NCT04197466

Brief Summary

This study aims to investigate the effects of pelvic floor muscle exercises, electrical stimulation and taping in patients with overactive bladder

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

December 11, 2019

Last Update Submit

January 23, 2021

Conditions

Overactive BladderOveractive Bladder SyndromeOveractive Detrusor

Keywords

Pelvic Floor Muscle ExerciseKinesio tapingElectric Stimulation

Outcome Measures

Primary Outcomes (1)

  • Bladder Diary

    Women will be asked to complete a 24-hour frequency-volume chart (urine diary) to assess bladder symptoms. Each woman will fill the chart for a total of 3 days filled in 3 consecutive days. In these diaries, women will be asked to record the number of their urination during the day, how much urine they produce each time they urinate, their incontinence, the type and amount of drinks. Women will be warned not to change their daily voiding habits and the amount of fluids they consume during filling these charts. The data obtained from these three days will be averaged to determine daily voiding frequency, night voiding frequency, average voiding volume, and daily urinary incontinence.

    Before the treatment, at end of 6 weeks

Secondary Outcomes (3)

  • King Health Questionnaire

    Before the treatment and end of 6 weeks

  • Pelvic Floor Muscle Strength

    Before the treatment and end of 6 weeks

  • Overactive bladder symptoms

    Before the treatment, at end of 6 weeks

Study Arms (3)

Pelvic Floor Exercise Group

EXPERIMENTAL

Pelvic floor muscle exercises will be recommended as a home program for 6 weeks every day of the week.

Other: Pelvic Floor Exercise Group

Kinesiotape Group

EXPERIMENTAL

In addition to pelvic floor exercise,kinesio tape application will be performed by ligament technique to the sacral region.

Other: Pelvic Floor Exercise GroupOther: Kinesio tape

Electrical Stimulation Group

EXPERIMENTAL

In addition to pelvic floor exercise,electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes

Other: Pelvic Floor Exercise GroupOther: Electrical stimulation

Interventions

Pelvic Floor Exercise GroupOTHER

The exercise program will be tailored according to the pelvic floor muscle strength, including fast and slow contractions. The number and duration of exercises will be increased according to progress..

Electrical Stimulation GroupKinesiotape GroupPelvic Floor Exercise Group
Kinesio tapeOTHER

Kinesio tape application will be performed by ligament technique to the sacral region.

Kinesiotape Group
Electrical stimulationOTHER

External electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes

Electrical Stimulation Group

Eligibility Criteria

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

You may qualify if:

  • Women
  • Being Volunteered to participate
  • Diagnosed as overactive bladder

You may not qualify if:

  • Pregnant women
  • Patients with a comorbid neurological disorder
  • A mental problem that may prevent cooperation and evaluation
  • Acute infection
  • Sensory loss
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt Üniversitesi

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Athletic TapeElectric Stimulation

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

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical EquipmentPhysical StimulationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 13, 2019

Study Start

December 6, 2019

Primary Completion

April 7, 2020

Study Completion

April 7, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

TU(1)