CClinicalTrials.gg
CompletedNCT07693465Updated Jul 9, 2026

Impact of Spinal Alignment on Pelvic Floor Efficiency

An observational study in Pelvic Floor Disorders and Spinal Deformity, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
80
Ages
25 Years to 35 Years
Sex
Female
01

Study summary

The purpose of this study was to determine the effect of spinal alignment on pelvic floor efficiency in nulliparous women.

Read the detailed description

Pelvic floor dysfunction (PFD) may extend beyond the pelvic region by inducing myofascial disturbances in anatomically distant structures connected through the myofascial network. Among these, low back pain (LBP) is one of the most frequently reported musculoskeletal conditions associated with PFD. This relationship is thought to arise from lumbopelvic instability and altered coordination of the core musculature. The pelvic floor muscles (PFMs), together with the transversus abdominis, diaphragm, and multifidus, form an integrated stabilizing system that contributes to spinal stability and postural control. Consequently, dysfunction of the transversus abdominis may compromise not only pelvic floor function but also overall lumbopelvic stability. Women with LBP have been shown to exhibit reduced PFM contraction strength despite preserved transversus abdominis activation, suggesting that impaired PFM function may play a more prominent role in the development of LBP than deficits in the abdominal muscles alone. Conversely, inadequate activation or endurance of the transversus abdominis has also been associated with impaired PFM function. Furthermore, altered movement patterns, dysfunctional breathing, and postural deviations can disrupt load transfer through the lumbopelvic region, thereby increasing the risk of PFD.

There is a dearth of knowledge regarding the effect of spinal alignment on pelvic floor efficiency in nulliparous women. This study, therefore, contributes valuable insights into a relatively unexplored area of nulliparous women's health. By assessing the pelvic floor muscles in nulliparous women with different spinal alignment patterns, including lordosis, kyphosis, and scoliosis, this study may enhance the well-being of nulliparous women, provide a more comprehensive approach to health improvement, help protect them from future pelvic floor dysfunction, and broaden the scope of physiotherapy in women's health.

02

Conditions studied

  • Pelvic Floor Disorders
  • Spinal Deformity
03

In context

Pelvic Floor Disorders

197 studies on the registry are indexed under Pelvic Floor Disorders; 45 are open to participants now.

This study's enrollment of 80 is below the median of 140 across 58 observational studies indexed under Pelvic Floor Disorders.

Browse Pelvic Floor Disorders studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

The study population consisted of 80 nulliparous women aged 25-35 years with different spinal alignment patterns (thoracolumbar scoliosis, hyperlordosis, thoracic kyphosis, or normal spinal alignment). Participants were recruited from the outpatient orthopedic clinic of Gesr El Suez, Cairo, Egypt. Eligible participants had a body mass index (BMI) of \<30 kg/m² and no history of pregnancy, spinal surgery, congenital spinal deformity, neuromuscular disorders, systemic diseases, malignancy, or urogenital disorders.

Inclusion criteria

  • Nulliparous women.
  • Their ages will range from 25 to 35 years old.
  • Their body mass index (BMI) will not exceed 29.9 Kg/m2.

Exclusion criteria

Exclusion Criteria:

  • Female with congenital spinal deformity.
  • Female with a history of neuromuscular disease.
  • Female Diagnosed with any systemic disease .
  • Female with a history of malignancy and/or ongoing treatment.
  • Female with a history of urogenital diseases and surgical history.
  • Female with previous spinal surgery.
  • Female with previous pregnancy .
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Nulliparous women with thoracolumbar scoliosis

    Twenty nulliparous women with thoracolumbar scoliosis. They will undergo assessment using Formetric analysis and vaginal pressure biofeedback.

    Other: No Intervention

  • Nulliparous women with hyperlordosis

    Twenty nulliparous women with hyperlordosis. They will undergo assessment using Formetric analysis and vaginal pressure biofeedback.

    Other: No Intervention

  • Nulliparous women with thoracic kyphosis

    Twenty nulliparous women with thoracic kyphosis. They will undergo assessment using Formetric analysis and vaginal pressure biofeedback.

    Other: No Intervention

  • Nulliparous women with normal spinal alignment

    Twenty nulliparous women with normal spinal alignment. They will undergo assessment using Formetric analysis and vaginal pressure biofeedback.

    Other: No Intervention

Interventions

  • OtherNo Intervention

    No Intervention

06

What researchers measure

Primary outcomes

  1. Pelvic floor muscle strength

    Pelvic floor muscle strength was measured using vaginal pressure biofeedback (maximum voluntary contraction pressure).

    Time frame: Baseline

Secondary outcomes

  1. Pelvic floor muscle endurance

    Pelvic floor muscle endurance was assessed using vaginal pressure biofeedback (duration of sustained maximal voluntary contraction).

    Time frame: Baseline

  2. Spinal alignment angle

    It was measured using the DIERS Formetric 4D system.

    Time frame: Baseline

  3. Pelvic floor dysfunction symptoms

    Total score and domain scores (bladder, bowel, prolapse, and sexual function) were assessed using the Australian Pelvic Floor Questionnaire (APFQ).

    Time frame: Baseline

  4. Health-related quality of life

    It was assessed by using Free online SF-12 Health Survey Version 2 (SF-12v2) score calculator. The SF-12V2 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.

    Time frame: Baseline

07

Study locations

1 site
  • Faculty of Physical Therapy, Cairo University
    Giza, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07693465
Lead sponsor
Cairo University
Responsible party
Mahitab Mostafa Fazaa (Principal Investigator, Cairo University) — Principal investigator
First posted
Jul 9, 2026
Start date
Sep 1, 2024
Primary completion
Aug 31, 2025
Completion
Aug 31, 2025
Last update
Jul 9, 2026

Study contacts

Afaf Mohamed Mahmoud Botla, PhD
study chair · Professor, Cairo University
Amira Nagy Abd Ellatief Hamad, PhD
study director · Lecturer, Cairo University
Amal Abd Elrahman Mohamed Elborady
study director · Assist. Professor, Cairo University

Oversight

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

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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