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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-5j32mm |
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Date of registration:
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25/09/2011 |
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Primary sponsor: |
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Public title:
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The exercises for the pelvic muscles improves female orgasm?
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Scientific title:
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Effect of kinesiotherapy in the contractility of pelvic floor in women with orgasmic dysfunction: electromyographic evaluation.
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Date of first enrolment:
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01/01/2010 |
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Target sample size:
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45 |
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Recruitment status: |
data analysis completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-5j32mm/ |
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Study type:
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Study design:
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Clinical trial, prospective, randomized, controlled and blind, with three arms of study
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Ana Helena
Lanza |
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Address:
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Rua Pernambuco, 482 apto 121
37701-021
Poços de Caldas/MG
Brazil |
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Telephone:
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(35) 91912149 |
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Email:
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j5lanza@terra.com.br |
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Affiliation:
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Universidade Estadual de Campinas - UNICAMP |
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Name:
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Ana Helena
Lanza |
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Address:
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Rua Pernambuco, 482 apto 121
37701-021
Poços de Caldas/MG
Brazil |
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Telephone:
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(35) 91912149 |
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Email:
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j5lanza@terra.com.br |
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Affiliation:
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Universidade Estadual de Campinas - UNICAMP |
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Key inclusion & exclusion criteria
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Inclusion criteria: Women aged between 18 and 40 years old;
With sexually active, regular partner at least one year;
Use oral contraceptives
No symptoms of urinary / fecal incontinence;
Domain orgasm FSFI with a score <3.0 (which features the orgasmic dysfunction, according to the instrument);
Coefficient of orgasmic capacity - COC <1 (low orgasmic capacity, according to the instrument);
Force of contraction of the pelvic floor compromised.
Exclusion criteria: Peripheral or central neurological disorders;
History of pelvic floor muscle training;
History of any treatment for sexual dysfunction;
Presence of symptoms of urinary / fecal incontinence;
Reporting of clinical diagnosis: vaginismus, type III and IV prolapse, diabetes, dislipedemias; menopause or menopause, hypertension, depression;
Reporting of primary anorgasmia (never had an orgasm);
Pregnant women;
More than three pregnancies and / or three births;
Have the orgasm domain scores >3.0; high orgasmic capacity (CCO > 1);
Without compromising the strength of contraction of the pelvic floor;
Patient has not achieved 75% of the proposed therapy.
Age minimum:
18Y
Age maximum:
40Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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C10.595.613.575
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Pelvic floor muscle hypotonia; orgasmic dysfunction F52.3
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Intervention(s)
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Group 1 (G1) consisted of 10 women, who were evaluated for orgasmic activity by questionnaire and validated coefficient. We evaluated the contractility of the pelvic floor muscles by digital palpation and electromyography, performed a protocol physiotherapists, and were reassessed on the contractility of the pelvic floor muscles, and the orgasmic activity. Group 2 (G2) comprised 10 women, who were evaluated for orgasmic activity; evaluated the contractility of the pelvic floor muscles; did not perform the protocol physiotherapists proposed, were evaluated on the contractility of the pelvic floor and the orgasmic activity while women of G1, and called G2-Control. Then, this group performed the same protocol physiotherapists proposed, was reassessed as orgasmic activity, and the contractility of the pelvic floor muscles, and called G2-Treaty.
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Primary Outcome(s)
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Assessment of contractility of the pelvic floor. Digital vaginal palpation: average of three successive maximal voluntary contractions of the pelvic floor muscles for 5 seconds, separated by a rest period with a doubling time of their maximum contraction to avoid fatigue, whose undergraduate degree was performed according to Ortis scale, ie 0 to 5 degrees. Surface electromyography: average of three RMS's in microvolts, captured by probe endovaginal (Physio-Med Services ®) connected to the electromyography (EMG-400C System in Brazil ®) after three maximal voluntary contractions and repeated the pelvic floor muscles . These tests were performed before and after kinesiotherapy, and by a single researcher.
Assessment of orgasmic activity. Field of the Female Orgasm Fexual Function Index (FSFI) questionnaire validated for the Portuguese by Thiel et al. (2008). The orgasm domain score ranges from 0 to 6, and this domain score <3 indicates dysfunction of orgasm. Coefficient of orgasmic capacity - COC: coefficient devised by Penteado (2002), and defined as the ratio between the sum of the number of orgasms achieved with the partner and obtained by masturbation, sexual frequency per month and monthly. The reference value is equal to 1, and defines two classes of women: COC> 1 (high orgasmic capacity) and COC <1 (low orgasmic capacity). These instruments were administered before and after kinesiotherapy.
Physiotherapists protocol: designed and taught by a researcher who was not part of the evaluation of the pelvic floor, and consisted of 12 individual sessions, lasting 30 minutes, twice a week, and whose goal was the pelvic floor muscle training.
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Secondary Outcome(s)
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The questionnaire International Consultation on Incontinence Questionnaire-Short Form (SF-ICIQ), validated to Portuguese by Tamanini et al. (2004) was used as a complement to anmenese in order to verify the coexistence of urinary incontinence.
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Secondary ID(s)
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CAAE 0308.0.213.213-07
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Source(s) of Monetary Support
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