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NCT Number: NCT07642180

Combined Effects of Pelvic Floor Retraining and Hypopressive Exercises in Uterine Prolapse Outcomes

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.

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Key information

Conditions

Uterine Prolapse Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urogenital Diseases Uterine Diseases

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ganga Ram Hospital

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Ghulam Fatima, PhD*

CONTACT

[email protected]

03034073057

About this study

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 it frequently manifests as pain, urine incontinence and a reduced quality of life. Although traditional pelvic floor muscle training (PFMT) is still commonly utilized, newer methods like Hypopressive Exercises (HE) and Pelvic Floor Functional Movement Retraining (PFFMR) offer promising, supplementary approaches. Whereas Hypopressive Exercises HE stresses posture and breathing strategies that lower intra-abdominal pressure and enhance pelvic organ support, Pelvic Floor Functional Movement Retraining (PFFMR) concentrates on retraining pelvic stability and function through integrated movement patterns. The primary aim of this study is to evaluate the combined effects of Pelvic Floor Functional Movement Retraining and Hypopressive Exercises on pain, urogynecological symptoms and quality of life in women with uterine prolapse. This study seeks to determine whether the combination provides superior outcomes compared to single interventions. This randomized clinical trial study will include 32 female participants age 30 to 60 years, diagnosed with stage I and II uterine prolapse, selected through Non-probability Convenience sampling. The setting of the study will be Ganga ram hospital Lahore. Participants will undergo 8 weeks intervention program combining Hypopressive Exercises (HE) and Pelvic Floor Functional Movement Retraining (PFFMR), with sessions conducted three times per week under physiotherapist supervision. Outcomes will be assessed at baseline and post-intervention using standardized tools: The Pelvic floor bother questionnaire (PFBQ) for urogynecological symptoms, the Numeric pain rating Scale (NPRS) for pain, and the Prolapse Quality of Life Questionnaire (P-QoL) for quality of life. Data will be analyzed using SPSS version 25.0 to determine statistically significant changes pre- and post-intervention.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Functional Movement Retraining + Hypopressive Exercises

Other

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).

Pelvic Floor Functional Movement Retraining

Other

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.

Primary outcomes

  1. 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.

  2. 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)

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PHD*

CONTACT

[email protected]

03324390125

Imran Amjad, PHD*

CONTACT

[email protected]

0515481826

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Combined Effects of Pelvic Floor Functional Movement Retraining and Hypopressive Exercises on Pain, Urogynecological Symptoms, and Quality of Life in Uterine Prolapse

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2026
Registry last updated
Jun 11, 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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