NCT07693465

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

July 3, 2026

Last Update Submit

July 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pelvic floor muscle strength

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

    Baseline

Secondary Outcomes (4)

  • Pelvic floor muscle endurance

    Baseline

  • Spinal alignment angle

    Baseline

  • Pelvic floor dysfunction symptoms

    Baseline

  • Health-related quality of life

    Baseline

Study Arms (4)

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

No Intervention

Nulliparous women with hyperlordosisNulliparous women with normal spinal alignmentNulliparous women with thoracic kyphosisNulliparous women with thoracolumbar scoliosis

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Study Officials

  • Afaf Mohamed Mahmoud Botla, PhD

    Professor, Cairo University

    STUDY CHAIR
  • Amira Nagy Abd Ellatief Hamad, PhD

    Lecturer, Cairo University

    STUDY DIRECTOR
  • Amal Abd Elrahman Mohamed Elborady

    Assist. Professor, Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 9, 2026

Study Start

September 1, 2024

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

July 9, 2026

Record last verified: 2026-07

Locations