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

Official title

Investigation of 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

Overview

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.

Detailed description

In multiple sclerosis (MS), disruption of the neural pathways responsible for bladder control leads to the development of lower urinary tract symptoms (LUTS). These symptoms, observed in approximately 32-96% of individuals with MS, have a significant negative impact on quality of life. Conservative management of LUTS includes lifestyle modifications, bladder training, and pelvic floor muscle training (PFMT). Although the effectiveness of PFMT has been demonstrated, there is no standardized protocol regarding exercise type or duration, indicating a gap in the literature concerning the identification of the most effective approach. Moreover, existing studies emphasize that the effective contraction of pelvic floor muscles requires the simultaneous activation of deep core muscles, particularly the transversus abdominis. This suggests that pelvic floor rehabilitation without the involvement of abdominal muscles may be insufficient. Spinal stabilization exercises target deep core muscles to enhance neuromuscular control, strength, and endurance. Recently, "spinal stabilization exercises focusing on the pelvic floor" have emerged as a promising strategy in the management of urinary incontinence. However, research on trunk control in individuals with MS remains limited and primarily focuses on neurological symptoms, with minimal attention given to LUTS and pelvic floor function.

This study is designed as a prospective, randomized controlled trial to evaluate the effects of spinal stabilization exercises focusing on the pelvic floor, delivered in addition to PFMT, on core stability, urinary symptoms, and pelvic floor muscle function in women with MS and LUTS. Eligible participants who consent to join the study will be randomly allocated into two groups using block randomization. The control group will receive PFMT alone, while the experimental group will receive PFMT combined with spinal stabilization exercises focusing on the pelvic floor . Both interventions will be delivered three times per week for eight weeks. Primary and secondary outcomes will be assessed using validated objective and subjective tools at baseline and post-intervention.

Interventions

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

Primary outcome measures

• Evaluation of Urinary Symptoms [Time frame: 8 week]
• Evaluation of Bladder Functions [Time frame: 8 week]

Secondary outcome measures (11)

• Evaluation of the degree of urinary symptoms [Time frame: 8 week]
• Evaluation of Pelvic Floor Muscle Function [Time frame: 8 week]
• Evaluation of pelvic floor muscle strength [Time frame: 8 week]
• Evaluation of the endurance of the lateral core muscles [Time frame: 8 week]
• Evaluation of the endurance of the anterior core muscles [Time frame: 8 week]
• Evaluation of endurance of the posterior core muscles [Time frame: 8 week]
• Evaluation of Deep Lumbar Muscular Strength [Time frame: 8 week]
• Evaluation of Quality of Life [Time frame: 8 week]
• Evaluation of Subjective Perception of Recovery [Time frame: 8 week]
• Evaluation of Perceived Health Problem [Time frame: 8 week]
• Evaluation of Compliance with Training [Time frame: 8 week]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Bolu Abant İzzet Baysal University, Faculty of Health Sciences, Department of Physiotherap — Merkez

Identifiers

NCT: NCT07074587 · AİBU-FTR-GT-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗