Indicated for Pelvic Radiotherapy, Vaginal Rehabilitation, and Alleviation of Late Toxic Reactions in the VaginaExerciserNCT07473271
Vaginal Function Exercisers and Vaginal Dilation Irrigation Drug Administration Tubes Are Used for Vaginal Rehabilitation Therapy in Pelvic Radiotherapy
A study testing Vaginal exerciser and vaginal dilator with irrigation tube in people with Indicated for Pelvic Radiotherapy, Vaginal Rehabilitation, and Alleviation of Late Toxic Reactions in the Vagina, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Indicated for Pelvic Radiotherapy, Vaginal Rehabilitation, and Alleviation of Late Toxic Reactions in the Vagina
- What is being tested?
- Vaginal exerciser and vaginal dilator with irrigation tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women aged 18 to 70 years.
- After radiotherapy for pelvic tumors, the tumor is well controlled (no macroscopically visible tumor). At least 1 week after radiotherapy, regular vaginal dilation and irrigation are expected to be performed subsequently.
- ECOG 0-2.
- prospected survival greater than 6 months.
- Good communication skills, no history of mental illness.
- Consent to participate in this trial and voluntarily sign the informed consent form.
Who cannot join
- Malignant tumors in other parts of the body.
- congenital vaginal stenosis or pre-enrollment confirmed vaginal stenosis.
- Allergic to silica gel and polyvinyl chloride materials.
- active vaginal bleeding.
- It is anticipated that cooperation with the treatment will not be possible.
- The disease may cause difficulties in treatment and evaluation (e.g., sepsis, inability of the patient to tolerate treatment, etc.).
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- pregnant and lactating women.
- Participated in other clinical trials involving drugs or medical devices within the past 3 months.
- The investigators consider other conditions unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
About this study
Official title: A Prospective, Multicenter, Single-Arm Clinical Trial to Evaluate the Safety and Efficacy of Vaginal Function Exercisers and Vaginal Dilation Irrigation Drug Delivery Tubes for Vaginal Rehabilitation in Patients Undergoing Pelvic Radiotherapy
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.
- Being tested
- Vaginal exerciser and vaginal dilator with irrigation tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal exerciser and vaginal dilator with irrigation tubeDevice
It is recommended to perform the procedure 2-3 times per week, with appropriate adjustments under the guidance of the investigator. In principle, it should not exceed once every other day. Each dilation session should last 10-20 minutes. For irrigation, it is suggested to use normal saline or warm water, with an irrigation volume of approximately 100-200 mL, and the procedure should be continued for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Device: Vaginal exerciser and vaginal dilator with irrigation tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of vaginal stenosis at 6 months after enrollment
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start23 Jan 2026
- Primary completion23 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indicated for Pelvic Radiotherapy, Vaginal Rehabilitation, and Alleviation of Late Toxic Reactions in the VaginaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473271
- Sponsor's protocol ID
- KS20251711
- Acronym
- Exerciser
- Status last verified
- Jan 2026
- First submitted
- 10 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm Clinical Trial to Evaluate the Safety and Efficacy of Vaginal Function Exercisers and Vaginal Dilation Irrigation Drug Delivery Tubes for Vaginal Rehabilitation in Patients Undergoing Pelvic Radiotherapy
- ClinicalTrials.gov ID
- NCT07473271
- Acronym / sponsor ID
- Exerciser / KS20251711
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 23 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Vaginal exerciser and vaginal dilator with irrigation tube |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- women aged 18 to 70 years.
- After radiotherapy for pelvic tumors, the tumor is well controlled (no macroscopically visible tumor). At least 1 week after radiotherapy, regular vaginal dilation and irrigation are expected to be performed subsequently.
- ECOG 0-2.
- prospected survival greater than 6 months.
- Good communication skills, no history of mental illness.
Key exclusion criteria (9 listed)
- Malignant tumors in other parts of the body.
- congenital vaginal stenosis or pre-enrollment confirmed vaginal stenosis.
- Allergic to silica gel and polyvinyl chloride materials.
- active vaginal bleeding.
- It is anticipated that cooperation with the treatment will not be possible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal exerciser and vaginal dilator with irrigation tubeIt is recommended to perform the procedure 2-3 times per week, with appropriate adjustments under the guidance of the investigator. In principle, it should not exceed once every other day. Each dilation session should last 10-20 minutes. For irrigation, it is suggested to use normal saline or warm water, with an irrigation volume of approximately 100-200 mL, and the procedure should be continued for 6 months. | Device | Test Group |
Primary outcome
Incidence of vaginal stenosis at 6 months after enrollment
Time frame: six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal exerciser and vaginal dilator with irrigation tube in people with Indicated for Pelvic Radiotherapy, Vaginal Rehabilitation, and Alleviation of Late Toxic Reactions in the Vagina, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of vaginal stenosis at 6 months after enrollment (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.