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Trial registered on ANZCTR


Registration number
ACTRN12608000321347
Ethics application status
Approved
Date submitted
10/06/2008
Date registered
11/07/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of quality of life in women with overactive bladder treated with two different methods of Electro Stimulation
Scientific title
Evaluation of quality of life in women with overactive bladder treated with Transvaginal Electro Stimulation or of the Posterior Tibial Nerve
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overactive bladder 3249 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3413 3413 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Posterior Tibial Nerve (frequency of the current 20 Hz, width of the pulse 200 µs, intensity according to patients tolerance, 30 minutes of electro stimulation). The treatment was carried out once a week, totalling twelve weeks.
Intervention code [1] 2990 0
Rehabilitation
Comparator / control treatment
Transvaginal electro stimulation (frequency of the current10 Hz, width of the pulse 700 µs, intensity according to patients tolerance, 20 minutes of electro stimulation). The treatment was carried out once a week, totalling twelve weeks.
Control group
Active

Outcomes
Primary outcome [1] 4310 0
Quality of life assessed by SF-36 a generic quality life questionnaire , and I-QOL. a specific questionnaire of quality of life related urinary incontinence
Timepoint [1] 4310 0
baseline before 12 weeks of electro stimulation and at 12 weeks after electro stimulation
Secondary outcome [1] 7263 0
Clinical complaint of urine loss was assessed by a voiding diary of 24 hours and Visual Analog Scale (VAS). To assess the satisfaction with treatment it was used subjective evaluation for clinical complaints and satisfaction with treatment, in which the patient reported to be cured, or better and satisfied with treatment (not requiring other therapy), or better although not satisfied with the treatment (seeking alternative therapy), or unchanged.
Timepoint [1] 7263 0
baseline before 12 weeks of electro stimulation and at 12 weeks after electro stimulation

Eligibility
Key inclusion criteria
urodynamic diagnosis of overactive bladder or mixed urinary incontinence, without drug therapy or drug therapy for more than 3 months
Minimum age
18 Years
Maximum age
79 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnant and pospartum, level III vaginal prolapses, pelvic tumor, urinary or vaginal infection, cardiac dispositves, nerologic disorders, cogntive problems, interruption of the drugtherapy during the reserch

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1002 0
Brazil
State/province [1] 1002 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 3473 0
Other
Name [1] 3473 0
Maira Menezes Franco
Address [1] 3473 0
Av. Governador Lucas Nogueira Garcez
Country [1] 3473 0
Brazil
Primary sponsor type
University
Name
University of São Paulo
Address
Av Bandeirantes 3900, Ribeirão Preto- SP CEP 14049-900
Country
Brazil
Secondary sponsor category [1] 3115 0
Hospital
Name [1] 3115 0
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Address [1] 3115 0
Av Bandeirantes 3900, Ribeirao Preto- SP CEP 14049-900
Country [1] 3115 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5503 0
Comite de Etica em pesquisa do HCFMRP-USP
Ethics committee address [1] 5503 0
Ethics committee country [1] 5503 0
Brazil
Date submitted for ethics approval [1] 5503 0
Approval date [1] 5503 0
04/12/2006
Ethics approval number [1] 5503 0
13247/2006

Summary
Brief summary
The objective of this study was to compare the effects of the treatment with intravaginal electro stimulation and with posterior tibial nerve electro stimulation in the life quality and complaints of urinary loss in women with overactive bladder. Method: It was constituted a sample that included 42 patients with overactive bladder or mixed urinary incontinence for treatment either by intravaginal electro stimulation or by the posterior tibial nerve electro stimulation. To assess the quality of life (QOL) questionnaire was used a generic quality life, the SF-36, and a questionnaire of quality specific to IU, the I-QOL. The reports of urinary loss and incommodious caused by the same respectively were evaluated by the voiding of 24 hours daily, and Visual Analog Scale (VAS). The treatment was carried out once a week, totalling twelve weeks. Result: The group that received posterior tibial nerve electro stimulation had significant improvement in three domains of the I-QOL, in VAS (p = 0.03), and four aspects of the miccional diary. For the group of intravaginal electro stimulation there was significant improvement in two domains of the SF-36, three domains of the I-QOL, in VAS (p <0.01) and four aspects of the miccional diary. The comparison of the two groups, after treatment didn’t reveal significant difference in any of the variables. Conclusion: There was improvements of the life quality by the use of the two treatment types, as well as a decrease of the complaints of urinary loss, however the group that received intravaginal electro stimulation obtained improvement in the scores in two domains of the generic questionnaire of life quality after the treatment, what didn't happen with the other group treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28659 0
Address 28659 0
Country 28659 0
Phone 28659 0
Fax 28659 0
Email 28659 0
Contact person for public queries
Name 11816 0
Maíra menezes franco
Address 11816 0
Av. Governador Lucas Nogueira Garcez n. 70. Ribeirão Preto -SP CEP 14051510
Country 11816 0
Brazil
Phone 11816 0
16 32346943
Fax 11816 0
Email 11816 0
mairamfranco@yahoo.com
Contact person for scientific queries
Name 2744 0
Maíra menezes franco
Address 2744 0
Av. Governador Lucas Nogueira Garcez n. 70. Ribeirão Preto -SP CEP 14051510
Country 2744 0
Brazil
Phone 2744 0
16 3632346943
Fax 2744 0
Email 2744 0
cristine@fmrp.usp.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary