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Study Protocol

Effects of pelvic floor muscle training (PFMT) on the sexual function of climacteric women: a systematic review protocol

[version 1; peer review: 2 approved with reservations]
PUBLISHED 24 Sep 2024
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Abstract

Introduction

Climacteric period signifies a transitional phase characterized by ovarian failure and a decline in estrogen levels, leading to various urogynecological alterations, including potential sexual dysfunctions. Among these, pelvic floor muscle (PFM) function plays a pivotal role in female sexual function. This study aims to evaluate the efficacy of pelvic floor muscle training (PFMT) on the sexual function of climacteric women.

Methods

Experimental or quasi-experimental studies published in peer-reviewed journals, assessing the sexual function of perimenopausal women with PFMT as an intervention, will be included. Studies conducted in institutionalized populations or with neurological and cognitive diseases will be excluded. This systematic review protocol follows the recommendations of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). The searches will be carried out in the Pubmed, LILACS (Latin American and Caribbean Literature on Health Sciences), Scopus, Web of Science, and PEDro, using the Search equation: climacteric women/menopause and PFMT and (sexual function or sexual dysfunction). The assessment of methodological quality will be carried out using the Pedro and GRADE scale, which will involve two independent researchers to evaluate the criteria. A third researcher will resolve discrepancies.

Ethics and disclosure

Ethical approval is not required as this is a secondary data study. This systematic review began in April 2024 and all steps are expected to be completed by November 2024.

PROSPERO registration number

CRD42024534297

Keywords

Climacteric Women; Pelvic floor muscle training; Sexual Function.

Introduction

Climeteric period corresponds to the transitional stage from the reproductive phase to the non-reproductive phase in women and is marked by ovarian failure and a consequent abrupt decline in circulating estrogen levels in the female body.1 As a result, there are numerous changes in the urogynecological system during perimenopause, which are a consequence of hypoestrogenism, such as increased risk of vaginal atrophy, reduced libido, and vaginal dryness.2 A greater impairment is observed when there is alteration in the function of the pelvic floor muscles (PFM).3

PFM constitutes a muscle group located in the pelvis, whose main functions include maintaining urinary and fecal continence, supporting pelvic organs, and enabling adequate sexual function.4,5 Female sexual function began to be studied more prominently by Masters and Johnson, who created the female sexual response cycle consisting of the phases of excitement, plateau, orgasm, and resolution.6 Nearly a decade later, Kaplan described a primary phase, which is desire, and suggested that the plateau phase does not exist. Thus, female sexual behavior would correspond to: desire, excitement, orgasm, and resolution.7

Basson (2000) revolutionized the current scenario related to female sexual response. In this proposal, the principle was to make the model nonlinear, bringing the possibility for a woman to initiate the relationship from a state of sexual neutrality. Thus, desire could develop subsequent to sexual activity.8 Female sexual dysfunction (FSD) is described as an alteration in one or more phases of the sexual response cycle.9 One of the risk factors for FSD is alterations in PFM, including muscular hyperactivity, which is related to genitopelvic pain disorder.10 Furthermore, studies show that women with good PFM function have more intense orgasms.11

Pelvic floor muscle training (PFMT) is a conservative, accessible, and globally utilized technique in the prevention and treatment of pelvic floor dysfunctions.12 This technique involves voluntary contraction exercises of the PFM, which promote improvement of muscle function.13 When linked to female sexual function, PFMT enhances local sensitivity and contributes to more satisfactory and intense orgasms, which may be reduced in perimenopausal women.14 In other phases of a woman’s life cycle, such as postpartum, there is already evidence showing the effectiveness of PFMT in sexual function.15 However, the literature still lacks data on the perimenopausal population. The aim of this review is to evaluate the effectiveness of pelvic floor muscle training on the sexual function of perimenopausal women.

Methods

Study design

The present protocol adheres to the guidelines established by the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P).16 It has been duly registered in the International Prospective Register of Systematic Reviews (PROSPERO) under the title: “Effects of pelvic floor muscle training on the sexual function of climacteric women: a systematic review” (CRD42024534297).

The PICO acronym was used as a strategy to formulate the following research question: “Is there a superior effect of PFMT over other interventions or placebo in climacteric women with sexual dysfunction?”. This acronym is detailed in Table 1.

Table 1. PICO acronym.

Acronym meaningSignificado
P (Population)Climacteric Women
I (Intervention)Pelvic Floor Muscle Training (PFMT)
C (Comparison)Others interventions/placebo
O (Outcome)Female Sexual Dysfunction/Female Sexual Function

Eligibility criteria

Types of studies

Included will be studies published in peer-reviewed journals, of experimental or quasi-experimental nature, whether randomized or non-randomized clinical trials, that have assessed the sexual function of perimenopausal women and have PFMT as an intervention.

Types of participants

Middle-aged and elderly women (above 40 years old) in the climacteric period. Excluded from the study will be institutionalized women and those with any condition that could negatively contribute to PFMT, such as neurological or cognitive alterations.17

Exposure

PFMT will be considered as the intervention and will be compared with other interventions (medicinal and non-medicinal interventions) and health education.

Primary outcome

The primary outcome of this study is sexual function, assessed through the Female Sexual Function Index (FSFI) questionnaire, which identifies possible alterations in sexual function, addressing characteristics involving sexual desire and arousal, as well as lubrication, ability to achieve orgasm, satisfaction, and pain during sexual activity.18

Identification of studies

To achieve the proposed objective, a search will be conducted in the following databases: PubMed, LILACS (Latin American and Caribbean Literature on Health Sciences), Scopus, Web of Science, and PEDro. The search strategy will adopt the following standard formula: “climacteric women/menopause and PFMT and (sexual function or sexual dysfunction)”. No language or publication year limits will be set. Additionally, a manual search will be conducted in the references of included articles. The detailed search strategy by database is described in Table 2.

Table 2. Search strategies by database.

Search strategiesDatabase
(((climacteric women) OR (menopause)) AND ((pelvic floor muscle training OR kegel exercise) AND ((sexual function OR sexual functions) OR (sexual dysfunction OR sexual dysfunctions))Pubmed
(mulheres climatéricas) OR (menopausa) AND (treinamento muscular do assoalho pélvico) OR (exercício de Kegel) AND (função sexual) OR (funções sexuais) OR (disfunção sexual) OR (disfunções sexuais)Lilacs
menopause sexual function/CLIMACTERIC women sexual functionPeDRO
(ALL=(CLIMACTERIC women OR menopause)) AND ALL=(pelvic floor muscle training OR kegel exercise) AND ALL=(sexual function OR sexual functions) AND ALL=(sexual dysfunction OR sexual dysfunctions)Web of Science
TITLE-ABS-KEY (((“pelvic floor” OR “pelvic diaphragm” OR “pelvic diaphragms” OR kegel*))) AND TITLE-ABS-KEY (((training OR exercise*))) AND TITLE-ABS-KEY (((“sexual function” OR “sexual functions” OR “sexual dysfunction” OR “sexual dysfunctions”))) AND TITLE-ABS-KEY (((climacteric AND women OR menopause*)))Scopus

Data extraction and analysis

The Rayyan platform (Doha, Qatar) will be used for the data collection and analysis process. Initially, duplicate articles will be excluded.19 Subsequently, titles and abstracts will be read, and eligibility criteria will be applied to select only articles relevant to the study. Articles that meet the inclusion criteria will then undergo full-text reading. This process will be carried out by two independent pairs of researchers. In case of discrepancies in the inclusion or exclusion of studies, a third researcher will resolve them.

Data extraction

After full-text reading and inclusion of articles, data extraction will be performed for each included article. This procedure will be carried out using an Excel spreadsheet and will be executed independently by the responsible researchers.

The extracted data from each article will include: primary author, year of publication, country, study design, sample size, mean age of the sample, level of sexual function, intervention and control groups, applied methodology, and main results.

Methodological quality of studies

The methodological quality of the studies will be assessed using the PEDro scale,20 which will be applied by the same researchers from the previous stages. The PEDro scale consists of a set of 11 items, ranging from 0 to 10 points. A score <4 is considered “poor”, 4 to 5 “fair”, 6 to 8 points are considered good, and above 8 are considered excellent. This assessment will be conducted by two independent researchers (M.F.C.A and S.B.G.C). Any discrepancies will be resolved by an independent researcher (M.D.A.L). The GRADE scale will also be used for methodological assessment, adopting the following criteria: risk of bias (PEDro scale), inconsistency, imprecision of results, and publication bias.21 This evaluation format is based on a similar systematic review.22

Data synthesis

All extracted results will be condensed into tables and Figures. A PRISMA flowchart will represent the entire process of study selection.16 If a meta-analysis is feasible, the Jamovi 2.3.28 software (https://www.jamovi.org/) will be used. Heterogeneity will be assessed using the I2 measure and a 95% confidence interval. The following criteria will be used to define heterogeneity cutoff points: ≤25%: low heterogeneity; 25% to 75%: moderate heterogeneity; 75% to 100%: considerable heterogeneity.23,24

Discussion

Although pelvic floor muscles play a significant role in the urogenital health of CLIMACTERIC women, the literature still lacks precise information regarding the effectiveness of pelvic floor muscle training (PFMT) on sexual function during this stage of female life. Understanding how an intervention focused on pelvic floor muscles affects sexual function can assist healthcare professionals in making focused and patient-centered decisions regarding patient rehabilitation.

Thus, this review will serve as support to guide physiotherapists in prescribing PFMT aiming to improve the sexual function of CLIMACTERIC women.

Author contributions

MDAL - Conceptualization, Methodology, Project administration, Writing – original draft, Writing – review & editing; VPSS - Conceptualization, Methodology, Visualization, Writing – review & editing; RJSS - Conceptualization, Methodology, Visualization, Writing – review & editing; MFCA - Conceptualization, Methodology, Visualization, Writing – review & editing; SBGC - Conceptualization, Methodology, Visualization, Writing – review & editing; ESRV - Conceptualization, Methodology, Visualization, Writing – review & editing

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Lima MDA, de Sousa VPS, de Souza RJS et al. Effects of pelvic floor muscle training (PFMT) on the sexual function of climacteric women: a systematic review protocol [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:1091 (https://doi.org/10.12688/f1000research.154974.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
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PUBLISHED 24 Sep 2024
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Reviewer Report 19 Nov 2024
Yasemin Karaaslan, Department of Physiotherapy and Rehabilitation, Hatay Mustafa Kemal University, Antakya, Turkey 
Approved with Reservations
VIEWS 2
- Ensure that the term climacteric is spelled correctly everywhere.
- It should be written more clearly and explicitly why PFMT should be used on sexual function in climacteric women.
- The discussion section should be written comprehensively.
... Continue reading
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HOW TO CITE THIS REPORT
Karaaslan Y. Reviewer Report For: Effects of pelvic floor muscle training (PFMT) on the sexual function of climacteric women: a systematic review protocol [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:1091 (https://doi.org/10.5256/f1000research.170083.r327041)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Views
2
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Reviewer Report 12 Nov 2024
Maria Letícia A. S. de Carvalho, Universidade Federal do Rio Grande do Norte, Natal, State of Rio Grande do Norte, Brazil 
Approved with Reservations
VIEWS 2
The work is well-developed and clear. However, I would like to highlight some points for improvement:
  1. Introduction: Improve the cohesion and flow between paragraphs. For instance, combine the following information, currently presented in separate paragraphs: “A
... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
de Carvalho MLAS. Reviewer Report For: Effects of pelvic floor muscle training (PFMT) on the sexual function of climacteric women: a systematic review protocol [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:1091 (https://doi.org/10.5256/f1000research.170083.r335827)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 1
VERSION 1 PUBLISHED 24 Sep 2024
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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