- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07642180
Combined Effects of Pelvic Floor Retraining and Hypopressive Exercises in Uterine Prolapse Outcomes
Combined Effects of Pelvic Floor Functional Movement Retraining and Hypopressive Exercises on Pain, Urogynecological Symptoms, and Quality of Life in Uterine Prolapse
One common pelvic floor condition, particularly in postpartum or later life, is uterine prolapse. It is caused by weak pelvic floor muscles and connective tissues and often presents with pain, urinary incontinence, and reduced quality of life. Although pelvic floor muscle training (PFMT) is commonly used, newer methods such as Hypopressive Exercises (HE) and Pelvic Floor Functional Movement Retraining (PFFMR) offer promising approaches. HE focuses on posture and breathing strategies to reduce intra-abdominal pressure, while PFFMR retrains pelvic stability and function through integrated movement patterns. This study aims to evaluate the combined effects of HE and PFFMR on pain, urogynecological symptoms, and quality of life in women with uterine prolapse, compared to single interventions.
This randomized clinical trial will include 32 women aged 30-60 years with stage I-II uterine prolapse at Ganga Ram Hospital, Lahore. Participants will undergo an 8-week program with supervised sessions three times per week. Outcomes will be assessed using the Pelvic Floor Bother Questionnaire (PFBQ), Numeric Pain Rating Scale (NPRS), and Prolapse Quality of Life Questionnaire (P-QoL), and analyzed using SPSS version 25.0.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PHD*
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Imran Amjad, PHD*
- Phone Number: 0515481826
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- Ganga Ram Hospital
-
Contact:
- Ghulam Fatima, PhD*
- Phone Number: 03034073057
- Email: ghulam.fatima@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Females aged 30-60 years.
- Diagnosed with stage I and II uterine prolapse.
- women with ≥1 parity
- women who have had a vaginal delivery
Exclusion Criteria:
- Recent pelvic surgery (<6 months).
- Pregnancy or postpartum within 6 months.
- Neurological conditions affecting muscle control.
- Participation in pelvic floor rehab in the past 6 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A: Functional Movement Retraining with Hypopressive Exercise
Participants in Group A will receive a combined intervention of pelvic floor functional movement retraining (PF-FMR) and hypopressive exercises.
PF-FMR will focus on posture correction, diaphragmatic breathing, and integrating pelvic floor contractions into functional movements such as squats, bridges, and walking to improve muscle activation, alignment, and core stability.
Hypopressive exercises will aim to reduce intra-abdominal pressure and activate deep core and pelvic floor muscles through apnea-based breathing in different positions, contributing to improved pelvic floor tone and symptom relief in women with pelvic organ prolapse.
|
Participants in Group A will receive a combined intervention consisting of pelvic floor functional movement retraining (PF-FMR) and hypopressive exercises (HE).
The intervention will be delivered in supervised sessions three times per week for 8 weeks, each lasting 30-45 minutes.
The PF-FMR component will include posture correction, diaphragmatic breathing, and integration of pelvic floor muscle contractions into functional movements such as squats, bridges, and walking.
These exercises aim to improve voluntary muscle activation, spinal-pelvic alignment, and core stability,(34) and significant improvements in pelvic floor dysfunction with functionally integrated physiotherapy.
In addition, hypopressive exercises will be included to reduce intra-abdominal pressure and stimulate involuntary activation of pelvic floor and deep core muscles through apnea-based breathing techniques.
Participants will perform HE in various postures (supine, seated, and standing).
|
|
Active Comparator: Group B: Functional Movement Retraining
Group B will receive pelvic floor functional movement retraining (PF-FMR) alone for the same duration and frequency as Group A. The program will focus on pelvic floor muscle training integrated into functional movements such as bridges, squats, postural correction, and diaphragmatic breathing with pelvic floor contraction to improve core-pelvic coordination, muscle control, alignment, and endurance, aiming to reduce pelvic organ prolapse symptoms and improve quality of life.
Participants will also follow a home exercise program and maintain adherence logs to track progress.
|
Group B will receive pelvic floor functional movement retraining (PF-FMR) alone, following the same frequency and duration as Group A. This group will focus on active pelvic floor muscle training embedded within dynamic postures and everyday functional tasks.
Exercises will include bridges, squats, postural corrections, and diaphragmatic breathing combined with pelvic floor contraction to facilitate core-pelvic coordination.
The objective is to retrain muscle control, improve pelvic alignment, and enhance pelvic floor endurance and PFMT to be effective in reducing symptoms of pelvic organ prolapse and improving quality of life.
Like Group A, participants in Group B will also be instructed to follow a home program of prescribed exercises, with progress tracked through self-maintained adherence logs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical Pain Rating Scale (NPRS)
Time Frame: 8 weeks
|
For people with musculoskeletal illnesses, the NPRS is a valid, internally consistent, and generalizable indicator of clinical and experimental pain severity.
On a scale of 0 to 10, where 10 represents "the worst pain imaginable" and 0 represents "no pain at all," participants scored their present level of discomfort.
Participants also evaluated their lowest degree of discomfort and worst pain during the previous week in order to gauge the variability and intensity of pain.
For statistical analysis, the average of all pain assessments was used.
The NPRS is regarded as a valid and acceptable pain intensity scale.
High test-retest reliability (r=0.96 and 0.95) has been demonstrated by NPRS.
|
8 weeks
|
|
Pelvic floor bother questionnaire (PFBQ)
Time Frame: 8 weeks
|
Based on clinical interviews and a review of popular surveys like the Urinary Distress Inventory, Pelvic Floor Distress Inventory (PFDI), and Pelvic Floor Impact Questionnaire (PFIQ), the Cleveland Clinic pelvic floor staff created the validated PFBQ.
USI, urgency, frequency, UUI, POP, dysuria, dyspareunia, defecatory dysfunction, fecal incontinence, and the respondent's handicap are all assessed by the PFBQ.
The questionnaire has nine elements, each with a score ranging from 0 to 5. The total score ranges from 0 to 45 points, where 0 denotes no discomfort and 45 denotes a higher level of disability.
To get a value between 0 and 100, the questionnaire's total score is multiplied by 20.(30) PFBQ is a valid and reliable tool for assessing the symptoms of bother and severity in women with pelvic floor dysfunction.
The test-retest reliability of the PFBQ is excellent (0.998, p < 0.0001)
|
8 weeks
|
|
Prolapse Quality of Life Questionnaire (P-QoL)
Time Frame: 8 weeks
|
General health (1 item), prolapse impact (1 item), role limitations (2 items), physical limitations (2 items), social limitations (3 items), personal relationships (2 items), emotions (3 items), sleep/energy (2 items), and severity measures (4 items) are the nine quality of life domains that are represented by the 20 self-reported questions that make up the P-QoL questionnaire.
Each domain has a score between 0 and 100.
Lower ratings signify a good quality of life, whereas higher values imply a larger degradation of quality of life.
P-QoL IS a valid tool with test-retest reliability high in all cases, with values from 0.725 to 0.938.
All the values were statistically significant (p < 0.001)
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zunaira Bilal, Riphah International University
Publications and helpful links
General Publications
- Gray LD, Kreger AS. Rabbit corneal damage produced by Pseudomonas aeruginosa infection. Infect Immun. 1975 Aug;12(2):419-32. doi: 10.1128/iai.12.2.419-432.1975.
- Merville C, Dosne AM, Caen JP. [Vascular subendothehlium: structure and functions (author's transl)]. Pathol Biol (Paris). 1976 Dec;24 Suppl:18-22. French.
- Hiramatsu M, Hatakeyama K, Abe I, Minami N. [Changes of ground substances and effect of some anti-inflammatory drugs in cotton pellet granuloma (author's transl)]. Josai Shika Daigaku Kiyo. 1977;6(1):123-33. No abstract available. Japanese.
- Joyce LD, Smith JM, Mauer HG, Ameli M, Lillehei RC. Zymosan-induced resistance to endotoxin and hemorrhagic shock. Adv Shock Res. 1978;1:125-47.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/25/0523
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Uterine Prolapse
-
Lyra Medical Ltd.CompletedAnterior Vaginal Wall Prolapse | Vaginal Apex/Uterine ProlapseHungary, Israel
-
Manchester University NHS Foundation TrustRecruitingProlapse; Female | Prolapse, VaginalUnited Kingdom
-
Centre Hospitalier Universitaire de NīmesCompletedVaginal ProlapseFrance
-
National Taiwan University HospitalCompletedVault Prolapse, Vaginal
-
Radboud University Medical CenterCompletedPelvic Organ ProlapseNetherlands
-
Peking Union Medical College HospitalUnknownUterine Prolapse | Vault ProlapseChina
-
Karolinska InstitutetThe Swedish Society of Medicine; The regional agreement on medical training... and other collaboratorsCompletedVaginal ProlapseSweden, Norway, Denmark, Finland
-
Ethicon, Inc.Completed
-
Mayo ClinicCompletedPelvic Organ Prolapse | Uterine Prolapse | Vaginal Vault Prolapse | Pelvic Floor ProlapseUnited States
-
Atlantic Health SystemRecruitingVaginal ProlapseUnited States
Clinical Trials on Functional Movement Retraining + Hypopressive Exercises
-
VA Office of Research and DevelopmentDuke UniversityCompletedArthroplasty, Replacement, HipUnited States
-
University of JaénCompletedMuscle Weakness | Postural; Defect | Pelvic Floor DisordersSpain
-
Riphah International UniversityCompletedUrinary IncontinencePakistan
-
Universidad de CórdobaCompletedAbdominal DiastasisSpain
-
University of AlcalaCompletedPelvic Floor DisordersSpain
-
Riphah International UniversityRecruiting
-
University of VigoCompleted
-
Riphah International UniversityCompleted
-
Riphah International UniversityCompletedPelvic Organ ProlapsePakistan
-
University of ValenciaCompleted