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

Sponsor
Ankara Yildirim Beyazıt University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05677841
Collaborator
(none)
40
2
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Stabilization exercise+lifestyle recommendation
  • Other: lifestyle recommendations
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Investigation of the Effects of Spinal Stabilization Exercises Focusing on the Pelvic Floor in Women With Overactive Bladder
Anticipated Study Start Date :
Jan 15, 2023
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Jan 15, 2024

Arms and Interventions

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. )

Outcome Measures

Primary Outcome Measures

  1. Overactive bladder symptoms [change from baseline at 8 weeks]

    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

  1. Bladder function [change from baseline at 8 weeks]

    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.

  2. Urgency severity [change from baseline at 8 weeks]

    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.

  3. Spinal stability [change from baseline at 8 weeks]

    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.

  4. Pelvic floor muscle function [change from baseline at 8 weeks]

    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.

  5. Life Quality [change from baseline at 8 weeks]

    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

  6. Perception of Recovery [after treatment (8th week)]

    A 4-item Likert-type scale (worse, same, better, cured) will be used to evaluate perception of recovery

  7. Compliance with recommendation [after treatment (8th week)]

    Visual Analog Scale will be used to evaluate the compliance with recommendation

Eligibility Criteria

Criteria

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

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:
NCT05677841
Other Study ID Numbers:
  • 2022/12/23
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 10, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2023