Effects of Pelvic Floor Rehab Protocol on Urinary Incontinence
18 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
48
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Islamabad
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Islamabad, Islamabad, Pakistan, 44000
- Riphah International Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Questionnaire for Incontinence Diagnosis
Lasso di tempo: 4 weeks
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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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incontinence Severity Index
Lasso di tempo: 4 weeks
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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)
Lasso di tempo: 4 weeks
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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.
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4 weeks
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Incontinence Impact Questionnaire
Lasso di tempo: 4 weeks
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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
Lasso di tempo: 4 weeks
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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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Dr Zahra Ijaz, Riphah International University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 novembre 2025
Completamento primario (Effettivo)
7 maggio 2026
Completamento dello studio (Stimato)
30 luglio 2026
Date di iscrizione allo studio
Primo inviato
18 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
18 maggio 2026
Primo Inserito (Effettivo)
22 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
22 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie urogenitali maschili
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Disturbi della minzione
- Sintomi del tratto urinario inferiore
- Manifestazioni urologiche
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Incontinenza urinaria
- Caratteristiche della popolazione
- Demografia
- Gruppi di popolazione
Altri numeri di identificazione dello studio
- Attiya Azhar
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .