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Completed

NCT Number: NCT07485556

Effects of Pelvic Floor Strengthening and Relaxation Exercises in Women Diagnosed With Multiple Sclerosis

The aim of this study was to compare the effects of pelvic floor strengthening and relaxation exercises on lower urinary tract dysfunction (LUTD), depression and quality of life (QoL) in women with Multiple Sclerosis (WwMS). The main questions it aims to answer are:

* Are pelvic floor relaxation exercises effective on lower urinary tract dysfunction (LUTD)? * Is there a difference in the effect on LUTD symptoms between pelvic floor strengthening exercises and relaxation exercises? Participants were divided into three groups: pelvic floor strengthening, relaxation and combined (both pelvic floor strengthening and relaxation together) exercise groups. Participants were called every week for 8 weeks and an online session was held one day per week. Participants were asked to perform the exercises 3 times a day, every other day. Urogenital Distress Inventory (UDI-6), Incontinence Impact Questioonaire (IIQ-7), International Consultation on Incontinence Questionnaire-Short form (ICIQ-SF), Overactive Bladder Assessment Form (OAB-V8), 24-Hour Voiding Diary and Patient Health Questionnaire (PHQ) were used to evaluate.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Male Urogenital Diseases Nervous System Diseases Neurogenic Bladder Disorder Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pelvic Floor Muscle Exercise Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, Çankaya, 06810, Turkey (Türkiye)

About this study

In MS, neurogenic bladder and lower urinary tract dysfunctions (LUTD) are common symptoms observed in approximately 75% of people with Multiple Sclerosis (PwMS) . Untreated urinary dysfunctions may lead to lower urinary tract infections, renal damage, emotional stress, sleep disturbances, social isolation, and a decline in quality of life (QoL) 6, 7. To manage neurogenic LUTD, the conservative treatment approaches constitute the first-line therapy for symptoms. Pelvic floor muscle exercises (PFME) have important role for treatment of urinary incontinence (UI) and neurogenic LUTD. Tension and spasm in the pelvic floor muscles (PFM) can lead to a variety of symptoms that negatively impact QoL, including voiding dysfunction, pain, sexual dysfunction, and anorectal disorders. Inadequate relaxation of the pelvic floor during micturition may result in symptoms such as urinary frequency, post-void residual urine, urgency, increased daytime voiding, and urge UI. Therefore, relaxation exercises targeting the PFM, as well as comprehensive pelvic floor rehabilitation, can be utilized in the management of these symptoms While PFM strengthening protocols have been utilized in the management of neurogenic LUTD in women with MS (WwMS), there is currently no therapeutic program in the literature that combines both relaxation and strengthening exercises applied simultaneously to the PFM. This study aims to evaluate the effects of a combined exercise protocol-targeting both relaxation and strengthening of the PFM-on neurogenic LUTD and depression in WwMS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants were eligible to participate if they:

  • were female and aged 18 years or older,
  • had a score of less than 6.5 on the Expanded Disability Status Scale (EDSS) and were ambulatory,
  • experienced neurogenic LUTD such as urgency, urge UI, urinary frequency, and nocturia,
  • had normal cognitive function, defined as a score above 24 on the Standardized Mini-Mental State Examination (SMMSE)-Turkish version.

Exclusion criteria

  • Participants were excluded if they:
  • had spasticity in the lower extremity muscles, particularly in the adductors,
  • experienced an MS relapse within the previous two months,
  • had a current urinary tract infection,
  • were pregnant,
  • had undergone urogynecological surgery within the past six months,
  • lacked access to or the ability to use tools required for telerehabilitation (e.g., internet, camera, microphone, or smartphone).

Treatment and study plan

Pelvic Floor Strengthening Exercises

Other

Patients received PFM strengthening exercises and behavioral modification therapies. Strengthening exercises consisted of maximal voluntary PFM contractions held for 5 seconds (fast-twitch training), and endurance exercises involved sustained contractions for 15 seconds (slow-twitch training). Ten repetitions were considered as one set. The number of sets was gradually increased-up to a maximum of four sets per session-based on muscle fatigue and adherence, as assessed during weekly online follow-ups. Patients were instructed to perform the exercises every other day. Weekly online sessions were conducted with each patient to monitor adherence, assess for any adverse effects, and adjust or progress the exercise program as needed. The intervention was carried out over a period of 8 weeks.

Pelvic Floor Relaxation Exercises

Other

The patients were prescribed a total of eight relaxation exercises. These exercises included: Cat-Cow (spinal stretching) exercise, lumbar extensor muscles combined with PFM stretching (Balasana, Child's Pose), piriformis stretch, hip flexor stretch, PFM relaxation in a squat position (Malasana, Garland Pose), hip adductor stretch, Happy Baby Pose (Ananda Balasana), and supine pelvic floor relaxation (Supta Baddha Konasana, Reclining Butterfly Pose). The exercises were demonstrated to the patients during a video-based online session by a physiotherapist, who also instructed the patients to repeat the exercises to ensure proper technique. Patients were asked to perform each relaxation exercise for 20 seconds, repeating them 3 to 4 times. The number of repetitions and progression of the exercises were increased weekly based on the patient's tolerance.

Combined Pelvic Floor Exercises

Other

The patients were prescribed both pelvic floor relaxation and strengthening exercises. The pelvic floor exercises were given in the form of strengthening, endurance and relaxation exercises, similar to those in Group 1 and 2. Patients were instructed to perform the strengthening and relaxation exercises alternately, allowing rest intervals between exercises.

Primary outcomes

  1. 24 Hours Voiding Diary

    Time frame: From enrollment to the end of treatment at 8 weeks.

    Patients were instructed to void into the container for 24 hours and record the volume of each urination. They were also asked to document all fluid intake, episodes of urgency, and any occurrences of UI.

Secondary outcomes

  1. Urogenital Distress Inventory (UDI-6)

    Time frame: From enrollment to the end of treatment at 8 weeks

    To evaluate lower urinary tract dysfunction and its impact on quality of life. The total score ranges from 0 to 18, and a higher score indicates a worse quality of life.

  2. Overactive Bladder Assessment Form (OAB-V8)

    Time frame: From enrollment to the end of treatment at 8 weeks

    To evaluate the severity of overactive bladder symptoms.The total score ranges from 0 to 40. The cutoff value for the total score has been calculated as 11. Scores above this value indicate that the individual has an overactive bladder.

  3. Patient Health Questionnaire (PHQ)

    Time frame: From enrollment to the end of treatment at 8 weeks.

    To assess depressive symptoms. The total questionnaire score indicates depression severity as follows: scores of 1-4 correspond to minimal, 5-9 to mild, 10-14 to moderate, 15-19 to moderately severe, and 20-27 to severe depression.

  4. Incontinence Impact Questionnaire (IIQ-7)

    Time frame: From enrollment to the end of treatment at 8 weeks.

    To assess the impact of urinary incontinence on quality of life. The total score ranges from 0 to 28, and a higher score indicates a worse quality of life.

  5. International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)

    Time frame: From enrollment to the end of treatment at 8 weeks.

    To assess the impact of urinary incontinence on quality of life. The total score ranges from 0 to 21, and a lower score indicates a better quality of life. A score of 8 or higher is recorded as bothersome urinary incontinence.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Comparison of the Effects of Pelvic Floor Strengthening and Relaxation Exercises Delivered Via Telerehabilitation in Women Diagnosed With Multiple Sclerosis: A Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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