IPSS), the Overactive Bladder Symptom Score (OABSS), and Quality of Life (QoL) assessments, this study aimed to provide a cost-effective and clinically feasible complementary and alternative therapy. Furthermore, the TCM constitutional characteristics of nocturia patients were analyzed through the Constitution in Chinese Medicine Questionnaire (CCMQ) combined with evaluations of abdominal muscle tension.

Interventions

  • Procedure Moxibustion
    Apply moxibustion on acupoint

Primary outcome measures

  • frequency of nocturia [Time frame: Baseline and Week 3 and Week 6]
  • nocturnal urine volume [Time frame: Baseline and Week 3 and Week 6]
Secondary outcome measures (7)
  • International Prostate Symptom Score (IPSS) [Time frame: Baseline and Week 3 and Week 6]
  • Overactive Bladder Symptom Score (OABSS) [Time frame: Baseline and Week 3 and Week 6]
  • Quality of Life (QoL) [Time frame: Baseline and Week 3 and Week 6]
  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline and Week 3 and Week 6]
  • Abdominal muscle tension [Time frame: Baseline and Week 3 and Week 6]
  • Abdominal muscle stiffness [Time frame: Baseline and Week 3 and Week 6]
  • Abdominal muscle elasticity [Time frame: Baseline and Week 3 and Week 6]

Eligibility criteria

Inclusion criteria

  • Patients aged 40 years or older.
  • Experiencing two or more nocturia episodes per night.

Exclusion criteria

  • Active urinary tract infection (UTI).
  • Poorly controlled diabetes mellitus (defined as HbA1c > 6.5%).
  • Presence of a neurogenic bladder caused by conditions such as multiple sclerosis, Parkinson's disease, stroke, spinal cord injury, or nerve damage resulting from major pelvic surgery.
  • Severe congestive heart failure (New York Heart Association \[NYHA\] functional class > II).
  • Use of other Traditional Chinese Medicine (TCM) therapies for nocturia symptoms within the past month (30 days).
  • Pregnant women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation — Hualien City

Identifiers

NCT: NCT07598227 · IRB114-009-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗