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

NCT07485556 | Completed

• 1 other identifier: E-77082166-302.08.01-240734
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Neurogenic Bladder Disorder; Pelvic Floor Muscle Exercise

Keywords

pelvic floor; multiple sclerosis; relaxation; neurogenic bladder disorder

Outcome Measures

Primary Outcomes (1)

• 24 Hours Voiding Diary

  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.

  From enrollment to the end of treatment at 8 weeks.

Secondary Outcomes (5)

• Urogenital Distress Inventory (UDI-6)

  From enrollment to the end of treatment at 8 weeks

• Overactive Bladder Assessment Form (OAB-V8)

  From enrollment to the end of treatment at 8 weeks

• Patient Health Questionnaire (PHQ)

  From enrollment to the end of treatment at 8 weeks.

• Incontinence Impact Questionnaire (IIQ-7)

  From enrollment to the end of treatment at 8 weeks.

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

  From enrollment to the end of treatment at 8 weeks.

Study Arms (3)

Pelvic Floor Strengthening Group

ACTIVE COMPARATOR

Patients received PFM strengthening exercises and behavioral modification therapies.

Other: Pelvic Floor Strengthening Exercises

Pelvic Floor Relaxation Group

EXPERIMENTAL

The patients in Group 2 were prescribed a total of eight relaxation exercises and behavioral modification therapy.

Other: Pelvic Floor Relaxation Exercises

Combined Exercise Group

EXPERIMENTAL

The patients in Group 3 were prescribed both pelvic floor relaxation and strengthening exercises and behavioral modification therapy.

Other: Combined Pelvic Floor Exercises

Interventions

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 Strengthening Group

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.

Pelvic Floor Relaxation Group

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.

Combined Exercise Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Çankaya, 06810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• İlke Keser, Proffesor

  Gazi University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Model Details: The participants were divided into the following three groups: Group 1 strengthening exercise group, group 2 Relaxation Exercise Group: received pelvic floor muscle relaxation exercises. Group 3 Combined Exercise Group: received a combination of both strengthening and relaxation exercises targeting the PFM.

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 20, 2026
• Study Start: February 2, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)