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

Sponsor
UPECLIN HC FM Botucatu Unesp (Other)
Overall Status
Completed
CT.gov ID
NCT01391780
Collaborator
(none)
51
Enrollment
1
Location
21
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    51 participants
    Time Perspective:
    Prospective
    Official Title:
    Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence. A Prospective Trial
    Study Start Date :
    Mar 1, 1997
    Actual Study Completion Date :
    Dec 1, 1998

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1

    Patients with stress urinary incontinence
    Group 2

    Patients with urgency urinary incontinence.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 65 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • presence of stress urinary or urgency incontinence
      Exclusion Criteria:

      • neurological diseases

      • previous pelvic surgeries

      • diabetes

      • cognitive difficulties

      • vaginal and urinary infection

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 São Paulo State University - Medical School of Botucatu Botucatu São Paulo Brazil 18618-970

      Sponsors and Collaborators

      • UPECLIN HC FM Botucatu Unesp

      Investigators

      • Principal Investigator: João L. Amaro, PhD, MD, Universidade Estadual Paulista Júlio de Mesquita Filho

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01391780
      Other Study ID Numbers:
      • 2011
      First Posted:
      Jul 12, 2011
      Last Update Posted:
      Dec 11, 2013
      Last Verified:
      Mar 1, 2011
      Keywords provided by , ,
      pelvic floor evaluation,
      women,
      stress urinary incontinence;
      urgency urinary incontinence.
      Additional relevant MeSH terms:
      Urinary Incontinence
      Enuresis
      Urinary Incontinence, Urge
      Urinary Incontinence, Stress

      Study Results

      No Results Posted as of Dec 11, 2013