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

Sponsor
Ankara Yildirim Beyazıt University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05672290
Collaborator
(none)
40
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Electrical stimulation 1
  • Other: Electrical stimulation 2
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of the Effects of External Electrical Stimulation Protocols in Women With Overactive Bladder
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

Group 1 will be applied external electric stimulation three days per week

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.
Active Comparator: Group 2

Group 2 will be applied external electric stimulation one day per week

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Overactive bladder symptoms [change from baseline at 3 weeks and 6 weeks]

    Overactive bladder symptoms will be assessed with the Overactive Bladder-V8 Questionnaire

Secondary Outcome Measures

  1. Urgency severity [change from baseline at 3 weeks and 6 weeks]

    Urgency severity will be assessed with Patients' Perception of Intensity of Urgency Scale

  2. Bladder functions [change from baseline at 3 weeks and 6 weeks]

    Bladder functions will be assessed with voiding diary

  3. Life quality [change from baseline at 3 weeks and 6 weeks]

    Life quality will be assessed with the King's Health Questionnaire

  4. Strength of pelvic floor muscle [change from baseline at 3 weeks and 6 weeks]

    Strength of pelvic floor muscle will be assessed with Modified Oxford Scale

  5. Perception of recovery [change from baseline at 3 weeks and 6 weeks]

    Perception of recovery will be assessed with a 4-point Likert scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ankara Yildirim Beyazıt University

Investigators

  • Principal Investigator: Seyda Toprak Celenay, Ankara Yildirim Beyazıt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
seyda toprak celenay, associate professor, Ankara Yildirim Beyazıt University
ClinicalTrials.gov Identifier:
NCT05672290
Other Study ID Numbers:
  • 2023/01/03
First Posted:
Jan 5, 2023
Last Update Posted:
Jan 5, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Urinary Bladder, Overactive

Study Results

No Results Posted as of Jan 5, 2023