Comparison of the puborectal muscle on MRI in women with POP and levator ani defects with those with normal support and no defect.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to compare puborectal muscle integrity and bulk in women with both major levator ani (LA) defects on MRI and pelvic organ prolapse (POP) to women with normal LA muscle and normal support. METHODS: This is a case-control study comparing 24 cases with known major LA defects and POP to 24 controls with normal LA and normal support. Axial T-2 weighted MRI scans of the pelvis were evaluated for integrity of the puborectal muscle and degree of muscle bulk. RESULTS: There were no significant group differences in age, body mass index, vaginal deliveries, or hysterectomy status. In all 48 subjects, the puborectal muscle was visible and had no disruption noted. There was no difference in muscle bulk between groups (control/case, thin 42% vs. 25%, average 42% vs. 38%, thick-17% vs. 38%; P = 0.47). CONCLUSIONS: Defects and loss of muscle bulk in the puborectal muscle are not seen on MRI in women with major LA defects and POP.

An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence.

INTRODUCTION: Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence. METHODS: Submucosal injection of Bulkamid® was performed in 135 women with urinary incontinence (stress, 67; mixed, 68) followed for 12 months. Forty-seven had a reinjection (35%). RESULTS: At 12 months, the subjective response rate was 66%. Incontinence episodes/24 h and urine leakage g/24 h decreased significantly (from 3.0 to 0.7 and 29 g to 4 g, respectively). Additionally, the median International Consultation on Incontinence Questionnaire score was reduced to approximately 50%, and the overall quality of life visual analogue scale score was decreased significantly (from 72 to 20). Efficacy was very similar between patients with stress and mixed incontinence. Thirty treatment-related adverse events were registered. The most frequent was urinary tract infection (n = 10). No polyacrylamide hydrogel-specific adverse events were seen. CONCLUSIONS: Bulkamid® is an effective and safe bulking agent in women with stress or mixed incontinence.

[No registration of complications for implants used in gynaecological surgery]. / Ingen registrering af komplikationer til implantater ved gynaekologiske operationer.

INTRODUCTION: In recent years, many new surgical implants (biological and synthetic) for female urinary incontinence and pelvic organ prolapse (POP) surgery have been launched in Denmark. In the literature, complications have been reported in up to 40% of cases depending on the type of operation, 2-5% as serious complications. An implant can achieve CE-marking if it seems likely that it is substantially equivalent to an implant already on the market. Thus implants can be launched without clinical data. MATERIAL AND METHODS: Correspondence or contact by phone to: 1) The Danish Ministry of Public Health, 2) The Danish National Board of Health (DB), 3) Danish Medicines Agency (DM), 4) Dansk Standard, and 5) companies/manufacturers in order to establish who has the responsibility for surveillance and approval of such medical devices in Denmark. Furthermore, we established how many surgical implants for urine incontinence and POP surgery are currently on the Danish market. RESULTS: Twenty-five different surgical devices are currently being marketed in Denmark. DM has the responsibility to collect, register and to act on complications. DM had four reports of complications in the period 2001-2006. Both the surgeon and the manufacturer/company have a duty to report complications. CONCLUSION: The Danish medical authorities have no records showing which surgical implants have been launched on the Danish market. There is an urgent need to establish a reliable registry which can facilitate surveillance of new surgical implants in order to improve patient safety. There is also a considerable need to increase the requirements, including the requirements for clinical data, before new surgical implants may be launched.

[Surgical treatment of female urinary incontinence]. / Kirurgisk behandling af urininkontinens hos kvinder.

INTRODUCTION: During the last decade, minimal invasive procedures have been introduced for treatment of urinary incontinence (UI) in women leading to shorter hospitalisation and fewer complications. The aim of this study was to outline clinical practice and attitudes among Danish UI surgeons. MATERIAL AND METHODS: Surgeons performing UI procedures were identified and mailed a questionnaire in 2007 concerning 2006. Questions included specialisation, number of procedures, type of surgery, complications and attitude towards learning surgery and maintaining a sufficient level of routine. RESULTS: In total, 94 operating gynaecologists and urologists were identified, 63 responded (71%) of whom 49 (78%) performed UI surgery. UI surgeons were gynaecologists 43 (88%) of these 24 (49%) were urogynecologists (working more than 50% with urogynecology) and five (10%) urologists. Tension-free Vaginal Tape (TVT) was the preferred sling in 2006. A total of 20 (47%) UI surgeons used only TVT, seven (17%) only transobturator slings (TOS) and 15 (36%) both TVT and TOS. Only 11 (24%) performed > 25 TVT per year and 11 (27%) performed > 25 TOS per year. In all, UI surgeons had experience with ten different slings. This study did not allow for a quantitative assessment of complications. The attitude was that 10-25 operations are needed to learn the procedure, and that > 10 operations per year are needed to maintain a sufficient level of routine. CONCLUSION: Practice and attitudes among urinary incontinence surgeons vary considerably and there is a lack of consensus. Many UI surgeons perform few operations with different techniques.

Soluble human leukocyte antigen-G isoforms in maternal plasma in early and late pregnancy.

PROBLEM: Human Leukocyte Antigen (HLA)-G is a class Ib gene located in the human major histocompatibility complex (MHC). Several lines of investigation indicate that the HLA-G molecule is involved in the maternal acceptance of the semi-allogenic fetus during pregnancy and in the development of tolerance. Expression of soluble HLA-G (sHLA-G) is positively correlated with successful in vitro fertilization (IVF) treatments, and aberrant expression of HLA-G in certain complications of pregnancy, such as pre-eclampsia and spontaneous abortion, has been reported. The main purpose of this study was to investigate the levels of different soluble HLA-G isoforms in maternal plasma in early and late pregnancy. METHOD OF STUDY: Soluble HLA-G (sHLA-G) can be detected in maternal blood, and in this study, two different isoforms of sHLA-G, namely sHLA-G1 generated by shedding of membrane-bound HLA-G1 and HLA-G generated by specific HLA-G transcripts, have been investigated early [median of 16.4 weeks of gestation (GW)] and late (median: 38.9 GW) in pregnancy in an original cohort of 580 pregnant Caucasian women. RESULTS: Lower concentrations of sHLA-G1 were found late in pregnancy (>32 GW) in a group of women with severe pre-eclampsia compared with controls with uncomplicated pregnancies (P = 0.029, P(C) = 0.09; Mann-Whitney; Logistic regression analysis: P = 0.024, OR = 0.920, 95% CI: 0.855-0.989). However, this was not the case with HLA-G5, and significantly more of the cases with severe pre-eclampsia had detectable plasma HLA-G5 compared with that of the control group (P = 0.013, P(C) = 0.04; Mann-Whitney). Similar findings were not observed in women with gestational hypertension or existing hypertension continuing into pregnancy. Furthermore, there was a trend toward lower maternal plasma sHLA-G1 in a group of women with premature birth (<37 GW) compared with that of the control group (P = 0.028, P(C) = 0.17; Mann-Whitney). On the contrary, HLA-G5 was lower in the control group compared with that in the premature group (P = 0.004, P(C) = 0.02; Mann-Whitney). CONCLUSION: This study shows in line with other published studies that a high, detectable soluble HLA-G concentration in maternal plasma or serum is not mandatory for a successful pregnancy. However, complications during pregnancy, such as (severe) pre-eclampsia, spontaneous abortion, IUGR, and premature birth, are associated with a low or undetectable level of soluble HLA-G in the maternal blood circulation. Also, this study indicates that sHLA-G1 is the interesting soluble HLA-G isoform in pre-eclampsia, and that low or undetectable levels of HLA-G5 at the end of pregnancy seem to be associated with an uncomplicated normal pregnancy, whereas in severe pre-eclampsia and possibly other pregnancy complications, such as preterm birth and IUGR, the level of HLA-G5 is higher.

Lower urinary tract symptoms after total and subtotal hysterectomy: results of a randomized controlled trial.

The aim of this Danish multicenter trial was to compare the proportion of women with lower urinary tract symptoms after total abdominal hysterectomy (TAH) and subtotal abdominal hysterectomy (SAH) for benign uterine disorders. A total of 319 women were randomized to TAH (n = 158) or SAH (n = 161). Women were followed up for 1 year by strict data collection procedures, including postal questionnaires. Results were analyzed by intention-to-treat analyses. Urinary incontinence was found less often among TAH women than among SAH women. This was due to a larger reduction of the number of women with stress and urinary incontinence in the TAH group. No other differences were found between the two operation methods. The number of women with urinary incontinence and frequency was reduced from study entry for follow-up, while double/triple voiding was increased. Incontinent women had significantly lower quality of life scores than continent women

Sexuality after total vs. subtotal hysterectomy.

BACKGROUND: The effect of hysterectomy on sexuality is not fully elucidated and until recently total and subtotal hysterectomies have only been compared in observational studies. AIMS: To compare total abdominal hysterectomy (TAH) to subtotal abdominal hysterectomy (SAH) regarding effects on sexuality. METHODS: In a Danish multicenter trial 319 women were randomized to TAH (n = 158) or SAH (n = 161); 185 women had self-selected TAH (n = 80) or SAH (n = 105) in a simultaneously conducted observational study. Women were followed for 1 year by strict data collection procedures, including postal questionnaires. Results were analyzed by intention to treat (ITT) analyses. RESULTS: No significant differences were observed between TAH and SAH at 1-year follow-up in both the randomized trial and the observational study regarding women's desire for sex, frequency of intercourse, frequency of orgasm, quality of orgasm, localization of orgasm, satisfaction with sexual life, and dyspareunia. None of these sexual variables changed significantly from entry to the 1-year follow-up, apart from dyspareunia, which was significantly (p = 0.009) reduced in both intervention groups. Significant (p < 0.05) predictors for satisfaction with sexual life after hysterectomy were the preoperative satisfaction with sexual life [odds ratio (OR) 32, 95% confidence interval (CI) 10-125], good relationship with partner (OR 50, 95% CI 9-354), physical well-being (OR 0.30, 95% CI 0.09-0.88) and hormone replacement therapy (OR 0.23, 95% CI 0.06-0.78). CONCLUSIONS: Both TAH and SAH significantly reduce dyspareunia without having a negative effect on sexual function. The shift toward SAH seems unwarranted.