Effects of Pelvic Floor Rehab Protocol on Urinary Incontinence
17 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
48
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Islamabad
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Islamabad, Islamabad, Pakistan, 44000
- Riphah International Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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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Expérimental: Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group (2nd Trimester)
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.
|
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.
|
|
Expérimental: Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group (3rd Trimester)
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Questionnaire for Incontinence Diagnosis
Délai: 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 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incontinence Severity Index
Délai: 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.
|
4 weeks
|
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International Consultation on Incontinence Questionnaire (ICIQ-UI-SF)
Délai: 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
Délai: 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 weeks
|
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Patient Global Impression of Improvement Scale
Délai: 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.
|
4 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Dr Zahra Ijaz, Riphah International University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 novembre 2025
Achèvement primaire (Réel)
7 mai 2026
Achèvement de l'étude (Estimé)
30 juillet 2026
Dates d'inscription aux études
Première soumission
18 mai 2026
Première soumission répondant aux critères de contrôle qualité
18 mai 2026
Première publication (Réel)
22 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies urogénitales masculines
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Troubles urinaires
- Symptômes des voies urinaires inférieures
- Manifestations urologiques
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Incontinence urinaire
- Caractéristiques de la population
- Démographie
- Groupes de population
Autres numéros d'identification d'étude
- Attiya Azhar
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .