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. 2023 Aug 7;30(9):947–953. doi: 10.1097/GME.0000000000002223

Tailor-made three-dimensional printing vaginal pessary to treat pelvic organ prolapse: a pilot study

Yi-Hao Lin 1,2, Chor-Kheng Lim 3, Shuenn-Dyh Chang 1,2, Chih-Chien Chiang 4, Chun-Hung Huang 1,2, Ling-Hong Tseng 4
PMCID: PMC10487415  PMID: 37625089

This study demonstrates that a tailor-made 3D pessary can be used for women with pelvic organ prolapse. A customized pessary can be made with the help of transvaginal ultrasound and 3D printing technology.

Key Words: Customized, Pessary, 3D (three-dimensional) printing, 3D scanner, Gellhorn pessary, Pelvic organ prolapse, Pessary, Transvaginal US (ultrasound)

Abstract

Objective

This study aimed to apply three-dimensional (3D) printing technology to treat women with pelvic organ prolapse (POP) and to evaluate efficacy based on the improvement by quality of life (QOL) questionnaires.

Methods

This was a pilot study at a tertiary urogynecology unit in Taiwan. Between January 2021 and June 6, 2021, participants who opted for self-management using Gellhorn pessaries to treat symptomatic POP were enrolled. For each woman, the original Gellhorn pessary was placed into the vagina to restore the prolapsed tissues and under transvaginal ultrasound guided to evaluate the gap which the Gellhorn pessary cannot cover. Otoform (an impression silicone) was used to make a model and have it hooked onto Gellhorn pessary (template). We collected templates and then applied 3D printing to customize the silicone vaginal pessary. All women completed multiple validated QOL questionnaires at baseline and at 3 and 6 months.

Results

Six women completed the study. The QOL questionnaires revealed significant improvements across the board.

Conclusions

Our study demonstrates that a tailor made 3D pessary can be used for women with POP. A customized pessary can be made with the help of transvaginal ultrasound and 3D printing technology.


Pelvic organ prolapse (POP) is a common gynecological condition among aged, postmenopausal, and parous women. It has been estimated that up to 50% of parous women experience some degree of POP.1 Women with POP may have symptoms including vaginal bulging, heaviness, and voiding/defecatory/sexual dysfunction that adversely affect their quality of life. In addition, women with POP are relatively old, usually live alone, and feel embarrassed to talk to someone else about their discomfort.

Pessaries, having been used for thousands of years,2 are offered as a first-line management of advanced prolapse to all women and as the only option for women who are poor surgical candidates. Pessaries are categorized as either supporting or space filling devices. Support pessaries, such as the ring, are generally easier to remove, cause less risk of erosion, and require fewer office visits. Space-filling pessaries, such as the Gellhorn, are reserved for advanced prolapse.3 A high rate of discontinuation was observed within 1 year with 56% of ring pessary users experiencing complications, including bleeding, extrusion, severe vaginal discharge, pain, and constipation.4 However, our data indicated that self-management of the Gellhorn pessary was safe and relatively effective and that it increased participants' autonomy and ability to manage their POP.5

Pessary products on the market have specific sizes to choose from and some women may not be able to find the right size. Each woman presents with unique anatomy, and thus, the effectiveness of commercially available pessaries may be limited by lack of customization. Recently, as a novel technology, 3D (three-dimensional) printing has been widely adopted in various fields of medicine.6 However, the technology has only just begun to branch into the fields of gynecology and obstetrics.712 Stitely et al7 conducted a proof-of-concept study using 3D printing to fabricate a tubing connector for dilation and evacuation in a surgical procedure. Sandrini et al8 reported their experience in 3D printing of fetal models of congenital heart disease derived from microfocus computed tomography. Baek et al9 used a 3D printer to create anatomical replicas of real lesions and tested its application in cervical cancer and then used it to plan and simulate the surgery. Mackey et al10 used a 3D-printed uterine model for surgical planning of a cesarean delivery complicated by multiple myomas and actually showed the model accurately represented the number, size, and locations of uterine myomas, hence improving surgical planning and optimizing outcomes for patients. Garcia de Paredes et al11 also reported two cases that highlight the utility of a 3D printing technique to aid in ex utero intrapartum treatment procedures during cesarean delivery. Nevertheless, only one article addressed the importance of a customized pessary.12 Barsky et al12 reported the successful insertion of a customized 3D-printed pessary in a participant. They thought that this idea was feasible and may extend to patients with anatomy incompatible with commercially available pessaries. We assumed that this issue had not been assessed robustly so we conducted this study to evaluate 3D printing technology in treating women with POP and to evaluate efficacy.

METHODS

This was a pilot study performed at a tertiary referral center and conducted after obtaining institutional review board approval (TYGH109052). All researchers involved in the study agreed to treat the data confidentially in accordance with the General Data Protection Regulation and informed consent was obtained from all participants.

Study design

Participants treated with a Gellhorn pessary (Panpac Medical Products, Corp, New Taipei City, Taiwan) as a first-line treatment for symptomatic POP were enrolled in our study. They had used a Gellhorn pessary before entering our study, and our study period was from January 2021 to June 2021. They were eligible candidates attending the urogynecology clinic during the study period; they all had POP-Q stage ≥ II symptomatic anterior, apical, and/or posterior prolapse according to the POP Quantification System/International Continence Society13 and opted to use a pessary for treatment.

The reason we chose Gellhorn pessary was based on our prior studies, the results showed a high long-term success rate for advanced POP,5,14 its merits include ease of use, a concave design to provide suction, a wide pessary base that adequately supports proximal prolapse, and significant improvements in quality of life.5

Template creation

For each woman, the original Gellhorn pessary was placed into the vagina to restore the prolapsed tissues and transvaginal ultrasound (US) was used to evaluate the gap (Fig. 1), which the Gellhorn pessary cannot cover.15 Otoform16 is an impression silicone for molding interdigital wedges, separators, dorsal toe protectors, and orthodigital splints and is putty-like silicone used with splints to aid in scar remodeling and healing. Its clinical utility, safety, and availability in clinics are the reasons why we selected Otoform for mapping the image gap captured in the transvaginal US. Otoform silicone was molded into an appropriate spherical shape and attached to the Gellhorn pessary to complete a participant-specific template (Fig. 2). Each woman might use a different size of Gellhorn pessary because of unique anatomy.

FIG. 1.

FIG. 1

How to use transvaginal US to evaluate the possible gap, which the Gellhorn pessary cannot cover. (A) Transvaginal US mainly focuses on the retropubic area containing the urethra, paraurethral tissue and bladder. (B) Transvaginal US picture. BL, bladder; U, urethra; PS, pubic symphysis. (C) Transvaginal US-guided Gellhorn pessary position (arrow); distance between 1 and 2 we assume an ellipsoid.

FIG. 2.

FIG. 2

Otoform made a model to mimic the gap and hook on to the Gellhorn pessary.

Practical considerations for 3D printing

We collected the template and then applied 3D printing to customize the silicone vaginal pessary. With regard to the 3D printing process, we used a noncontact active 3D scanner (both turnable table and handheld type [EinScan Pro+ supplied by Shinning3D]; Fig. 3)17 to capture the object, followed by texture mapping and 3D-matching. The data obtained from this scanner will be forwarded to a computer and converted to a 3D model by software.

FIG. 3.

FIG. 3

Handheld 3D scanner, EinScan Pro+ supplied by Shinning3D.

The custom templates were scanned using an industrial handheld laser EinScanPro+ supplied by Shinning 3D. An automated model creation system18 was used to build the appearance model from the template. The four main processes incorporated in this study are described as follows:

  • 1. A fast and accurate customized scanning process

Because of the complexity of the human body, it is not possible to use fixed scanning equipment to scan a localized part of the body. A handheld scanner therefore must be used to obtain accurate digital information. The template to be scanned should remain in a fixed position during scanning, which takes 1 to 2 minutes to complete. The automated model creation system we used can simplify and speed up the editing on the mesh model obtained from scanning.

  • 2. Digital model with simplified “parameter-based” editing

The digital model captured by 3D scanning is a point cloud information and then converted to a triangular 3D mesh model,19 which is then converted to editable nonuniform rational b-spline (NURBS) model in model operation20 (Fig. 4). It is intended to use the Grasshopper program, a parameter-based tool, for editing a tedious model conversion process. Simply importing the file from scanning can create an editable 3D model file right away and produce adjustable parameters that allow the user to make adjustments based on design requirements.

FIG. 4.

FIG. 4

The conversion of meshes to editable NURBS model in model operation.

  • 3. Appearance design model of “parameter texture”

Based on the NURBS model from conversion, which allows the design of the assistive device's appearance directly in the Grasshopper parameter tool,21 our study creates a simple operation mode to allow a designer to create a customized digital 3D model of a pessary according to the participant's status and the doctor's clinical judgments and recommendations.

  • 4. “Customized production” of a model using 3D printing

What characterizes the production process using 3D printing is its ability to customize production in a smaller volume. Our study designs a fast printing assembly method according to individual requirements of a pessary. This study was based on resin material made with the stereolithography printing technique. Because a pessary must be placed within a vagina, this study uses for 3D printing, FABRIAL-R,22 as the 3D printing filament material developed by JSR of Japan that is suitable for application on human skin and has been tested for irritation and skin sensitization in accordance with ISO 10993-10 standards.

To make the material suitable for fused filament fabrication 3D printing, improvements have been made, including making it odorless during printing and reducing the deformation of printed items resulting from thermal shrinkage. This medical-grade silicone has a 35-durometer (a unitless measurement of polymer hardness; shore scleroscope hardness) and a tensile strength of 850 psi when completed, thus giving the pessary adequate mechanical strength. Figure 5 shows a polylactic acid (PLA) model for 3D printing, obtained from scanning a customized pessary with a turntable table 3D scanner.

FIG. 5.

FIG. 5

A polylactic acid model for 3D printing, obtained from scanning a customized pessary with a noncontact active 3D scanner. (A) The process of using a structured-light 3D scanner, obtained from scanning a customized pessary with a turnable table 3D scanner. (B) In the process of stereolithography 3D printing, the density of the support material and the model's orientation were adjusted and set to simulate the printing process and calculate the printing time. (C) The 3D model is finished printing after 11 hours, and it needs to wait for the liquid on the model's surface to dry. Then put the model into the UV light curing chamber for model curing. (D) The final product.

Customized pessary management

Each participant underwent the 3D printing vaginal pessary fitting trial. A pessary fitting trial was conducted at our urogynecology department within the female pelvic health center, this procedure was carried out by L.H.T. with the assistance of a trained physiotherapist (C.C.C.) helping in fitting each participant with the tailor-made pessaries. The customized pessary was inserted into each participant's vagina. The pessary should be retained during physical activities such as standing, coughing, and straining, and the woman should experience no discomfort/expulsion/difficulty in urination or defecation. Pessary fitting was considered unsuccessful if we failed to obtain an adequate fit after at least three attempts, when the pessary caused pain, or if the participant did not plan to use the pessary after fitting. An in-home pessary trial then followed for 1 week. In addition, a participant's family members or home-care assistants, if available, were taught to assist. Participants were taught how to clean and maintain the pessary on their own every day. The pessary was removed and cleaned when the participant bathed and was reinserted and maintained as needed.

All postmenopausal participants were offered local intravaginal estrogen application prior to and after pessary treatment unless it was contraindicated or if the woman refused this treatment. Outpatient follow-up evaluations were scheduled at 1, 3, and 6 months. Evaluations included pelvic examination and participants were asked about adverse effects, such as discomfort, expulsion of the pessary, urinary incontinence, difficulty in urination or bowel movements, and vaginal bleeding. The pessary was then removed and cleaned, and the vagina was examined for erosion. If the pessary fit well and no adverse effects were noted, the pessary was reinserted, and the next follow-up was scheduled.5

Outcome measures

All participants also completed multiple validated Chinese versions of QOL questionnaires23 at baseline and at between 3- and 6-month follow-up, including Urogenital Distress Inventory 6,24 Incontinence Impact Questionnaire 7,25 and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12.26

Statistical analysis

The χ2 test was used and all statistical analyses were performed using SPSS version 17 (IBM Corp, Armonk, NY).

RESULTS

All six participants, four of whom chose to use vaginal estrogen, mean age 68 years (57-74 years) completed the study and the QOL questionnaires (Urogenital Distress Inventory 6, Incontinence Impact Questionnaire 7 and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12). Significant improvements were revealed across the board (11.5–5.7, P = 0.032, 10.1–5.4, P = 0.006, and 23.3–28.5, P < 0.001, respectively). No participant complained of adverse effects, such as discomfort, expulsion of the pessary, urinary incontinence, difficulty in urination or bowel movements, or vaginal bleeding during the study.

DISCUSSION

Main findings

Our study offers proof of concept where a process to manufacture customized pessaries can be achieved for women with POP if the commercial pessary failed. A customized pessary can be made through the application of transvaginal US and 3D printing technology. In any local clinic, even in remote areas, provided that simple tools (ie, transvaginal US and pessary) are available plus the help of a 3D printing center, a customized pessary can be made to improve quality of life.

Strengths and limitations

The major strength of our study is the development of a practical approach to answer a need among women with POP when use of a conventional pessary fails. Our method can be applied to any woman already using an existing pessary on the market. Because conventional pessaries have only a limited number of fixed sizes, it is difficult to meet the needs of all women. The only published article8 reported performing the pelvic examination as the main guide to create the customized pessary. Our understanding is that it is difficult to choose a suitable template if we only perform a pelvic examination. We know that such a method cannot be scientifically verified. Therefore, in our research, we found the best way to get to the anatomic position and come up with a proper size to create a customized pessary. Only through the positioning of the Gellhorn pessary inside the vagina can we find out where the exact site the customized pessary should be located for this woman. By observing the position of the Gellhorn pessary in the vagina by US, we can determine the most suitable, neutral position for the woman. Then, we assess the area not covered enough by the Gellhorn pessary and use it as a reference for subsequent 3D printing.

The second and equally important strength of this investigation is that we did not use any expensive instruments or special technologies, but instead started with US, a common tool every obstetrician-gynecologist is familiar with. Almost all clinics have US machines. While the US image is displayed on the US screen after the pessary is inserted into the vagina, we take a picture as a template, which the subsequent 3D production center can apply to manufacture. Combining the vaginal US and commercial available pessary, we are able to demonstrate a scientific, reproducible way to create each customized pessary. When considering the cost of a custom made pessary, it is not very different from producing a commercially available pessary.

The limitations of this study were that there were a relatively small number of participants and that we had to use Otoform to aid in template production to transfer the parameters needed in the 3D printing process.

Challenges in the development of the process and interpretation

Before starting this study, creating the template employed for later 3D printing use was the most challenging issue. In our first approach, we applied Otoform directly to the prolapsed tissue. The problems with using Otoform are as follows: (1) the shaping timing must be very precise. If the time is too short or too long, shaping cannot be completed. (2) Because the prolapsed tissue is soft, it is difficult to adhere. (3). Even though it was attached to it, the thickness of the attachment part was difficult to control. In the second approach, we used a 3D scanner (handheld laser) (Fig. 3) to scan the prolapsed portion directly. The disadvantages of external scanning are as follows: (1) it is difficult to estimate or grasp precisely the contour of the prolapsed tissue and (2) the width of the vagina cannot be accurately evaluated. Finally, we put a Gellhorn-type pessary into the vagina and use transvaginal US to evaluate the possible gap which the Gellhorn pessary did not cover. We then used Otoform to make a model and hook it on to the Gellhorn pessary, an approach later proven to be morel reliable and practical. In addition, going through pessary fitting trials and having a skillfully trained physiotherapist at hand are essential to the success of our study.

Currently, 3D printing technology has a broad range of applications within the medical field including medical equipment manufacturing, diagnosis and surgical planning, simulated surgery, medical education, tissue engineering, and lastly, the potential of accomplishing individualized medical usage. Barsky et al12 reported the successful insertion of a customized 3D-printed pessary in a patient with stress urinary incontinence in 2018, which is the only article appearing in the literature so far. They thought that this way was feasible and their utility may extend to the patient with anatomical anatomy incompatible with commercially available pessaries. They chose the template based on physical examination and fit the previously unfit pessaries and used a fused deposition modeling printer to create the mold. In addition, grade silicone elastomer was chosen for pessary fabrication.

Our original idea was to find a more reliable and easy way to create the template, which a general obstetrician-gynecologist can do. Ultrasound offers a better understanding of disease entity, and because of the advantages of noninvasiveness, and absence of radiation exposure, it is currently the most convenient imaging method available.15 Transvaginal US is a basic skill all obstetricians-gynecologists have acquired throughout their residency training. A device can be applied to restore the prolapsed tissue of the woman and is easily available. Thus, combining the use of transvaginal US and placement of Gellhorn pessary inside the vagina constituted our original concept. We also applied 3D US to see whether there is any substantial benefit for the making of a customized pessary and abandoned this approach due to cost and unavailability at a local clinic. We do know the benefit of perineal (translabial) or introital US approaches can prevent distortion of the anatomy of the lower urinary tract15; however, the availability at a local clinic also poses a problem.

Future directions

We will continue our efforts and improvements will be made in the following ways: (1) any type of pessary will do as long as it pushes the prolapsed tissue back or (2) or not necessarily a pessary, anything else that can push the prolapsed tissue back if the US can distinguish and capture the picture needed. By doing so, we can send the image back to the 3D printing center and thus it is achievable anywhere in the world.

CONCLUSIONS

Pessaries are currently the only option other than surgery for women with pelvic organ prolapse. There are still a small number of women who cannot use commercially available pessaries. Thus, producing customized pessaries is extremely important to them. We have come up with a creative approach by using US with 3D processing to meet the needs of these women. Hopefully, our ideas will inspire more obstetricians and gynecologists to make this goal a reality by providing better care, thereby improving the quality of life for women with POP.

Acknowledgments

The authors appreciate the contribution to this research made by Mr Chung Feng Yu (Coprothotic Assistive Technology Design Co, Ltd, Taoyuan, Taiwan) for his kind assistance in facilitating the Otoform molding process and Panpac Medical Corp, New Taipei City 22179, Taiwan, for supplying the Gellhorn pessary in this study.

Footnotes

Funding/support: This study was funded by Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan (grant number PTH110004).

Financial disclosures/conflicts of interest: None reported.

Author contributions: YHL and CKL contributed equally to this work. YHL and CKL wrote the paper. SDC and LHT developed analytical tools and analyzed data. CHH and CCC validated the results. LH supervised the project.

Details of ethics approval: The study was approved by the human research ethics committee at each participating institution (TYGH109052).

Contributor Information

Yi-Hao Lin, Email: linyihaou@yahoo.com.tw.

Chor-Kheng Lim, Email: kheng@saturn.yzu.edu.tw.

Shuenn-Dyh Chang, Email: gene@cgmh.org.tw.

Chih-Chien Chiang, Email: 12jojo0330@gmail.com.

Chun-Hung Huang, Email: hank08132005@gmail.com.

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