Effect of Vitamin D Supplementation on Severity of Stress Urinary Incontinence in Premenopausal Women With Vitamin D Insufficiency

NCT06689813 | Completed

• 1 other identifier: IRB - 597 - 8
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale for conducting the study is based on the fact that stress urinary incontinenc is a prevalent condition among middle age or older women and Vitamin D deficiency may have clinical effects on the pelvic floor muscles and bladder function. Therefore, the study aims to explore the potential link between vitamin D levels and SUI in women in our local population.

Conditions

Stress Urinary Incontinence

Keywords

vitamin D; stress urinary incontinence; premenopausal; incontinence questionnaire short form

Outcome Measures

Primary Outcomes (1)

• to see the effect of vitamin supplementation on severity of urinary incontinence

  Scoring of the stress urinary incontinence was done based on the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form Questionnaire. Severity of SUI was based on these scores, 1-5 (mild), 6-12 (moderate), 13-18 (severe), 19-21 (very severe).

  0,4,8 and 12 weeks of treatment

Secondary Outcomes (1)

• Impact on qulaity of life

  0,4,8 and 12 weeks of treatment

Study Arms (2)

Vitamin D group

ACTIVE COMPARATOR

Group A participants received vitamin D supplements orally for 8 weeks along with pelvic floor exercises

Dietary Supplement: Vitamin D tablets

Placebo group

PLACEBO COMPARATOR

Group B participants received ispaghula husk tablets for 8 weeks along with pelvic floor exercises

Other: Ispaghula husk

Interventions

Vitamin D tablets DIETARY_SUPPLEMENT

Vitamin D supplements is thought to reduce the severity of urinary incontinence.Vitamin D supplements were given to Group A

Vitamin D group

Ispaghula husk OTHER

Ispaghula husk tablets were given to Group B participants

Placebo group

Eligibility Criteria

• Age: 40 Years - 49 Years
• Gender Eligibility Details: females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women age between 40-49 years
• Women with SUI

You may not qualify if:

• Using hormonal medications (estrogen supplementation)
• Undergoing urogenital-related surgery (incontinence and prolapse surgery)
• Diabetes Mellitus
• Participants with any disorder that interferes with vitamin D absorption, such as inflammatory bowel disease, intestinal bypass surgery, or chronic liver or kidney disease
• Neurological disease affecting the urinary system such as multiple sclerosis, degenerative muscle disease, spinal cord injury
• Women with urinary tract infections
• Women taking supplements ( multivitamins or already taking vitamin D supplementation)

Sponsors & Collaborators

• Shalamar Institute of Health Sciences: lead

Study Sites (1)

Shalamar Institute of Health Sciences

Lahore, Punjab Province, 40050, Pakistan

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Vitamin D; ispaghula seed

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: second fellowship trainee in urogynaecology

Model Details: Group A was given oral vitamin D supplements Group B was given isphagula husk tablets

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 14, 2024
• Study Start: February 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

PA (1)