Comparison of the Effects of External Electrical Stimulation Protocols in Women With Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

Comparison of the Effects of External Electrical Stimulation Protocols in Women With Overactive Bladder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05672290
• Other study ID #: 2023/01/03
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: January 2023
• Source: Ankara Yildirim Beyazit University
• Contact: Seyda Toprak Celenay
• Phone: +90312 906 1000
• Email: sydtoprak[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study is a comparison of the effects of external electrical stimulation protocols in women with overactive bladder (OAB).

Description:

OAB is a condition defined by the International Continence Society as the presence of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. External electrical stimulation has positive effects on OAB. However, there are not enough studies on how often this stimulation is applied. Studies are needed on this subject.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Being in the age range of 18-65 ,

• Having diagnosed with OAB,

• Being a volunteer

Exclusion Criteria:

• Being pregnant,

• presence of severe pelvic organ prolapse,

• malignant disease,

• urinary infection,

• neurological disease,

• have electronic and metal implant,

• loss of sensation,

• lumbosacral peripheral nerve lesion

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Other:
• Electrical stimulation 1
External electrical stimulation will be applied for 30 minutes 3 days a week during 6 weeks. Electrodes were placed around the pelvis.
• Electrical stimulation 2
External electrical stimulation will be applied for 30 minutes one day a week during 6 weeks. Electrodes were placed around the pelvis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overactive bladder symptoms	Overactive bladder symptoms will be assessed with the Overactive Bladder-V8 Questionnaire	change from baseline at 3 weeks and 6 weeks
Secondary	Urgency severity	Urgency severity will be assessed with Patients' Perception of Intensity of Urgency Scale	change from baseline at 3 weeks and 6 weeks
Secondary	Bladder functions	Bladder functions will be assessed with voiding diary	change from baseline at 3 weeks and 6 weeks
Secondary	Life quality	Life quality will be assessed with the King's Health Questionnaire	change from baseline at 3 weeks and 6 weeks
Secondary	Strength of pelvic floor muscle	Strength of pelvic floor muscle will be assessed with Modified Oxford Scale	change from baseline at 3 weeks and 6 weeks
Secondary	Perception of recovery	Perception of recovery will be assessed with a 4-point Likert scale	change from baseline at 3 weeks and 6 weeks