Multiple SclerosisNCT07485556
Effects of Pelvic Floor Strengthening and Relaxation Exercises in Women Diagnosed With Multiple Sclerosis
A study testing Pelvic Floor Strengthening Exercises, Pelvic Floor Relaxation Exercises and Combined Pelvic Floor Exercises in people with Multiple Sclerosis and Neurogenic Bladder Disorder, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Multiple Sclerosis, Neurogenic Bladder Disorder, Pelvic Floor Muscle Exercise
- What is being tested?
- Pelvic Floor Strengthening Exercises, Pelvic Floor Relaxation Exercises and Combined Pelvic Floor Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Being tested
- Pelvic Floor Strengthening Exercises, Pelvic Floor Relaxation Exercises, Combined Pelvic Floor Exercises
- Keywords
- pelvic floor, multiple sclerosis, relaxation, neurogenic bladder disorder
- Medical subject headings
- Multiple Sclerosis, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Strengthening ExercisesOther
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 ExercisesOther
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 ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Strengthening Group | Active comparator | Patients received PFM strengthening exercises and behavioral modification therapies. Receives: 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. Receives: 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. Receives: Other: Combined Pelvic Floor Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 8 weeks.
Secondary outcomes (5)
Urogenital Distress Inventory (UDI-6)
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.
Measured: From enrollment to the end of treatment at 8 weeks
Overactive Bladder Assessment Form (OAB-V8)
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.
Measured: From enrollment to the end of treatment at 8 weeks
Patient Health Questionnaire (PHQ)
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.
Measured: From enrollment to the end of treatment at 8 weeks.
Incontinence Impact Questionnaire (IIQ-7)
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.
Measured: From enrollment to the end of treatment at 8 weeks.
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
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.
Measured: From enrollment to the end of treatment at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start2 Feb 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilke Keser, Gazi University
- Investigators
- İlke Keser, Proffesor, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485556
- Sponsor's protocol ID
- E-77082166-302.08.01-240734
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07485556
- Acronym / sponsor ID
- E-77082166-302.08.01-240734
- Keywords
- pelvic floor, multiple sclerosis, relaxation, neurogenic bladder disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Strengthening Group | Active comparator | Other: Pelvic Floor Strengthening ExercisesPatients received PFM strengthening exercises and behavioral modification therapies. |
| Pelvic Floor Relaxation Group | Experimental | Other: Pelvic Floor Relaxation ExercisesThe patients in Group 2 were prescribed a total of eight relaxation exercises and behavioral modification therapy. |
| Combined Exercise Group | Experimental | Other: Combined Pelvic Floor ExercisesThe patients in Group 3 were prescribed both pelvic floor relaxation and strengthening exercises and behavioral modification therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Participants were excluded if they:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor Strengthening ExercisesPatients 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. | Other | Pelvic Floor Strengthening Group |
| Pelvic Floor Relaxation ExercisesThe 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. | Other | Pelvic Floor Relaxation Group |
| Combined Pelvic Floor ExercisesThe 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. | Other | Combined Exercise Group |
Primary outcome
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.
5 secondary outcomes
Urogenital Distress Inventory (UDI-6)
Time frame: 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
Patient Health Questionnaire (PHQ)
Time frame: 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.
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time frame: From enrollment to the end of treatment at 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlke Keser, Proffesor study chair
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Strengthening Exercises, Pelvic Floor Relaxation Exercises and Combined Pelvic Floor Exercises in people with Multiple Sclerosis and Neurogenic Bladder Disorder, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 Hours Voiding Diary (time frame: From enrollment to the end of treatment at 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.