ClinicalTrials.gg
RecruitingNCT07642180Updated Jun 11, 2026

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

An interventional study of Functional Movement Retraining + Hypopressive Exercises and Pelvic Floor Functional Movement Retraining in Uterine Prolapse, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to female participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 2 months after the study started (first participant enrolled Apr 2025, registered Jun 2026).
  • Started Apr 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Uterine Prolapse

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Keywords

  • Exercise Therapy
  • Quality of Life
  • urogynecological symptoms
03

In context

Uterine Prolapse

111 studies on the registry are indexed under Uterine Prolapse; 18 are open to participants now.

This study's planned enrollment of 32 is below the median of 70 across 76 interventional studies indexed under Uterine Prolapse.

Browse Uterine Prolapse studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • 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.

    Other: Functional Movement Retraining + Hypopressive Exercises

  • 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.

    Other: Pelvic Floor Functional Movement Retraining

Interventions

  • OtherFunctional Movement Retraining + Hypopressive Exercises

    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).

  • OtherPelvic Floor Functional Movement Retraining

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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)

    Time frame: 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)

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for Jun 2026, 14 months after the start.

Of 37 interventional studies with no phase under Uterine Prolapse, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 68. This study's planned 14 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 8, 2026
First posted
Jun 11, 2026
StartActual
Apr 2, 2025
Primary completionEst.
Jun 2, 2026
CompletionEst.
Aug 15, 2026
Last update
Jun 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07642180
Responsible party
Sponsor
First posted
Jun 11, 2026
Start date
Apr 2, 2025
Primary completion
Jun 2, 2026 (estimated)
Completion
Aug 15, 2026 (estimated)
Last update
Jun 11, 2026

Study contacts

Imran Amjad, PHD*
Contact
imran.amjad@riphah.edu.pk
03324390125
Imran Amjad, PHD*
Contact
imran.amjad@riphah.edu.pk
0515481826
Zunaira Bilal
principal investigator · Riphah International University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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