868
Views
0
CrossRef citations to date
0
Altmetric
Research Article

Effects of vaginal dilation therapy on vaginal length, vaginal stenosis, vaginal elasticity and sexual function of cervical cancer survivors

, & ORCID Icon
Article: 2317387 | Received 26 Jul 2023, Accepted 05 Dec 2024, Published online: 11 Mar 2024

Abstract

Background

Cervical cancer survivors can experience vaginal length shortening, vaginal stenosis, vaginal elasticity deterioration, sexual frequency reduction and sexual dysfunction. This prospective, uncontrolled, monocentric clinical interventional study aimed to evaluate the effect of vaginal dilation therapy on vaginal condition and sexual function of cervical cancer survivors who had not received timely vaginal dilation.

Methods

A total of 139 patients completed the study. They received 6 months of vaginal dilation therapy. We evaluated their vaginal elasticity, vaginal diameter, vaginal length and sexual function before and after vaginal dilation therapy. Their vaginal conditions were evaluated by customised vaginal moulds, and the sexual function was assessed by female sexual function index. The SPSS 25 software was used to analyse all the data.

Results

Age, vaginal diameter and sexual intercourse frequency before diagnosis were significantly associated with female sexual dysfunction of the patients after cancer treatment. Vaginal dilation therapy improved vaginal stenosis, vaginal length and sexual function in all the patients; however, the vaginal elasticity and incidence of sexual dysfunction did not improve significantly. Sexual intercourse frequency before diagnosis, vaginal elasticity, time interval from last treatment and treatment modalities were significantly associated with the change in female sexual function index score before and after vaginal dilation therapy. Patients with a time interval from the last treatment less than 24 months or those who had moderate or good vaginal elasticity, benefitted more from vaginal dilatation therapy.

Conclusions

Cervical cancer survivors who had not received timely vaginal dilation still benefitted from vaginal dilation therapy, irrespective of the treatment methods they received. Moreover, vaginal dilation therapy should be performed as early as possible after cervical cancer treatment.

PLAIN LANGUAGE SUMMARY

Cervical cancer survivors can experience vaginal condition deterioration and sexual dysfunction after treatment. Vaginal dilation can help improve vaginal stenosis, vaginal length and sexual function of these patients. However, some medical institutions in China do not provide timely vaginal dilation for this population. This study aimed to explore whether vaginal dilation was still effective for cervical cancer survivors who had not received timely vaginal dilation. The results showed that these patients still benefitted from vaginal dilation, irrespective of the treatment methods they received. Patients with a time interval from the last treatment less than 24 months or those who had moderate or good vaginal elasticity, benefitted more from vaginal dilation. The findings of the study is an indication to developing countries that more attention should be given to sexual issue of cervical cancer survivors in clinical practice, and vaginal dilation therapy should be performed promptly after treatment.

Introduction

Cervical cancer is the fourth most common malignant tumour in women globally. According to current cancer statistics, the 5-year survival rate of cervical cancer patients has improved (Siegel et al. Citation2023), and it has contributed to an increase in attentiveness to female sexual dysfunction (FSD) of cervical cancer survivors (Reed Citation2022). A proportion of 23% to 70% of cervical cancer survivors report one or more forms of FSD (Zhang et al. Citation2020). Further, FSD can persist over time and even worsen after cancer treatment (Zhang et al. Citation2020). Sexual problems associated with cancer are usually caused by physiological damage from cancer treatment. At present, surgery and radiotherapy are the main therapeutic modalities for cervical cancer. Different treatment modalities have different impairments on vaginal conditions of patients, including reduced vaginal length (Wang et al. Citation2021), worse vaginal elasticity (Hofsjö et al. Citation2018), vaginal dryness and vaginal stenosis (Damast et al. Citation2019), which further deteriorate the sexual function of cervical cancer survivors by affecting their sexual intercourse experience and sexual desire (Damast et al. Citation2019). Psychosocial factors are also essential in sexual rehabilitation, including the quality of the relationship with sexual partners, sexual coping skills, sexual attitudes, and impaired body image (Schover Citation2019).

To date, evidence has shown that vaginal dilation therapy (VDT) can help in increasing the vaginal length and in improving vaginal stenosis and the sexual function of cervical cancer survivors (Damast et al. Citation2019). As the vaginal stenosis begins in the early weeks or months following radiotherapy, VDT should be applied in a timely manner (Damast et al. Citation2019; Wu et al. Citation2021); however, some medical institutions in China are unaware and do not provide preventative VDT for patients after treatment, especially those following radiotherapy. Further, patients are reluctant to discuss sex or fertility with their care providers and tend to be resistant to VDT due to conservative sexual attitudes in China. In our current study, we found that majority of the cervical cancer patients who visited Beijing Obstetrics and Gynaecology Hospital had not received VDT before. Therefore, this study aimed to evaluate the effect of VDT on vaginal stenosis, vaginal length, vaginal elasticity and the sexual function of cervical cancer survivors who had not received timely VDT after treatment.

Methods

This was a clinical report describing a prospective, uncontrolled, monocentric interventional study. The intervention was VDT. Evaluations took place at two time points: before VDT and 6 months after VDT. We used the STROBE checklist to assure reporting the relevant points of our clinical report. The study was approved by the Science and Technology Division of Beijing Obstetrics and Gynaecology Hospital, Capital Medical University. The approval number was 2021-YW-011-01. Written informed consent was obtained from all participants.

Participants

Previous research estimated the prevalence of FSD in Chinses women to be 74.1% (Jin Citation2017). The minimum sample size of the study was calculated to be 134 (n=Z2*p*(1p)δ2=1.962*0.741*(10.741)(0.741*10%)2≈134). A total of 147 cervical cancer survivors who visited the Department of Gynecological Oncology, Beijing Obstetrics and Gynaecology Hospital, Capital Medical University between December, 2020, and September, 2021, were enrolled in this study. The inclusion criteria were as follows: pathological diagnosis of cervical cancer, International Federation of Gynaecology and Obstetrics (FIGO) stage I–III, time interval from the last treatment ≥ 3 months. The exclusion criteria were as follows: suspected recurrence, metastasis, or co-occurrence of other malignant tumours, denial of sexual history, inability to maintain a stable sexual life, cognitive deficiencies, and non-acceptance of the invitation to participate.

Main outcome measures

The main outcome measures included vaginal diameter, vaginal length, vaginal elasticity, and the sexual function. The assessment time points included 0 and 6 months of vaginal dilation. The vaginal conditions of the patients were assessed in a private room. We customised a series of vaginal dilating moulds with different diameters in advance. We used four of them with a diameter of 20, 25, 30 and 35 mm to perform the rough measurement of vaginal diameter (). Vaginal diameter was defined as the diameter of the vaginal mould that could be accommodated by the vagina without discomfort. Patients with vaginal narrowing were those whose vagina could not accommodate a vaginal dilator of 30 mm, considering the average penis size of Chinese men (Yi Citation2017) and the average size of male condoms sold in China. Regarding the vaginal length measurement, we slowly pushed the vaginal dilator into the patient’s vagina until it stopped at the point of resistance, marked the position of the hymen edge, and measured the length between the top of the vaginal dilator mould and the marked position; this was the vaginal length, which we measured in cm. In addition, vaginal elasticity was assessed according to the visceral elasticity criteria (a texture comparable to that of the lips, nasal tip, and forehead corresponded to a good, medium, and poor elasticity, respectively). To ensure the consistency and accuracy of the results, the vaginal condition assessment of all the patients were performed by a fixed examiner throughout the whole study period. Afterwards, we adopted the common terminology criteria for adverse events 4.0 (CTCAE v4.0) (Damast et al. Citation2019) to evaluate vaginal stenosis. We also asked the patients to recall their sexual intercourse frequency before they were diagnosed with cervical cancer. The Female Sexual Function Index (FSFI) was used to assess the sexual function of patients. It consists of six dimensions: desire, arousal, lubrication, orgasm, satisfaction and pain. The higher the FSFI score, the better the sexual function. A total score below 26.55 is defined as FSD (Meston et al. Citation2020).

Figure 1. We customised a series of vaginal dilating moulds with different diameters, four of which with a diameter of 20, 25, 30, and 35 mm were shown here. The length of these moulds were all ≥14cm.

Figure 1. We customised a series of vaginal dilating moulds with different diameters, four of which with a diameter of 20, 25, 30, and 35 mm were shown here. The length of these moulds were all ≥14cm.

Intervention

At the beginning of the study, patients were provided vaginal dilators with increasing diameters (which were the same things as the vaginal dilating moulds mentioned above) according to their vaginal diameter (e.g. patients with a measured vaginal diameter of 20 mm were given six vaginal dilators of 22, 24, 26, 28, 30, and 32 mm). Patients were instructed to insert a vaginal dilator whose diameter was most similar to their vaginal diameter for vaginal dilation at home and to use force or dilator rotation as appropriate to aid vaginal stretching. Before inserting the dilator to vagina, the patients were recommended to apply lubricant to the surface of the dilator to help reduce the discomfort of insertion. The dilation time was 5–10 min per time and three times per week. A time interval extension of 30 min was encouraged depending on the patients’ peculiarity. When a specific vaginal dilator was fully accommodated, it was replaced with another dilator of a larger size under the guidance of the physician. The above steps were repeated until the vaginal dilator with the largest diameter (32 mm) could be used and maintained. Patients were encouraged to adhere to the use of vaginal dilators by creating a WeChat (an instant messaging app widely used in China, manufactured by Tencent in Shenzhen) account for each patient. Patients were asked to timely report vaginal dilation progress and sexual recovery through WeChat. After the study was concluded, we asked the patients to continue to use a vaginal dilator and/or maintain regular sexual intercourse.

Statistical analysis

The Statistical Package for Social Sciences (SPSS) version 25 software (IBM Corp., Armonk, NY, USA) was used to analyse all the data. Various physiological indexes (including age, body mass index and so on) were expressed as mean ± standard deviation (SD). Count data (including education level, cancer stage and so on) were presented as frequency (n[%]). The paired t-test (P < 0.05) was used to compare variables at two different time points: (1) before VDT and (2) after 6 months of VDT. According to the treatment modalities of cervical cancer, patients could be divided into the surgery, surgery with radiotherapy and primal concurrent chemoradiotherapy (CRT) groups. According to the visceral elasticity criteria, the patients could be divided into good, medium and poor elasticity groups. The Friedman test was used to compare variables among these different groups. In the analysis of influencing factors correlated with FSFI score < 26.55 before VDT and the factors correlated with the change in FSFI score before and after VDT, single factor analysis was conducted for all variables. P < 0.05 indicated that the difference was statistically significant. Then multivariate logistic regression analysis or multivariate linear regression analysis was conducted for all variables with statistical significance. The confidence interval was set to 95%.

Results

Eight patients (6.0%) were discontinued from the study because of declining to continue to participate in the trial (n = 5), not answering phone call or messages (n = 2), and inability to maintain a stable sexual life (n = 1). Finally, a total of 139 patients completed the study. The patients’ ages ranged from 27 to 70 years with a mean age of 49.8 ± 9.3 years. summarises the recruitment process. The demographics and baseline characteristics of these participants are presented in . During the study period, no patient reported any severe complications such as bleeding, infection or vaginal fistula.

Figure 2. Flow diagram.

Figure 2. Flow diagram.

Table 1. Demographics and baseline characteristics (n = 139).

Vaginal condition and sexual function of patients before VDT

The total incidence of vaginal stenosis was 36.7%, and the incidence of vaginal stenosis was 0.0%, 34.2%, and 55.4% in the surgery, surgery with radiotherapy, and primal CRT groups, respectively. The mean vaginal length of the patients was 6.19 ± 1.34 cm, while that of the surgery, surgery with radiotherapy, and primal CRT groups was 6.63 ± 1.11, 6.25 ± 1.52, and 5.91 ± 1.31 cm, respectively. Details of baseline vaginal diameter and vaginal elasticity are presented in .

Table 2. Baseline vaginal diameter and elasticity (n = 139).

Most of the patients reported a low sexual frequency―only 10.1% could maintain a sexual frequency of ≥1 weekly. Sixty-two patients had not resumed sexual activity after treatment. The mean FSFI score of all the patients was 12.11 ± 9.92. A total of 118 (84.9%) patients developed FSD. The sexual function of the surgery group was the best, followed by that of the surgery with radiotherapy group and the primal CRT group (P < 0.05). According to univariate analysis, age, tumour stage, treatment modalities, vaginal diameter, vaginal length and sexual intercourse frequency before diagnosis were significantly correlated with FSD (P < 0.05). According to the results of the multivariate analysis, age (odds ratio [OR]: 0.913, 95% confidence interval [CI]: −0.984, −0.830, P = 0.049), vaginal diameter (OR: 1.252, 95%CI:1.016, 1.543, P = 0.035), sexual intercourse frequency before diagnosis (OR: 25.050, 95%CI: 2.067, 303.637, P = 0.011) were significantly correlated with FSD after treatment ().

Table 3. Factors associated with FSFI score < 26.55 before VDT.

Vaginal condition and sexual function of patients after 6 months of VDT

The incidence of vaginal stenosis in these patients was 3.1%. The incidence of vaginal stenosis was 0.0% in the surgery group, 0.0% in the surgery with radiotherapy group, and 6.2% in the primal CRT group. VDT effectively improved vaginal stenosis in all the patients (P < 0.05). Furthermore, the average vaginal length of the patients after 6 months of VDT was 6.87 ± 1.33 cm, while that of the surgery, surgery with radiotherapy, and primal CRT groups was 7.32 ± 0.99, 7.13 ± 1.45, and 6.47 ± 1.32 cm, respectively. VDT increased vaginal length in all patients (P < 0.001). Generally, VDT had a better effect on vaginal length extension in the surgery and surgery with radiotherapy groups as compared to that in the primal CRT group (P < 0.05). Details of vaginal length before and after VDT in different groups are presented in . However, VDT was ineffective in improving vaginal elasticity in cervical cancer survivors (P > 0.05). Further details are presented in Table S1.

Figure 3. (A) The vaginal length before vaginal dilation therapy (VDT) and after 6 months of VDT in the different groups (cm). (B) The percentage of sexual intercourse ≥1 weekly before diagnosis, before VDT and after 6 months of VDT in the different groups.

Figure 3. (A) The vaginal length before vaginal dilation therapy (VDT) and after 6 months of VDT in the different groups (cm). (B) The percentage of sexual intercourse ≥1 weekly before diagnosis, before VDT and after 6 months of VDT in the different groups.

After 6 months of VDT, 45 patients resumed sexual activity, and 32.4% of patients had a frequency of sexual activity greater than once weekly, which was higher than that at the beginning of the study (10.1%) but was still much lower than that before diagnosis (52.5%). Further details are presented in . Though the mean FSFI score (17.75 ± 7.73) of all the patients after VDT was higher than the baseline, the incidence of FSD (83.5%) remained stable. According to univariate analysis, fee type, sexual intercourse frequency before diagnosis, vaginal elasticity, time interval from last treatment and treatment modalities were significantly correlated with the change in FSFI score before and after VDT (P < 0.05). According to multivariate analysis, sexual intercourse frequency before diagnosis (OR: 4.150, 95%CI: 0.137, 2.708, P = 0.030), vaginal elasticity (OR: 5.883, 95%CI: 0.157, 3.387, P = 0.032), time interval from last treatment (OR: 0.946, 95%CI: −0.101, −0.009, P = 0.019) and treatment modalities (OR: 7.135, 95%CI: 0.452, 3.477, P = 0.011) were significantly correlated with the change in FSFI score before and after VDT (Table S2). To be more specific, compared with those in the primal CRT group, patients in the surgery and surgery with radiotherapy groups benefitted more from VDT in improving sexual function (P < 0.05). Patients with moderate or good vaginal elasticity performed better than those with poor vaginal elasticity after VDT (Table S3). It is worth noting that patients with a time interval from the last treatment less than 24 months had greater improvement in sexual function after 6 months of VDT than those with a time interval ≥ 24 months (P = 0.027).

Discussion

Cervical cancer survivors after treatment can experience vaginal length shortening, vaginal stenosis, and vaginal elasticity deterioration. This study showed that all patients had a reduced incidence of vaginal stenosis, increased vaginal length, and improved sexual function after VDT. In our study, patients who underwent surgery only also received VDT though they did not develop vaginal stenosis as we wanted to explore the effect of VDT on increasing vaginal length. However, the vaginal length did not return to the average Chinese women vaginal length (Zhang Citation2011) and sexual intercourse frequency also did not fully return to pre-diagnosis status after VDT. Although all the patients did not receive timely VDT at the end of treatment, they still benefitted from VDT, and the patients with a time interval from the last treatment < 24 months benefitted more. Therefore, VDT should be performed promptly after treatment. In the EMBRACE cohort, Pötter (Citation2018) showed that an incidence of grade 1 or higher stenosis was approximately 20% at 3 months after treatment, 50% at 6 months, and approximately 70% at 24 months, after which time it appeared to level out. Martins (2021) reported that cervical cancer patients at stage IIB–III had a lower incidence and severity of vaginal stenosis after 1-year of VDT. Araya-Castro et al. (Citation2020) found that the application of vaginal dilators improved the vaginal length and diameter of cervical cancer patients after radiotherapy. Haddad et al. (Citation2021) found that patients with cervical cancer with better vaginal function after treatment (most of them had early disease) had better compliance, improved vaginal condition, and improved sexual quality of life. These conclusions were all consistent with our findings.

In our study, the frequency of sexual intercourse in cervical cancer survivors before and after VDT were both significantly lower than that before the diagnosis of the disease. The most common causes of reduced sexual intercourse were fear of disease recurrence or progression, painful intercourse, vaginal dryness, low libido (caused by low satisfaction, inferiority, psychological factors, and age), and sex partner-related factors (including poor physical condition of the sex partner, cohabitation status with sexual partner and loss of affection for sex partner). Although their sex partners remained sexually active, some patients refused to engage in any sexual activity for years after treatment, which somewhat affected the quality of their relationship. Interestingly, patients with sexual intercourse frequency before diagnosis of two or more times per week were less likely to develop FSD after treatment although their sexual intercourse frequency still decreased after treatment. Most of these patients reported good relationships with their sexual partners. It indicated that the quality of the relationship with the sexual partners can help decrease the incidence of FSD. In this study, patients were encouraged to return to their normal sexual life in time after the vagina could fully accommodate a vaginal dilator of ≥ 30 mm. Most of the patients were able to gradually change to a larger vaginal dilator 2–3 months after the intervention, eventually maintaining a vaginal dilator with a diameter of 30–32 mm and resuming sexual activity or increasing sexual frequency 3–4 months after the intervention. Twenty-four patients reported on WeChat that their relationship with their sex partners had greatly improved.

The advantages of this study are that all patients received standardised treatment for cervical cancer. A new follow-up method of communication on a phone application named WeChat with the patients was used for individual counselling and guidance. This new type of follow-up was more efficient than telephone follow-up, and patients could communicate or leave real-time message with our physicians whenever and wherever possible. Moreover, the study considered the vaginal condition and sexual function of patients with cervical cancer who underwent surgery alone and the factors related to the patients’ sex partners. In addition to the direct effect of VDT, the effect of vaginal dilators on the extension of vaginal length was also explored.

However, this study had some limitations. The follow-up period in this study was only 6 months, which was relatively short, and further follow-up is ongoing. Regarding the procedures of the study, the persistence of VDT depended more on the patients’ perseverance and our supervision and education. In comparison, patients with moderate or good vaginal elasticity had better compliance and were more willing to communicate with us regarding sexual issues than those with poor vaginal elasticity. Moreover, this study was a clinical study without a control group due to the difficulties associated with performing well-designed randomised controlled trials on this topic, such as the high probability of cross-over between groups, and interference of sexual activity; therefore, we could not establish a partial causal relationship. For example, whether VDT alone could help patients recover their sexual activities or increase sexual intercourse frequency remains unclear as we cannot completely rule out psychological effects in the process.

Conclusion

VDT increased vaginal length, improved vaginal stenosis and sexual function of cervical cancer survivors, irrespective of the treatment methods they received. However, since the occurrence of vaginal stenosis is progressive and irreversible, patients who received VDT earlier benefitted more. This is an indication to developing countries that more attention should be given to sexual issue of cervical cancer patients after treatment.

Authors’ contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Yu-Xuan Lin and Fei-Fei Zhao. The first draft of the manuscript was written by Yu-Xuan Lin, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Ethics approval and consent to participate

All procedures performed in studies involving human participants were in accordance with the ethical standards of the Science and Technology Division of Beijing Obstetrics and Gynaecology Hospital, Capital Medical University and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Written informed consent was obtained for participation in this study. The approval number was 2021-YW-011-01.

Consent for publication

Informed consent was obtained from all individual participants included in the study. All authors provided consent for the publication of this manuscript.

Supplemental material

Supplemental Material

Download MS Word (15.3 KB)

Supplemental Material

Download MS Word (19.9 KB)

Supplemental Material

Download MS Word (31.1 KB)

Acknowledgments

We would like to thank Editage (www.editage.cn) for English language editing.

Disclosure statement

The authors declare no conflicts of interests.

Data availability statement

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Additional information

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

References

  • Araya-Castro, P., et al., 2020. Vaginal dilator and pelvic floor exercises for vaginal stenosis, sexual health and quality of life among cervical cancer patients treated with radiation: clinical report. Journal of Sex & Marital Therapy, 46 (6), 1–9.
  • Damast, S., et al., 2019. Literature review of vaginal stenosis and dilator use in radiation oncology. Practical Radiation Oncology, 9 (6), 479–491.
  • Haddad, N. C., et al., 2021. Diagnostic methods for vaginal stenosis and compliance to vaginal dilator use: a systematic review. The Journal of Sexual Medicine, 18 (3), 493–514.
  • Hofsjö, A., et al., 2018. Radiotherapy for cervical cancer - impact on the vaginal epithelium and sexual function. Acta Oncologica (Stockholm, Sweden), 57 (3), 338–345.
  • Jin, F.Y., 2017. Investigation and analysis of sexual status of perimenopausal women in Beijing and surrounding areas. Journal of Capital Medical University, 38 (4), 509–514.
  • Meston, C. M., et al., 2020. Scoring and interpretation of the FSFI: what can be learned from 20 years of use? The Journal of Sexual Medicine, 17 (1), 17–25.
  • Pötter, R., 2018. The EMBRACE II study: The outcome and prospect of two decades of evolution within the GEC-ESTRO GYN working group and the EMBRACE studies. Clinical and Translational Radiation Oncology, 9, 48–60.,
  • Reed, M.A., 2022. Female sexual dysfunction. Clinics in Plastic Surgery, 49 (4), 495–504.
  • Schover, L.R., 2019. Sexual quality of life in men and women after cancer. Climacteric: The Journal of the International Menopause Society, 22 (6), 553–557.
  • Siegel, R. L., et al., 2023. Cancer statistics, 2023. CA: a Cancer Journal for Clinicians, 73 (1), 17–48.
  • Wang, Z., et al., 2021. Use of vaginal reconstructive surgery in cervical cancer patients to prevent vaginal stump contracture. Journal of Investigative Surgery: The Official Journal of the Academy of Surgical Research, 34 (7), 747–753.
  • Wu, X., et al., 2021. Evaluation of the sexual quality of life and sexual function of cervical cancer survivors after cancer treatment: a retrospective trial. Archives of Gynecology and Obstetrics, 304 (4), 999–1006.
  • Yi, Q.J., 2017. Penis growth and development in children and adolescents: a study based on GAMLSS. Zhongguo Dang Dai Er Ke Za Zhi, 19 (8), 893–898.
  • Zhang, M., 2011. Vaginal reconstruction with tissue engineering technology. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi, 25 (7), 863–866.
  • Zhang, Y., et al., 2020. The effect of different surgical methods on female and male sexual activity and marital quality in patients with early-stage cervical cancer. Sexual Medicine, 8 (2), 307–314.