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Active, Not Recruiting

NCT Number: NCT07603388

Effects of 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • • Patients with High-risk pregnancy.
  • Known neurological disorders.
  • History of pelvic surgery.
  • ACOG Contraindications for Exercise

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incontinence Severity Index

    Time frame: 4 weeks

    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.

  2. International Consultation on Incontinence Questionnaire (ICIQ-UI-SF)

    Time frame: 4 weeks

    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.

  3. Incontinence Impact Questionnaire

    Time frame: 4 weeks

    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. Patient Global Impression of Improvement Scale

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Pregnancy Specific Pelvic Floor Rehab Protocol on Urinary Incontinence

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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