Abstract
Vesicovaginal fistulas (VVFs), abnormal openings between the vagina and bladder, disrupt the lives of over 3 million people worldwide due to resulting incontinence and infections. VVFs are commonly treated with surgery after the fistula has had time to heal over several months. In low-resource areas, immediate incontinence often leads to ostracization from the community and can be devastating for the patient. To address this problem, we have designed a three-tiered silicone plug consisting of a bladder-dwelling disk, a midfistula disk, and a vagina-dwelling cross-shaped tapered plug, all supported on a central stem. The system is designed to occlude the fistula and enable full continence until the patient is able to access surgery. This proof-of-concept device withstands typical expulsion forces from the bladder and does not leak under typical bladder filling or urination pressures. The maximum device expulsion force is 3.69 N and it is watertight up to 9.8 kPa. It is designed to be easily deployed by trained community members.
Issue Section:
Technical Brief
References
1.
Stamatakos
,
M.
,
Sargedi
,
C.
,
Stasinou
,
T.
, and
Kontzoglou
,
K.
, 2014
, “
Vesicovaginal Fistula: Diagnosis and Management
,” Indian J. Surg.
,
76
(2
), pp. 131
–136
.10.1007/s12262-012-0787-y2.
El-Azab
,
A. S.
,
Abolella
,
H. A.
, and
Farouk
,
M.
, 2019
, “
Update on Vesicovaginal Fistula: A Systematic Review
,” Arab. J. Urol.
,
17
(1
), pp. 61
–68
.10.1080/2090598X.2019.15900333.
Rajaian
,
S.
,
Pragatheeswarane
,
M.
, and
Panda
,
A.
, 2019
, “
Vesicovaginal Fistula: Review and Recent Trends
,” Indian J. Urol.
,
35
(4
), pp. 250
–258
.10.4103/iju.IJU_147_194.
Yan
,
A.
,
George
,
M.
,
Pietro
,
S.
,
Malika
,
B.
,
Laurent
,
M.
,
Patrick
,
M.
,
Bruno
,
C.
, and
Patrie
,
M.
, 2007
, “
Latzko Operation for Vault Vesicovaginal Fistula
,” Gynecol. Oper. Gynecol.
,
62
, pp. 22
–24
.10.1097/01.ogx.0000251483.61830.aa5.
Buckley
,
B. S.
, 2019
, “
User Perspectives, Preferences and Priorities Relating to Products for Managing Bladder and Bowel Dysfunctions
,” J. Eng. Med.
,
233
(1
), pp. 7
–18
.10.1177/09544119177501936.
Semere
,
L.
, and
Nour
,
N. M.
, 2008
, “
Obstetric Fistula: Living With Incontinence and Shame
,” Rev. Obstet. Gynecol.
,
1
(4
), pp. 193
–197
.www.ncbi.nlm.nih.gov/pmc/articles/PMC2621054/7.
Salomon
,
J. A.
,
Haagsma
,
J. A.
,
Davis
,
A.
,
de Noordhout
,
C. M.
,
Polinder
,
S.
,
Havelaar
,
A. H.
,
Cassini
,
A.
,
Devleesschauwer
,
B.
,
Kretzschmar
,
M.
,
Speybroeck
,
N.
,
Murray
,
C. J. L.
, and
Vos
,
T.
, 2015
, “
Disability Weights for the Global Burden of Disease 2013 Study
,” Lancet Global Health
,
3
(11
), pp. 712
–723
.10.1016/S2214-109X(15)00069-88.
Goh
,
J. T.
, 2004
, “
A New Classification for Female Genital Tract Fistula
,” Aust. New Zealand J. Obstet. Gynaecol.
,
44
(6
), pp. 502
–504
.10.1111/j.1479-828X.2004.00315.x9.
Lara
,
L. A. D. S.
,
Silva
,
A. R. D.
,
Rosa-e-Silva
,
J. C.
,
Silva-de-Sá
,
M. F.
,
e Silva
,
A. R. M.
, and
Rosa-e-Silva
,
A. C. J. D. S.
, 2009
, “
Menopause Leading to Increased Vaginal Wall Thickness in Women With Genital Prolapse: Impact on Sexual Response
,” J. Sex. Med.
,
6
, pp. 3097
–3110
.10.1111/j.1743-6109.2009.01407.x10.
Li
,
C.
,
Guan
,
G.
,
Zhang
,
F.
,
Song
,
S.
,
Wang
,
R. K.
,
Huang
,
Z.
, and
Nabi
,
G.
, 2014
, “
Quantitative Elasticity Measurement of Urinary Bladder Wall Using Laser Induced Surface Acoustic Waves
,” Biomed. Opt. Exp.
,
5
(12
), pp. 4313
–4328
.10.1364/BOE.5.00431311.
Egorov
,
V.
,
van Raalte
,
H.
, and
Lucente
,
V.
, 2012
, “
Quantifying Vaginal Tissue Elasticity Under Normal and Prolapse Conditions by Tactile Imaging
,” Int. Urogynecol. J.
,
23
(4
), pp. 459
–466
.10.1007/s00192-011-1592-z12.
Egorov
,
V.
,
Murphy
,
M.
,
Lucente
,
V.
,
van Raalte
,
H.
,
Ephrain
,
S.
,
Bhatia
,
N.
, and
Sarvazyan
,
N.
, 2018
, “
Quantitative Assessment and Interpretation of Vaginal Conditions
,” Sex. Med.
,
6
(1
), pp. 39
–48
.10.1016/j.esxm.2017.08.00213.
Levy
,
L.
, and
Goldman
,
S. M.
, 1985
, “
Foley Catheter Calcification
,” Am. Fam. Phys.
,
32
(1
), pp. 131
–133
.https://pubmed.ncbi.nlm.nih.gov/4013964/14.
Dover
,
S.
,
Aroutcheva
,
A.
,
Faro
,
S.
, and
Chikindas
,
M.
, 2008
, “
Natural Antimicrobials and Their Role in Vaginal Health: A Short Review
,” Int. J. Probiotics Prebiotics
,
3
(4
), pp. 219
–230
.www.ncbi.nlm.nih.gov/pmc/articles/PMC2908489/15.
Health
,
W.
, and
Center
,
E.
, “
Urodynamic Assessment: Techniques
,” Women's Health and Education Center
, New York.http://www.womenshealthsection.com/content/urog/urog003.php316.
Stanley
,
C.
, and
Paul
,
R. H.
, Jr., 2017, “
Vascular Closure Device Suture Tension Limiting and Indication Mechanism
,” U.S. Patent No. 9,642,605
.https://patents.google.com/patent/US964260517.
Ovesco Endoscopy AG, 2022, “
Ovesco Fistula Closure with the OTSC System
,” Ovesco Endoscopy AG, Tuebingen, Germany, accessed Feb. 3, 2022, https://ovesco.com/wp-content/uploads/2018/07/OVE_PM_OTSC_System_Fistula_closure_Broschuere_eng_Rev01_2017-09-27_sec.pdf
18.
Bruckner
,
B. A.
, “
The Use of Coseal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery
,” The Methodist Hospital Research Institute
, Houston, TX.https://clinicaltrials.gov/ct2/show/NCT0160501919.
Parsemus Foundation, 2022, “
Parsemus Foundation Vasalgel Human Healt
,” Parsemus Foundation, accessed Feb. 3, 2022, https://www.parsemus.org/humanhealth/vasalgel/
20.
eSutures.com, 2022, “
Baxter Coseal Surgical Sealant
,” eSutures.com, online, accessed Feb. 3, 2022, https://www.esutures.com/product/0-in-date/84-baxter/739-coseal/29008-baxter-coseal-surgical-sealant-4ml-934071/
21.
Luong
,
P.
,
Browning
,
M.
,
Bixler
,
R.
, and
Cosgriff-Hernandez
,
E.
, 2014
, “
Drying and Storage Effects on Poly(Ethylene Glycol) Hydrogel Mechanical Properties and Bioactivity
,” J. Biomed. Mater. Res. A.
,
102
(9
), pp. 3066
–3076
.10.1002/jbm.a.3497722.
Brancadoro
,
M.
,
Tognarelli
,
S.
,
Fambrini
,
F.
,
Ragusa
,
A.
, and
Menciassi
,
A.
, 2018
, “
Devices for Measuring Cervical Dilation During Labor: Systematic Review and Meta-Analysis
,” Obstet. Gynecol. Surv.
,
73
(4
), pp. 231
–241
.10.1097/OGX.000000000000054823.
Viera
,
A. J.
, and
Larkins-Pettigrew
,
M.
, 2000
, “
Practical Use of the Pessary
,” Am. Family Phys.
,
61
(9
), pp. 2719
–2726
.www.aafp.org/afp/2000/0501/p2719.html24.
Avantor, 2022, “
Avantor Nusil High-Purity Silicones for the Most Demanding Environments
,” Avantor, Radnor, PA, accessed Feb. 3, 2022, https://www.avantorsciences.com/pages/en/nusil
25.
Ceresa
,
C.
,
Tessarolo
,
F.
,
Maniglio
,
D.
,
Tambone
,
E.
,
Carmagnola
,
I.
,
Fedeli
,
E.
,
Caola
,
I.
,
Nollo
,
G.
,
Chiono
,
V.
,
Allegrone
,
G.
,
Rinaldi
,
M.
, and
Fracchia
,
L.
, 2019
, “
Medical- Grade Silicone Coated With Rhamnolipid r89 is Effective Against staphylococcus Spp. biofilms
,” Molecules
,
24
(21
), p. 3843
.10.3390/molecules2421384326.
Pokhrel
,
D.
,
Bhattarai
,
S.
,
Emgård
,
M.
,
von Schickfus
,
M.
,
Forsberg
,
B. C.
, and
Biermann
,
O.
, 2021
, “
Acceptability and Feasibility of Using Vaginal Menstrual Cups Among Schoolgirls in Rural Nepal: A Qualitative Pilot Study
,” Reprod. Health
,
18
(1
), pp. 1
–10
.10.1186/s12978-020-01036-027.
McGoldrick
,
M.
, 2016
, “
Frequency for Changing Long-Term Indwelling Urethral Catheters
,” Home Healthc. Now
,
34
(2
), pp. 105
–106
.10.1097/NHH.000000000000034228.
North
,
B. B.
, and
Oldham
,
M. J.
, 2011
, “
Preclinical, Clinical, and Over-the-Counter Postmarketing Experience With a New Vaginal Cup: Menstrual Collection
,” J. Womens Health (Larchmt)
,
20
(2
), pp. 303
–311
.10.1089/jwh.2009.192929.
Alibaba.com, 2022, “
Alibaba Medical Grade Silicone Price
,” Alibaba.com, online, accessed Feb. 3, 2022, https://www.alibaba.com/showroom/medical-grade-silicone-price.html
30.
Resource Recycling, Inc., 2022, “
RecyclingMarkets.net Mixed News for Recovered Plastics Pricing
,” Resource Recycling, Inc., Portland, OR, accessed Feb. 3, 2022, https://resource-recycling.com/plastics/2019/02/13/mixed-news-for-recovered-plastics-pricing/#:~:text=The\%20national\%20average\%20price\%20of\%20polypropylene\%20(PP)\%20remains\%20steady\%20at,at\%208.38\%20cents\%20per\%20pound31.
Roylance
,
D.
, 1993
, “
Assessment of Olefin-Based IUD Tail Strings
,” J. Appl. Biomater.
, 4, pp. 289
–301
.https://web.mit.edu/roylance/www/iud.pdf32.
Sekhon Randhawa
,
K. K.
, and
Rahman
,
P. K. S. M.
, 2014
, “
Rhamnolipid Biosurfactants-Past, Present, and Future Scenario of Global Market
,” Front. Microbiol
., 5(454).10.3389/fmicb.2014.0045433.
Smooth-On, Inc., 2022, “
Smooth-on Ecoflex Series
,” Smooth-On, Inc., Macungie, PA, accessed Feb. 3, 2022, https://www.smooth-on.com/tb/files/ECOFLEX_SERIES_TB.pdf
34.
Mahfouz
,
W.
,
Afraa
,
T. A.
,
Campeau
,
L.
, and
Corcos
,
J.
, 2012
, “
Normal Urodynamic Parameters in Women
,” Int. Urogynecol. J.
,
23
(3
), pp. 269
–277
.10.1007/s00192-011-1585-y35.
Smooth-On, Inc., 2022, “
Smooth-on Mold Star 19t, 20t, 31t
,” Smooth-On, Inc., Macungie, PA, accessed Feb. 3, 2022, https://www.smooth-on.com/tb/files/MOLD_STAR_T_SERIES_TB.pdf36.
MIT Abaqus Docs, 2022, “
MIT Abaqus Docs Buckling of a Ring in a Plane Under External Pressure
,” MIT Abaqus Docs, accessed Feb. 3, 2022, https://abaqus-docs.mit.edu/2017/English/SIMACAEBMKRefMap/simabmk-c-ringbuckling.htm
37.
Smooth-On, Inc., 2022, “
Smooth-On Shore Hardness Scales
,” Smooth-On, Inc., Macungie, PA, accessed Feb. 3, 2022, https://www.smooth-on.com/page/durometer-shore-hardness-scale/
38.
Browning
,
J. H. D.
, Wynne, R. I.,
and
Hayes
,
H.
, 1996
, “
Sanitary Tampon
,” U.S. Patent No. US5554108A
.https://patents.google.com/patent/US555410839.
Johnson
,
B. A.
, 2005
, “
Insertion and Removal of Intrauterine Devices
,” Am. Family Phys.
,
71
(1
), pp. 95
–102
.https://www.aafp.org/afp/2005/0101/p95.html40.
Abdulaziz
,
M.
,
Stothers
,
L.
,
Lazare
,
D.
, and
Macnab
,
A.
, 2015
, “
An Integrative Review and Severity Classification of Complications Related to Pessary Use in the Treatment of Female Pelvic Organ Prolapse
,” Can. Urol. Assoc. J.
,
9
(5–6
), p. 400
.10.5489/cuaj.278341.
Coelho
,
S.
,
Giraldo
,
P.
,
Florentino
,
J.
,
Castro
,
E.
,
Brito
,
L.
, and
Juliato
,
C.
, 2017
, “
Can the Pessary Use Modify the Vaginal Microbiological Flora? A Cross-Sectional Study
,” Rev. Brasil. Ginecol. Obstet./RBGO Gynecol. Obstet.
,
39
(4
), pp. 169
–174
.10.1055/s-0037-160143742.
Collins
,
S.
,
Beigi
,
R.
,
Mellen
,
C.
,
O'Sullivan
,
D.
, and
Tulikangas
,
P.
, 2015
, “
The Effect of Pessaries on the Vaginal Microenvironment
,” Am. J. Obstet. Gynecol.
,
212
(1
), p. 60
.10.1016/j.ajog.2014.07.02443.
Hanson
,
L.-A. M.
,
Schulz
,
J. A.
,
Flood
,
C. G.
,
Cooley
,
B.
, and
Tam
,
F.
, 2006
, “
Vaginal Pessaries in Managing Women With Pelvic Organ Prolapse and Urinary Incontinence: Patient Characteristics and Factors Contributing to Success
,” Int. Urogynecol. J.
,
17
(2
), pp. 155
–159
.10.1007/s00192-005-1362-x44.
Prabhakaran
,
S.
, and
Chuang
,
A.
, 2011
, “
In Office Retrieval of Intrauterine Contraceptive de-Vices With Missing Strings
,” Contraception
,
83
(2
), pp. 102
–106
.10.1016/j.contraception.2010.07.00445.
Davidson
,
J.
,
Ford
,
K.
,
Ade-Ajayi
,
N.
, and
Paul
,
A.
, 2019
, “
Improvise, Adapt, Overcome: Mobile Phone Led Used as a Light Source for Cystoscopy and Resection of Posterior Urethral Valves in a Low-Cost Setting
,” J. Pediatr. Urol.
,
15
(1
), pp. 85
–86
.10.1016/j.jpurol.2018.11.012Copyright © 2022 by ASME
You do not currently have access to this content.
