NCT07473271: Exerciser

Vaginal Function Exercisers and Vaginal Dilation Irrigation Drug Administration Tubes Are Used for Vaginal Rehabilitation Therapy in Pelvic Radiotherapy

ENROLLING BY INVITATION NA Last updated 16 March 2026

What this trial tests

NA trial testing Vaginal exerciser and vaginal dilator with irrigation tube in Indicated for Pelvic Radiotherapy, Vaginal Rehabilitation, and Alleviation of Late Toxic Reactions in the Vagina in 76 participants. Enrolling by invitation.

Timeline

23 January 2026

Primary endpoint
23 July 2026

31 December 2026

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	76
Start date	23 January 2026
Primary completion	23 July 2026
Estimated completion	31 December 2026
Sites	1 location across China

Drugs / interventions tested

• Vaginal exerciser and vaginal dilator with irrigation tube

Conditions studied

• Indicated for Pelvic Radiotherapy, Vaginal Rehabilitation, and Alleviation of Late Toxic Reactions in the Vagina — all drugs for Indicated for Pelvic Radiotherapy, Vaginal Rehabilitation, and Alleviation of Late Toxic Reactions in the Vagina →

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 18 to 70, female only, with Indicated for Pelvic Radiotherapy, Vaginal Rehabilitation, and Alleviation of Late Toxic Reactions in the Vagina. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Gynecological pelvic tumors primarily include ovarian cancer, cervical cancer, and endometrial cancer. Radiotherapy (RT) is one of the key treatment modalities for gynecological tumors. It is a necessary therapeutic approach for 80% to 90% of cervical cancer patients and 60% of endometrial cancer patients . The vagina, as a target organ and critical vulnerable organ for RT, may be affected by radiation, leading to adverse effects such as vaginal mucosal changes, adhesions, stenosis, or atresia . Vaginal stenosis (VS) is a common yet often overlooked side effect in female patients undergoing pelvic tumor RT, frequently causing symptoms such as dyspareunia, pain, vaginal dryness, or vaginal bleeding . Brand AH et al. prospectively recorded VS data from 179 cervical cancer patients receiving RT, with an average follow-up of 9.6 months, and found that 38% of patients developed VS. Park HS et al. documented VS data from endometrial cancer patients undergoing intravaginal brachytherapy, with an average follow-up of 12.9 months, and reported a VS incidence of 33%. Thais de Morais Siqueira et al. recorded subsequent VS in patients who underwent pelvic RT, with VS prevalence rates of 79% in cervical cancer patients and 67% in endometrial cancer patients. The occurrence of vaginal stenosis can impair patients' later sexual quality of life and comfort satisfaction, which is a crucial factor affecting marital relationship . Failure to prevent or address vaginal stenosis promptly may lead to psychological issues such as anxiety and depression in patients, while both physical and psychological distress can result in a decline in overall quality of life . When progressing to severe vaginal stenosis or vaginal atresia, it not only increases the discomfort during gynecological examinations but also reduces the probability of early detection of tumor recurrence, thereby affecting long-term patient survival .

Current research in China regarding the contributing factors and preventive measures for vaginal stenosis remains in the exploratory phase, with insufficient attention paid to this condition. Current clinical practice predominantly emphasizes the preventive role of vaginal irrigation against infections . During vaginal irrigation, dilators are only briefly used as a substitute for dilation. For cervical cancer patients undergoing radical radiotherapy, routine vaginal irrigation is performed both during and after the treatment. Post-radiotherapy, patients are advised to undergo routine vaginal dilation therapy.

The most commonly used method for preventing vaginal stenosis is the application of vaginal dilators or related molds. Bakker et al. demonstrated that regular use of finger dilation, vaginal dilators, or other types of dilators can improve female patients' sexual function and gradually restore normal vaginal size. Law et al. confirmed that persistent use of vaginal dilators for 6 months significantly restored vaginal size to pre-radiotherapy levels. A study investigating the use of vaginal dilators in patients undergoing pelvic tumor radiotherapy found that 80.0% of patients did not develop vaginal stenosis at 12 months post-radiotherapy, demonstrating that consistent use of vaginal dilators effectively reduces the severity of vaginal stenosis . Martins J et al. conducted a trial comparing local estrogen, local testosterone, placebo, and vaginal dilators for the prevention of vaginal stenosis (VS) in women undergoing radiotherapy for cervical cancer. After 12 months of follow-up, among 142 patients, the prevalence of VS was 11% in those treated with vaginal dilators, 57% in placebo users, and 56.8% in estrogen-treated women, confirming the efficacy of vaginal dilators in reducing VS incidence. Stahl JM et al. enrolled 243 patients who received high-dose brachytherapy (HDR) in the vagina, all of whom were treated with vaginal dilators. At 12 months, the rate of no VS occurrence was 63.5% in non-adherent patients, 70.2% in standard-adherent patients, and 81.2% in extended-adherence patients, further validating the effectiveness of persistent vaginal dilator use in reducing vaginal stenosis. Jiang Song et al. retrospectively analyzed 80 cervical cancer patients who underwent radical radiotherapy at Xuzhou Cancer Hospital from January 2017 to December 2018. The patients were divided into two groups: the control group (40 cases) received only vaginal irrigation, while the observation group (40 cases) received vaginal irrigation combined with vaginal mold application. The incidence of vaginal stenosis was compared between the two groups at 3 months post-radiotherapy. Results: The vaginal stenosis rate in the observation group was 32.50%, while that in the control group was 70.00%, with a statistically significant difference (P \<0.05). The use of vaginal mold was associated with a reduced incidence of radiation-induced vaginal stenosis in cervical cancer patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.