Newly-designed Vaginal Stent to Improve Tissue Healing for Girls and Women With Congenital and Reproductive Anomalies
Phase: NA
Conditions: Vaginal Stricture
Sponsor: Baylor College of Medicine

Institutional Review Board for Baylor College of Medicine and Affiliated
Hospitals
Protocol Number:
H-45549
Status:                        Approved
Initial Submit Date:  7/17/2019
Approval Period:       3/18/2022 - 3/17/2023
Section Aa:  Title & PI
A1.  Main Title
NEWLY-DESIGNED VAGINAL STENT TO IMPROVE TISSUE HEALING FOR GIRLS AND WOMEN WITH
CONGENITAL AND REPRODUCTIVE ANOMALIE
A2.  Principal Investigator
Name:  
JULIE HAKIM
Phone:  
(832) 826-7464
Id: 
185416
Fax:  
Department:  OB-GYN: ADMINISTRATIVE
Email:   
jhakim@bcm.edu
Center:  
Mail Stn:  BCM610
A3.  Administrative Contact
Name:
JENNIFER MCCRACKEN
Phone:  
832-824-5833
Id: 
201048
Fax:  
Email:   
mccracke@bcm.edu
Mail Stn:  BCM610
A3a.  Financial Conflict of Interest
Does any member of study personnel (Investigator (including investigator’s spouse and/or dependent children)) that are
involved in the design, conduct, or reporting of the research have a Significant Financial Interest (SFI) that would
reasonably appear to be affected by the research for which funding is sought and/or associated with an entity/business
that would reasonably appear to be affected by the research?
     No
Section Ab:  General Information    
A4.  Co-Investigators
Name:  
JENNIFER DIETRICH
Phone:  
832-826-7464
Id: 
130087
Fax:  
832-832-9349
Department:  OB-GYN: GYNECOLOGY
Email:   
jedietri@bcm.edu
Center:  
Mail Stn:  BCM610
Name:  
ANTHONY COSTALES
Phone:  
832 8267466
Id: 
208504
Fax:  
Department:  OB-GYN: GYNECOLOGIC ONCOLOGY
Email:   
costales@bcm.edu
Center:  
Mail Stn:  122609
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Name:  
DALLESE JONES
Phone:  
Id: 
232479
Fax:  
Department:  OB-GYN: ADMINISTRATIVE
Email:   
232479@bcm.edu
Center:  
Mail Stn:  
Name:  
KENESHIA LANE
Phone:  
Id: 
232877
Fax:  
Department:  OB-GYN: ADMINISTRATIVE
Email:   
232877@bcm.edu
Center:  
Mail Stn:  
Name:  
GISELE CALDERON
Phone:  
832-824-5833
Id: 
233562
Fax:  
Department:  OB-GYN: GYNECOLOGY
Email:   
233562@bcm.edu
Center:  
Mail Stn:  
Name:  
LINDA ALPUING RADILLA
Phone:  
Id: 
238014
Fax:  
Department:  OB-GYN: ADMINISTRATIVE
Email:   
u238014@bcm.edu
Center:  
Mail Stn:  
A5.  Funding Source:
Organization:  NATIONAL INSTITUTES OF HEALTH (NIH)
A6a.  Institution(s) where work will be performed:
BCM: Baylor College of Medicine
HCHD: Harris County Hospital District Ben Taub
TCH: Texas Children's Hospital
Texas Children's Hospital- Women's Pavilion
A6b.  Research conducted outside of the United States:
Country: 
Facility/Institution:  
Contact/Investigator:  
Phone Number: 
If documentation of assurances has not been sent to the Office of Research, please explain:
A7.  Research Category:
A8. Therapeutic Intent
Does this trial have therapeutic intent?
Yes
A9. ClinicalTrials.gov Registration
Does this protocol/trial require registration on ClinicalTrials.gov due to it: meeting the definition of an Applicable Clinical
Trial, being required under the terms and conditions of an award, or being proposed to be published in ICMJE journals?
Yes
Who will be responsible for registering and maintaining the registration of this Applicable Clinical Trial?
The BCM PI will register the trial because either:
-   the trial is BCM PI-initiated,
-   BCM is the lead site of this multicenter trial, or,
-   the industry sponsor has instructed the BCM PI to register the trial, or,
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-   registration of this trail is required as a term and condition of the reward by the funding agency.
ClinicalTrials.gov Identifier:
NCT04807387
Section B:  Exempt Request
B.  Exempt From IRB Review
Not Applicable
Section C:  Background Information
There is an Urgent Need for a Commercially-Available Vaginal Stents. As many as 50,000 patients per year in North
America require the surgical reconstruction of a new vaginal canal [1]. The success of this procedure is dependent how
well the vaginal tissues are kept from apposing one another during the post-surgical period [1]. Currently, there are no
effective methods to maintain the separation of vaginal tissues vaginal reconstruction. A vaginal stent is a medical
device with an inner rigid core surrounded by an inflatable balloon that is placed into the vaginal canal postoperatively
such that the vaginal walls do not appose each other during the healing process. The importance of efficacious vaginal
stents in the success of neo-vaginal creation in post-adolescent populations cannot be overstated; if the new vaginal
canal does not maintain its patency while the tissues heal, postoperative complications may occur. The most common
complication after vaginal reconstruction is restenosis and scar tissue formation, which can occur in up to 73% of
patients, necessitating persistent perineal dilatation using vaginal dilators after surgery in order to maintain the caliber
of the neo-vagina [2] in order to maintain the ideal vaginal structure (such as ideal length) and to avoid expensive and
unpleasant surgical revisions.
For adult women undergoing surgery or gynecologic cancer treatments, the effects on vaginal length and quality of life
are significant. About 19% of women after hysterectomy alone experience substantial vaginal length reduction and
more than 100,000 women per year in the United States seek treatment for vaginal foreshortening causing
dyspareunia [3,6]. After pelvic surgery and/or pelvic radiation for treatment of gynecologic cancers, up to 88% of
women will develop significant vaginal stenosis with shortening, scarring with narrowing of the vagina leading to
dyspareunia, tissue friability, and vaginal bleeding and pain [4,5]. Sexual dysfunction can be as high as 33% in women
undergoing radiation therapy and quality of life for these women can be compromised [6]. Significant vaginal scarring
may occur in 1/70 women due to dermatological diseases such as lichen sclerosis [10]. The only method to maintain
the vaginal caliber postradiation is with the use of vaginal dilators after radiation treatments have concluded. Despite
the vital role perineal dilation plays in restoring normal vaginal function, and in maintaining quality of life, adherence to
the recommended dilation regimes is consistently low, with less than 50% of females using dilators at the
recommended frequency, and as many as 75% stopping the use of the dilator within a year [11]. A vaginal stent placed
after radiation treatments may maintain the vaginal caliber, reduce post-radiation fibrosis, and eliminate the need for
perineal dilatation. Thus the role of vaginal stents for successful outcomes after neovaginal surgery and post-radiation
is even more clear.
Post-operative difficulties with healing are even more problematic in the pediatric population, due to the simple fact that
no commercially-available vaginal stent has ever existed for adolescents to prevent the need for difficult and
unpleasant dilation regimes which show low patient adherence. Recent increases in malformations such as specific
congenital genitourinary anomalies [12], and a societal shift towards better acceptance of male-to-female transgender
surgeries have led to a surge in the number of surgeries for neo-vaginal creation in girls and young women. There are
as many as 50,000 girls per year and 213,000 women per year who could benefit from postoperative treatment using
newly designed vaginal stents [1,3]. Extensive scar tissue formation in the vagina, vaginal restenosis and vaginal
foreshortening can have profound effects on young girls and women. As in the post-radiation population, the need for
persistent dilatation post-surgery can lead to early discontinuation due to noncompliance or to significant complications
including vaginal bleeding or even perforation of the vagina or bladder and fistula formation [4]. Many pediatric surgical
centers quote a risk of surgical revision after vaginal reconstruction to be about 50% [5].
The availability of a vaginal stent for the pediatric and post-radiation populations offers unimaginable benefits: by
reducing the need for perineal dilation, vaginal stents offer the promise of a reduction in vaginal scar tissue formation,
in post-surgical and post-radiation morbidity, surgical revisions, lifelong perineal dilatation, and improvement in sexual
function. Together, the improvements to the quality of life of these populations would yield physical and psychological
benefits for both patients and families as well as significant health care cost savings.
Current Vaginal Stents are hand-crafted and outcomes are poor. In adolescent populations, hand-crafted, ill-fitting
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vaginal stents are routinely placed via a number of procedures which can vary enormously by indication. Some
inpatient procedures require stays in hospital with a tractioned vaginal stent for up to 5 days. These patients then wear
a stent intermittently thereafter for up to 4 weeks depending on vaginal healing. Outpatient procedures may require use
of a vaginal stent intermittently for up to two weeks. Patients are currently required to be able to remove and reinsert
the vaginal stent themselves at home (usually same stent that is washed and re-used). However, due to the relative
non-existence of a commercially available product, physicians are relegated to creating their own makeshift stents for
their gynecology patients either using finger slots from sterile gloves and gauze, sterile cement coated in bone wax and
placed in a condom, or plastic moulding. All of these are suboptimal options with resultant low patient compliance,
stent egress and emergency room hospital visits for replacements, and poor patient outcomes.
Adult vaginal stents used to exist (Mentor Stent, Coloplast, Inc.), and were sold up until 2010 by Coloplast, when
despite enormous benefits to patients, these devices were withdrawn due to financial and legal issues surrounding an
entirely different device made by the same company. Coloplast had previously acquired Mentor's urogynecologic line
that included vaginal stents, and discontinued the product after massive recalls on their breast implants due to safety
issues and it was never replaced. A new company PMT corporation has recently begun selling the previous Mentor
Stents with no design changes. Both the Mentor stent and makeshift devices frequently fall out, and are associated
with a high numbers of complaints regarding their discomfort. Many patients require their labia sutured around the stent
in order to retain it. Despite being one of the only ways to prevent the need for perineal dilation and subsequent
surgical revision, difficulties with these devices lead to low patient compliance. More concerning, there has never been
a vaginal stent designed for, and tested on a pediatric population. This population is left vulnerable to effects of being
forced to rely on procedures such as perineal dilation for good outcomes. The need to help these patients and their
physicians with a simple device that can improve both surgical outcomes and patient quality of life beyond surgery
cannot be overstated. Similarly, the commercial potential for this project to lead to marketable product is significant as
there is pent up demand for this product. This along with the larger commercial markets outlined in the
commercialization plan, and the experience of this team in bringing novel products to market, greatly increase the
chances for commercial success.
A Predicate Device for Stents in Pediatrics. We have assembled a unique team of engineers, commercialization
experts, and clinicians, representing the first group, to our knowledge, to design a vaginal stent system that addresses
the anatomic needs of the pediatric patients, and could be expanded to use in a much larger post-gynecologic cancer
patient population. Members of our team, as well as those of our outside advisory board of pediatric gynecology and
gynecologic oncology experts have strong confidence in the potential of our device to eliminate post-surgical stricture,
facilitate physician procedures, and reduce early discontinuation in patients. Our work supporting this premise will be
presented at the 2021 North American Society for Pediatric Adolescent Gynecology (NASPAG) Annual Clinical
Meeting, and published in their conference literature. Our group, at this time, is on the cusp of improving outcomes for
tens of thousands of girls every year undergoing vaginal surgery and those women undergoing radiation treatments.
Now is the time to move this project forward and optimize the stent design and complete steps required for
commercialization so it can reach patient populations as soon as possible, reducing the need for dilation and / or
surgical revision in females who have undergone neovaginal surgery or radiation treatments.
(Works cited and copy of NIH grant submission are attached in Section S.)
Section D:  Purpose and Objectives
This proposal seeks to develop a production-ready novel vaginal stent specifically designed to improve postsurgical
outcomes with regard to restenosis for girls who have undergone neo-vaginal creation and for women who have
undergone pelvic surgery or radiation due to gynecologic cancer treatment. In our Phase I project we designed, built,
and tested multiple configurations of our stent design, performed bench-top testing in anatomical models and excised
porcine tissue using our stent prototypes, and evaluated the performance of the vaginal stent prototypes in vivo in a
porcine animal model. In this Phase II project, we will refine the current device into a final clinically-ready format, test
usability factors in a population of healthy volunteers, and finally evaluate its use in a broad cohort of our target clinical
populations. The end result of this effort will be a new clinical instrument specifically designed for maintenance of the
vaginal caliber after surgery and/or pelvic radiation.
Specific Aim I: Finalize design for a clinical-ready version of our vaginal stent system and perform preliminary
verification and validation testing.
1a: Optimize the stent design. Biotex engineers will integrate our current prototype designs into two different inflatable
configurations which cover desired diameters and length ranges. Efficacy of our vaginal stent is shown by its retention
in the vaginal canal for 2 weeks. We will work closely with clinical collaborators to refine our stent designs as well as
insertion and retrieval tools with the goal to finalize stent materials, size ranges, and factors which will improve patient
compliance with stent use.
1b: Completion of product testing required for FDA submission and commercialization. Vital steps towards enabling
product distribution include performing required validation activities (biocompatibility, sterilization, packaging,
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performance testing) for FDA 510(k) submission. After finalization of stent designs, product development engineers will
develop protocols under design controls, manage production of final units, and execute required testing.
Specific Aim II: Examine the acceptance and success of our novel vaginal stent in healthy (non- clinical) subjects.
Accruing clinical samples large enough for both development and testing can be prohibitive due to the low numbers of
adolescent patients at any one institution requiring neovaginal surgery. In addition, clinical samples a can be
heterogenous on key variables which may relate to the success of our stent, such as age,maturity, or comorbid
conditions. Therefore, we will conduct aim 2 in a non-clinical population.
2: Quantify key factors to better understand stent efficacy. In 20 non-clinical volunteers, we will associate factors such
as design, pull-out forces, comfort, and inflation/ deflation / retrieval ergonomics with stent retention.
Specific Aim III: Evaluate the success of our vaginal stent in a broad cohort of clinical subjects. After establishing the
regulatory (aim 1), practical (aims 1 and 2) and patient factors (aim 2), we will use this information to inform the
protocol of our pseudo-clinical trial in aim 3.
3a: Demonstrate vaginal stent retention in the vaginal canal for two weeks in a clinical population. In 10 post-surgical
patients and 10 post-radiation adult women, the efficacy of our novel vaginal stent will be demonstrated both through
lack of egress and through patient compliance to using the device.
3b: Demonstrate that retention of our novel vaginal stent in the vaginal canal is superior to that of existing makeshift /
handmade vaginal stents.
By leveraging the unique medical database available at our institutions (Texas Children's Hospital and Baylor College
of Medicine), we will demonstrate success of our new vaginal stent by comparing the number of vaginal stents still in
place at a 2-week post-surgical follow-up in neovaginal surgery.
Section E:  Protocol Risks/Subjects
E1.  Risk Category
Category 2: Research involving greater than minimal risk, but presenting the prospect of direct benefit to the individual
subjects.
E2.  Subjects
Gender:
Female
Age:
Adolescent (13-17 yrs), Adult (18-64 yrs)
Ethnicity:
All Ethnicities
Primary Language:
English, Spanish
Groups to be recruited will include:
Both patients and healthy, non-patient, normals
Which if any of the following vulnerable populations will be recruited as subjects?
Children
Vulnerable populations require special protections.  How will you obtain informed consent, protect subject confidentiality,
and prevent undue coercion?
Informed consent will be obtained by trained research personnel. An initial screening interview via phone will be held,
followed by an invitation to speak with a study coordinator (plus interpreter if needed). The study risks and procedures
will be fully explained, eligibility assessed, and the participants' rights enumerated (including the right to withdraw at
any time). Potential participants will be given time to answer questions. For subjects under age 18, parental consent
and adolescent assent will be obtained prior to participation. Subject confidentiality will be maintained at all times;
phone calls and in-person recruitment will be held in private rooms. All patient information will be kept on a secure,
HIPAA-compliant electronic server or in a locked file cabinet when not in use.
**Please note** The Spanish forms -consent form, recruitment flyers, questionnaires- are being translated as of 2/2/21.
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We will attach these forms when translation is complete.
E3.  Pregnant woman/fetus
Will pregnant women and/or fetuses (as described in 45 CFR 46 Subpart B) be enrolled in the research?
No
E4.  Neonates
Will neonates of uncertain viability or nonviable neonates (as described in 45 CFR 46 Subpart B) be enrolled in the
research?
No
E5.  Children
Will children be enrolled in the research?
Yes
Section F:  Design/Procedure
F1.  Design
Select one category that most adequately describes your research:
k) Device, Phase II, Single Center
Discuss the research design including but not limited to such issues as: probability of group assignment, potential for
subject to be randomized to placebo group, use of control subjects, etc.
This is a non-randomized clinical trial of healthy and patient cohorts, females ages 13-64 years will be recruited into
different groups. 20 healthy participants (ages between 13-64 years) will be recruited initially to try wearing 2 stents
separately for 24 hours each, provide feedback, then wear the preferred stent for 2 weeks. Subsequently, 20 patient
participants, 10 post-surgical adolescent patients and 10 post-radiation adult patients, will be recruited to wear the
stent for 2 or 4 weeks, respectively. Neither healthy nor patient participant will be randomized. (Procedure details in
section F2.) A control cohort will not be recruited; rather, within-group outcomes will be measured. The adolescent
versus adult female patient outcomes will also be compared.
Physician participants will be asked to complete a post-stent questionnaire which will evaluate the level of difficulty with
stent insertion and removal.
Inclusion Criteria:
Healthy volunteers: (a) female between 13-64 years of age, (b) not currently pregnant, (c) if under age 18, parents
must be able to give informed consent and volunteer must give informed assent, (d) ability to understand the
requirements of the study and abide by the restrictions, (e) ability to travel to Houston for study evaluations, (f) ability to
understand English or Spanish to a grade 5 level, (g) no history of prior vaginal surgery or radiation.
Patient volunteers: (a) adolescent female patients, ages 13-18 undergoing vaginal reconstructive surgery at high risk
for vaginal fibrosis including those with transverse vaginal septa, vaginal atresia, or post-radiation, (b) adult female
patients undergoing vaginal brachytherapy for cancer at high risk of vaginal fibrosis, (c) not currently pregnant, (d)
ability to give informed consent (If patient is under age 18, must be able to give informed assent with parent consent),
(e) ability to understand the requirements of the study and abide by the restrictions, (f) ability to travel to Houston for
study evaluations, (g) ability to understand English or Spanish to a grade 5 level.
Physician volunteers: Physicians who oversee the patient volunteers and deploy the current vaginal stent post
surgery/post radiation will be asked to complete a Physician Post-Stent Questionnaire (attached to Section S).
Exclusion Criteria:
All volunteers: (a) Non-English or Spanish language (b) pregnant patients (c) women with BMI >45 (d) women with
prior vaginal surgeries (e) women with comorbid conditions such as diabetic neuropathy or other conditions limiting use
of hands for stent removal, vaginismus, urinary retention, bacterial or fungal infections, allergies to stent material such
as silicone, seizure disorder. (f) in healthy participants only: any pain with sexual intercourse or tampon insertion. in
post-surgical and post-radiation participants: pain >5 on a 10 pt Likert Scale with sexual intercourse or tampon
insertion
F2.  Procedure
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This study has 3 phases. Phase 1: 20 healthy volunteers to determine the better of 2 stents, based on highest retention
and comfort. Phase 2: the same 20 healthy volunteers will wear the stent for 2 weeks to evaluate retention and
comfort. Phase 3: 20 patient volunteers (adolescent females after surgery and adult females after radiation treatment)
will evaluate stent on same criteria. During all phases, the option of obtaining vaginal pressure measurements will be
available. For pressure measurements, a pressure gauge will be attached to the end of the stent, outside of the vagina,
and the pressure between the stent and vagina will be measured as the participant lies, stands, squats, walks around
the clinical room, and intentionally exerts downward pressure in the vaginal cavity. The pressure will be measured for 1
minute during each activity, after which the pressure gauge will be removed.
Phase 1: 20 Healthy volunteers will be recruited through flyers placed at hospitals, research institutions, and device
accelerators within TMC, the study recruitment pages of BCM website, and through the electronic BCM and TCH
newsletters. Social media will be used to promote the study with a direct link to the BCM recruitment page. All
comments and replies will be disable and no PHI will be obtained or discussed via social media. (See Section S).
Following an initial screening call with research personnel, eligible participants will be invited to TCH for orientation and
to obtain consent by a study coordinator (interpreter if needed). Participants will then undergo a urine pregnancy test,
vaginal assessment via visual exam, speculum, or colposcopy to assess vaginal mucosa and a vaginal swab to rule
out presence of bacterial or fungal infections. Physicians will complete the Vaginal Assessment Form (VAF).
Participants will complete a Pre-Stent Questionnaire to establish any vaginal baselines that may effect stent
performance and a trained clinician will insert one of two stents. Instructions will be reiterated to the participant. After
24 hours, the participant will return to the clinic and the clinician will remove the stent. A vaginal exam and culture will
be performed to ensure the tissue is intact and the participant did not experience any unexpected adverse events (AE).
The participant will complete a Phase I Questionnaire and the clinician will complete VAF. The participant will return 24
hours later for a vaginal exam and culture, the clinician will insert the second stent, and the patient instructions will be
reiterated. The participant will wear the second stent for 24 hours, return to clinic for removal, exam, and culture and
both clinician and participant will complete the same questionnaires.
Phase 2: Based on feedback from all participants in this healthy cohort, the stent with the highest retention and
comfort/acceptability ratings will subsequently be worn by all volunteers for 2 weeks. Vaginal exam, culture, urinalysis,
and pregnancy test will occur prior to stent placement. Participants will be sent a secure link to complete a daily Phase
II Questionnaire. Participants in this healthy cohort will return to the clinic for a final visit after 2 weeks to have the stent
removed by a clinician and have a vaginal exam and culture. The participant will complete a Phase II Questionnaire
and clinician will complete VAF. One additional follow up Phase II Questionnaire one day after stent removal.
If we sense low success, or increased AEs (see section H) based on feedback from participants and clinicians, we will
continue to optimize design for the vaginal stent system. The results of from healthy volunteers will help us understand
factors which may alter the success rate of stent placement in our patient volunteers. We will also generate data for
future studies aimed at increased adherence to vaginal stent retention, elimination of need for future vaginal dilatation,
and reduction in vaginal fibrosis.
Phase 3: 20 patient participants ("patients") will subsequently be enrolled into the following groups: a) 20 adolescent
female patients who will undergo reconstructive gynecologic surgery, and b) 10 adult female patients who will complete
vaginal brachytherapy treatment. Patients will be recruited from the principal investigator's department adolescent
patient population at TCH and in an adult gynecology oncology collaborator's patient population at Ben Taub Hospital.
Flyers will be posted in general waiting areas at the Obstetrics and Gynecology clinics. Eligibility assessments and
informed consent/assent will be obtained on an individual patient timeline prior to enrollment. The sterilization process
for vaginal stents will occur prior to using the devices in the patient population.
a) Post-Surgical Adolescent Patients: Subjects will complete Pre-Stent Questionnaire. Prior to surgery, patients will
undergo standard of care (SOC) testing including urine pregnancy and infection screening. The vaginal canal and
mucosa will be assessed while in the operating room by vaginoscopy and a vaginal culture collected to rule out
preoperative infection and vaginal length measurement. Vaginal surgery will be carried out per indication. A sterilized,
vaginal stent will be placed postoperatively in the operating room, and instructions given to patients prior to discharge.
Patients will continue to wear the vaginal stent for two weeks without removal and complete daily questionnaire on
retention and comfort.
At 2 weeks post-surgery, patients will complete evaluation of the stent including tolerability, ease of use, comfort,
reasons for early discontinuation, as well as any vaginal symptoms such as pain, bleeding or other AE. They will then
be reassessed in the operating room (SOC) for stent removal, vaginal length measurement, vaginal culture, urinalysis,
evaluation of the vaginal mucosa via vaginoscopy to assess for adhesions, granulation tissue, stricture, and remaining
septal tissue. Physicians will complete the VAF.
Subsequent Visits: Patient participants will be re-evaluated at 4 and 6 weeks and 3, 6, and 12 months postop in the
clinic. This visit frequency is considered SOC for adolescents who are postop from vaginal reconstructive surgery.
Measured outcomes will include possible pain, bleeding, painful intercourse at 3 months postop, difficulty with tampon
insertion, menstrual fluid retention, need for vaginal dilators. A physical exam will also be completed including a single
digit vaginal exam to evaluate stricture, granulation tissue and adhesions. Patients may also be asked to demonstrate
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placement of the vaginal stent (used as a corollary to adequate and maintained vaginal caliber).
b) Adult Females, Post-Radiation: Post-radiation vaginal fibrosis occurs more slowly than post-surgical fibrosis and
these women do not have post-surgical wounds, so we expect the adult post-radiation patient population to be able to
wear the vaginal stent continuously for two weeks and then for an additional 2 weeks. Following consent adult patients
undergoing vaginal brachytherapy treatments, will complete Pre-Stent Questionnaire and the vaginal stent will be
placed by Dr. Anthony Costales or another co-investigator physician at the conclusion of their final brachytherapy
treatment. Prior to stent placement, the vaginal canal and mucosa will be assessed by speculum exam, vaginal culture,
urine pregnancy test, and urinalysis will be obtained and the physician will complete the VAF. Instructions will be given
to the patients prior to discharge. If the participant is at a high risk for tissue erosion, per physician discretion, she will
be prescribed a topical vaginal estrogen (e.g. Premarin cream or Repagyn hyaluronic acid gel). It is SOC to prescribe
vaginal estrogen to current patients with vaginal stents or pessaries who are at higher risk for tissue erosion (e.g. post-
menopausal patients); thus, use of the cream or gel in the current study is not experimental. Participants will be sent a
secure link to complete a daily questionnaire on retention and comfort.
Evaluation at 2 and 4 weeks: Patients will be examined in clinic by a physician co-investigator at 2 weeks post-stent
placement. At the time of assessment, patients will complete evaluation surveys on the vaginal stent as well vaginal
symptoms such as pain or bleeding. The vaginal stent will be removed and the vaginal cavity will be assessed by a
physician for any adhesions, granulation tissue, stricture, fibrosis, necrosis by speculum exam and vaginal culture.
Vaginal length will be measured. Physicians will also rate ease of stent removal and complete VAF for each patient.
Any patient-reported symptoms will be documented. At 2 weeks, if no AEs are reported, vaginal stent will be replaced
by a physician for an additional two weeks of use. If AEs are reported, clinical decisions regarding continued use of
stent will be made. Participants will be sent a secure link to complete a daily survey. If no AE seen in first three
patients, clinician may determine two week follow up is not necessary and patients can wear stent for four weeks
continuously.
Subsequent Visits: Adult patients will be re-evaluated 3, 6, and 12 months as SOC. Patients will complete
questionnaires regarding vaginal symptoms at each clinical visit as described above for adolescents. Physicians will
complete the VAF regarding ease of instruction, placement, improvement over standard of care, overall utility for the
stent system, and any complications. Outcomes will include pain, bleeding, painful intercourse at 3 months postop,
difficulty with tampon insertion, menstrual fluid retention, and need for vaginal dilators. A physical exam will also be
completed including a single digit vaginal exam to evaluate stricture, granulation tissue and adhesions. Patients may
be be asked to demonstrate placement of the vaginal stent (used as a corollary to adequate and maintained vaginal
caliber).
AE monitoring: Participants will be informed about the potential for AEs at the screening call, first clinic visit, and at the
visit for insertion of subsequent stents. Participants will be asked to report all AEs via a study phone line. A Data Safety
Monitoring Board consisting of an independent investigator recruited from BCM clinical faculty will take responsibility
for ensuring that all AEs are reported to the IRB at BCM, in accordance with their standard procedures. In the event of
a severe AE (infection, bleeding, mucosal reaction, or inability to carry out Activities of Daily Living), the Board member
and representatives from the BCM IRB will meet and discuss mitigation plans and plans for the study future. We
anticipate that stopping criteria will include severe AEs in 20% of subjects. Data Safety Monitoring Plan is attached to
Section S. Materials- Each vaginal stent system will be individually packaged. Healthy females will receive devices that
are sanitary (akin to the cleanliness of a tampon) that have been swabbed with alcohol or other compatible solutions.
Devices prepared for the patient population will undergo a 66-hour, costly sterilization process due to the vulnerability
of the vaginal tissue after surgery and radiation treatment. The stent size most appropriate to the patients' age and
approximate vaginal canal dimensions will be selected. Testing will be monitored by a physician at all stages of the
project. All stents will be discarded after single use.
Participant feedback - Participants will be given questionnaires, via RedCap, with questions related to baseline vaginal
metrics, stent comfort (during insertion, wear, removal), retention, ability to carry out normal Activities of Daily Living,
and any AEs. At all points of instruction during clinic visits, patients will be given ample time to ask questions and voice
concerns. A research coordinator or clinician will be available via phone for patient questions.
Section G:  Sample Size/Data Analysis
G1.  Sample Size
How many subjects (or specimens, or charts) will be used in this study?
Local: 40              Worldwide: 40
Please indicate why you chose the sample size proposed:
As a feasibility study, the low recruitment numbers will be used to evaluate the design concept with respect to
functionality, comfort and any unforeseen safety issues (beyond those which were accounted for in earlier stages of the
product design). The current participants will guide additional device refinements.
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G2.  Data Analysis
Provide a description of your plan for data analysis. State the types of comparisons you plan (e.g. comparison of means,
comparison of proportions, regressions, analysis of variance). Which is the PRIMARY comparison/analysis? How will the
analyses proposed relate to the primary purposes of your study?
Exploratory analyses of 20 healthy community participants: We code the stent as successful if, after 2 weeks, it has
been retained in the vaginal canal. We will tentatively explore predictors of success using binomial logistic regression
models, with a log-link estimator, which specify success (retained / not retained) as the outcome and participant group
(under 18/over 18), and presence of bacterial / fungal infection at baseline and followup as three separate models. We
will also run exploratory binomial logistic regression models, as above, with comfort, acceptability, ability to carry out
normal Activities of Daily Living (ADLs), and number of AEs as outcomes, and participant group as the predictor. To
maximize power, and recognize the exploratory nature of these analyses, we will not correct for multiple testing.
Analyses of 20 clinical patient participants: Initial analyses will compare the two patient groups on baseline
characteristics (vaginal cavity assessments by physicians and patient and physician questionnaires) using two sample
t-tests, specifying patient group as the predictor. T-tests were selected for the robust to non-normal distributions with
small sample sizes, and their suitability to small sample sizes as low as four per group (ref: york.ac.uk/depts/maths
/histstat/student.pdf). Our main analyses will examine whether the stent was successful in our population (ie.
examining whether the proportion of retained stents was significantly different from zero). A one-sample t-test will be
run, with success (returned at 2 weeks coded as 1, not retained coded as 0) as the independent variable. Significance
will be set at P<.05.
All analyses will be conducted in the latest version of R (version 5.1.2).
Section H:  Potential Risks/Discomforts
H1.  Potential Risks/Discomforts
Describe and assess any potential risks/discomforts; (physical, psychological, social, legal, or other) and assess the
likelihood and seriousness of such risks:
The participant may experience mild discomfort while using the stent. A thorough vaginal assessment will be
performed by a clinician immediately after insertion to assess for any discomfort outside of normal range.
The likelihood of adverse events is small but could include bleeding, displacement of the stent such as egress, urinary
retention, mucosal irritation, tearing, erosion, abscess, granulation tissue, or infection. The principal investigator will
likely stop the trial for persistent displacement (>5), tearing or erosion of tissue, or abscess. The principal investigator
will likely pause the trial and assess for further detail in instances of urinary retention, mucosal irritation, granulation
tissue, or infection.
More severe outcomes, however unlikely, include tearing of the mucosal lining, infection, irritation, urinary retention,
bleeding, or formation of granulation tissue around the stent. The most severe outcomes include vaginal tearing and
formation of a fistula (abnormal connection between two structures). Symptoms of a vaginal infection may include
yellow/green vaginal discharge, vaginal pain, fevers, or abdominal pain. Symptoms of urinary retention may include
inability to empty the bladder or pelvic pain. Symptoms of vaginal tearing or granulation tissue formation in the vagina
may include unexpected vaginal bleeding or vaginal pain. Symptoms of a vaginal fistula may include passage of urine
or feces from the vaginal cavity as well as fevers or pelvic and vaginal pain. These outcomes are highly unlikely and
we do not expect them to occur. Please reference attachment "Adverse Event Grading Chart".
A clinician or study nurse will be available at all times via phone for additional participant questions or concerns.
H2.  Data and safety monitoring plan
    Do the study activities impart greater than minimal risk to subjects?
     Yes
NOTE:  The answer to the questions in H2 requires the completion of the form: 'Section H – Data and Safety
Monitoring Plan' as an attachment in Section S.
H3.  Coordination of information among sites for multi-site research
Is the BCM Principal Investigator acting as the SPONSOR-INVESTIGATOR for this multi-site research?
     No or Not Applicable
Is BCM the COORDINATING CENTER for this multi-site research?
     No or Not Applicable
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Section I:  Potential Benefits
Describe potential benefit(s) to be gained by the individual subject as a result of participating in the planned work.
There are no direct benefits from participating as a healthy volunteer. Clinical patients may benefit from a reduced
likelihood of restenosis, additional surgeries, and scarring.
Describe potential benefit(s) to society of the planned work.
Benefits to society include improved post-surgical outcomes for females after pelvic surgery or radiation due to
gynecologic cancer treatment. Increased comfort and effectiveness will increase adherence to wearing the stent, which
will reduce the likelihood of restenosis, perineal dilation, surgical revision, and scarring. Sexual function is likely to
improve. Overall, the improvements to quality of life will yield physical and psychological benefits for both patients and
families, as well as significant health care cost savings.
Do anticipated benefits outweigh potential risks? Discuss the risk-to-benefit ratio.
Due to the unforeseen likelihood of experiencing an adverse event, compared to the potential to permanently improve
the quality of life in young women after gynecologic revisions and gynecologic cancer populations, the anticipated
benefits outweigh potential risks.
Section J:  Consent Procedures
J1.  Waiver of Consent
Will any portion of this research require a waiver of consent and authorization?
No
J1a.  Waiver of requirement for written documentation of Consent
Will this research require a waiver of the requirement for written documentation of informed consent?
Yes
Explain how the research involves no more than minimal risk to the participants, and the specifics demonstrating that the
research does not involve procedures for which written consent is normally required outside of the research context.
The waiver for written documentation of consent applies to physicians who will complete a vaginal assessment form.
The form includes a cover letter (attached to Section S), indicating that completing any portion of the survey evidences
their desire to participate in the study. Participating poses no more than minimal risk and will not affect their
employment status in any way. Physician participant names will not be disclosed to anyone outside of the research
team. Their responses will be kept confidential and reported only in aggregate, de-identified form.
J2.  Consent Procedures
Who will recruit subjects for this study?
PI
PI's staff
Describe how research population will be identified, recruitment procedures, any waiting period between informing the
prospective participant and obtaining consent, steps taken to minimize the possibility of coercion or undue influence and
consent procedures in detail.
Potential participants will be recruited through flyers placed at hospitals, research institutions, and device accelerators
within the Texas Medical Center, via the study recruitment pages of the BCM website, and through the electronic BCM
and TCH newsletters. Flyers will also be sent to BCM graduate students, post docs, and medical students through list
respective list servs. (See flyers in Section S.) Additional flyers may be placed on local college campuses. No
individual will be allowed to participate that is or may be graded or trained by any co-investigator. Interested
participants will be invited to speak to a study coordinator (plus an interpreter if needed). (However, no Spanish
speaking individuals will be consented in the research until all applicable English documents - informed consent form,
flyers, questionnaires- are translated into Spanish and submitted to the IRB via an amendment.) Interested participants
will be provided a copy of the current informed consent document either via email or in the clinic prior to consenting in
order to allow adequate time to review before the first appointment.
The meeting with the study coordinator will be held in a private room within the TCH Clinical Research Center or
Pavilion for Women or Ben Taub Hospital. At that time, the study risks and procedures will be fully explained, eligibility
assessed, and the participant's rights (including the right to withdraw at any time) enumerated. Eligibility will be
determined by the inclusion and exclusion criteria described in Section F1. The study coordinator will review the criteria
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with interested participants to determine eligibility. If eligible, the study coordinator will review the consent form and
reiterate items related to study objectives, procedures, risks, benefits, compensation, and participant rights. Adequate
time will be given for any questions the potential participant may have. The potential participant will have the option of
signing the consent form at that time, declining participation, or returning at a later date to provide consent.
Are foreign language consent forms required for this protocol?
Yes
Which of the following ways will you document informed consent in languages other than English?
A full-length informed consent document
J3.  Privacy and Intrusiveness
Will the research involve observation or intrusion in situations where the subjects would normally have an expectation of
privacy?
No
J4.  Children
Will children be enrolled in the research?
Yes
J5.  Neonates
Will non-viable neonates or neonates of uncertain viability be involved in research?
No
J6.  Consent Capacity - Adults who lack capacity
Will Adult subjects who lack the capacity to give informed consent be enrolled in the research?
No
J7.  Prisoners
Will Prisoners be enrolled in the research?
No
Section K:  Research Related Health Information and Confidentiality
Will research data include identifiable subject information?
Yes
Information from health records such as diagnoses, progress notes, medications, lab or radiology findings, etc.
Yes
Specific information concerning alcohol abuse:
No
Specific information concerning drug abuse:
No
Specific information concerning sickle cell anemia:
No
Specific information concerning HIV:
No
Specific information concerning psychiatry notes:
No
Demographic information (name, D.O.B., age, gender, race, etc.):
Yes
Full Social Security #:
Yes
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Partial Social Security # (Last four digits):
No
Billing or financial records:
No
Photographs, videotapes, and/or audiotapes of you:
No
Identifiable biospecimens
No
Other:
No
At what institution will the physical research data be kept?
Records will be kept in a secure area at in locked credenzas or investigator offices at Texas Children's Hospital and
Baylor College of Medicine. Minimal physical research data will be collected.
How will such physical research data be secured?
Data will be accessed, used, disclosed, and/or extracted and kept in a locked cabinet in or adjacent to investigator
offices at Texas Children's Hospital and Baylor College of Medicine. The records will be located in personnel-restricted
floors and accessible only to research personnel.
At what institution will the electronic research data be kept?
Electronic research data will be maintained by secure, institutional server or using a secured, cloud-based services at
all times. Research personnel will store all research-related data in a secure manner.
Such electronic research data will be secured via BCM IT Services- provided secured network storage of electronic
research data (Non-Portable devices only):
Yes
Such electronic research data will be secured via Other:
No
Will there be anyone besides the PI, the study staff, the IRB and the sponsor, who will have access to identifiable research
data?
No
Please describe the methods of transmission of any research data (including PHI, sensitive, and non-sensitive data) to
sponsors and/or collaborators.
N/A
Will you obtain a Certificate of Confidentiality for this study?
No
Please further discuss any potential confidentiality issues related to this study.
N/A
Section L:  Cost/Payment
Delineate clinical procedures from research procedures. Will subject's insurance (or subject) be responsible for research
related costs? If so state for which items subject's insurance (or subject) will be responsible (surgery, device, drugs, etc). If
appropriate, discuss the availability of financial counseling.
The cost of the device and any service that is strictly research related (i.e. stent insertion, removal, study
questionnaires) and outside of the normal standard of care for post-surgical or post radiation treatment will be covered
by the research study. However, any clinic fees, procedures, or labs done as part of standard of care (i.e. as part of
normal, post-surgical or post-treatment clinical follow-up) will not be covered by the research study. Services provided
as part of standard of care will be billed to the subject's insurance.
All direct costs associated with the healthy volunteers participation will be covered by the study.
Services outside of standard of care for each patient participant group include the following:
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1. Adolescent patients: - pre-operative urine analysis and vaginal culture in operating room - at 2 weeks postoperative
evaluation: vaginal culture in operating room at stent removal
2. Radiation patients:  - Prior to stent placement: physician vaginal assessment exam, vaginal culture, urine analysis,
pregnancy test, vaginal length measurement - Evaluation at 2 weeks post stent placement: physician vaginal
examination, vaginal length measurement, vaginal culture
If subjects will be paid (money, gift certificates, coupons, etc.) to participate in this research project, please note the total
dollar amount (or dollar value amount) and distribution plan (one payment, pro-rated payment, paid upon completion, etc)
of the payment.
Dollar Amount:
600
Distribution Plan:
Healthy participants will be compensated fairly for their time and parking. Healthy participants will be compensated
$250 for the first phase of the study (5 clinic visits, including orientation, vaginal exam/labs, insertion/removal of 2
separate stents which will be worn for 24 hrs each, questionnaires), and $350 for the second phase of the study (3
clinic visits, vaginal exam/labs, and wearing 1 stent for 2 weeks, daily questionnaires). They will incur no cost to
themselves or their insurance for participation. Vaginal exams, device, and lab fees will be paid for by the research
study.
Healthy participants will be issued a ClinCard Prepaid Mastercard at the time of consent. Compensation amounts will
be distributed electronically to the participant's ClinCard number upon completing clinic visits and/or surveys.The
participant will be notified via email or text when the card is reloaded with additional funds.
Patient participants will not receive monetary compensation.
Section M:  Genetics
How would you classify your genetic study?
Discuss the potential for psychological, social, and/or physical harm subsequent to participation in this research. Please
discuss, considering the following areas: risks to privacy, confidentiality, insurability, employability, immigration status,
paternity status, educational opportunities, or social stigma.
Will subjects be offered any type of genetic education or counseling, and if so, who will provide the education or
counseling and under what conditions will it be provided? If there is the possibility that a family's pedigree will be
presented or published, please describe how you will protect family member's confidentiality?
Section N:  Sample Collection
SAMPLE:  Urine
What is the purpose of the sample collection?
To determine pre-stent infection and pregnancy. This is standard of care for pre-operative adolescent patients.
For blood draws, specify the amount drawn, in teaspoons, at each visit and across the course of the subjects entire
participation time.
Is there the possibility that cell lines will be developed with this sample?No
Sample will be obtained from:
Pathology
Will the sample be stripped of identifiers?
No
If sample will be released outside the hospital:
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Will sample be released to anyone not listed as an investigator on the protocol? Will the information be identifiable, coded
or de-identified?
no
Will sample material be sold or transferred to any third parties? Will the information be de-identified?
no
If sample will be banked for future use:
Where will the sample be banked and for how long?
sample will not be banked
Does the banking institution have an approved policy for the distribution of samples?
If the entire sample will NOT be used during the course of this research study:
Will the remaining tissue be discarded? If not what will be done with the remaining sample after study completion and how
long will the sample be kept?
Remaining sample will be discarded appropriately
Will samples be made available to the research subject (or his/her medical doctor) for other testing?
No
If a subject withdraws from the study:
Will subject have the option to get the remaining portion of their sample back?
No
Will samples be destroyed? If not, will they be kept anonymously? What will happen to the sample if the subject revokes
authorization?
Remaining sample will be discarded appropriately
Will data obtained from their sample be deleted? What will happen to the sample if the subject revokes authorization?
Data from the sample will not be deleted as long as subject remains on study.
Will study data or test results be recorded in the subject's medical records?
Yes
Will results of specific tests and/or results of the overall study be revealed to the research subject and or his/her doctor?
Yes, subject will be notified of results and instructed to contact primary care physician if needed.
Please identify all third parties, including the subject's physician, to receive the test results.
Section O:  Drug Studies
Does the research involve the use of ANY drug* or biologic? (*A drug is defined as any substance that is used to elicit a
pharmacologic or physiologic response whether it is for treatment or diagnostic purposes)
No
Does the research involve the use of ANY gene transfer agent for human gene transfer research?
No
O1.  Current Drugs
Is this study placebo-controlled?
No
Will the research involve a radioactive drug?
No
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Section P:  Device Studies
    Does this research study involve the use of ANY device?
     Yes
Device 1:  vaginal stent
Section Q:  Consent Form(s)
Vaginal Stent Study in Healthy Participants
Vaginal stent to improve post-surgical outcomes and gynecologic cancer treatment
Section R:  Advertisements
None
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