NCT05672277

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

First Submitted

Initial submission to the registry

January 3, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

January 3, 2023

Last Update Submit

January 3, 2023

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Urgency severity

    change from baseline at 3 weeks and 6 weeks

  • Bladder functions

    change from baseline at 3 weeks and 6 weeks

  • Life quality

    change from baseline at 3 weeks and 6 weeks

  • Strength of pelvic floor muscle

    change from baseline at 3 weeks and 6 weeks

  • Perception of recovery

    change from baseline at 3 weeks and 6 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1 will be applied TENS three days per week

Other: TENS 1

Group 2

ACTIVE COMPARATOR

Group 2 will be applied TENS one day per week

Other: TENS 2

Interventions

TENS 1OTHER

Parasacral TENS will be applied for 30 minutes 3 days a week during 6 weeks.

Group 1
TENS 2OTHER

Parasacral TENS will be applied for 30 minutes one day a week during 6 weeks.

Group 2

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with overactive bladder
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being in the age range of 18-65 ,
  • Having diagnosed with OAB,
  • Being a volunteer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • Seyda Toprak Celenay

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

+90312 906 1000sydtoprak@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 5, 2023

Study Start

February 15, 2023

Primary Completion

June 15, 2023

Study Completion

February 15, 2024

Last Updated

January 5, 2023

Record last verified: 2023-01