The Pelvic Floor Muscles Strength and Sexual Function in Primigravid and Non-pregnant Nulliparous

NCT02866292 | Completed DMC

• 1 other identifier: CEP UFU 145.623/2012
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

This study has two aims: a) to evaluate the pelvic floor muscles strength in primigravid and non-pregnant nulliparous women and to correlate with their sexual function and b) to compare PFM strength and sexual function between women in the second and third pregnancy trimesters.

Conditions

Sexual Behavior

Keywords

Pelvic Floor; Pregnancy; Physical Therapy Specialty

Outcome Measures

Primary Outcomes (2)

• muscle strength with Oxford scale

  through study completion, an average of 1 year

• score of Female Sexual Function Index questionnaire

  through study completion, an average of 1 year

Study Arms (2)

non-pregnant nulliparous

Nulliparous without previous gestation. Pelvic floor muscle evaluation by means of vaginal palpation and vaginal squeeze pressure (perineometer), and evaluation of the sexual function by the Female Sexual Function Index (FSFI) questionnaire.

Other: Pelvic floor muscle and sexual function evaluation

primigravid

Pregnant women on her first pregnancy and gestational age above 14 weeks. Pelvic floor muscle evaluation by means of vaginal palpation and vaginal squeeze pressure (perineometer), and evaluation of the sexual function by the Female Sexual Function Index (FSFI) questionnaire.

Other: Pelvic floor muscle and sexual function evaluation

Interventions

Pelvic floor muscle and sexual function evaluation OTHER

PFM evaluation was performed by vaginal palpation and vaginal squeeze pressure. During vaginal palpation the physiotherapist introduced the index and middle fingers about 4cm inside the vagina, and requested to hold the maximum contraction of the PFM. Muscle function was classified by the Oxford Scale Modified. The vaginal squeeze pressure was measured through Perineometer.To obtain the measurements, the subjects remained positioning and vaginal sensor was introduced into the vaginal cavity. The women were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them. Sexual function was evaluated by the Female Sexual Function Index (FSFI) questionnaire. The questionnaire consists of 19 multiple-choice questions, which involves six sexual response domains: desire, arousal, lubrication, orgasm, satisfaction and pain.

non-pregnant nulliparous; primigravid

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The sample consisted of 154 women divided into two groups: the first of pregnant women, formed by 76 primigravidae participants in the Prenatal Program of the public health system in Uberlandia city (Brazil). The second consists of 78 non-pregnant nulliparous.

You may qualify if:

• Be non-pregnant nulliparous or primigravid women with pregnant only one fetus alive and without abnormalities that could increase uterine volume
• Present ability to contract the pelvic floor muscles
• Report at least one sexual relationship in the four weeks prior to data collection

You may not qualify if:

• Were previous urogynecological surgery history
• Non-pregnant nulliparous who did not have sexual intercourse with vaginal penetration
• Presence of cognitive impairment or neurological condition that could affect muscle activation
• Present urinary tract infection at the time of data collection.

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Marília Duarte dos Santos

Uberlândia, Minas Gerais, 38405024, Brazil

Location

Related Publications (3)

• Pereira VS, Hirakawa HS, Oliveira AB, Driusso P. Relationship among vaginal palpation, vaginal squeeze pressure, electromyographic and ultrasonographic variables of female pelvic floor muscles. Braz J Phys Ther. 2014 Sep-Oct;18(5):428-34. doi: 10.1590/bjpt-rbf.2014.0038. Epub 2014 Oct 10.

  PMID: 25372005 BACKGROUND

• Bo K, Finckenhagen HB. Vaginal palpation of pelvic floor muscle strength: inter-test reproducibility and comparison between palpation and vaginal squeeze pressure. Acta Obstet Gynecol Scand. 2001 Oct;80(10):883-7. doi: 10.1034/j.1600-0412.2001.801003.x.

  PMID: 11580731 RESULT

• Arab AM, Behbahani RB, Lorestani L, Azari A. Correlation of digital palpation and transabdominal ultrasound for assessment of pelvic floor muscle contraction. J Man Manip Ther. 2009;17(3):e75-9. doi: 10.1179/jmt.2009.17.3.75E.

  PMID: 20046616 RESULT

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 15, 2016
• Study Start: November 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 15, 2016

Record last verified: 2016-08

Locations

BR (1)