NCT07598227

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2025Dec 2026

Study Start

First participant enrolled

January 1, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 20, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 4, 2026

Last Update Submit

May 17, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • frequency of nocturia

    Baseline and Week 3 and Week 6

  • nocturnal urine volume

    Baseline and Week 3 and Week 6

Secondary Outcomes (7)

  • International Prostate Symptom Score (IPSS)

    Baseline and Week 3 and Week 6

  • Overactive Bladder Symptom Score (OABSS)

    Baseline and Week 3 and Week 6

  • Quality of Life (QoL)

    Baseline and Week 3 and Week 6

  • Pittsburgh Sleep Quality Index (PSQI)

    Baseline and Week 3 and Week 6

  • Abdominal muscle tension

    Baseline and Week 3 and Week 6

  • +2 more secondary outcomes

Study Arms (2)

Moxibustion

EXPERIMENTAL
Procedure: Moxibustion

Control

NO INTERVENTION

Interventions

MoxibustionPROCEDURE

Apply moxibustion on acupoint

Moxibustion

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, Taiwan

RECRUITING

MeSH Terms

Conditions

Nocturia

Interventions

Moxibustion

Condition Hierarchy (Ancestors)

Lower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeutics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2026

First Posted

May 20, 2026

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 20, 2026

Record last verified: 2026-03

Locations