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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group | Experimental | 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. |
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| Standard Pelvic floor Rehab Protocol Group | Active Comparator | This group receives standard protocol for strengthening of pelvic floor to prevent urinary incontinence. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregnancy Specific Pelvic floor rehab protocol (PSPFR) Group | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| International Consultation on Incontinence Questionnaire (ICIQ-UI-SF) |
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Inclusion Criteria:
Exclusion Criteria:
• Patients with High-risk pregnancy.
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| Name | Affiliation | Role |
|---|---|---|
| Dr Zahra Ijaz | Riphah International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riphah International Hospital | Islamabad | Islamabad | 44000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39473377 | Background | 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. | |
| 37315962 | Background | Kamali 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. |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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There will be comparison between experimental group and control group.
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| Standard Protocol for Pelvic floor strengthening | Other | in this group, standard exercises used for strengthening of pelvic floor to prevent urinary incontinence will be implemented. |
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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. |
| 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. | 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. | 4 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |