What the women say- complications after stress urinary incontinence surgery.

Zacharias S1, Uustal E2

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 690
Urogynaecology 6 - Mesh / Sling Complications
Scientific Podium Short Oral Session 33
Friday 6th September 2019
15:15 - 15:22
Hall G3
Stress Urinary Incontinence Surgery Outcomes Research Methods Female
1.Hudiksvalls sjukhus, 2.Linköping university hospital
Presenter
S

Stefan Zacharias

Links

Abstract

Hypothesis / aims of study
The use of mid-urethral slings (MUS), has been the subject of almost 2000 published articles and has come to dominate the treatment of female stress urinary incontinence for almost 20 years(1).  Long term effects are good, and complications have been considered rare. Because of this, individual surgeons have seen only a handful of women with complications and may thus underestimate the impact of possible adverse outcomes. However, as more women are treated, rare but serious side effects accumulate(2).  Affected women all over the world have come together in support groups with the aid of social media. The UK Department of Health and Social care put a pause in the use of MUS in the summer of 2018. A set of terms for surgeons were determined and needed to be fulfilled by clinics to allow for further MUS use.
One of the terms set up by the UK government was that SUI surgery should be monitored in a register. In Sweden this has been done since 2007.   From that dataset, we have access to womens´ own words to gain more information about what women are experiencing. What do the women write when they give their doctor their opinion about the surgery?
Study design, materials and methods
The Swedish National Registry for Gynecologic Surgery (GynOP) is a nation- wide register with patient reported function and outcome data before, 8 weeks and 1 year after surgery as well as perioperative data.  Over 90% of the women reply to the questionnaires, that are either postal or web-based according to their preference. All women having had incontinence operations with one of the three MUS methods TVT, TVT-O or TOT during the year 2017 comprised the original dataset. Combined operations were excluded.
We chose to text-analyze answers from women who answered that a complication had occurred, their condition was worse than before the operation or that they were very dissatisfied with the operation. Questionnaires were selected for analysis if they contained free text data in one of the open-end responses considering a possible complication at the one year follow up. 
We have used inductive qualitative content analysis to investigate written open-ended responses from 578 women after incontinence surgery(3).
Results
The domains we identified were:
Urinating problems:
“Emptying the bladder has become difficult.” The women describe transient or persistent need of catheterization, a feeling of not being able to empty the bladder completely, having to stand up to pee. Having infections in the bladder all the time.
“I have to pee all the time” that was not the case before the operation.
Sexual problems:
“Intercourse is painful, we can’t have sex in any position anymore. “I can feel the mesh in the vagina” “it is sharp and painful to my partner” “I can´t come anymore ” several women stated that they had lost their ability to have an orgasm 
“I had orgasms all the time during sleep at night for several month after the operation”.
Pain:
“I have constant pain”, at standing sitting or crouching. “I can’t lie on my stomach at the gym”. “I can’t move my leg without pain”.
My life has been changed:
“Before I had urinary leakage, now I can’t pee.
 “My urethra was damaged, and I am waiting for surgery”
“I do not know where to turn”
Many patients write about several domains like pain, sexual dysfunction and urinating problems at the same time.
Interpretation of results
Although complications are rare, for the women affected, their lives are changed to the worse by the surgery. Any one surgeon may see only a handful of women getting severe complication during their working years. These harrowing accumulated tales of adverse outcomes are sobering. It is  an important use of the of The Swedish National Registry for Gynecologic Surgery (GynOP). Qualitative methods have been used in another branch of the register, the perineal tear register(3,) where those insights have contributed in depth to a new national information leaflet.
A significant number of women take the time and effort to describe to their surgeon serious and persistent negative effects on their quality of life. The serious sexual dysfunction, pain and struggles to urinate reported by the women should be included in patient counselling as rare but potentially debilitating outcomes. Further quantitative analysis of the material is in progress.
A wide range of different complications occur after incontinence surgery. Most complications are minor, and many do not persist at one year follow up but there are women experiencing serious persistent negative effects on their quality of life.
Concluding message
MUS complications at one-year follow up, although rare, can be potentially severe. The Swedish National Registry for Gynecologic Surgery (GynOp) is unique in giving the affected women a chance to be heard with their own voices.  It is important that surgeons inform patients correctly and include the worst-case scenario when suggesting incontinence surgery. While most women are very satisfied, a few are much worse off after the procedure than before.
References
  1. Fusco F, Abdel-Fattah M, Chapple CR, Creta M, La Falce S, Waltregny D, et al. Updated Systematic Review and Meta-analysis of the Comparative Data on Colposuspensions, Pubovaginal Slings, and Midurethral Tapes in the Surgical Treatment of Female Stress Urinary Incontinence. Eur Urol. 2017;72(4):567-91.
  2. Gurol-Urganci I, Geary RS, Mamza JB, Duckett J, El-Hamamsy D, Dolan L, et al. Long-term Rate of Mesh Sling Removal Following Midurethral Mesh Sling Insertion Among Women With Stress Urinary Incontinence. JAMA. 2018;320(16):1659-69.
  3. Lindqvist M, Persson M, Nilsson M, Uustal E, Lindberg I. "Struggling to settle with a damaged body” – A Swedish qualitative study of women’s experiences one year after obstetric anal sphincter muscle injury (OASIS) at childbirth. Sexual & Reproductive Healthcare. 2019;Volume 19 , March 2019, Pages: 36-41
Disclosures
Funding GynOP Clinical Trial No Subjects Human Ethics not Req'd did not require ethics committee because the register data are anonymized Helsinki Yes Informed Consent Yes