Postpartum Pelvic Floor DysfunctionNCT07702565
Exercise-Based Sensorimotor Physiotherapy for Postpartum Pelvic Health and Functional Recovery
A study testing Exercise-Based Sensorimotor Physiotherapy Program and Standard Postpartum Education and Home Advice in people with Postpartum Pelvic Floor Dysfunction and Postpartum Urinary Incontinence, run by Özge BAYKAN ÇOPUROĞLU at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated whether a 12-week exercise-based sensorimotor physiotherapy program could improve pelvic health and functional recovery in postpartum women. Participants were women aged 18-40 years who were between 6 weeks and 6 months after a singleton delivery. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postpartum Pelvic Floor Dysfunction, Postpartum Urinary Incontinence, Postpartum Functional Recovery
- What is being tested?
- Exercise-Based Sensorimotor Physiotherapy Program and Standard Postpartum Education and Home Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Mar 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-40 years.
- Postpartum women between 6 weeks and 6 months after delivery.
- Singleton delivery.
- Vaginal delivery or cesarean delivery.
- Ability to understand and perform the required assessment procedures.
- Ability to participate in the exercise-based intervention procedures.
- Provision of written informed consent before enrollment.
Who cannot join
- Third- or fourth-degree perineal tears.
- Pelvic organ prolapse stage II or higher according to the POP-Q classification.
- Active urinary tract infection or genital infection.
- Previous pelvic or abdominal surgery unrelated to cesarean delivery.
- Neurological conditions affecting lumbopelvic motor control.
- Musculoskeletal conditions affecting lumbopelvic motor control.
Show all 9Show fewer
- Chronic pelvic pain syndromes.
- Psychiatric disorders limiting participation.
- Participation in structured physiotherapy or pelvic rehabilitation within the preceding 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a 12-Week Exercise-Based Sensorimotor Physiotherapy Program on Postpartum Pelvic Health and Functional Recovery: A Stratified Randomized Controlled Trial
This study evaluated whether a 12-week exercise-based sensorimotor physiotherapy program could improve pelvic health and functional recovery in postpartum women. Participants were women aged 18-40 years who were between 6 weeks and 6 months after a singleton delivery. They were randomly assigned to either a sensorimotor physiotherapy group or a control group. The physiotherapy group received supervised exercises targeting pelvic floor activation, lumbopelvic motor control, sensory re-education, proprioceptive training, functional stabilization, and biofeedback-assisted training. The control group received standard postpartum education and home advice.
The main outcomes were pelvic motor control and perineal sensory function. Other outcomes included pelvic floor muscle strength, urinary symptoms, pelvic distress, core endurance, postural stability, pain intensity, and health-related quality of life. Outcomes were assessed at baseline, week 6, week 12, and week 24. The study aimed to determine whether structured sensorimotor physiotherapy provides greater benefits than standard postpartum advice and whether recovery patterns differ according to vaginal or cesarean delivery.
Read the detailed description
This was a prospective, single-center, assessor-blinded, stratified, parallel-group randomized controlled trial conducted in postpartum women. The study was designed to evaluate the effects of a structured 12-week exercise-based sensorimotor physiotherapy program on postpartum pelvic health, lumbopelvic motor control, sensory function, and functional recovery.
Eligible postpartum women were stratified according to delivery mode, vaginal delivery or cesarean delivery, and then randomly allocated to either the Sensorimotor Physiotherapy Group or the Control Group. The intervention group received supervised individual physiotherapy sessions twice weekly for 12 weeks, together with a structured home exercise program. The intervention included pelvic floor activation, lumbopelvic motor control training, proprioceptive exercises, sensory re-education, functional stabilization, and surface electromyography-assisted biofeedback. The control group received standard postpartum education and general home advice.
Outcome assessments were performed at baseline, week 6, week 12, and week 24 by blinded assessors. The primary focus was to determine whether the sensorimotor physiotherapy program improved pelvic motor control and perineal sensory function compared with standard postpartum advice. Secondary outcomes were used to evaluate broader functional and patient-reported recovery, including pelvic floor strength, urinary symptoms, pelvic distress, core endurance, postural stability, pain intensity, and health-related quality of life. Delivery mode was examined as an exploratory factor that could influence recovery patterns.
- Conditions
- Postpartum Pelvic Floor Dysfunction, Postpartum Urinary Incontinence, Postpartum Functional Recovery, Lumbopelvic Motor Control Impairment, Perineal Sensory Dysfunction
- Being tested
- Exercise-Based Sensorimotor Physiotherapy Program, Standard Postpartum Education and Home Advice
- Keywords
- Postpartum Exercise, Sensorimotor Physiotherapy, Pelvic Floor Rehabilitation, Lumbopelvic Motor Control, Perineal Sensory Function, Biofeedback, Functional Recovery, Postpartum Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-Based Sensorimotor Physiotherapy ProgramBehavioural
Also called Sensorimotor Physiotherapy
A 12-week physiotherapist-led exercise-based sensorimotor physiotherapy program delivered individually twice weekly for approximately 45 minutes per session. The program included pelvic floor activation, diaphragmatic breathing, lumbopelvic motor control training, abdominal-pelvic floor synergy exercises, proprioceptive training, tactile discrimination tasks, sensory re-education, functional stabilization, task-specific training, and surface electromyography-assisted biofeedback. Participants also completed a structured home exercise program for 15-20 minutes per day, five days per week.
Standard Postpartum Education and Home AdviceOther
Also called Standard Postpartum Advice
A standard postpartum education and home advice program including information on postpartum anatomy, posture correction, bladder care, and general pelvic floor exercises. Participants received a printed home exercise leaflet and two telephone contacts at weeks 4 and 8 to encourage continuation of general advice. No supervised physiotherapy, individualized exercise progression, biofeedback, or structured sensorimotor training was provided.
| Study group | Role | What they receive |
|---|---|---|
| Exercise-Based Sensorimotor Physiotherapy Program | Experimental | A 12-week physiotherapist-led exercise-based sensorimotor physiotherapy program delivered individually twice weekly for approximately 45 minutes per session. The program included pelvic floor activation, diaphragmatic breathing, lumbopelvic motor control training, abdominal-pelvic floor synergy exercises, proprioceptive stimulation, tactile discrimination tasks, sensory re-education, functional stabilization, task-specific training, and surface electromyography-assisted biofeedback. Participants also completed a structured home exercise program for 15-20 minutes per day, five days per week. Receives: Behavioral: Exercise-Based Sensorimotor Physiotherapy Program |
| Standard Postpartum Education and Home Advice | Other | A standard postpartum education and home advice program including information on postpartum anatomy, posture correction, bladder care, and general pelvic floor exercises. Participants received a printed home exercise leaflet and two telephone contacts at weeks 4 and 8 to encourage continuation of general advice. No supervised physiotherapy, individualized exercise progression, biofeedback, or structured sensorimotor training was provided. Receives: Other: Standard Postpartum Education and Home Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pelvic Motor Control Composite Score
Pelvic motor control was assessed using the Pelvic Motor Control Composite Score, an experimental composite index derived from surface electromyography-based parameters including normalized root mean square amplitude, onset latency, relaxation time, and contraction intermittency. Higher scores indicate better lumbopelvic motor control.
Measured: Baseline, week 6, week 12, and week 24
Change in Perineal Sensory Function
Perineal sensory function was assessed using pressure detection threshold measured with a calibrated handheld algometer and two-point discrimination measured with a precision caliper. Lower values indicate better sensory responsiveness and tactile discrimination.
Measured: Baseline, week 6, week 12, and week 24
Secondary outcomes (8)
Change in Pelvic Floor Muscle Strength
Pelvic floor muscle strength was assessed using the Modified Oxford Scale and the PERFECT scheme. Higher scores indicate greater pelvic floor muscle strength and function.
Measured: Baseline, week 6, week 12, and week 24
Change in Urinary Incontinence Severity
Urinary incontinence severity was assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form. Higher scores indicate greater urinary incontinence severity.
Measured: Baseline, week 6, week 12, and week 24
Change in Pelvic Floor Distress
Pelvic floor-related distress was assessed using the Pelvic Floor Distress Inventory-20. Higher scores indicate greater pelvic floor symptom-related distress.
Measured: Baseline, week 6, week 12, and week 24
Change in Pelvic Floor Impact on Daily Function
The functional impact of pelvic floor symptoms was assessed using the Pelvic Floor Impact Questionnaire-7. Higher scores indicate greater negative impact of pelvic floor symptoms on daily activities and quality of life.
Measured: Baseline, week 6, week 12, and week 24
Change in Core Endurance
Core endurance was assessed using prone plank and side plank duration. Longer duration indicates better core endurance.
Measured: Baseline, week 6, week 12, and week 24
Change in Postural Stability
Postural stability was assessed using center-of-pressure displacement during stabilometry. Lower center-of-pressure displacement or sway area indicates better postural stability.
Measured: Baseline, week 6, week 12, and week 24
Change in Pain Intensity
Pain intensity was assessed using a 0-10 visual analogue scale. Higher scores indicate greater pain intensity.
Measured: Baseline, week 6, week 12, and week 24
Change in Health-Related Quality of Life
Health-related quality of life was assessed using the 12-item Short Form Health Survey version 2. Higher scores indicate better perceived health-related quality of life.
Measured: Baseline, week 6, week 12, and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Mar 2024
- Primary completion1 Dec 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Pelvic Floor DysfunctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were stratified by delivery mode, vaginal delivery or cesarean delivery, and then randomly allocated in a 1:1 ratio to either the Sensorimotor Physiotherapy Group or the Control Group. The Sensorimotor Physiotherapy Group received a 12-week supervised exercise-based sensorimotor physiotherapy program, while the Control Group received standard postpartum education and home advice.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Özge BAYKAN ÇOPUROĞLU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Özge BAYKAN ÇOPUROĞLU, Kayseri University
- Investigators
- Özge Çopuroğlu, Study chair, Kayseri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702565
- Sponsor's protocol ID
- KayseriUniversity111
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 12-Week Exercise-Based Sensorimotor Physiotherapy Program on Postpartum Pelvic Health and Functional Recovery: A Stratified Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07702565
- Acronym / sponsor ID
- KayseriUniversity111
- Conditions
- Postpartum Pelvic Floor Dysfunction, Postpartum Urinary Incontinence, Postpartum Functional Recovery, Lumbopelvic Motor Control Impairment, Perineal Sensory Dysfunction
- Keywords
- Postpartum Exercise, Sensorimotor Physiotherapy, Pelvic Floor Rehabilitation, Lumbopelvic Motor Control, Perineal Sensory Function, Biofeedback, Functional Recovery, Postpartum Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Özge BAYKAN ÇOPUROĞLUUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 14 Jul 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.
This study evaluated whether a 12-week exercise-based sensorimotor physiotherapy program could improve pelvic health and functional recovery in postpartum women. Participants were women aged 18-40 years who were between 6 weeks and 6 months after a singleton delivery. They were randomly assigned to either a sensorimotor physiotherapy group or a control group. The physiotherapy group received supervised exercises targeting pelvic floor activation, lumbopelvic motor control, sensory re-education, proprioceptive training, functional stabilization, and biofeedback-assisted training. The control group received standard postpartum education and home advice.
The main outcomes were pelvic motor control and perineal sensory function. Other outcomes included pelvic floor muscle strength, urinary symptoms, pelvic distress, core endurance, postural stability, pain intensity, and health-related quality of life. Outcomes were assessed at baseline, week 6, week 12, and week 24. The study aimed to determine whether structured sensorimotor physiotherapy provides greater benefits than standard postpartum advice and whether recovery patterns differ according to vaginal or cesarean delivery.
Detailed description
This was a prospective, single-center, assessor-blinded, stratified, parallel-group randomized controlled trial conducted in postpartum women. The study was designed to evaluate the effects of a structured 12-week exercise-based sensorimotor physiotherapy program on postpartum pelvic health, lumbopelvic motor control, sensory function, and functional recovery.
Eligible postpartum women were stratified according to delivery mode, vaginal delivery or cesarean delivery, and then randomly allocated to either the Sensorimotor Physiotherapy Group or the Control Group. The intervention group received supervised individual physiotherapy sessions twice weekly for 12 weeks, together with a structured home exercise program. The intervention included pelvic floor activation, lumbopelvic motor control training, proprioceptive exercises, sensory re-education, functional stabilization, and surface electromyography-assisted biofeedback. The control group received standard postpartum education and general home advice.
Outcome assessments were performed at baseline, week 6, week 12, and week 24 by blinded assessors. The primary focus was to determine whether the sensorimotor physiotherapy program improved pelvic motor control and perineal sensory function compared with standard postpartum advice. Secondary outcomes were used to evaluate broader functional and patient-reported recovery, including pelvic floor strength, urinary symptoms, pelvic distress, core endurance, postural stability, pain intensity, and health-related quality of life. Delivery mode was examined as an exploratory factor that could influence recovery patterns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were stratified by delivery mode, vaginal delivery or cesarean delivery, and then randomly allocated in a 1:1 ratio to either the Sensorimotor Physiotherapy Group or the Control Group. The Sensorimotor Physiotherapy Group received a 12-week supervised exercise-based sensorimotor physiotherapy program, while the Control Group received standard postpartum education and home advice.
| Arm | Type | Receives |
|---|---|---|
| Exercise-Based Sensorimotor Physiotherapy Program | Experimental | Behavioral: Exercise-Based Sensorimotor Physiotherapy ProgramA 12-week physiotherapist-led exercise-based sensorimotor physiotherapy program delivered individually twice weekly for approximately 45 minutes per session. The program included pelvic floor activation, diaphragmatic breathing, lumbopelvic motor control training, abdominal-pelvic floor synergy exercises, proprioceptive stimulation, tactile discrimination tasks, sensory re-education, functional stabilization, task-specific training, and surface electromyography-assisted biofeedback. Participants also completed a structured home exercise program for 15-20 minutes per day, five days per week. |
| Standard Postpartum Education and Home Advice | Other | Other: Standard Postpartum Education and Home AdviceA standard postpartum education and home advice program including information on postpartum anatomy, posture correction, bladder care, and general pelvic floor exercises. Participants received a printed home exercise leaflet and two telephone contacts at weeks 4 and 8 to encourage continuation of general advice. No supervised physiotherapy, individualized exercise progression, biofeedback, or structured sensorimotor training was provided. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women aged 18-40 years.
- Postpartum women between 6 weeks and 6 months after delivery.
- Singleton delivery.
- Vaginal delivery or cesarean delivery.
- Ability to understand and perform the required assessment procedures.
Key exclusion criteria (9 listed)
- Third- or fourth-degree perineal tears.
- Pelvic organ prolapse stage II or higher according to the POP-Q classification.
- Active urinary tract infection or genital infection.
- Previous pelvic or abdominal surgery unrelated to cesarean delivery.
- Neurological conditions affecting lumbopelvic motor control.
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 |
|---|---|---|
| Exercise-Based Sensorimotor Physiotherapy ProgramAlso: Sensorimotor PhysiotherapyA 12-week physiotherapist-led exercise-based sensorimotor physiotherapy program delivered individually twice weekly for approximately 45 minutes per session. The program included pelvic floor activation, diaphragmatic breathing, lumbopelvic motor control training, abdominal-pelvic floor synergy exercises, proprioceptive training, tactile discrimination tasks, sensory re-education, functional stabilization, task-specific training, and surface electromyography-assisted biofeedback. Participants also completed a structured home exercise program for 15-20 minutes per day, five days per week. | Behavioural | Exercise-Based Sensorimotor Physiotherapy Program |
| Standard Postpartum Education and Home AdviceAlso: Standard Postpartum AdviceA standard postpartum education and home advice program including information on postpartum anatomy, posture correction, bladder care, and general pelvic floor exercises. Participants received a printed home exercise leaflet and two telephone contacts at weeks 4 and 8 to encourage continuation of general advice. No supervised physiotherapy, individualized exercise progression, biofeedback, or structured sensorimotor training was provided. | Other | Standard Postpartum Education and Home Advice |
Primary outcome
Change in Pelvic Motor Control Composite Score
Time frame: Baseline, week 6, week 12, and week 24
Pelvic motor control was assessed using the Pelvic Motor Control Composite Score, an experimental composite index derived from surface electromyography-based parameters including normalized root mean square amplitude, onset latency, relaxation time, and contraction intermittency. Higher scores indicate better lumbopelvic motor control.
Change in Perineal Sensory Function
Time frame: Baseline, week 6, week 12, and week 24
Perineal sensory function was assessed using pressure detection threshold measured with a calibrated handheld algometer and two-point discrimination measured with a precision caliper. Lower values indicate better sensory responsiveness and tactile discrimination.
8 secondary outcomes
Change in Pelvic Floor Muscle Strength
Time frame: Baseline, week 6, week 12, and week 24
Change in Urinary Incontinence Severity
Time frame: Baseline, week 6, week 12, and week 24
Change in Pelvic Floor Distress
Time frame: Baseline, week 6, week 12, and week 24
Change in Pelvic Floor Impact on Daily Function
Time frame: Baseline, week 6, week 12, and week 24
Change in Core Endurance
Time frame: Baseline, week 6, week 12, and week 24
Change in Postural Stability
Time frame: Baseline, week 6, week 12, and week 24
Change in Pain Intensity
Time frame: Baseline, week 6, week 12, and week 24
Change in Health-Related Quality of Life
Time frame: Baseline, week 6, week 12, and week 24
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 14 Jul 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.
Özge Çopuroğlu study chair
Kayseri 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 Exercise-Based Sensorimotor Physiotherapy Program and Standard Postpartum Education and Home Advice in people with Postpartum Pelvic Floor Dysfunction and Postpartum Urinary Incontinence, run by Özge BAYKAN ÇOPUROĞLU 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 7 inclusion and 9 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 14 Jul 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 Pelvic Motor Control Composite Score (time frame: Baseline, week 6, week 12, and week 24). The study lists 2 primary outcomes in all. 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 14 Jul 2026.