Pelvic Floor DisordersNCT07693465
Impact of Spinal Alignment on Pelvic Floor Efficiency
An observational study of Pelvic Floor Disorders and Spinal Deformity, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study was to determine the effect of spinal alignment on pelvic floor efficiency in nulliparous women. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Pelvic Floor Disorders, Spinal Deformity
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 to 35 years
- Women only
- Adult
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.
Who may be able to join
- Nulliparous women.
- Their ages will range from 25 to 35 years old.
- Their body mass index (BMI) will not exceed 29.9 Kg/m2.
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pelvic Floor Disorders, Spinal Deformity
- Being tested
- No Intervention
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Nulliparous women with thoracolumbar scoliosis | Twenty nulliparous women with thoracolumbar scoliosis. They will undergo assessment using Formetric analysis and vaginal pressure biofeedback. Receives: Other: No Intervention | |
| Nulliparous women with hyperlordosis | Twenty nulliparous women with hyperlordosis. They will undergo assessment using Formetric analysis and vaginal pressure biofeedback. Receives: 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. Receives: 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle strength
Pelvic floor muscle strength was measured using vaginal pressure biofeedback (maximum voluntary contraction pressure).
Measured: Baseline
Secondary outcomes (4)
Pelvic floor muscle endurance
Pelvic floor muscle endurance was assessed using vaginal pressure biofeedback (duration of sustained maximal voluntary contraction).
Measured: Baseline
Spinal alignment angle
It was measured using the DIERS Formetric 4D system.
Measured: Baseline
Pelvic floor dysfunction symptoms
Total score and domain scores (bladder, bowel, prolapse, and sexual function) were assessed using the Australian Pelvic Floor Questionnaire (APFQ).
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Sep 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahitab Mostafa Fazaa, Cairo University
- Investigators
- Afaf Mohamed Mahmoud Botla, PhD, Study chair, Professor, Cairo UniversityAmira Nagy Abd Ellatief Hamad, PhD, Study director, Lecturer, Cairo UniversityAmal Abd Elrahman Mohamed Elborady, Study director, Assist. Professor, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693465
- Sponsor's protocol ID
- P.T.REC/012/005314
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Spinal Alignment on Pelvic Floor Efficiency
- ClinicalTrials.gov ID
- NCT07693465
- Acronym / sponsor ID
- P.T.REC/012/005314
- Conditions
- Pelvic Floor Disorders, Spinal Deformity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine the effect of spinal alignment on pelvic floor efficiency in nulliparous women.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nulliparous women with thoracolumbar scoliosis | – | Other: No InterventionTwenty nulliparous women with thoracolumbar scoliosis. They will undergo assessment using Formetric analysis and vaginal pressure biofeedback. |
| Nulliparous women with hyperlordosis | – | Other: No InterventionTwenty nulliparous women with hyperlordosis. They will undergo assessment using Formetric analysis and vaginal pressure biofeedback. |
| Nulliparous women with thoracic kyphosis | – | Other: No InterventionTwenty nulliparous women with thoracic kyphosis. They will undergo assessment using Formetric analysis and vaginal pressure biofeedback. |
| Nulliparous women with normal spinal alignment | – | Other: No InterventionTwenty nulliparous women with normal spinal alignment. They will undergo assessment using Formetric analysis and vaginal pressure biofeedback. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Nulliparous women.
- Their ages will range from 25 to 35 years old.
- Their body mass index (BMI) will not exceed 29.9 Kg/m2.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | Nulliparous women with hyperlordosis, Nulliparous women with normal spinal alignment, Nulliparous women with thoracic kyphosis, Nulliparous women with thoracolumbar scoliosis |
Primary outcome
Pelvic floor muscle strength
Time frame: Baseline
Pelvic floor muscle strength was measured using vaginal pressure biofeedback (maximum voluntary contraction pressure).
4 secondary outcomes
Pelvic floor muscle endurance
Time frame: Baseline
Spinal alignment angle
Time frame: Baseline
Pelvic floor dysfunction symptoms
Time frame: Baseline
Health-related quality of life
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders and Spinal Deformity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle strength (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.