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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey (Türkiye)
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Pelvic Floor Strengthening Group
Patients received PFM strengthening exercises and behavioral modification therapies.
Other: Pelvic Floor Strengthening Exercises
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.
Other: Pelvic Floor Relaxation Exercises
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.
Other: Combined Pelvic Floor Exercises
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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