ANZCTR - Registration

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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

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

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]

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]

baseline before 12 weeks of electro stimulation and at 12 weeks after electro stimulation

Secondary outcome [1]

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]

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

Sex

Females

Can healthy volunteers participate?

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

6/03/2006

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]

Brazil

State/province [1]

Sao Paulo

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Maira Menezes Franco

Address [1]

Av. Governador Lucas Nogueira Garcez

Country [1]

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]

Hospital

Name [1]

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

Address [1]

Av Bandeirantes 3900, Ribeirao Preto- SP CEP 14049-900

Country [1]

Brazil

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comite de Etica em pesquisa do HCFMRP-USP

Ethics committee address [1]

Ethics committee country [1]

Brazil

Date submitted for ethics approval [1]

Approval date [1]

04/12/2006

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Maíra menezes franco

Address

Av. Governador Lucas Nogueira Garcez n. 70. Ribeirão Preto -SP CEP 14051510

Country

Brazil

Phone

16 32346943

Fax

mairamfranco@yahoo.com

Contact person for scientific queries

Name

Maíra menezes franco

Address

Av. Governador Lucas Nogueira Garcez n. 70. Ribeirão Preto -SP CEP 14051510

Country

Brazil

Phone

16 3632346943

Fax

cristine@fmrp.usp.br

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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