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

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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Other: Stabilization exercise+lifestyle recommendation; Other: lifestyle recommendations

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Esenboğa Külliyesi
    • Ankara, Esenboğa Külliyesi, Turkey, 06760
      • Ankara Yıldırım Beyazıt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group; Exercise group will be given spinal stabilization exercises focusing on the pelvic floor and lifestyle reccommendations	Other: Stabilization exercise+lifestyle recommendation; 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. )
Active Comparator: Control group; Control group will be given lifestyle recommendations	Other: lifestyle recommendations; 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. )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from baseline at 8 weeks
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.	change from baseline at 8 weeks
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.	change from baseline at 8 weeks
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.	change from baseline at 8 weeks
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	change from baseline at 8 weeks
Perception of Recovery	A 4-item Likert-type scale (worse, same, better, cured) will be used to evaluate perception of recovery	after treatment (8th week)
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).	after treatment (8th week)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): May 25, 2023

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: December 29, 2022
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive
• Other Study ID Numbers: 2022/12/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No