Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence

NCT01391780 | Completed

• 1 other identifier: 2011
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Aims: To assess pelvic floor muscle (PFM) strength in women with stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). Methods: 51 women were prospectively divided into two groups, according to the symptoms as SUI (G1 = 22) or UUI (G2 = 29). Demographic data, such as number of Pads/ 24 hours, number of micturitions/ 24 hours and nocturia, delay time of urgent void (i.e., the time period for which an urgent void could be voluntarily postponed), number of parity and vaginal deliveries were obtained using a clinical questionnaire. Objective urine loss was evaluated by 60-min Pad Test. Subjective \[urine stream interruption test (UST), visual survey of perineal contraction and transvaginal digital palpation\] and objective (vaginal manometry) evaluations of PFM were performed in all patients.

Conditions

Urinary Incontinence, Stress; Urge Incontinence

Keywords

pelvic floor evaluation,; women,; stress urinary incontinence;; urgency urinary incontinence.

Study Arms (2)

Group 1

Patients with stress urinary incontinence

Group 2

Patients with urgency urinary incontinence.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The sample size was established considering a significance level of 5%, the test power of 80%, and the estimated error of 10%. According to these results and considering the range between percentages of answers as the casual error, each group was established with approximately 20 participants.

You may qualify if:

• presence of stress urinary or urgency incontinence

You may not qualify if:

• neurological diseases
• previous pelvic surgeries
• diabetes
• cognitive difficulties
• vaginal and urinary infection

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead

Study Sites (1)

São Paulo State University - Medical School of Botucatu

Botucatu, São Paulo, 18618-970, Brazil

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence, Urge

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

Study Officials

• João L. Amaro, PhD, MD

  Universidade Estadual Paulista Júlio de Mesquita Filho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 12, 2011
• Study Start: March 1, 1997
• Study Completion: December 1, 1998
• Last Updated: December 11, 2013

Record last verified: 2011-03

Locations

BR (1)