NCT03829137

Brief Summary

Overactive bladder (OAB) is a syndrome causes urgency, with or without urgent incontinence, daytime frequency and nocturia. Urgency incontinence is more common in older women and may be associated with comorbid conditions that occur with age. The standard OAB medical treatments may induced several intolerable side effects including dry mouth, constipation, and so on, therefore alternative therapies are often considered. Acupuncture had been proved effective to OAB treatment, however, this invasive procedure also cause pain and hematoma. Laser acupuncture has minimal side effects comparing to conventional acupuncture, but its effects against OAB had never been examined. Experiments with laser acupuncture are expected to be another way to relieve OAB symptoms.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2022

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

3.3 years

First QC Date

January 31, 2019

Last Update Submit

February 1, 2019

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

  • OAB symptom score (OABSS)

    This is a four symptoms questionnaire to quantify OAB symptoms.

    3 weeks

Secondary Outcomes (1)

  • The Urogenital Distress Inventory (UDI-6)

    3 weeks

Other Outcomes (1)

  • Incontinence Impact Questionnaire (IIQ-7)

    3 weeks

Study Arms (2)

Verum laser acupuncture

EXPERIMENTAL

Verum laser acupuncture：Low level laser therapy stimulates 7 acupuncture points on both sides of the body .

Device: Verum laser acupuncture

Sham laser acupuncture

SHAM COMPARATOR

sham laser acupuncture (no laser output)

Device: Sham laser acupuncture

Interventions

Verum laser acupunctureDEVICE

The patients lay in the supine position before treatment and the gallium aluminum arsenide LaserPan (RJ-Laser, Reimers \& Janssen GmbH, Waldkirch, Germany) will be applied to each selected acupoints for 3 weeks, total of 9 sessions.

Verum laser acupuncture
Sham laser acupunctureDEVICE

The acupuncture points and procedure of the control group are identical to the experimental group but there are no laser beam energy.

Sham laser acupuncture

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women are older than 18 years old.
  • Participant is willing to sign the consent.
  • Women havea moderate OAB symptoms.
  • Total scores of OABSS \> 6 points and the 3rd question of OABSS \> 2 points.
  • Not using anticholinergic drugs for more than three weeks.

You may not qualify if:

  • Patients with lower urinary tract infection.
  • Patients who cannot complete the questionnaire.
  • Patients who use Botox to inject bladder and pelvic floor muscles within one year.
  • Pregnant patients.
  • Patients who continue to have electrical stimulation and acupuncture in the legs, waist and pelvis.
  • Patients with vaginal bleeding.
  • Other herbal and folklore therapies are being used to improve patients with overactive bladder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hsin-Ning Chang

    Chang Gung Memorial Hospital

    STUDY CHAIR

Central Study Contacts

Hsin-Ning Chang

CONTACT

(02)243131318705015@cgmh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 4, 2019

Study Start

January 1, 2019

Primary Completion

April 5, 2022

Study Completion

April 5, 2022

Last Updated

February 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)