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Effects of Spinal Stabilization Exercises Focusing on the Pelvic Floor in Women With Overactive Bladder

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Stabilization exercise+lifestyle recommendation
lifestyle recommendations
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Being between the ages of 18-65 Women with a diagnosis of overactive bladder Women who volunteered to participate in the study Exclusion Criteria: Women with only stress urinary incontinence Presence of advanced pelvic organ prolapse Having a mental problem that will prevent cooperation in assessment and/or practices Women with the presence of a malignant condition Concomitant neurological disease and/or neurogenic bladder Presence of infection Pregnancy

Sites / Locations

  • Ankara Yıldırım Beyazıt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise group

Control group

Arm Description

Exercise group will be given spinal stabilization exercises focusing on the pelvic floor and lifestyle reccommendations

Control group will be given lifestyle recommendations

Outcomes

Primary Outcome Measures

Overactive bladder symptoms
The Overactive Bladder Questionnaire -V8 will be used for the overactive bladder symptoms severity. It has 8 items and the total score can range from 0 to 40. As the score increases, the severity of symptoms increases.

Secondary Outcome Measures

Bladder function
Voiding dairy will be used to evaluate the bladder function. In the diary, women will be asked to record some parameters such as voiding time and volume, number of UI, and the amount and type of fluid intake.
Urgency severity
Patients' Perception of Intensity of Urgency Scale will be used to evaluate urgency severity. According to this scale, "0" means no sense of urgency, "1" means mild urge to urinate, "2" means moderate urge to urinate, "3" means severe urge to urinate, and "4" means urge type incontinence.
Spinal stability
The Sharman test will be used to evaluate spinal stability. In this test, the inflatable pad of a pressure biofeedback unit was placed in the natural lordotic curve of the back and was inflated to 40mmHg whilst the subject is lying supine. The subject will be activated the stabilising musculature via the abdominal bracing technique and then the participants will be asked to bring their leg to different positions. The test consists of five levels with each level increasing in difficulty.
Pelvic floor muscle function
Digital palpation will be used to evaluate pelvic floor muscle function while woman will be in the lithotomy position. Index + middle fingers will be inserted into the vagina.The women will be asked to squeeze these fingers in her vagina. force, endurance and speed parameters will be recorded.
Life Quality
King's Health Questionnaire will be used to evaluate life quality. It includes 9 sub-dimensions (General Health Perception, Incontinence Impact, Role Limitation, Physical Limitation, Social Limitation, Personal Limitation, Sleep/Energy Disturbance, Emotional Problems, and Severity Measures related UI). These sub-domains scores range from 0 to 100, where higher scores of indicate greater impairment in life quality
Perception of Recovery
A 4-item Likert-type scale (worse, same, better, cured) will be used to evaluate perception of recovery
Compliance with recommendation
Visual Analog Scale will be used to evaluate the compliance with recommendation.Participants were asked to rate compliance with recommendation on a 10 cm VAS line from 0 (not following recommendations at all) to 10 (completely following recommendations).

Full Information

First Posted
December 29, 2022
Last Updated
July 17, 2023
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT05677841
Brief Title
Effects of Spinal Stabilization Exercises Focusing on the Pelvic Floor in Women With Overactive Bladder
Official Title
Investigation of the Effects of Spinal Stabilization Exercises Focusing on the Pelvic Floor in Women With Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to examine the effects of spinal stabilization exercises focusing on the pelvic floor on urinary symptoms, spinal stability, pelvic floor muscle functions, quality of life and perception of recovery in women with overactive bladder.
Detailed Description
Overactive bladder (OAB) is defined by the International Continence Society and the International Society of Urogynecology as urinary urgency with or without urinary incontinence, usually accompanied by frequency and nocturia. Among the treatment options of OAB; first-line treatments include lifestyle recommendations, exercise approaches, and bladder training. Lifestyle recommendations; healthy lifestyle includes behavioral changes. Spinal stabilization exercise also aims to improve the neuromuscular control, strength and endurance of the muscles that are important in maintaining trunk stability. In recent years, it has been stated that trunk stability is impaired in women with OAB. However, no study was found on spinal stabilization exercises in patients with OAB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Exercise group will be given spinal stabilization exercises focusing on the pelvic floor and lifestyle reccommendations
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control group will be given lifestyle recommendations
Intervention Type
Other
Intervention Name(s)
Stabilization exercise+lifestyle recommendation
Intervention Description
Exercise program was given both spinal stabilization exercises focusing on the pelvic floor 3 days a week for eight weeks and a booklet related to the lower urinary system symptoms, the structure of the pelvic floor and healthy behavioral strategies recommendations (fluid intake, diet, weight control etc. )
Intervention Type
Other
Intervention Name(s)
lifestyle recommendations
Intervention Description
The control group will be given a booklet related to the lower urinary system symptoms, the structure of the pelvic floor and healthy behavioral strategies recommendations (fluid intake, diet, weight control etc. )
Primary Outcome Measure Information:
Title
Overactive bladder symptoms
Description
The Overactive Bladder Questionnaire -V8 will be used for the overactive bladder symptoms severity. It has 8 items and the total score can range from 0 to 40. As the score increases, the severity of symptoms increases.
Time Frame
change from baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Bladder function
Description
Voiding dairy will be used to evaluate the bladder function. In the diary, women will be asked to record some parameters such as voiding time and volume, number of UI, and the amount and type of fluid intake.
Time Frame
change from baseline at 8 weeks
Title
Urgency severity
Description
Patients' Perception of Intensity of Urgency Scale will be used to evaluate urgency severity. According to this scale, "0" means no sense of urgency, "1" means mild urge to urinate, "2" means moderate urge to urinate, "3" means severe urge to urinate, and "4" means urge type incontinence.
Time Frame
change from baseline at 8 weeks
Title
Spinal stability
Description
The Sharman test will be used to evaluate spinal stability. In this test, the inflatable pad of a pressure biofeedback unit was placed in the natural lordotic curve of the back and was inflated to 40mmHg whilst the subject is lying supine. The subject will be activated the stabilising musculature via the abdominal bracing technique and then the participants will be asked to bring their leg to different positions. The test consists of five levels with each level increasing in difficulty.
Time Frame
change from baseline at 8 weeks
Title
Pelvic floor muscle function
Description
Digital palpation will be used to evaluate pelvic floor muscle function while woman will be in the lithotomy position. Index + middle fingers will be inserted into the vagina.The women will be asked to squeeze these fingers in her vagina. force, endurance and speed parameters will be recorded.
Time Frame
change from baseline at 8 weeks
Title
Life Quality
Description
King's Health Questionnaire will be used to evaluate life quality. It includes 9 sub-dimensions (General Health Perception, Incontinence Impact, Role Limitation, Physical Limitation, Social Limitation, Personal Limitation, Sleep/Energy Disturbance, Emotional Problems, and Severity Measures related UI). These sub-domains scores range from 0 to 100, where higher scores of indicate greater impairment in life quality
Time Frame
change from baseline at 8 weeks
Title
Perception of Recovery
Description
A 4-item Likert-type scale (worse, same, better, cured) will be used to evaluate perception of recovery
Time Frame
after treatment (8th week)
Title
Compliance with recommendation
Description
Visual Analog Scale will be used to evaluate the compliance with recommendation.Participants were asked to rate compliance with recommendation on a 10 cm VAS line from 0 (not following recommendations at all) to 10 (completely following recommendations).
Time Frame
after treatment (8th week)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with overactive bladder
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being between the ages of 18-65 Women with a diagnosis of overactive bladder Women who volunteered to participate in the study Exclusion Criteria: Women with only stress urinary incontinence Presence of advanced pelvic organ prolapse Having a mental problem that will prevent cooperation in assessment and/or practices Women with the presence of a malignant condition Concomitant neurological disease and/or neurogenic bladder Presence of infection Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda Toprak Celenay
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Yıldırım Beyazıt University
City
Ankara
State/Province
Esenboğa Külliyesi
ZIP/Postal Code
06760
Country
Turkey

12. IPD Sharing Statement

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Effects of Spinal Stabilization Exercises Focusing on the Pelvic Floor in Women With Overactive Bladder

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