Predictor of Surgical Failure Following Transvaginal Mesh Repair Using Minimally Invasive Prolapse System Device (MIPS)
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Surgical Technique
2.3. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
- Hendrix, S.L.; Clark, A.; Nygaard, I.; Aragaki, A.; Barnabei, V.; McTiernan, A. Pelvic organ prolapse in the Women’s Health Initiative: Gravity and gravidity. Am. J. Obstet. Gynecol. 2002, 186, 1160–1166. [Google Scholar] [CrossRef]
- Olsen, A.L.; Smith, V.J.; Bergstrom, J.O.; Colling, J.C.; Clark, A.L. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet. Gynecol. 1997, 89, 501–506. [Google Scholar] [CrossRef] [PubMed]
- Smith, F.J.; Holman, C.D.J.; Moorin, R.E.; Tsokos, N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet. Gynecol. 2010, 116, 1096–1100. [Google Scholar] [CrossRef] [PubMed]
- Jelovsek, J.E.; Maher, C.; Barber, M.D. Pelvic organ prolapse. Lancet 2007, 369, 1027–1038. [Google Scholar] [CrossRef] [PubMed]
- Ng-Stollmann, N.; Fünfgeld, C.; Gabriel, B.; Niesel, A. The international discussion and the new regulations concerning transvaginal mesh implants in pelvic organ prolapse surgery. Int. Urogynecology J. 2020, 31, 1997–2002. [Google Scholar] [CrossRef] [PubMed]
- U.S. Food & Drug Administration. FDA’s Activities: Urogynecologic Surgical Mesh. 2022. Available online: https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/fdas-activities-urogynecologic-surgical-mesh (accessed on 17 October 2022).
- Zhang, C.; Sun, Z.; Yang, J.; Xu, T.; Zhu, L.; Lang, J. Sacrocolpopexy Compared with Transvaginal Mesh Surgery: A Systematic Review and Meta-Analysis. BJOG Int. J. Obstet. Gynaecol. 2020, 128, 14–23. [Google Scholar] [CrossRef] [PubMed]
- Bump, R.C.; Mattiasson, A.; Bø, K.; Brubaker, L.P.; DeLancey, J.O.; Klarskov, P.; Shull, B.L.; Smith, A.R. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am. J. Obs. Gynecol 1996, 175, 10–17. [Google Scholar] [CrossRef] [PubMed]
- Homma, Y.; Yoshida, M.; Seki, N.; Yokoyama, O.; Kakizaki, H.; Gotoh, M.; Yamanishi, T.; Yamaguchi, O.; Takeda, M.; Nishizawa, O. Symptom assessment tool for overactive bladder syndrome—Overactive bladder symptom score. Urology 2006, 68, 318–323. [Google Scholar] [CrossRef] [PubMed]
- Uebersax, J.S.; Wyman, J.F.; Shumaker, S.A.; McClish, D.K.; Fantl, J.A. Short forms to assess life quality and symptom distress for urinary incontinence in women: The Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol. Urodyn. 1995, 14, 131–139. [Google Scholar] [CrossRef]
- Ibinaeva, I.S.; Apolikhina, I.A.; Makhmedzhanova, F.N.; Muslimova, S.Z. [ICIQ-SF questionnaire in women with urinary incontinence]. Urologiia 2012, 1, 38–42. [Google Scholar]
- Barber, M.D.; Walters, M.D.; Bump, R.C. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am. J. Obstet. Gynecol. 2005, 193, 103–113. [Google Scholar] [CrossRef] [PubMed]
- Ellington, D.R.; Richter, H.E. Indications, Contraindications, and Complications of Mesh in Surgical Treatment of Pelvic Organ Prolapse. Clin. Obstet. Gynecol. 2013, 56, 276–288. [Google Scholar] [CrossRef] [PubMed]
- Tailor, V.; Digesu, A.; Swift, S.E. Update in Transvaginal Grafts: The Role of Lightweight Meshes, Biologics, and Hybrid Grafts in Pelvic Organ Prolapse Surgery. Obs. Gynecol Clin. 2021, 48, 515–533. [Google Scholar] [CrossRef] [PubMed]
- Naumann, G.; Hüsch, T.; Mörgeli, C.; Kolterer, A.; Tunn, R. Mesh-augmented transvaginal repair of recurrent or complex anterior pelvic organ prolapse in accordance with the SCENIHR opinion. Int. Urogynecology J. 2020, 32, 819–827. [Google Scholar] [CrossRef] [PubMed]
- Wu, P.-C.; Wu, C.-H.; Liu, Y.; Loo, Z.; Lin, K.-L.; Long, C.-Y. The clinical and urodynamic outcomes of single-incision mesh surgery using the Uphold system for the treatment of pelvic organ prolapse. Sci. Rep. 2020, 10, 13506. [Google Scholar] [CrossRef] [PubMed]
- Lo, T.-S.; Rom, E.; Harun, F.; Jhang, L.-S.; Hsieh, W.-C.; Lin, Y.-H. Anterior–apical Transvaginal Mesh (Calistar-S) for Treatment of Advanced Urogenital Prolapse: Surgical and Functional Outcomes at 1 Year. Int. Urogynecology J. 2024, 35, 1011–1019. [Google Scholar] [CrossRef] [PubMed]
- Long, C.Y.; Lo, T.-S.; Wang, C.-L.; Wu, C.-H.; Liu, C.-M.; Su, J.-H. Risk factors of surgical failure following transvaginal mesh repair for the treatment of pelvic organ prolapse. Eur. J. Obstet. Gynecol. Reprod. Biol. 2012, 161, 224–227. [Google Scholar] [CrossRef]
- Chen, H.-Y.; Yeh, L.-S.; Chang, W.-C.; Ho, M. Analysis of risk factors associated with surgical failure of inside-out transobturator vaginal tape for treating urodynamic stress incontinence. Int. Urogynecology J. Pelvic Floor Dysfunct. 2007, 18, 443–447. [Google Scholar] [CrossRef] [PubMed]
- Amaye-Obu, F.A.; Drutz, H.P. Surgical management of recurrent stress urinary incontinence: A 12-year experience. Am. J. Obs. Gynecol. 1999, 181, 1296–1309. [Google Scholar] [CrossRef]
- Ker, C.-R.; Lin, K.-L.; Loo, Z.-X.; Juan, Y.-S.; Long, C.-Y. Comparison of UpholdTM Vaginal Mesh Procedure with Hysterectomy or Uterine Preservation for the Treatment of Pelvic Organ Prolapse. Sci. Rep. 2018, 8, 9438. [Google Scholar] [CrossRef] [PubMed]
n = 218 | |
---|---|
Age (yrs) | 68.91 ± 8.49 |
Parity | 2.99 ± 1.14 |
BMI (kg/m2) | 24.37 ± 3.63 |
Hormone therapy | 39 (17.89) |
Menopause | 101 (46.33) |
Hypertension | 110 (50.46) |
Diabetes mellitus | 52 (23.85) |
Hysterectomy | 12 (5.5) |
Previous POP surgery | 5 (2.29) |
SUI surgery | 3 (1.38) |
Follow-up (months) | 12–46 months |
Procedures | n (%) |
---|---|
Cervical amputation | 28 (12.8) |
Anterior colporrhaphy with mesh insertion | 218 (100) |
Vaginal hysterectomy | 31 (14.2) |
Mid-urethral sling insertion | 87 (39.9) |
Posterior colporrhaphy | 49 (22.5) |
Success (n = 211) | Failure (n = 7) | p Value | OR | ||
---|---|---|---|---|---|
Age (yrs) | <60 | 26 (12.32) | 0 (0) | 1 | |
≧60 | 185 (87.68) | 7 (100) | |||
Parity | <4 | 164 (77.73) | 5 (71.43) | 0.6559 | |
≧4 | 47 (22.27) | 2 (28.57) | |||
BMI (kg/m2) | <25 | 130 (61.61) | 4 (57.14) | 1 | |
≧25 | 81 (38.39) | 3 (42.86) | |||
Past history | HT | 39 (18.48) | 0 (0.00) | 0.3567 | |
Menopause | 99 (46.92) | 2 (28.57) | 0.4545 | ||
Hypertension | 106 (50.24) | 4 (57.14) | 1 | ||
Diabetes mellitus | 50 (23.70) | 2 (28.57) | 0.6726 | ||
Hysterectomy | 12 (5.69) | 0 (0.00) | 1 | ||
Previous POP | 5 (2.37) | 0 (0.00) | 1 | ||
SUI surgery | 3 (1.42) | 0 (0.00) | 1 | ||
Involved compartment | Cystocele | 149 (70.62) | 3 (42.86) | 0.2027 | |
Uterine prolapse | 91 (43.13) | 2 (28.57) | 0.7014 | ||
Vault prolapse | 16 (7.58) | 2 (28.57) | 0.1056 | ||
Rectocele | 12 (5.69) | 1 (14.29) | 0.3538 | ||
All | 45 (21.33) | 3 (42.86) | 0.1814 | ||
Concomitant surgery | Cervical amputation | 28 (13.27) | 0 (0.00) | 0.5989 | |
VTH | 31 (14.69) | 0 (0.00) | 0.5969 | ||
MUS insertion | 84 (39.81) | 3 (42.86) | 1 | ||
Mesh erosion | 4 (1.90) | 0 (0.00) | 1 | ||
Pre-op symptoms | Frequency | 131 (62.38) | 3 (42.86) | 0.4319 | |
SUI | 131 (62.09) | 5 (71.43) | 0.7134 | ||
UUI | 122 (58.10) | 6 (85.71) | 0.2443 | ||
Incomplete emptying | 178 (84.76) | 6 (85.71) | 1 | ||
Hesitancy | 147 (70.00) | 5 (71.43) | 1 | ||
Nocturia | 168 (79.62) | 7 (100.00) | 0.3498 | ||
Surgical experience | First 60 case | 55 (26.07) | 5 (71.43) | 0.0181 | 7.09 (1.34, 37.61) |
61–218 case | 156 (73.93) | 2 (28.57) |
Success (n = 211) | Failure (n = 7) | p Value | OR | ||
---|---|---|---|---|---|
Detrusor overactivity | 74 (35.07) | 3 (42.86) | 0.6997 | ||
One hour pad test (g) | <6 | 188 (89.1) | 6 (85.71) | 0.5634 | |
≧6 | 23 (10.9) | 1 (14.29) | |||
Q max (mL/s) | <15 | 126 (59.72) | 3 (42.86) | 0.4473 | |
≧15 | 85 (40.28) | 4 (57.14) | |||
RU (mL) | <50 | 82 (38.86) | 2 (28.57) | 0.7095 | |
≧50 | 129 (61.14) | 5 (71.43) | |||
FS (mL) | <100 | 57 (27.01) | 4 (57.14) | 0.0979 | |
≧100 | 154 (72.99) | 3 (42.86) | |||
MCC (mL) | <300 | 63 (29.86) | 2 (28.57) | 1 | |
≧300 | 148 (70.14) | 5 (71.43) | |||
Pdet (cm H2O) | <25 | 145 (68.72) | 7 (100) | 0.103 | |
≧25 | 66 (31.28) | 0 (0) | |||
FUL (mm) | <20 | 49 (23.22) | 5 (71.43) | 0.0111 | 8.27 (1.55, 43.94) |
≧20 | 162 (76.78) | 2 (28.57) | |||
MUCP (cm H2O) | <40 | 99 (46.92) | 2 (28.57) | 0.4545 | |
≧40 | 112 (53.08) | 5 (71.43) | |||
OABSS | <6 | 117 (55.45) | 4 (57.14) | 1 | |
≧6 | 94 (44.55) | 3 (42.86) | |||
UDI-6 | <6 | 119 (56.4) | 3 (42.86) | 0.7021 | |
≧6 | 92 (43.6) | 4 (57.14) | |||
IIQ-7 | <6 | 93 (44.08) | 4 (57.14) | 0.7026 | |
≧6 | 118 (55.92) | 3 (42.86) | |||
ICIQ-SF | <7 | 135 (63.98) | 1 (14.29) | ||
≧7 | 76 (36.02) | 6 (85.71) | 0.0122 | 10.66 (1.26, 90.16) | |
POPDI-6 | <10 | 99 (46.92) | 4 (57.14) | 0.7097 | |
≧10 | 112 (53.08) | 3 (42.86) | |||
Aa | ≦1 | 97 (45.97) | 2 (28.57) | 0.4596 | |
>1 | 114 (54.03) | 5 (71.43) | |||
Ba | ≦1 | 34 (16.11) | 1 (14.29) | 1 | |
>1 | 177 (83.89) | 6 (85.71) | |||
C | ≦1 | 106 (50.24) | 3 (42.86) | 1 | |
>1 | 105 (49.76) | 4 (57.14) | |||
Ap | ≦1 | 179 (84.83) | 6 (85.71) | 1 | |
>1 | 32 (15.17) | 1 (14.29) | |||
Bp | ≦1 | 137 (64.93) | 4 (57.14) | 0.6997 | |
>1 | 74 (35.07) | 3 (42.86) | |||
TVL | ≦8 | 74 (35.07) | 4 (57.14) | 0.2521 | |
>8 | 137 (64.93) | 3 (42.86) |
Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content. |
© 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
Share and Cite
Yang, Y.-Y.; Loo, Z.-X.; Lin, K.-L.; Long, C.-Y. Predictor of Surgical Failure Following Transvaginal Mesh Repair Using Minimally Invasive Prolapse System Device (MIPS). J. Clin. Med. 2024, 13, 5352. https://doi.org/10.3390/jcm13185352
Yang Y-Y, Loo Z-X, Lin K-L, Long C-Y. Predictor of Surgical Failure Following Transvaginal Mesh Repair Using Minimally Invasive Prolapse System Device (MIPS). Journal of Clinical Medicine. 2024; 13(18):5352. https://doi.org/10.3390/jcm13185352
Chicago/Turabian StyleYang, Yao-Yu, Zi-Xi Loo, Kun-Ling Lin, and Cheng-Yu Long. 2024. "Predictor of Surgical Failure Following Transvaginal Mesh Repair Using Minimally Invasive Prolapse System Device (MIPS)" Journal of Clinical Medicine 13, no. 18: 5352. https://doi.org/10.3390/jcm13185352