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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01391780
Other study ID # 2011
Secondary ID
Status Completed
Phase N/A
First received July 8, 2011
Last updated December 10, 2013
Start date March 1997
Est. completion date December 1998

Study information

Verified date March 2011
Source UPECLIN HC FM Botucatu Unesp
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date December 1998
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- presence of stress urinary or urgency incontinence

Exclusion Criteria:

- neurological diseases

- previous pelvic surgeries

- diabetes

- cognitive difficulties

- vaginal and urinary infection

Study Design

Time Perspective: Prospective


Locations

Country Name City State
Brazil São Paulo State University - Medical School of Botucatu Botucatu São Paulo

Sponsors (1)

Lead Sponsor Collaborator
UPECLIN HC FM Botucatu Unesp

Country where clinical trial is conducted

Brazil, 

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