Stress Urinary Incontinence (SUI)NCT07762391
Pelvic Floor Muscle Exercise and Progressive Muscle Relaxation for Stress Urinary Incontinence
A study testing Pelvic Floor Muscle Exercise, Progressive Muscle Relaxation (PMR) and Combined Pelvic Floor Muscle Exercise and Progressive Muscle Relaxation in people with Stress Urinary Incontinence (SUI), run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
Stress urinary incontinence (SUI) is a common condition in women that causes involuntary urine leakage during activities such as coughing, sneezing, laughing, or exercising. This condition can negatively affect physical, emotional, and social well-being and reduce overall comfort. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Pelvic Floor Muscle Exercise, Progressive Muscle Relaxation (PMR) and Combined Pelvic Floor Muscle Exercise and Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 May 2026
- 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female participants aged 40-60 years Diagnosis of stress urinary incontinence Turkish-speaking Literate Access to the internet Access to a smartphone No active urinary tract infection Not pregnant No neurological or cognitive disorder
Who cannot join
- Previous participation in pelvic floor muscle exercise (PFME) or progressive muscle relaxation (PMR) training programs.
- Withdrawal from the study after enrollment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Eğitim ve Araştırma Hastanesi
Karaman, 70200
About this study
Official title: The Effect of Pelvic Floor Muscle Exercise, Progressive Muscle Relaxation Exercise, and Their Combined Application on Comfort in Women With Stress Urinary Incontinence: A Four-Arm Parallel Randomized Controlled Trial
Stress urinary incontinence (SUI) is a common condition in women that causes involuntary urine leakage during activities such as coughing, sneezing, laughing, or exercising. This condition can negatively affect physical, emotional, and social well-being and reduce overall comfort. Pelvic floor muscle exercise (PFME) is the recommended first-line conservative treatment for SUI, while progressive muscle relaxation (PMR) may help reduce muscle tension and improve psychological well-being. However, the combined effects of these two interventions on comfort have not been well studied.
This randomized controlled trial aims to compare the effects of PFME, PMR, their combined application, and routine care on comfort in women with stress urinary incontinence. Participants will be randomly assigned to one of four study groups and followed for six weeks. Comfort will be assessed at baseline and at Weeks 2, 4, and 6 using a validated questionnaire. The findings are expected to provide evidence for improving conservative treatment strategies and enhancing patient-centered care for women with stress urinary incontinence.
Read the detailed description
Stress urinary incontinence (SUI) is the most common type of urinary incontinence among women and is characterized by the involuntary leakage of urine during activities that increase intra-abdominal pressure, such as coughing, sneezing, laughing, exercising, or lifting heavy objects. Beyond urinary symptoms, SUI has substantial physical, psychological, social, and economic consequences that adversely affect women's daily functioning and overall well-being. Although pelvic floor muscle exercise (PFME) is recommended as the first-line conservative treatment for women with SUI, treatment outcomes may be influenced by factors such as exercise adherence, psychological stress, anxiety, and impaired neuromuscular coordination.
Progressive muscle relaxation (PMR) is a structured behavioral intervention that aims to reduce muscle tension and psychological stress through the sequential contraction and relaxation of major muscle groups. Previous studies have demonstrated beneficial effects of PMR on anxiety, stress-related symptoms, and muscle relaxation. Because psychological factors may contribute to pelvic floor dysfunction and symptom perception, combining PFME with PMR may enhance the effectiveness of conservative rehabilitation by addressing both physical and psychophysiological mechanisms. However, evidence regarding the combined effects of these interventions on patient comfort remains limited.
This study was designed as a prospective, four-arm, parallel-group randomized controlled trial conducted at the Urology Outpatient Clinic of Karaman Training and Research Hospital, Karaman, Türkiye. Eligible women diagnosed with stress urinary incontinence were randomly allocated to one of four study groups: (1) pelvic floor muscle exercise (PFME), (2) progressive muscle relaxation (PMR), (3) combined PFME and PMR, or (4) routine outpatient care (control). Participants in the intervention groups followed standardized home-based exercise programs for six weeks after receiving individualized education from a Physical Medicine and Rehabilitation specialist. Adherence to the intervention was supported through weekly telephone follow-up and reminder messages.
The primary objective of the trial was to compare changes in comfort among the four study groups over the six-week intervention period. Comfort was selected as the primary patient-centered outcome because it reflects physical, psychospiritual, sociocultural, and environmental well-being as described in Kolcaba's Comfort Theory. The findings of this study are expected to contribute to the evidence supporting conservative management strategies for stress urinary incontinence and to determine whether integrating progressive muscle relaxation into pelvic floor rehabilitation provides additional clinical benefit beyond conventional pelvic floor muscle training alone.
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- Pelvic Floor Muscle Exercise, Progressive Muscle Relaxation (PMR), Combined Pelvic Floor Muscle Exercise and Progressive Muscle Relaxation
- Keywords
- Progressive Muscle Relaxation, Pelvic Floor Muscle Exercise, Comfort, Stress Urinary Incontinence
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle ExerciseBehavioural
Participants received a standardized pelvic floor muscle exercise (PFME) program delivered individually by a Physical Medicine and Rehabilitation specialist. During the initial 40-minute face-to-face session, participants received education on pelvic floor anatomy, urinary continence mechanisms, identification of the correct pelvic floor muscles, and proper exercise techniques. Participants were instructed to perform slow maximal voluntary contractions of the pelvic floor muscles with progressive contraction duration (3-10 seconds) followed by equal periods of relaxation. The home-based exercise program consisted of three sets of ten contractions performed daily for six weeks. Participants received an educational booklet, an exercise diary, and weekly telephone follow-up to monitor adherence and reinforce compliance.
Progressive Muscle Relaxation (PMR)Behavioural
articipants received progressive muscle relaxation (PMR) training based on Jacobson's relaxation technique. The intervention was introduced during an individual face-to-face session conducted by a Physical Medicine and Rehabilitation specialist. Participants were instructed to sequentially contract and relax major muscle groups while practicing slow diaphragmatic breathing to reduce muscle tension and promote physical and psychological relaxation. The standardized home-based PMR program was performed once daily for approximately 20-30 minutes over a six-week period. Participants were provided with written instructions and received weekly telephone follow-up to encourage adherence.
Combined Pelvic Floor Muscle Exercise and Progressive Muscle RelaxationBehavioural
Participants received both the standardized pelvic floor muscle exercise (PFME) program and the progressive muscle relaxation (PMR) program throughout the six-week intervention period. PFME and PMR were introduced during individualized face-to-face training sessions by a Physical Medicine and Rehabilitation specialist. Participants were instructed to perform both interventions daily according to the standardized protocols. Weekly telephone follow-up, an exercise diary, and reminder messages were used to support adherence and ensure consistency of the combined intervention.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Exercise (PFME) | Experimental | Pelvic Floor Muscle Exercise (PFME) Receives: Behavioral: Pelvic Floor Muscle Exercise |
| Progressive Muscle Relaxation (PMR) | Experimental | Progressive Muscle Relaxation (PMR) Receives: Behavioral: Progressive Muscle Relaxation (PMR) |
| Combined PFME + PMR | Experimental | Combined PFME + PMR Receives: Behavioral: Combined Pelvic Floor Muscle Exercise and Progressive Muscle Relaxation |
| Routine Care (Control) | No intervention | Routine Care (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Comfort Level
To evaluate the effect of pelvic floor muscle exercises, progressive muscle relaxation exercises, and their combined application on comfort levels in women with stress urinary incontinence. Comfort level was assessed using the Urinary Incontinence and Frequency Comfort Questionnaire (UIFCQ).
Measured: Baseline, Week 2, Week 4, and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Jun 2025
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a prospective, single-center, four-arm, parallel-group randomized controlled trial. Eligible women with stress urinary incontinence were randomly assigned in one of four study groups: (1) Pelvic Floor Muscle Exercise (PFME), (2) Progressive Muscle Relaxation (PMR), (3) Combined PFME and PMR, or (4) Routine Care (Control). Participants remained in their allocated intervention group throughout the six-week intervention period. Outcome assessments were performed at baseline and at Weeks 2, 4, and 6. Owing to the nature of the interventions, participant and therapist blinding was not feasible; however, outcome assessments were conducted using standardized procedures, and statistical analyses were performed by an investigator blinded to group allocation.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GAMZE GOKE ARSLAN, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762391
- Sponsor's protocol ID
- KMU-SUI-RCT-2025-001
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanli A, Goke Arslan G, Celik D, Demir B. The effect of pelvic floor muscle exercise, progressive muscle relaxation exercise, and their combined application on comfort in women with stress urinary incontinence: a four-arm randomized controlled trial. Front Med (Lausanne). 2026 Oct 20;13:1967374. doi: 10.3389/fmed.2026.1967374. eCollection 2026.
PubMed 42978560
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor Muscle Exercise, Progressive Muscle Relaxation Exercise, and Their Combined Application on Comfort in Women With Stress Urinary Incontinence: A Four-Arm Parallel Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07762391
- Acronym / sponsor ID
- KMU-SUI-RCT-2025-001
- Conditions
- Stress Urinary Incontinence (SUI)
- Keywords
- Progressive Muscle Relaxation, Pelvic Floor Muscle Exercise, Comfort, Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 13 Aug 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.
Stress urinary incontinence (SUI) is a common condition in women that causes involuntary urine leakage during activities such as coughing, sneezing, laughing, or exercising. This condition can negatively affect physical, emotional, and social well-being and reduce overall comfort. Pelvic floor muscle exercise (PFME) is the recommended first-line conservative treatment for SUI, while progressive muscle relaxation (PMR) may help reduce muscle tension and improve psychological well-being. However, the combined effects of these two interventions on comfort have not been well studied.
This randomized controlled trial aims to compare the effects of PFME, PMR, their combined application, and routine care on comfort in women with stress urinary incontinence. Participants will be randomly assigned to one of four study groups and followed for six weeks. Comfort will be assessed at baseline and at Weeks 2, 4, and 6 using a validated questionnaire. The findings are expected to provide evidence for improving conservative treatment strategies and enhancing patient-centered care for women with stress urinary incontinence.
Detailed description
Stress urinary incontinence (SUI) is the most common type of urinary incontinence among women and is characterized by the involuntary leakage of urine during activities that increase intra-abdominal pressure, such as coughing, sneezing, laughing, exercising, or lifting heavy objects. Beyond urinary symptoms, SUI has substantial physical, psychological, social, and economic consequences that adversely affect women's daily functioning and overall well-being. Although pelvic floor muscle exercise (PFME) is recommended as the first-line conservative treatment for women with SUI, treatment outcomes may be influenced by factors such as exercise adherence, psychological stress, anxiety, and impaired neuromuscular coordination.
Progressive muscle relaxation (PMR) is a structured behavioral intervention that aims to reduce muscle tension and psychological stress through the sequential contraction and relaxation of major muscle groups. Previous studies have demonstrated beneficial effects of PMR on anxiety, stress-related symptoms, and muscle relaxation. Because psychological factors may contribute to pelvic floor dysfunction and symptom perception, combining PFME with PMR may enhance the effectiveness of conservative rehabilitation by addressing both physical and psychophysiological mechanisms. However, evidence regarding the combined effects of these interventions on patient comfort remains limited.
This study was designed as a prospective, four-arm, parallel-group randomized controlled trial conducted at the Urology Outpatient Clinic of Karaman Training and Research Hospital, Karaman, Türkiye. Eligible women diagnosed with stress urinary incontinence were randomly allocated to one of four study groups: (1) pelvic floor muscle exercise (PFME), (2) progressive muscle relaxation (PMR), (3) combined PFME and PMR, or (4) routine outpatient care (control). Participants in the intervention groups followed standardized home-based exercise programs for six weeks after receiving individualized education from a Physical Medicine and Rehabilitation specialist. Adherence to the intervention was supported through weekly telephone follow-up and reminder messages.
The primary objective of the trial was to compare changes in comfort among the four study groups over the six-week intervention period. Comfort was selected as the primary patient-centered outcome because it reflects physical, psychospiritual, sociocultural, and environmental well-being as described in Kolcaba's Comfort Theory. The findings of this study are expected to contribute to the evidence supporting conservative management strategies for stress urinary incontinence and to determine whether integrating progressive muscle relaxation into pelvic floor rehabilitation provides additional clinical benefit beyond conventional pelvic floor muscle training alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study was designed as a prospective, single-center, four-arm, parallel-group randomized controlled trial. Eligible women with stress urinary incontinence were randomly assigned in one of four study groups: (1) Pelvic Floor Muscle Exercise (PFME), (2) Progressive Muscle Relaxation (PMR), (3) Combined PFME and PMR, or (4) Routine Care (Control). Participants remained in their allocated intervention group throughout the six-week intervention period. Outcome assessments were performed at baseline and at Weeks 2, 4, and 6. Owing to the nature of the interventions, participant and therapist blinding was not feasible; however, outcome assessments were conducted using standardized procedures, and statistical analyses were performed by an investigator blinded to group allocation.
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Muscle Exercise (PFME) | Experimental | Behavioral: Pelvic Floor Muscle ExercisePelvic Floor Muscle Exercise (PFME) |
| Progressive Muscle Relaxation (PMR) | Experimental | Behavioral: Progressive Muscle Relaxation (PMR)Progressive Muscle Relaxation (PMR) |
| Combined PFME + PMR | Experimental | Behavioral: Combined Pelvic Floor Muscle Exercise and Progressive Muscle RelaxationCombined PFME + PMR |
| Routine Care (Control) | No intervention | –Routine Care (Control) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female participants aged 40-60 years Diagnosis of stress urinary incontinence Turkish-speaking Literate Access to the internet Access to a smartphone No active urinary tract infection Not pregnant No neurological or cognitive disorder
Key exclusion criteria (2 listed)
- Previous participation in pelvic floor muscle exercise (PFME) or progressive muscle relaxation (PMR) training programs.
- Withdrawal from the study after enrollment.
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 Muscle ExerciseParticipants received a standardized pelvic floor muscle exercise (PFME) program delivered individually by a Physical Medicine and Rehabilitation specialist. During the initial 40-minute face-to-face session, participants received education on pelvic floor anatomy, urinary continence mechanisms, identification of the correct pelvic floor muscles, and proper exercise techniques. Participants were instructed to perform slow maximal voluntary contractions of the pelvic floor muscles with progressive contraction duration (3-10 seconds) followed by equal periods of relaxation. The home-based exercise program consisted of three sets of ten contractions performed daily for six weeks. Participants received an educational booklet, an exercise diary, and weekly telephone follow-up to monitor adherence and reinforce compliance. | Behavioural | Pelvic Floor Muscle Exercise (PFME) |
| Progressive Muscle Relaxation (PMR)articipants received progressive muscle relaxation (PMR) training based on Jacobson's relaxation technique. The intervention was introduced during an individual face-to-face session conducted by a Physical Medicine and Rehabilitation specialist. Participants were instructed to sequentially contract and relax major muscle groups while practicing slow diaphragmatic breathing to reduce muscle tension and promote physical and psychological relaxation. The standardized home-based PMR program was performed once daily for approximately 20-30 minutes over a six-week period. Participants were provided with written instructions and received weekly telephone follow-up to encourage adherence. | Behavioural | Progressive Muscle Relaxation (PMR) |
| Combined Pelvic Floor Muscle Exercise and Progressive Muscle RelaxationParticipants received both the standardized pelvic floor muscle exercise (PFME) program and the progressive muscle relaxation (PMR) program throughout the six-week intervention period. PFME and PMR were introduced during individualized face-to-face training sessions by a Physical Medicine and Rehabilitation specialist. Participants were instructed to perform both interventions daily according to the standardized protocols. Weekly telephone follow-up, an exercise diary, and reminder messages were used to support adherence and ensure consistency of the combined intervention. | Behavioural | Combined PFME + PMR |
Primary outcome
Change in Comfort Level
Time frame: Baseline, Week 2, Week 4, and Week 6
To evaluate the effect of pelvic floor muscle exercises, progressive muscle relaxation exercises, and their combined application on comfort levels in women with stress urinary incontinence. Comfort level was assessed using the Urinary Incontinence and Frequency Comfort Questionnaire (UIFCQ).
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 21 Oct 2026.
- Derived from this study: PubMed 42978560Sanli A, Goke Arslan G, Celik D, Demir B. The effect of pelvic floor muscle exercise, progressive muscle relaxation exercise, and their combined application on comfort in women with stress urinary incontinence: a four-arm randomized controlled trial. Front Med (Lausanne). 2026 Oct 20;13:1967374. doi: 10.3389/fmed.2026.1967374. eCollection 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Muscle Exercise, Progressive Muscle Relaxation (PMR) and Combined Pelvic Floor Muscle Exercise and Progressive Muscle Relaxation in people with Stress Urinary Incontinence (SUI), run by Karamanoğlu Mehmetbey 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 1 inclusion and 2 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 21 Oct 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?
Change in Comfort Level (time frame: Baseline, Week 2, Week 4, and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07762391, which also lists 1 linked publication.
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 21 Oct 2026.