Vaginal Spheres Versus Pelvic Floor Muscle Training in the Treatment of Urinary Incontinence and Sexual Dysfunction: A Randomized, Single-Blind, Controlled Trial

doi:10.21203/rs.3.rs-4707601/v1

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Vaginal Spheres Versus Pelvic Floor Muscle Training in the Treatment of Urinary Incontinence and Sexual Dysfunction: A Randomized, Single-Blind, Controlled Trial

https://doi.org/10.21203/rs.3.rs-4707601/v1

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Background

Female sexual dysfunction is closely linked to pelvic floor muscle dysfunction, especially in the context of urinary incontinence. While pelvic floor muscle training can be performed through exercises alone or with intravaginal medical spheres, the benefits of incorporating these devices into therapy remain unclear. This study aimed to compare the efficacy of pelvic floor exercises combined with vaginal spheres versus exercises alone in improving stress and stress-predominant mixed urinary incontinence and sexual function.

Methods

This randomized, single-blind trial was conducted at the RAPBarcelona Center and included 71 adult women with stress or stress-predominant mixed urinary incontinence and sexual dysfunction. Participants were randomly assigned to either pelvic floor muscle exercises alone (control group) or exercises combined with vaginal Enna Balls (intervention group), and the intervention period lasted four months, with assessments at baseline and follow-ups at 8 and 16 weeks. The primary outcome measure was the impact on incontinence, which was assessed using the ICIQ-UI-SF questionnaire. Secondary outcomes included sexual function, measured by the Female Sexual Function Index, and monitoring of adverse events and treatment adherence at weeks 4, 8, 12, and 16.

Results

The mean age of participants was 46.85 ± 1.58 years. Post-treatment, the ICIQ-UI-SF score significantly decreased from 9.01 ± 0.52 to 3.92 ± 0.59 (p < 0.05). No significant changes were observed in the overall Female Sexual Function Index score (p > 0.05), except for an increase in desire, which showed statistical differences between groups at the end of treatment (p = 0.041). Tolerance and adherence to the interventions did not significantly differ between groups.

Conclusions

Home-based pelvic floor muscle training, both with and without vaginal spheres, is effective and safe for women with stress urinary incontinence or stress-predominant mixed urinary incontinence and sexual dysfunction. Vaginal spheres are particularly recommended for their safety, popularity, and ability to enhance female desire. However, they do not significantly improve overall female sexual function in the short term. Further research is needed to explore their long-term benefits and broader impacts on sexual health.

Trial Registration:

The study was registered on clinicaltrials.gov with the identifier NCT05732844 on January 29, 2023. More details can be found at (https://www.clinicaltrials.gov/study/NCT05732844?term=NCT05732844&rank=1&tab=history&a=1#version-content-panel)

Urinary Incontinence

Female Sexual Dysfunction

Vaginal Spheres

Kegel exercises

Pelvic Floor Muscle Training

Sexuality plays a vital role in women's quality of life and is closely linked to their psychological and social well-being (1, 2). Female sexual dysfunction affects between 19% and 50% of women (3). This dysfunction can arise from multiple sources, including anatomical, hormonal, and neurological issues, pelvic disorders, medication or substance abuse, and psychological, social, and cultural influences (1).

In recent years, research has consistently shown a strong relationship between female sexual dysfunction and pelvic floor muscle dysfunction (4), particularly in the context of urinary incontinence (UI). It has been reported that pelvic floor rehabilitation not only improved UI but also enhanced sexual function (5). Moreover, it has been highlighted the role of pelvic floor exercises in improving the sexual function of women with stress urinary incontinence (SUI) not only because it decreases the episodes of urine leakage but also because it strengthens pelvic floor muscles (6, 7).

Pelvic Floor Muscle Training (PFMT) can be done through Kegel exercises alone or in combination with electrical stimulation, biofeedback techniques, or the use of intravaginal medical devices, for example, spheres or vaginal cones (8–10). However, to date, there is a lack of contrasted clinical evidence on the benefits and risks associated with the use of such devices as part of pelvic floor rehabilitation treatment. Further research is needed to clarify whether their use is beneficial as part of therapy to improve UI and female sexual dysfunction (8–12).

This study aimed to compare the efficacy and safety of pelvic floor exercises (Kegel exercises) combined with vaginal spheres to the same exercises performed without any device for the treatment of stress and stress-predominant mixed UI. Additionally, the study hypothesized that the use of vaginal spheres would improve the final score and all domains of the Female Sexual Function Index.

This single-blind, parallel randomized clinical study was conducted at RAPBarcelona Physiotherapy Clinical Center between October 2022 and May 2023 (ClinicalTrials.gov identifier NCT05732844). The study adhered to the CONSORT statement for the design and reporting (13).

A total of 71 adult women with a clinical diagnosis of stress and stress-predominant mixed UI and symptoms of sexual dysfunction were enrolled. Inclusion criteria included adult women presenting with mild or moderate SUI or mixed urinary incontinence (MUI) (as defined by the International Continence Society and assessed by the International Consultation on Incontinence Questionnaire Short Form Score [ICIQ-UI-SF]) (14). Exclusion criteria were medication interfering with urine retention, severe pelvic organ prolapse, obesity (BMI ≥ 30), anal incontinence or complicated UI, pregnancy, post-partum period under six months, chronic pelvic pain syndrome, and previous pelvic floor exercises.

The sample size was calculated based on ICIQ-UI-SF scores, targeting a three-point difference detection, with a standard deviation of 3.3, α of 5%, and β level of 20%, ensuring 80% statistical power and accounting for a 10% dropout rate based on the ICIQ-UI-SF and the Hirakawa et al., 2013 results (15).

Participants were randomly assigned (1:1) to either the experimental group (Kegel exercises with vaginal spheres) or the control group (Kegel exercises alone) using Sealed Envelope Ltd. online randomization. Investigators managed enrollment and group assignments using a sequentially numbered container system. The investigator performing assessments was blinded to group allocation.

The study adhered to the principles of the Declaration of Helsinki. Ethics approval was obtained from the Vall d’Hebron Hospital Ethics Committee (PR(RAP)402/2019), and all participants signed informed consent before starting treatment.

The treatment group used vaginal spheres (Enna Balls, ECARE YOU, SL.) at home according to a progressively increasing schedule over 16 weeks. The control group performed the same PFMT program without the spheres. Both groups conducted 16 Kegel exercises thrice a day, seven days a week, for four months. Exercises were taught and supervised initially and reviewed at follow-up visits at weeks 4, 8, 12, and 16. The exercises could be realized lying down, semi-recumbent, or standing up (16). The PERFECT Scale was used to assess the duration of slow contractions (17).

Initial assessments and follow-up clinical evaluations at weeks 8 and 16 included the ICIQ-UI-SF questionnaire (14, 18) to assess urine leakage and the Female Sexual Function Index to evaluate sexual function (3). Adverse events and treatment adherence were monitored at weeks 4, 8, 12, and 16 using an adapted Morisky-Green Test (8, 9, 19). For this study, as previously reported (8), the words ‘‘taking medication’’ in the original test were replaced by ‘‘performing pelvic floor exercises’’ to adapt it to our non-pharmacologic treatment.

Baseline characteristics were compared for each outcome measure to ensure similarity between groups. The Kolmogorov-Smirnov test assessed data normality. Non-parametric Mann-Whitney U tests compared the effects of the two training programs at baseline, week 8 and week 16. Data were reported as mean values and standard deviation (SD), or median (Md) and interquartile range (IQR) for quantitative data and as counts and percentages for qualitative data. Statistical tests were performed using SPSS version 29.0, with significance at p < 0.05.

Data sets are available at Harvard Dataverse (https://doi.org/10.7910/DVN/DVOHPZ).

71 women were included and randomized into two groups: 35 to PFMT with intravaginal spheres and 36 to PFMT alone. Data from 69 patients (34 in the treatment group and 35 in the control group) were analyzed at week 8, as two patients (one from each group) only attended the initial consultation. Complete data from 51 patients were analyzed at week 16 (Figure 1).

The demographic and clinical data of the two groups were homogeneous. None of the control group patients received hormone replacement therapy, while only one patient in the intervention group did. Over 80% of women in both groups did not take any medication, with only seven women (three in the control group and four in the intervention group) receiving topical hormone treatment. Regarding UI at the study's start, 68.6% of the control group and 55.9% of the intervention group reported mild incontinence. Additionally, 25.7% of the control group and 38.2% of the intervention group reported moderate incontinence. Severe UI was reported by 5.7% of the control group and 5.9% of the intervention group, with no statistically significant differences in incontinence severity between groups (p = 0.523). No significant difference was observed in the type of incontinence at baseline (p = 0.103), with 77.1% and 58.8% of women having SUI in the control and intervention groups, respectively. Baseline ICIQ-UI-SF and Female Sexual Function Index score (FSFI) results showed no significant differences between the groups (Table I).

Table I. Baseline clinical characteristics of control and intervention groups

	Group (n=69)
	Control group (n=35)		Intervention (n=34)
	Md (IQR)	Mean (SD)	Md (IQR)	Mean (SD)	p-value^a
Age	40.00 (34.00 - 57.00)	45.63 (13.23)	50.00 (35.00-59.00)	48.12 (13.07)	0.364
UI symptoms duration	27.00 (8.00-84.00)	63.88 (108.00)	24.00 (10.00-72.00)	76.79 (122.44)	0.930
Full-term pregnancies	1.00 (1.00-2.00)	1.37 (0.81)	2.00 (1.00-2.00)	1.59 (0.89)	0.303
Menopause age	50.00 (46.00-53.00)	49.67 (3.96)	51.00 (47.00-53.00)	49.89 (3.68)	0.794
ICIQ-UI-SF	8.00 (6.00-12.00)	9.00 (4.44)	8.00 (6.00-13.00)	9.03 (4.34)	0.895
Desire	2.40 (1.80-3.60)	2.57 (1.06)	3.00 (2.40-3.60)	2.88 (1.28)	0.382
Arousal	3.60 (2.40-4.80)	3.34 (1.84)	3.90 (2.10-4.80)	3.40 (1.99)	0.796
Lubrication	3.90 (2.70-5.40)	3.71 (1.94)	3,90 (2.40-4.80)	3.25 (1.84)	0.160
Orgasm	4.00 (2.40-5.20)	3.65 (2.08)	4,40 (2.80-5.60)	3.86 (1.99)	0.646
Satisfaction	4.40 (2.40-5.20)	3.85 (1.69)	4.00 (2.40-5.20)	3.69 (1.72)	0.717
Pain	4.40 (1.60-5.60)	3.58 (2.28)	4,20 (2.00-5.60)	3.62 (2.26)	0.947
FSFI Score	19.40 (15.90-22.60)	18.06 (7.00)	20,40 (14.70-25.80)	19.08 (7.86)	0.401
Oxford power	2.00 (1.00-2.00)	1.77 (0.91)	2.00 (1.00-2.00)	1.82 (0.83)	0.975

n: number of patients; Md: Median; IQR: Interquartile Range; SD: Standard Deviation; UI: Urinary Incontinence; ICIQ-UI-SF: International Consultation on Incontinence Questionnaire Short Form; FSFI: Female Sexual Function Index. Mann-Whitney U Test

Both groups experienced a statistically significant improvement in urine leakage frequency and amount over time (p < 0.000). However, no statistically significant differences were observed between groups at visit 3 (8 weeks) (p = 0.355) or visit 5 (16 weeks) (p = 0.442) (Tables II and III). No differences were found between groups or over time within each group regarding sexual function (arousal, lubrication, orgasm, satisfaction, and pain). However, statistically significant differences in desire were found at week 16 (p = 0.041), with no differences in previous weeks (Tables II and III).

Table II: Values of ICIQ-UI-SF and FSFI at week 8

	Group (n=69)
	Control group (n=35)		Intervention (n=34)
Week 8	Md (IQR)	Mean (SD)	Md (IQR)	Mean (SD)	p-value^a
ICIQ-UI-SF	5.00 (4.00-9.00)	6.49 (4.09)	5.00 (3.00-6.00)	5.56 (4.18)	0.355
Desire	2.40 (2.40-3.60)	2.73 (1.04)	3.60 (2.40-4.20)	3.18 (1.31)	0.076
Excitation	3.90 (2.70-5.10)	3.64 (1.81)	4.35 (2.40-5.10)	3.54 (2.14)	0.875
Lubrication	4.50 (3.00-5.10)	3.75 (1.90)	4.50 (1.20-5.10)	3.44 (2.13)	0.708
Orgasm	4.40 (2.40-5.60)	3.77 (2.10)	4.80 (2.80-5.60)	3.84 (2.13)	0.809
Satisfaction	4.80 (2.40-5.20)	3.82 (1.89)	4.40 (1.60-5.20)	3.56 (2.12)	0.707
Pain	5.20 (1.60-6.00)	3.86 (2.42)	4.40 (0.00-6.00)	3.46 (2.57)	0.486
FSFI Score	20.10 (16.40-22.70)	18.75 (6.89)	19.35 (14.30-24.00)	18.43 (8.59)	0.792

n: number of patients; Md: Median; IQR: Interquartile Range; SD: Standard Deviation; ICIQ-UI-SF: International Consultation on Incontinence Questionnaire Short Form; FSFI: Female Sexual Function Index. Mann-Whitney U Test

Table III: Values of ICIQ-UI-SF and FSFI at the end of treatment

	Group (n=51)
	Control group (n=27)		Intervention (n=24)
Week 16	Md (IQR)	Mean (SD)	Md (IQR)	Mean (SD)	p-value^a
ICIQ-UI-SF	4.00 (0.00-8.00)	4.52 (4.85)	3.50 (0.00-5.00)	3.31 (3.69)	0,442
Desire	3.00 (2.40-3.60)	2.89 (1.15)	3.60 (2.40-4.20)	3.53 (1.25)	0,041*
Arousal	4.50 (3.00-5.40)	3.81 (2.02)	5.10 (3.30-5.40)	4.24 (1.74)	0,361
Lubrification	4.8 (2.40-5.10)	3.69 (2.10)	4.50 (3.60-5.40)	4.07 (1.81)	0,596
Orgasm	4.80 (3.20-5.20)	3.91 (2.12)	5.20 (3.60-5.60)	4.33 (1.81)	0,474
Satisfaction	4.8 (3.60-5.20)	4.27 (1.68)	4.80 (3.20-5.20)	4.15 (1.60)	0,681
Pain	5.60 (0.00-6.00)	4.15 (2.54)	5.20 (0.00-6.00)	4.00 (2.49)	0,665
FSFI score	19.40 (16.90-21.70)	18.35 (5.47)	18.20 (15.20-23.30)	19.00 (7.10)	0,869

At week 4, statistically significant differences in tolerance were observed (p = 0.005). No discomfort was reported in the control group, while 20.6% of the intervention group reported discomfort related to the vaginal spheres. At week 8, 3% of the control group and 11% of the intervention group reported discomfort, with no significant differences between groups (p = 0.174). These percentages were similar at week 12 (2.9% in the control group and 15.2% in the intervention group, p = 0.074). At week 16, no discomfort was reported in the control group, and 11.5% of the intervention group reported local discomfort. No withdrawals occurred due to side effects. According to the adapted Morisky-Green Test, at week 4, 80% of the control group reported forgetting to do exercises daily, compared to 50% in the intervention group, showing statistically significant differences in adherence (p < 0.05). This difference in adherence remained statistically significant at weeks 12 and 16 (p < 0.05).

The main findings from our study show that performing pelvic floor exercises at home taught by a Pelvic Floor Physiotherapist and supervised one time a month for four months is effective, with or without vaginal spheres, to treat mild and/or moderate SUI or MUI.

However, the degree of incontinence (measured according to ICIQ-UI-SF) improved significantly in both groups. Therefore, although one previous study conducted comparing PFMT alone to performing pelvic floor exercises with vaginal spheres had faster beneficial results on ICIQ-UI-SF test scores, in our results, both groups achieved similar improvement results with no differences between both of them (9). These inconclusive results regarding the incontinence outcomes may be related to the different types of rehabilitation programs and follow-up periods (from 16 to 24 weeks), as the methodology used is similar in both studies.

These findings are consistent with the recommendations of the worldwide guidelines, which consider techniques that focus on strengthening the pelvic floor muscles the gold standard in conservative treatment for SUI dysfunction (11, 14).

The results from our study support data from earlier studies (20–22) that found the benefits of PFMT were similar with or without vaginal medical devices (as, for example, the vaginal cones), with no significant differences observed between the two treatment options.

Regarding our second aim of the study, it has been hypothesized that the use of vaginal spheres may improve involuntary muscle contraction and can help the patient in terms of voluntary and specific control of this musculature (6, 9). Moreover, research has consistently demonstrated a strong relationship between female sexual dysfunction and pelvic floor muscle dysfunction, particularly in the context of UI. Bortolami (2015) (4) found that low pelvic floor tone was significantly associated with sexual dysfunction, while Preda (2019) (5) reported that pelvic floor rehabilitation not only improved UI but also improved sexual function. Rosenbaum (2007) (6) and Verbeek (2019) (7) further highlighted the prevalence of sexual dysfunction in women with pelvic floor disorders, and PFMT showed promise in improving sexual function, emphasizing the potential role of the pelvic floor.

Surprisingly, and despite previous studies in which PFMT has been shown to improve female sexual function, in our research, the FSFI has not improved in either of the two study groups or in either of the measurement periods. Only in the subgroup of women who were analyzed between weeks 8 and 16 was an improvement in the desire domine observed (between weeks 12 and 16) in the group using the Enna Balls intravaginal spheres.

The FSFI's domain of desire reflects the motivation for sexual intercourse (23). Desire domain factors examine the frequency and intensity of a woman's sexual desire, where ratings range from 1.2 to 6. Of the six domains of sexual function included in the FSFI, only the domain of desire can be used independently. Using ROC analysis in two independent groups of women with and without Hypoactive Sexual Desire Disorder (HSDD), Gerstenberger et al. (24) found that a cut-off score of five in the desired range had high diagnostic sensitivity and specificity. This means that women with a score of five or less in the desire domain may meet the diagnostic criteria for HSDD, and women with a score higher than five may not meet the criteria. In our research, when we look at the change in desire domine average score for all women receiving the treatment, we observed that although the difference is statistically significant, the established cut-off point is not exceeded to be able to determine that clinically there is a change, going from meeting the criteria for HSDD to not meeting them (23, 24).

Regarding the safety of pelvic floor exercises (Kegel exercises) combined with the vaginal spheres, we can confirm that it is a treatment without risk or side effects. Tolerance improved throughout the study in both groups. Seven patients reported mild adverse effects at visit 2 (week 4). Only one patient from the control group manifested low tolerance to physical therapy and reported pain in the pelvic floor area, and four in the vaginal spheres group (hypersensitivity, irritation, itching, and local discomfort). By the next follow-up visit, these adverse effects had subsided or reduced in all patients, reflecting a precise adaptation to the physical therapy methods. A slight local discomfort was reported at the end of treatment for those women who had reported irritation and itching previously.

For the goal of this study, the vaginal spheres of the ENNA BALLS brand were used, with a weight of 0.13 grams and 0.103 m height with an amplitude of 0.073. Perhaps these measures in a non-perimenopausal population, as the samples involved in previous studies as the one by Porta et al. (2014) (9), would not have generated the slight discomfort that they have caused in this peri-menopausal women with more significant vaginal atrophy due to the genitourinary syndrome of menopause that entails the age of the women involved in our study, next to 50 years old (mean age = 46.85 ± 1.58). In addition, only one of the patients included in the study received hormone replacement therapy, and only seven of the total women (3 in the control group and four in the intervention group) received topical hormone treatment. From a clinical point of view, it seems a good option to include in future studies topical hormone treatment or at least the combined use of vaginal moisturizers together with the use of the spheres to avoid irritating discomfort due to contact with atrophic mucosa.

Both groups reported good adherence to treatment, a condition for not dropping out from the study; however, when we asked if they had ever forgotten to do the exercises in the last four weeks, 28 patients in the control group and 17 in the intervention group said they had forgotten to do a set of exercises, noting that in the group using the vaginal spheres the women were more aware of the importance of doing well and each time prescribed their exercises than in the group not using the spheres. Long-term adherence to PFMT may vary widely (8, 19). Thus, we hypothesized that the use of vaginal spheres could increase adherence to home treatment in long-term PFMT in which the physiotherapist could not be present.

Our study has some limitations. On the one hand, the therapist who carried out the treatment was not blinded; only the one who assessed at baseline and 8 and 16 weeks was blinded. On the other hand, although we used the ICIQ-UI-SF (14, 25) questionnaire and the FSFI fields (3), we did not use other objective outcome measures, such as the one-hour pad test.

Finally, only 51 completed questionnaires were included in the second analysis, so the sample in this second period (from weeks 8 to 16) was very small. This does not allow us to show what results would have been obtained if the initial 71 women had completed all the questionnaires. Further studies with larger samples are needed to confirm these results.

Taking into account the obtained results, we hypothesize that a more extended period of treatment could have been necessary to demonstrate changes in sexual function due to the vaginal spheres and PFMT, as previous studies did (8, 9). This work again opens a line of research to assess the use of devices available on the market in terms of long-term effectiveness.

In conclusion, PFMT performed at home by women with SUI or stress-predominant MUI and sexual dysfunction is effective and safe, whether with or without spheres. Vaginal spheres can be recommended as part of the domiciliary PFMT program and to improve female desire; nevertheless, further research is needed to identify the exact contribution of the spheres.

CONSORT	Consolidated Standards of Reporting Trials
FSFI	Female Sexual Function Index
HSDD	Hypoactive Sexual Desire Disorder
MUI	Mixed urinary incontinence
PFMT	Pelvic Floor Muscle Training
SUI	Stress urinary incontinence
UI	Urinary incontinence

Conflicts of interest

The authors received research support from ECARE YOU SL.

Funding

ECARE YOU, SL. supported the provision of study materials.

Author Contribution

Laia Blanco-Ratto, Stéphanie Kauffmann, and Inés Ramirez-Garcia made substantial contributions to the manuscript's conception and design. Montserrat Girabent and Inés Ramirez-Garcia contributed to the acquisition, analysis, and interpretation of the data. Cristina Naranjo Ortiz wrote, reviewed, and revised the manuscript for structure, clarity, written expression, and accuracy. All authors participated in drafting the manuscript, with Inés Ramirez-Garcia and Montserrat Girabent providing critical revisions. All authors have read and approved the final version of the manuscript.

Acknowledgement

The authors acknowledge Joan Garriga (CEO of ECARE YOU SL.) for supporting the equipment used for this study and especially Claudia Martínez-Puente, who helped collect the data.

Data Availability

Sequence data that support the findings of this study have been deposited at Harvard Dataverse (https://doi.org/10.7910/DVN/DVOHPZ).

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No competing interests reported.

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Vaginal Spheres Versus Pelvic Floor Muscle Training in the Treatment of Urinary Incontinence and Sexual Dysfunction: A Randomized, Single-Blind, Controlled Trial

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Data Availability

References

Additional Declarations

Status:

Version 1