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.
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.
Pakistan1 site, 1 recruiting
- Recruiting
Ganga Ram Hospital
Lahore, Punjab Province, 54000
Ghulam Fatima, PhD*, 03034073057, ghulam.fatima@riphah.edu.pk
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.
- Conditions
- Uterine Prolapse
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pelvic Floor Functional Movement Retraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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.
- First posted11 Jun 2026
- Study start2 Apr 2025
- Primary completion2 Jun 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Uterine ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zunaira Bilal, Principal investigator, Riphah International University
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 169202Merville C, Dosne AM, Caen JP. [Vascular subendothehlium: structure and functions (author's transl)]. Pathol Biol (Paris). 1976 Dec;24 Suppl:18-22. French.
PubMed 796806Hiramatsu 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 156570Joyce 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