Stress Urinary IncontinenceNCT06537544
Comparison of Comprehensive Rehab Program and Pelvic Floor Training in Women With Stress Urinary Incontinence
A study testing Comprehensive Rehabilitation Program and Conventional Pelvic Floor Training in people with Stress Urinary Incontinence, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare a comprehensive rehabilitation program and a conventional pelvic floor training program in women with stress urinary incontinence,to compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on the severity of SUI, on the strength… 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
- What is being tested?
- Comprehensive Rehabilitation Program and Conventional Pelvic Floor Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2024to 10 Jan 2025
- 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
- Perimenopausal and post-menopausal women
- Age 40-60 years
- Medically diagnosed patients of stress urinary incontinence
Who cannot join
- History of pelvic surgery within the past six months.
- Current urinary tract infections or other active urinary tract disorders.
- Neurological conditions affecting bladder control.
- Inability to participate in the prescribed intervention due to physical or cognitive limitations.
- Participation in other pelvic floor rehabilitation programs concurrently or previously within the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Comprehensive Rehabilitation Program and Conventional Pelvic Floor Training in Women With Stress Urinary Incontinence
The goal of this clinical trial is to compare a comprehensive rehabilitation program and a conventional pelvic floor training program in women with stress urinary incontinence,to compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on the severity of SUI, on the strength of pelvic floor muscle and on quality of life in women with SUI. Following the randomization into either the conventional pelvic floor training or comprehensive rehabilitation program group, participants will receive their assigned interventions of three weekly sessions for eight weeks.
Read the detailed description
The proposed study comparing the effects of conventional pelvic floor training versus a comprehensive rehabilitation program on stress urinary incontinence (SUI) among perimenopausal women holds significant rationale and importance. Given the prevalence and impact of SUI on the quality of life of perimenopausal women, investigating the comparative efficacy of these interventions is crucial for informing evidence-based clinical practice. The study aims to provide insights into the most effective management strategies for SUI in this population, potentially leading to improved treatment outcomes, enhanced quality of life, and reduced healthcare burden associated with this common condition. By addressing this research gap, the study has the potential to significantly benefit both individual patients and the broader healthcare system.
This will be a randomized controlled trial. Non probability sampling technique will be used.The data collection procedure begins with the recruitment phase, potential participants meeting the study's criteria will be identified and provided with detailed information about the research aims and procedures. Once recruited, participants will undergo a screening process to confirm their eligibility, including assessments such as medical history reviews and diagnostic tests. After obtaining informed consent, baseline assessments will be conducted to establish the participants' initial status regarding urinary symptoms and quality of life. Following randomization into either the conventional pelvic floor training or comprehensive rehabilitation program group, participants will receive their assigned interventions of three weekly sessions for eight weeks.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Comprehensive Rehabilitation Program, Conventional Pelvic Floor Training
- 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.
Comprehensive Rehabilitation ProgramOther
Pelvic Floor Muscle Strengthening Exercises Core Strengthening Exercises Breathing Exercises Patient education about bladder diary Postural education
Conventional Pelvic Floor TrainingOther
Kegels exercises in different body positions
| Study group | Role | What they receive |
|---|---|---|
| Conventional Pelvic Floor Training | Active comparator | This group will receive pelvic floor muscle training exercises in supine, sitting , kneeling and standing position with gradual increase in frequency, dosage and duration of exercises. Receives: Other: Conventional Pelvic Floor Training |
| Comprehensive Rehabilitation Program | Experimental | This group will receive Core Strengthening Exercises, Breathing Exercises and education along with Pelvic Floor Muscle Strengthening Exercises Receives: Other: Comprehensive Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of stress urinary incontinence
To compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on the severity of stress urinary incontinence
Measured: Changes from Baseline to 8 weeks
Secondary outcomes (2)
Strength of pelvic floor muscle
To compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on the strength of pelvic floor muscle
Measured: Changes from Baseline to 8 weeks
Quality of life in women with stress urinary incontinence
To compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on quality of life in women with stress urinary incontinence
Measured: Changes from Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Aug 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PhD, Study chair, Riphah International University, Islamabad, PakistanShahzadi Safoora Shamail, DPT, Principal investigator, Riphah International University, Islamabad, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537544
- Sponsor's protocol ID
- Shahzadi Safoora Shamail
- Status last verified
- Mar 2025
- First submitted
- 27 Jul 2024
- Last updated
- 5 Mar 2025
- 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 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Comprehensive Rehabilitation Program and Conventional Pelvic Floor Training in Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06537544
- Acronym / sponsor ID
- Shahzadi Safoora Shamail
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 5 Aug 2024 (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 goal of this clinical trial is to compare a comprehensive rehabilitation program and a conventional pelvic floor training program in women with stress urinary incontinence,to compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on the severity of SUI, on the strength of pelvic floor muscle and on quality of life in women with SUI. Following the randomization into either the conventional pelvic floor training or comprehensive rehabilitation program group, participants will receive their assigned interventions of three weekly sessions for eight weeks.
Detailed description
The proposed study comparing the effects of conventional pelvic floor training versus a comprehensive rehabilitation program on stress urinary incontinence (SUI) among perimenopausal women holds significant rationale and importance. Given the prevalence and impact of SUI on the quality of life of perimenopausal women, investigating the comparative efficacy of these interventions is crucial for informing evidence-based clinical practice. The study aims to provide insights into the most effective management strategies for SUI in this population, potentially leading to improved treatment outcomes, enhanced quality of life, and reduced healthcare burden associated with this common condition. By addressing this research gap, the study has the potential to significantly benefit both individual patients and the broader healthcare system.
This will be a randomized controlled trial. Non probability sampling technique will be used.The data collection procedure begins with the recruitment phase, potential participants meeting the study's criteria will be identified and provided with detailed information about the research aims and procedures. Once recruited, participants will undergo a screening process to confirm their eligibility, including assessments such as medical history reviews and diagnostic tests. After obtaining informed consent, baseline assessments will be conducted to establish the participants' initial status regarding urinary symptoms and quality of life. Following randomization into either the conventional pelvic floor training or comprehensive rehabilitation program group, participants will receive their assigned interventions of three weekly sessions for eight weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Pelvic Floor Training | Active comparator | Other: Conventional Pelvic Floor TrainingThis group will receive pelvic floor muscle training exercises in supine, sitting , kneeling and standing position with gradual increase in frequency, dosage and duration of exercises. |
| Comprehensive Rehabilitation Program | Experimental | Other: Comprehensive Rehabilitation ProgramThis group will receive Core Strengthening Exercises, Breathing Exercises and education along with Pelvic Floor Muscle Strengthening Exercises |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Perimenopausal and post-menopausal women
- Age 40-60 years
- Medically diagnosed patients of stress urinary incontinence
Key exclusion criteria (5 listed)
- History of pelvic surgery within the past six months.
- Current urinary tract infections or other active urinary tract disorders.
- Neurological conditions affecting bladder control.
- Inability to participate in the prescribed intervention due to physical or cognitive limitations.
- Participation in other pelvic floor rehabilitation programs concurrently or previously within the last 6 months.
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 |
|---|---|---|
| Comprehensive Rehabilitation ProgramPelvic Floor Muscle Strengthening Exercises Core Strengthening Exercises Breathing Exercises Patient education about bladder diary Postural education | Other | Comprehensive Rehabilitation Program |
| Conventional Pelvic Floor TrainingKegels exercises in different body positions | Other | Conventional Pelvic Floor Training |
Primary outcome
Severity of stress urinary incontinence
Time frame: Changes from Baseline to 8 weeks
To compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on the severity of stress urinary incontinence
2 secondary outcomes
Strength of pelvic floor muscle
Time frame: Changes from Baseline to 8 weeks
Quality of life in women with stress urinary incontinence
Time frame: Changes from Baseline to 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 5 Mar 2025.
- 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.
Huma Riaz, PhD study chair
Riphah International University, Islamabad, Pakistan
Shahzadi Safoora Shamail, DPT principal investigator
Riphah International University, Islamabad, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Rehabilitation Program and Conventional Pelvic Floor Training in people with Stress Urinary Incontinence, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 5 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 5 Mar 2025. 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 Pakistan. 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?
Severity of stress urinary incontinence (time frame: Changes from Baseline to 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 5 Mar 2025.