Effects of Pelvic Floor Rehab Protocol on Urinary Incontinence
18. Mai 2026 aktualisiert von: Riphah International University
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.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
48
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Islamabad
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Islamabad, Islamabad, Pakistan, 44000
- Riphah International Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group
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.
|
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.
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Aktiver Komparator: Standard Pelvic floor Rehab Protocol Group
This group receives standard protocol for strengthening of pelvic floor to prevent urinary incontinence.
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in this group, standard exercises used for strengthening of pelvic floor to prevent urinary incontinence will be implemented.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Questionnaire for Incontinence Diagnosis
Zeitfenster: 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.
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4 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incontinence Severity Index
Zeitfenster: 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.
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4 weeks
|
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International Consultation on Incontinence Questionnaire (ICIQ-UI-SF)
Zeitfenster: 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.
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4 weeks
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Incontinence Impact Questionnaire
Zeitfenster: 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.
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4 weeks
|
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Patient Global Impression of Improvement Scale
Zeitfenster: 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.
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4 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Dr Zahra Ijaz, Riphah International University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. November 2025
Primärer Abschluss (Tatsächlich)
7. Mai 2026
Studienabschluss (Geschätzt)
30. Juli 2026
Studienanmeldedaten
Zuerst eingereicht
18. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. Mai 2026
Zuerst gepostet (Tatsächlich)
22. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
22. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
18. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Männliche Urogenitalerkrankungen
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Störungen beim Wasserlassen
- Symptome der unteren Harnwege
- Urologische Manifestationen
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Harninkontinenz
- Bevölkerungseigenschaften
- Demographie
- Bevölkerungsgruppen
Andere Studien-ID-Nummern
- Attiya Azhar
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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