- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07485556
Effects of Pelvic Floor Strengthening and Relaxation Exercises in Women Diagnosed With Multiple Sclerosis
March 17, 2026 updated by: Ilke Keser, Gazi University
Comparison of the Effects of Pelvic Floor Strengthening and Relaxation Exercises Delivered Via Telerehabilitation in Women Diagnosed With Multiple Sclerosis: A Randomized Controlled Study
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.
Study Overview
Status
Completed
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Çankaya
-
Ankara, Çankaya, Turkey (Türkiye), 06810
- Gazi University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Pelvic Floor Strengthening Group
Patients received PFM strengthening exercises and behavioral modification therapies.
|
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.
|
|
Experimental: Pelvic Floor Relaxation Group
The patients in Group 2 were prescribed a total of eight relaxation exercises and behavioral modification therapy.
|
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.
|
|
Experimental: Combined Exercise Group
The patients in Group 3 were prescribed both pelvic floor relaxation and strengthening exercises and behavioral modification therapy.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to the end of treatment at 8 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to the end of treatment at 8 weeks
|
|
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.
|
From enrollment to the end of treatment at 8 weeks
|
|
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.
|
From enrollment to the end of treatment at 8 weeks.
|
|
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.
|
From enrollment to the end of treatment at 8 weeks.
|
|
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.
|
From enrollment to the end of treatment at 8 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: İlke Keser, Proffesor, Gazi University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2022
Primary Completion (Actual)
December 15, 2022
Study Completion (Actual)
December 15, 2022
Study Registration Dates
First Submitted
March 6, 2026
First Submitted That Met QC Criteria
March 17, 2026
First Posted (Actual)
March 20, 2026
Study Record Updates
Last Update Posted (Actual)
March 20, 2026
Last Update Submitted That Met QC Criteria
March 17, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Neurologic Manifestations
- Nervous System Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Autoimmune Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Urinary Bladder Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Multiple Sclerosis
- Urinary Bladder, Neurogenic
Other Study ID Numbers
- E-77082166-302.08.01-240734
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
Cabaletta BioNot yet recruitingProgressive Multiple Sclerosis | Multiple Sclerosis | Multiple Sclerosis (Relapsing Remitting) | Relapsing Multiple Sclerosis (RMS) | Progressive Multiple Sclerosis (PMS) | Multiple Sclerosis (MS) - Relapsing-remitting | Multiple Sclerosis - Relapsing Remitting
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsActive, not recruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Novartis PharmaceuticalsCompletedRelapsing-remitting Multiple Sclerosis | Active Secondary Progressive Multiple SclerosisJapan
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
Clinical Trials on Pelvic Floor Strengthening Exercises
-
Riphah International UniversityCompletedUrinary IncontinencePakistan
-
Riphah International UniversityCompletedUrinary Incontinence, StressPakistan
-
British University In EgyptEnrolling by invitationStress Urinary Incontinence (SUI) | Isokinetic Strengthening | Pelvic Floor MusclesEgypt
-
Mashhad University of Medical SciencesWithdrawnPelvic Floor Muscle Syndrome
-
Queen's UniversityOttawa Hospital Research InstituteCompletedStress Urinary IncontinenceCanada
-
Cigdem CinarCompleted
-
Riphah International UniversityCompleted
-
Foundation University IslamabadRecruitingPost Partum | Sacro Iliac Joint Pain | Strength TrainingPakistan
-
Foundation University IslamabadActive, not recruiting
-
eman elhosaryUnknownStress Urinary Incontinence