Urinary IncontinenceNCT07603388
Effects of Pelvic Floor Rehab Protocol on Urinary Incontinence
A study testing Pregnancy Specific Pelvic floor rehab protocol (PSPFR) Group and Standard Protocol for Pelvic floor strengthening in people with Urinary Incontinence, run by Riphah International University at 1 site in Pakistan.
Trial summary
Urinary incontinence is a serious health issue that deeply affects a person's daily life and overall well-being. The global prevalence of UI is between 5 to 69% during a woman's lifetime, with higher prevalence in older age groups. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Pregnancy Specific Pelvic floor rehab protocol (PSPFR) Group and Standard Protocol for Pelvic floor strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged 18-35 yrs.
- Score ≥1 on stress or urge subscale of the Questionnaire for Incontinence Diagnosis
- No participation in a structured pelvic floor rehabilitation program within the last six months.
Who cannot join
- • Patients with High-risk pregnancy.
- Known neurological disorders.
- History of pelvic surgery.
- ACOG Contraindications for Exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pregnancy Specific Pelvic Floor Rehab Protocol on Urinary Incontinence
Urinary incontinence is a serious health issue that deeply affects a person's daily life and overall well-being. The global prevalence of UI is between 5 to 69% during a woman's lifetime, with higher prevalence in older age groups. The goal of this randomized controlled trial is to compare the effects of pregnancy specific pelvic floor rehab protocol with the standard protocol on urinary incontinence. Participants will be randomly assigned to one of the two groups. The results of this trial would be helpful in this way that how Pregnancy specific pelvic floor rehab protocol can provide support for pregnant ladies with urinary incontinence and improve health outcomes.
Read the detailed description
The International Continence Society defines urinary incontinence as the 'unintentional or involuntary leakage of urine'. Urinary incontinence is a serious health issue that deeply affects a person's daily life and overall well-being. It can be physically exhausting and emotionally overwhelming, often leading to embarrassment, loss of confidence, and feelings of helplessness. Many people dealing with it also struggle with anxiety and depression, as it limits their freedom and makes even simple daily tasks feel challenging. Urinary incontinence (UI) is common during pregnancy with prevalence rates of 31% in nulliparous women and 42% in parous women. The global prevalence of UI is between 5 to 69% during a woman's lifetime, with higher prevalence in older age groups. . Urinary incontinence during pregnancy affects women's physical comfort, emotional well-being, and quality of life, yet it remains under-identified and undertreated in standard antenatal care. Although pelvic floor exercises are widely recommended, most existing programs are not adapted to the unique demands of pregnancy. A structured, pregnancy-specific pelvic floor rehabilitation protocol can address these needs more effectively by offering trimester-based guidance, functional training, and education. . This pregnancy-specific pelvic floor rehabilitation protocol follows a progressive 4-week plan focused on pelvic floor muscle training, core activation, and functional strengthening. Exercises such as Kegels, abdominal drawing-in, bridging, and clamshells are performed in various positions with controlled breathing. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education. Participants will be randomly assigned through convenient sampling method to each groups. Ethical considerations will be completely taken and data will be analyzed through SPSS version 26. This study aims to evaluate the impact of such a protocol and provide evidence to support its integration into routine prenatal care, potentially improving maternal outcomes and long-term recovery.
- Conditions
- Urinary Incontinence
- Being tested
- Pregnancy Specific Pelvic floor rehab protocol (PSPFR) Group, Standard Protocol for Pelvic floor strengthening
- Keywords
- Pregnancy Specific Pelvic Floor Rehab Protocol, Pregnant Women, Urinary Incontinence
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnancy Specific Pelvic floor rehab protocol (PSPFR) GroupOther
This pregnancy-specific pelvic floor rehabilitation protocol follows a progressive 4-week plan focused on pelvic floor muscle training, core activation, and functional strengthening. Exercises such as Kegels, abdominal drawing-in, bridging, and clamshells are performed in various positions with controlled breathing. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education. The instructions of the supervised exercises would be Hold for 2 s in 3 repetitions, 5 seconds rest, 1 minute of rest between each exercise \& 2 sets each. The record of each session will be written in diaries.
Standard Protocol for Pelvic floor strengtheningOther
in this group, standard exercises used for strengthening of pelvic floor to prevent urinary incontinence will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group (2nd Trimester) | Experimental | This group will receive a pregnancy-specific supervised pelvic floor rehabilitation protocol and basic antenatal education. There will be 2 sessions per week for 4 weeks. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education. Receives: Other: Pregnancy Specific Pelvic floor rehab protocol (PSPFR) Group |
| Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group (3rd Trimester) | Experimental | This group will receive a pregnancy-specific supervised pelvic floor rehabilitation protocol and basic antenatal education. There will be 2 sessions per week for 4 weeks. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education. Receives: Other: Pregnancy Specific Pelvic floor rehab protocol (PSPFR) Group |
| Standard Pelvic floor Rehab Protocol Group | Active comparator | This group receives standard protocol for strengthening of pelvic floor to prevent urinary incontinence. Receives: Other: Standard Protocol for Pelvic floor strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire for Incontinence Diagnosis
The Questionnaire for Incontinence Diagnosis is a self-reported screening tool used to identify the presence and type of urinary incontinence, such as stress, urge, or mixed incontinence. It consists of structured questions related to symptom triggers, frequency, and leakage patterns. Each item scores 0 (None of the time), 1 (Rarely), 2 (Once in a while), 3 (Often), 4 (Most of the time) or 5 (All of the time). Responses to items 1, 2 and 3 are summed for the Stress score; and responses to items 4, 5, and 6 are summed for the Urge score.
Measured: 4 weeks
Secondary outcomes (4)
Incontinence Severity Index
The ISI is a quick, two-question tool that assesses the frequency and amount of urine leakage. Scores range from 0 to 12, indicating severity from none to very severe. It is simple to administer and useful for tracking symptom changes over time.
Measured: 4 weeks
International Consultation on Incontinence Questionnaire (ICIQ-UI-SF)
The ICIQ-UI-SF is a validated self-reported questionnaire that assesses the frequency, severity, and impact of urinary incontinence. Scores range from 0 to 21, with higher scores indicating greater symptom severity and quality-of-life impact. It is widely used to quantify the patient-reported burden of incontinence.
Measured: 4 weeks
Incontinence Impact Questionnaire
The IIQ-7 assesses the psychosocial and functional impact of urinary incontinence on daily life, including physical activity, travel, and emotional well-being. Scores range from 0 to 100, with higher scores reflecting a greater negative impact. It is a useful tool for evaluating quality of life related to incontinence.
Measured: 4 weeks
Patient Global Impression of Improvement Scale
The PGI-I is a single-item scale that captures the patient's overall perception of symptom improvement after treatment. It reflects subjective satisfaction with the intervention. The 7-point scale ranges from 1 (very much better) to 7 (very much worse), with lower scores indicating greater improvement.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Nov 2025
- Primary completion7 May 2026
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- There will be comparison between experimental group and control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Zahra Ijaz, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603388
- Sponsor's protocol ID
- Attiya Azhar
- Status last verified
- Jul 2026
- First submitted
- 18 May 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu Y, Li T, Cai F, Ye X, Xu M. Stable pelvic floor muscle training improves urinary incontinence in women with gestational diabetes mellitus. J Obstet Gynaecol. 2024 Dec;44(1):2420192. doi: 10.1080/01443615.2024.2420192. Epub 2024 Oct 30.
PubMed 39473377Kamali S, Ozengin N, Topcuoglu MA. The effect of e-pelvic floor muscle training on symptoms in women with stress urinary incontinence: a randomized controlled trial. Women Health. 2023 Jul 3;63(6):473-483. doi: 10.1080/03630242.2023.2223729. Epub 2023 Jun 14.
PubMed 37315962
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pregnancy Specific Pelvic Floor Rehab Protocol on Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07603388
- Acronym / sponsor ID
- Attiya Azhar
- Conditions
- Urinary Incontinence
- Keywords
- Pregnancy Specific Pelvic Floor Rehab Protocol, Pregnant Women, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 22 May 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.
Urinary incontinence is a serious health issue that deeply affects a person's daily life and overall well-being. The global prevalence of UI is between 5 to 69% during a woman's lifetime, with higher prevalence in older age groups. The goal of this randomized controlled trial is to compare the effects of pregnancy specific pelvic floor rehab protocol with the standard protocol on urinary incontinence. Participants will be randomly assigned to one of the two groups. The results of this trial would be helpful in this way that how Pregnancy specific pelvic floor rehab protocol can provide support for pregnant ladies with urinary incontinence and improve health outcomes.
Detailed description
The International Continence Society defines urinary incontinence as the 'unintentional or involuntary leakage of urine'. Urinary incontinence is a serious health issue that deeply affects a person's daily life and overall well-being. It can be physically exhausting and emotionally overwhelming, often leading to embarrassment, loss of confidence, and feelings of helplessness. Many people dealing with it also struggle with anxiety and depression, as it limits their freedom and makes even simple daily tasks feel challenging. Urinary incontinence (UI) is common during pregnancy with prevalence rates of 31% in nulliparous women and 42% in parous women. The global prevalence of UI is between 5 to 69% during a woman's lifetime, with higher prevalence in older age groups. . Urinary incontinence during pregnancy affects women's physical comfort, emotional well-being, and quality of life, yet it remains under-identified and undertreated in standard antenatal care. Although pelvic floor exercises are widely recommended, most existing programs are not adapted to the unique demands of pregnancy. A structured, pregnancy-specific pelvic floor rehabilitation protocol can address these needs more effectively by offering trimester-based guidance, functional training, and education. . This pregnancy-specific pelvic floor rehabilitation protocol follows a progressive 4-week plan focused on pelvic floor muscle training, core activation, and functional strengthening. Exercises such as Kegels, abdominal drawing-in, bridging, and clamshells are performed in various positions with controlled breathing. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education. Participants will be randomly assigned through convenient sampling method to each groups. Ethical considerations will be completely taken and data will be analyzed through SPSS version 26. This study aims to evaluate the impact of such a protocol and provide evidence to support its integration into routine prenatal care, potentially improving maternal outcomes and long-term recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- There will be comparison between experimental group and control group.
| Arm | Type | Receives |
|---|---|---|
| Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group (2nd Trimester) | Experimental | Other: Pregnancy Specific Pelvic floor rehab protocol (PSPFR) GroupThis group will receive a pregnancy-specific supervised pelvic floor rehabilitation protocol and basic antenatal education. There will be 2 sessions per week for 4 weeks. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education. |
| Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group (3rd Trimester) | Experimental | Other: Pregnancy Specific Pelvic floor rehab protocol (PSPFR) GroupThis group will receive a pregnancy-specific supervised pelvic floor rehabilitation protocol and basic antenatal education. There will be 2 sessions per week for 4 weeks. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education. |
| Standard Pelvic floor Rehab Protocol Group | Active comparator | Other: Standard Protocol for Pelvic floor strengtheningThis group receives standard protocol for strengthening of pelvic floor to prevent urinary incontinence. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women aged 18-35 yrs.
- Score ≥1 on stress or urge subscale of the Questionnaire for Incontinence Diagnosis
- No participation in a structured pelvic floor rehabilitation program within the last six months.
Key exclusion criteria (4 listed)
- • Patients with High-risk pregnancy.
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 |
|---|---|---|
| Pregnancy Specific Pelvic floor rehab protocol (PSPFR) GroupThis pregnancy-specific pelvic floor rehabilitation protocol follows a progressive 4-week plan focused on pelvic floor muscle training, core activation, and functional strengthening. Exercises such as Kegels, abdominal drawing-in, bridging, and clamshells are performed in various positions with controlled breathing. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education. The instructions of the supervised exercises would be Hold for 2 s in 3 repetitions, 5 seconds rest, 1 minute of rest between each exercise \& 2 sets each. The record of each session will be written in diaries. | Other | Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group (2nd Trimester), Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group (3rd Trimester) |
| Standard Protocol for Pelvic floor strengtheningin this group, standard exercises used for strengthening of pelvic floor to prevent urinary incontinence will be implemented. | Other | Standard Pelvic floor Rehab Protocol Group |
Primary outcome
Questionnaire for Incontinence Diagnosis
Time frame: 4 weeks
The Questionnaire for Incontinence Diagnosis is a self-reported screening tool used to identify the presence and type of urinary incontinence, such as stress, urge, or mixed incontinence. It consists of structured questions related to symptom triggers, frequency, and leakage patterns. Each item scores 0 (None of the time), 1 (Rarely), 2 (Once in a while), 3 (Often), 4 (Most of the time) or 5 (All of the time). Responses to items 1, 2 and 3 are summed for the Stress score; and responses to items 4, 5, and 6 are summed for the Urge score.
4 secondary outcomes
Incontinence Severity Index
Time frame: 4 weeks
International Consultation on Incontinence Questionnaire (ICIQ-UI-SF)
Time frame: 4 weeks
Incontinence Impact Questionnaire
Time frame: 4 weeks
Patient Global Impression of Improvement Scale
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 39473377Wu Y, Li T, Cai F, Ye X, Xu M. Stable pelvic floor muscle training improves urinary incontinence in women with gestational diabetes mellitus. J Obstet Gynaecol. 2024 Dec;44(1):2420192. doi: 10.1080/01443615.2024.2420192. Epub 2024 Oct 30.
- Background: PubMed 37315962Kamali S, Ozengin N, Topcuoglu MA. The effect of e-pelvic floor muscle training on symptoms in women with stress urinary incontinence: a randomized controlled trial. Women Health. 2023 Jul 3;63(6):473-483. doi: 10.1080/03630242.2023.2223729. Epub 2023 Jun 14.
- 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.
Dr Zahra Ijaz principal investigator
Riphah International 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 Pregnancy Specific Pelvic floor rehab protocol (PSPFR) Group and Standard Protocol for Pelvic floor strengthening in people with 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 4 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: under way, not looking for participants, as of the sponsor's last update on 20 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Questionnaire for Incontinence Diagnosis (time frame: 4 weeks). 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 NCT07603388, which also lists 2 linked publications.
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 Jul 2026.