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

Phase 4

Completed

• Conditions: 10004994; bladder dysfunction; urine incontinence; 10012303

• Registration Number: NL-OMON31325
• Lead Sponsor: Multiple Sclerose Centrum Nijmegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome parameters for the feasibility of the study are:<br /><br>- percentage of eligible patients that are willing to have electroacupuncture<br /><br>- reasons for refusion to participate<br /><br>- percentage of patients who are compliant with record keeping for the 3-day<br /><br>bladder diary<br /><br>- reasons for drop out during the study</p><br>

Secondary Outcome Measures

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