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Uterine ProlapseNCT07642180

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

A study testing Functional Movement Retraining + Hypopressive Exercises and Pelvic Floor Functional Movement Retraining in people with Uterine Prolapse, run by Riphah International University at 1 site in Pakistan.

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Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 60 years, women only
Conditions the study is for
Uterine Prolapse
What is being tested?
Functional Movement Retraining + Hypopressive Exercises and Pelvic Floor Functional Movement Retraining
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
2 Apr 2025to 15 Aug 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Females aged 30-60 years.
  • Diagnosed with stage I and II uterine prolapse.
  • women with ≥1 parity
  • women who have had a vaginal delivery

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Imran Amjad, PHD* contact

03324390125

imran.amjad@riphah.edu.pk

Imran Amjad, PHD* contact

0515481826

imran.amjad@riphah.edu.pk

Pakistan1 site, 1 recruiting
  • Ganga Ram Hospital

    Lahore, Punjab Province, 54000

    Ghulam Fatima, PhD*, 03034073057, ghulam.fatima@riphah.edu.pk

    Recruiting

Other trials in Pakistan

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Functional Movement Retraining + Hypopressive Exercises, Pelvic Floor Functional Movement Retraining
Keywords
Exercise Therapy, Quality of Life, urogynecological symptoms
Medical subject headings
Uterine Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Movement Retraining + Hypopressive ExercisesOther

    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 RetrainingOther

    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.

Study groups in NCT07642180
Study groupRoleWhat they receive
Group A: Functional Movement Retraining with Hypopressive ExerciseExperimentalParticipants 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.
Receives: Other: Functional Movement Retraining + Hypopressive Exercises
Group B: Functional Movement RetrainingActive comparatorGroup 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.
Receives: Other: Pelvic Floor Functional Movement Retraining

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numerical Pain Rating Scale (NPRS)

    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.

    Measured: 8 weeks

  2. Pelvic floor bother questionnaire (PFBQ)

    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)

    Measured: 8 weeks

  3. Prolapse Quality of Life Questionnaire (P-QoL)

    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)

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2026
  2. Study start2 Apr 2025
  3. Primary completion2 Jun 2026 (estimated)
  4. Study completion15 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07642180
Sponsor's protocol ID
REC/RCR & AHS/25/0523
Status last verified
May 2026
First submitted
8 Jun 2026
Last updated
11 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 169202
  • Merville C, Dosne AM, Caen JP. [Vascular subendothehlium: structure and functions (author's transl)]. Pathol Biol (Paris). 1976 Dec;24 Suppl:18-22. French.

    PubMed 796806
  • 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.

    PubMed 156570
  • 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.

    PubMed 262077

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