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An observational study on the effect of acupuncture with electric stimulation in multiple sclerosis patients with bladder dysfunction.

An observational study on the effect of acupuncture with electric stimulation in multiple sclerosis patients with bladder dysfunction. - Acums

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON31325
Enrollment
20
Registered
2007-06-30
Start date
2007-09-10
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder dysfunction urine incontinence

Interventions

None listed

Sponsors

Multiple Sclerose Centrum Nijmegen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with MS and voiding complaints during at least 6 months: greater than 8 voids per day, subjective urgency to void and urge-associated incontinence at least twice during a 3-day period of time.

Exclusion criteria

Exclusion criteria: bladder infection at baseline, post voiding residual volume more than 100 ml, bladder complaints less than 6 months, a relapse less than 30 days before screening, complaints of spasms; pregnancy; sacral neurostimulator implanted, severe cardiopulmonary disease, unable to complete a 3-day voiding diary or the questionnaire.

Design outcomes

Primary

MeasureTime frame
Primary outcome parameters for the feasibility of the study are: - percentage of eligible patients that are willing to have electroacupuncture - reasons for refusion to participate - percentage of patients who are compliant with record keeping for the 3-day bladder diary - reasons for drop out during the study

Secondary

MeasureTime frame
Secondary outcome parameter relating to the effectiveness of the electroacupuncture: - patients' perceptions of improvement of their quality of life determined by the I-QOL instruments. - Reduction in the frequency of voiding, number of incontinent episodes, severity of incontinence, number of nocturia episodes and urgency, over 3 days determined by the 3-day bladder diary - The severity of the incontinency will be measured in by the number of pads used, (daily registering of number of pads)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)