Effects of Spinal Stabilization on the Pelvic Floor in Women With Multiple Sclerosis

NCT07074587 | Enrolling By Invitation

• 1 other identifier: AİBU-FTR-GT-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to investigate the effects of spinal stabilization exercises focusing on the pelvic floor on core stability, urinary symptoms and pelvic floor muscle function in women with Multiple Sclerosis and lower urinary tract symptoms. Participants will be randomly assigned to a control group that receives pelvic floor muscle exercises only or an experimental group that receives both pelvic floor muscle exercises and spinal stabilization exercise focused on the pelvic floor. Outcome measures will be assessed pre- and post-intervention using validated instruments.

Conditions

Multiple Sclerosis; Urinary Incontinence; Lower Urinary Tract Symptoms

Keywords

Multiple Sclerosis; Lower Urinary Tract Symptoms; Urinary Incontinence; Core Stability; Spinal Stabilization

Outcome Measures

Primary Outcomes (2)

• Evaluation of Urinary Symptoms

  Urinary symptoms will be assessed with the International Incontinence Questionnaire Short Form. The International Incontinence Questionnaire Short Form consists of a total of six questions. The total score is obtained by summing the scores of questions 3, 4 and 5. Scores that can be obtained from the scale vary between 0-21; a low score indicates that urinary incontinence affects quality of life a little, while a high score indicates that it affects it a lot.

  8 week

• Evaluation of Bladder Functions

  A bladder diary will be used to assess bladder function for lower urinary tract symptoms. Patients will be asked to complete a 24-hour bladder diary on three non-consecutive days. Average day-night voiding frequency, voiding volume and number of urinary incontinence will be calculated by averaging the three daily urinary diaries.

  8 week

Secondary Outcomes (11)

• Evaluation of the degree of urinary symptoms

  8 week

• Evaluation of Pelvic Floor Muscle Function

  8 week

• Evaluation of pelvic floor muscle strength

  8 week

• Evaluation of the endurance of the lateral core muscles

  8 week

• Evaluation of the endurance of the anterior core muscles

  8 week

Study Arms (2)

Pelvic floor muscle exercises

ACTIVE COMPARATOR

Pelvic floor muscle exercises will be taught with an innovative approach based on the principles of finding, feeling, forcing, following and functional training of the pelvic floor muscles. Pelvic floor muscle exercises will be applied as 3 sets in the first 2 weeks, 4 sets in the 3rd and 4th weeks, 5 sets in the 5th and 6th weeks, and finally 6 sets in the 7th and 8th weeks. Individuals will continue their pelvic floor muscle exercises as a home program.

Behavioral: Pelvic floor muscle exercises

Spinal stabilization exercises focusing on the pelvic floor + Pelvic floor muscle exercises

EXPERIMENTAL

Spinal stabilization exercises focusing on the pelvic floor will be administered under physiotherapist supervision three times per week for eight weeks. Each session will consist of 5 minutes of warm-up, 30 minutes of pelvic floor-focused spinal stabilization exercises, and 5 minutes of cool-down. Stabilization and posture training will be provided at the outset, including instruction on identifying the neutral position of the spine to ensure proper posture. Correct pelvic floor muscle contraction and abdominal bracing techniques will be demonstrated. The exercise program will comprise three phases: static (weeks 1-2), dynamic (weeks 3-5), and functional (weeks 6-8). Throughout all exercises, participants will maintain a neutral spine position and abdominal bracing, with contractions held for 5-10 seconds and repeated 10 times. Additionally, participants will be instructed to continue pelvic floor exercises as a home program on non-supervised days.

Behavioral: Spinal stabilization exercises focusing on the pelvic floor + Pelvic floor muscle exercises

Interventions

Pelvic floor muscle exercises BEHAVIORAL

Pelvic floor muscle exercises will be taught with an innovative approach based on the principles of finding, feeling, forcing, following and functional training of the pelvic floor muscles. Pelvic floor muscle exercises will be applied as 3 sets in the first 2 weeks, 4 sets in the 3rd and 4th weeks, 5 sets in the 5th and 6th weeks, and finally 6 sets in the 7th and 8th weeks. Individuals will continue their pelvic floor muscle exercises as a home program.

Pelvic floor muscle exercises

Spinal stabilization exercises focusing on the pelvic floor + Pelvic floor muscle exercises BEHAVIORAL

This program consists of 3 phases: 30 minutes of spinal stabilization exercises focusing on the pelvic floor, 5 minutes of warm-up and 5 minutes of cool-down exercises.The exercises will consist of 3 phases: static, dynamic and functional phases. Individuals will perform static phase exercises for the first 2 weeks, then dynamic phase exercises in the 3rd and 5th weeks and finally functional phase exercise in the 6th and 8th weeks. Individuals will be asked to maintain neutral spine position and abdominal bracing during pelvic floor muscle contraction during all exercises. Individuals will maintain the contraction for 5-10 seconds for 10 repetitions in each position in all phases.

Spinal stabilization exercises focusing on the pelvic floor + Pelvic floor muscle exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants aged between 18 and 65 years
• Being diagnosed with Multiple Sclerosis by a specialist neurologist and having lower urinary system symptoms \[Overactive Bladder-V8 scale score ≥ 9 and having at least two of the lower urinary system symptoms (urinary incontinence, nocturia, daytime urination frequency \>8, storage symptoms such as sudden feeling of tightness, intermittent urination, slow urine flow and emptying symptoms such as incomplete emptying)
• Being in the mild or moderate stage of the disease (Expanded Disability Status Scale (EDSS) score ˂ 6
• No relapse experienced within the past month
• Scoring 24 or above on the Mini-Mental State Examination (MMSE)
• Being literate
• Willingness to voluntarily participate in the study
• Ability to perform voluntary pelvic floor muscle contractions
• No changes in medical treatment within the past three months
• Ability to understand and cooperate with the assessments and interventions involved in the study

You may not qualify if:

• Diagnosis of one or more neurological disorders other than Multiple Sclerosis
• Body mass index (BMI) ≥ 30
• Diagnosis of overflow urinary incontinence
• History of antimuscarinic medication use
• Presence of advanced pelvic organ prolapse (stage ≥ 2)
• Active urinary tract infection
• History of cesarean section or vaginal delivery within the past 6 months
• Diagnosis of any other neurological condition that may cause urinary incontinence
• History of urological or gynecological surgery
• History of malignancy
• Currently pregnant or not sexually active (coitus negative)
• Participation in exercise training or physical therapy for lower urinary tract symptoms within the past 6 months

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant İzzet Baysal University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Merkez, Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Incontinence; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• gözde tekin, Msc

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to group allocation to minimize bias during post-intervention evaluations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Model Details: Participants will be randomly assigned to a control group that receives pelvic floor muscle exercises only or an experimental group that receives both pelvic floor muscle exercises and spinal stabilization exercise focused on the pelvic floor.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 20, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)