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

NCT07642180 | Recruiting

• 1 other identifier: REC/RCR & AHS/25/0523
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Prolapse

Keywords

Exercise Therapy; Quality of Life; urogynecological symptoms

Outcome Measures

Primary Outcomes (3)

• 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.

  8 weeks

• 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)

  8 weeks

• 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)

  8 weeks

Study Arms (2)

Group A: Functional Movement Retraining with Hypopressive Exercise

EXPERIMENTAL

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

Group B: Functional Movement Retraining

ACTIVE COMPARATOR

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

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.

Group B: Functional Movement Retraining

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).

Group A: Functional Movement Retraining with Hypopressive Exercise

Eligibility Criteria

• Age: 30 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Ganga Ram Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (4)

• 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.

  PMID: 169202 BACKGROUND

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

  PMID: 796806 BACKGROUND

• 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.

  PMID: 156570 BACKGROUND

• 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.

  PMID: 262077 BACKGROUND

MeSH Terms

Conditions

Uterine Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

• Zunaira Bilal

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PHD*

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Imran Amjad, PHD*

CONTACT

0515481826; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: April 2, 2025
• Primary Completion: June 2, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)