Segmental Acupuncture for Prevention of Recurrent Urinary Tract Infections. A Randomised Clinical Trial.

INTRODUCTION AND HYPOTHESIS: Urinary tract infections (UTIs) are a common medical problem and prophylaxis of recurrent UTIs is an ongoing clinical challenge. In the present study we examined whether acupuncture is able to prevent recurrent UTIs in women. METHODS: This multicentre randomised controlled trial, based at a University clinic and private acupuncture clinics, recruited women suffering from recurrent uncomplicated UTIs. Participants were randomised to the acupuncture group or control group. Acupuncture therapy consisted of 12 treatments over a period of 18 weeks, using a set of predefined body and ear acupuncture points. Cranberry products were recommended to all participants as standard of care. RESULTS: A total of 137 women were randomised (68 acupuncture, 69 control group) and occurrence of UTIs at 6 and 12 months could be assessed in 123 and 120 women respectively. Acupuncture combined with cranberry slightly increased the proportion of UTI-free women compared with cranberry alone at 6 months (59% vs 46%, p = 0.2). Between 6 and 12 months the proportion of UTI-free women was significantly higher in the acupuncture group (66 vs 45%, p = 0.03). The number of UTIs decreased from baseline to 12 months in both study groups. The number of UTIs at 12 months was significantly lower in the acupuncture group (median difference 1, p = 0.01). CONCLUSIONS: Segmental acupuncture may be an effective treatment option for women with recurrent UTIs over a longer follow-up period and may limit antibiotics use. Further studies are needed.

Aesthetic Outcome and Psychosexual Distress After Treatment for Vulvar High-Grade Squamous Intraepithelial Lesions.

OBJECTIVES: This study compared aesthetic outcome, psychosexual distress, and treatment satisfaction between women receiving surgical treatment or medical treatment with imiquimod for vulvar high-grade squamous intraepithelial lesion. MATERIALS AND METHODS: This is an extended analysis of the multicenter, randomized noninferiority trial "topical imiquimod versus surgery for vulvar intraepithelial neoplasia." Patients were randomized to primary topical treatment or surgery and stratified by unifocal or multifocal disease. Digital photos of vulvar appearance were subsequently assessed for aesthetic outcome by 3 investigators blinded to group allocation. Psychosexual distress and treatment satisfaction were assessed with the Cervical Dysplasia Distress Questionnaire, the Sexual Activity Questionnaire, and the Client Satisfaction Questionnaire at baseline and follow-up. RESULTS: One hundred ten patients aged between 19 and 82 years were enrolled. Per-protocol analysis showed complete clinical response in 80% (37/46) using imiquimod, compared with 79% (41/52) after one surgical intervention. Photodocumentation at baseline and 6-month follow-up was available for 84 of these patients (44 imiquimod, 40 surgery). Blinded reviewer assessments of lesion size and lesion severity showed improvement from baseline to follow-up, with no differences between treatment groups. Sexual pleasure, discomfort, and distress remained stable from baseline to follow-up in both groups. CONCLUSIONS: Good aesthetic outcome of vulvar high-grade squamous intraepithelial lesion treatment can be achieved with imiquimod and surgery, consisting of ablation or local excision. Treatment satisfaction and stable psychosexual health may not be dependent on chosen treatment modality, but rather on counseling in accordance with patients' preferences.

Topical imiquimod versus surgery for vulvar intraepithelial neoplasia: a multicentre, randomised, phase 3, non-inferiority trial.

BACKGROUND: The optimal management of vulvar high-grade squamous intraepithelial lesions (vHSILs) is challenging. Surgery is the standard treatment, but recurrences are observed in half of patients. Medical treatment with imiquimod is an effective alternative, but the two modalities have not been compared in a randomised trial. The aim of this study was to compare the clinical effectiveness, histological response, human papillomavirus (HPV) clearance, acceptance, and psychosexual morbidity of primary imiquimod treatment versus surgical treatment in women with vHSIL. METHODS: This study was a multicentre, randomised, phase 3, non-inferiority clinical trial done by the Austrian Gynaecological Oncology group at six hospitals in Austria. We recruited female patients aged 18-90 years with histologically confirmed vHSIL with visible unifocal or multifocal lesions. Main exclusion criteria were clinical suspicion of invasion, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, and any active treatment for vHSIL within the previous 3 months. Women with known immunodeficiency, who were pregnant, or who were lactating were excluded. Patients were randomly assigned (1:1) by block randomisation to imiquimod or surgery, and stratified by unifocal or multifocal disease. Treatment with imiquimod was self-administered in a slowly escalating dosage scheme up to three times per week for a period of 4-6 months. Surgery consisted of excision or ablation. Patients were assessed with vulvoscopy, vulvar biopsy, HPV tests, and patient-reported outcomes at baseline and after 6 months and 12 months. The primary endpoint was complete clinical response (CCR) at 6 months after local imiquimod treatment or one surgical intervention. Primary analysis was per protocol with a non-inferiority margin of 20%. This trial is registered at ClinicalTrials.gov, NCT01861535. FINDINGS: 110 patients with vHSIL (78% with unifocal vHSIL and 22% with multifocal vHSIL) were randomly assigned between June 7, 2013, and Jan 8, 2020. Clinical response to treatment could be assessed in 107 patients (54 in the imiquimod group and 53 in the surgery group), and 98 patients (46 in the imiquimod group and 52 in the surgery group) completed the study per protocol. 37 (80%) of 46 patients using imiquimod had CCR, compared with 41 (79%) of 52 patients after one surgical intervention, showing non-inferiority of the new treatment (difference in proportion -0·016, 95% CI -0·15 to -0·18; p=0·0056). Invasive disease was found in five patients at primary or secondary surgery, but not in patients with per-protocol imiquimod treatment. There was no significant difference in HPV clearance, adverse events, and treatment satisfaction between study groups. INTERPRETATION: Imiquimod is a safe, effective, and well accepted alternative to surgery for women with vHSIL and can be considered as first-line treatment. FUNDING: Austrian Science Fund and Austrian Gynaecological Oncology group.

Topical imiquimod compared with conization to treat cervical high-grade squamous intraepithelial lesions: Multicenter, randomized controlled trial.

OBJECTIVE: In a previous phase II trial, we showed that topical imiquimod (IMQ) therapy is an efficacious treatment for high-grade squamous intraepithelial lesion (HSIL). Aim of the present study was to investigate the non-inferiority of a 16-week topical, self-applied IMQ therapy compared to large loop excision of the transformation zone (LLETZ) in patients diagnosed with HSIL. METHODS: Phase III randomized, controlled, multicenter, open trial performed by Austrian Gynecologic Oncology group. Patients with histologically proven cervical intraepithelial neoplasia (CIN)2 (30 years and older) or CIN3 (18 years and older) and satisfactory colposcopy were randomized to topical IMQ treatment or LLETZ. Successful treatment was defined as negative HPV high-risk test result 6 months after start of the treatment. Secondary endpoints were histological outcome and HPV clearance rates. RESULTS: Within 3 years 93 patients were randomized, received the allocated treatment and were available for ITT analysis. In the IMQ group negative HPV test at 6 months after treatment start was observed in 22/51 (43.1%) of patients compared to 27/42 (64.3%) in the LLETZ group on ITT analysis (rate difference 21.2%-points, 95% two-sided CI: 0.8 to 39.1). In the IMQ group histologic regression 6 months after treatment was observed in 32/51 (63%) of patients and complete histologic remission was observed in 19/51 (37%) of patients. Complete surgical resection was observed in 84% after LLETZ. CONCLUSION: In women with HSIL, IMQ treatment results in lower HPV clearance rates when compared to LLETZ. LLETZ remains the standard for women with HSIL when treatment is required. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01283763, EudraCT number: 2012-004518-32.

Longitudinal Study of Pelvic Floor Characteristics Before, During, and After Pregnancy in Nulliparous Women.

OBJECTIVES: To investigate the changes in the pelvic floor before, during, and after pregnancy in the same collective of nulliparous women. METHODS: In a prospective observational pilot study between April 2015 and June 2019 in nulliparous women with planned pregnancy, we used the pelvic organ prolapse quantification (POP-Q) system; a 2-dimensional (2D) sonography to investigate the bladder neck, cervix, and anorectal junction positions; and a 3D/4D sonography to measure the hiatus of the levator ani muscle (LH area) during Valsalva maneuver. Five visits were planned: 1 before, 3 during, and 1 visit after pregnancy. RESULTS: Twenty-four women participated in the study. We achieved a minimum of 2 visit measurements from 10 women who became pregnant. The LH area decreased during the first trimester and then increased until the third trimester. Postpartum, the LH area reached the prepregnancy state. We observed changes in the bladder neck mobility, bladder neck position, cervix, and anorectal junction from the first trimester. Postpartum, the bladder neck mobility was higher, and the position of the bladder neck and anorectal junction was lower than before pregnancy. We observed no remarkable changes in the POP-Q state during pregnancy. CONCLUSION: This was the first study to investigate pelvic floor characteristics in the same collective before, during, and after pregnancy. We observed pelvic floor changes from the prepregnancy state to the first trimester to postpartum. The study results need to be confirmed in a larger study.

Psychometric properties and validation of two global impression questionnaires (PGI-S, PGI-I) for stress incontinence in a German-speaking female population.

AIMS: The Patient Global Index of Severity (PGI-S) and the Patient Global Index of Improvement (PGI-I) are global impression questionnaires developed in English and validated in women with stress urinary incontinence (SUI). This validation study tested the psychometric properties of German-language versions of the two questionnaires in German-speaking women with SUI. METHODS: The German-language PGI-S and PGI-I were psychometrically tested and validated using the SF-12 questionnaire, the Kinǵs Health Questionnaire (KHQ), clinical parameters, incontinence episode frequency and pad use in 311 patients before and 3 months after receiving a TVT-O or TVT tape for SUI. RESULTS: At baseline and 3 months postoperatively there was a positive correlation between PGI-S response categories and clinical parameters, IEF and pad use, and nearly all KHQ subscales. There were no correlations between response categories of PGI-S at baseline and PGI-I at 3 months and the SF-12 scales PCS-12 and MCS-12. CONCLUSION: Our results demonstrated good psychometric properties of the German-language PGI-S and PGI in German-speaking women with SUI.

Prenatal acupuncture: Women's expectations and satisfaction and influence on labor.

BACKGROUND: Use of prenatal acupuncture for labor preparation is common, but there is still conflicting evidence with respect to its objective obstetric benefits. There is little information on women's expectations and subjective experiences with acupuncture treatments. METHODS: In this retrospective cohort study, a validated questionnaire on women's treatment satisfaction was sent to women who had received prenatal acupuncture at the obstetric clinic of the Medical University of Graz, Austria within the last 3 years. The electronic obstetric database was used to extract detailed clinical and obstetric data of women who received acupuncture and delivered at the hospital. For comparison, obstetric data were matched with a control group of women without prenatal acupuncture, who had given birth at the hospital during the study period. RESULTS: The questionnaire was sent to 150 women, out of which 70 (46.7%) completed and returned the questionnaire. Analysis of the questionnaire indicated good overall satisfaction (mean sum score 26.22 ± 4.72) with acupuncture treatment-97.1% indicated that they were very or quite satisfied. Responders did not differ from nonresponders, except for the time between delivery and questionnaire (P = .015). Comparisons between the deliveries after prenatal acupuncture (n = 144) and the matched control deliveries (n = 576) showed no statistical significant differences in the length of labor and use of analgesics. CONCLUSION: Prenatal acupuncture is likely to have positive effects on pregnant women, aside from an objective influence on labor duration and pain.

Objective outcome and quality-of-life assessment in women with repeat incontinence surgery.

AIMS: To evaluate subjective and objective outcome after repeat surgery for stress urinary incontinence (SUI). METHODS: Patients who underwent a midurethral tape after failed Burch colposuspension or failed midurethal tape between 1999 and 2014 were invited for follow-up. Urogynecological examination and urodynamics was performed, and objective cure was defined as a negative cough stress test; subjective cure was defined as negotiation of SUI symptoms. Quality-of-life (QoL), sexual health, and subjective success was assessed with the King's Health Questionnaire, Incontinence Outcome Questionnaire, Female Sexual Function Index, and the Patient Global Impression of Improvement (PGI-I) score. RESULTS: Overall 52 women underwent repeat incontinence surgery. Out of the 44 women still alive, 33 (75%) were available for follow-up. All 33 women completed the questionnaires; 23 women (70%) attended the clinic and also had an urogynecological examination. At a median follow-up of 11 years, subjective cure was 67% (22/33), objective cure was 65% (16/23), and subjective success according to PGI-I was 78% (18/23), with no significant differences between groups. No erosions of suture or tape material into the bladder, urethra, or vagina were seen. Two women had received a third anti-incontinence operation with TVT after failed tape after failed Burch, and were continent at follow-up. Two women with tape after colposuspension required division of the tape and both were continent at the time of follow-up. With regard to QoL and sexual health, no significant differences were seen for most domains. CONCLUSIONS: Midurethral tapes are an option for women with recurrent SUI after previous colposuspension or midurethral tape.

Ten-Year Followup after Tension-Free Vaginal Tape-Obturator Procedure for Stress Urinary Incontinence.

PURPOSE: Suburethral tapes are a standard surgical treatment for stress urinary incontinence. The aim of the study was to evaluate subjective and objective cure rates 10 years after a tension-free vaginal tape-obturator procedure. MATERIALS AND METHODS: All 124 patients who underwent the tension-free vaginal tape-obturator procedure at a total of 2 centers in 2004 and 2005 were invited for followup. Objective cure was defined as a negative cough stress test at 300 ml. Subjects completed KHQ (King's Health Questionnaire), IOQ (Incontinence Outcome Questionnaire), FSFI (Female Sexual Function Index Questionnaire) and PGI-I (Patient Global Impression of Improvement). RESULTS: Overall, 55 of 112 women (49%) who were alive were available for clinical examination and 71 (63%) completed the questionnaires. The objective cure rate in the 55 women examined clinically was 69%, 22% were not cured and 9% (5) had undergone reoperation for recurrent or persistent stress urinary incontinence. Treatment was counted as having failed in these 5 women for study purposes. Subjective cure was reported by 45 of 71 women (64%). Three patients (5%) had vaginal tape extrusion at the time of clinical examination. Extrusion in all of them was small and asymptomatic, and did not require treatment for a cumulative extrusion rate of 7%. Six women (9%) had undergone reoperation for tension-free vaginal tape-obturator associated complications and 18 (26%) experienced de novo overactive bladder. CONCLUSIONS: Subjective and objective cure rates 10 years after the tension-free vaginal tape-obturator procedure were 69% and 64%, respectively. The vaginal extrusion rate in this study was slightly higher than in other series but major long-term complications appeared to be rare.

Sexual Activity, Psychosexual Distress, and Fear of Progression in Women With Human Papillomavirus-Related Premalignant Genital Lesions.

INTRODUCTION: Genital human papillomavirus (HPV) infections are very common in women 18 to 30 years old and substantially affect women's sexual health. AIM: To examine sexual activity, psychosexual distress, and fear of progression in women diagnosed with HPV-related precancerous genital lesions. METHODS: In this observational study, women diagnosed with premalignant lesions of the cervix, vagina, or vulva were recruited from a university hospital-based colposcopy clinic. MAIN OUTCOME MEASURES: Quantitative data from three validated patient-administered questionnaires (Sexual Activity Questionnaire, German version of the Cervical Dysplasia Distress Questionnaire, and Fear of Progression Questionnaire) were compared within the study population, according to the location of the genital lesion, and with relevant reference populations. Qualitative data from two written open-ended questions about women's thoughts regarding diagnosis and information were analyzed. RESULTS: Two-hundred nine women completed the questionnaires. Seventy-eight percent of women (n = 162) were referred for evaluation of suspect lesions of the cervix, 8% (n = 17) of the vagina, and 14% (n = 30) of the vulva. There were no significant differences in questionnaire results among the three patient groups, except for sexual consequences (Cervical Dysplasia Distress Questionnaire) and recent sexual activity (Sexual Activity Questionnaire). Women with vulvar lesions were most likely to worry about sexual consequences (ie, being unable to have children, being sexually less attractive, or infecting a sexual partner; P = .04). The Sexual Activity Questionnaire subscales sexual pleasure (P = .15) and sexual habits (P = 1.00) were similar to those in a healthy control population, whereas sexual discomfort (P = .51) was comparable to that in a reference population of women who survived cervical cancer. The subscale partner-specific concerns (Fear of Progression Questionnaire) was similar to that in a reference population of patients with cancer (P = .28). CONCLUSION: HPV-related precancerous genital lesions, especially of the vulva, are likely to cause concerns about sexual health. Effective information and communication are important to lessen negative sexual consequences and anxiety.

German translation and validation of the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-IUGA revised (PISQ-IR).

INTRODUCTION AND HYPOTHESIS: Condition-specific sexual questionnaires are essential for clinical trials and important patient-reported outcome measures. The aim of the study was to translate the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-International Urogynecology Association Revised (PISQ-IR) into German and to clinically validate it in a German-speaking population. METHODS: The translated PISQ-IR was linguistically validated in two rounds of cognitive interviews. The final instrument was psychometrically validated in women presenting to urogynecological clinics with pelvic floor dysfunction. For analysis of criterion validity, three related self-reported measures were administered: the Female Sexual Function Index (FSFI), the Kings Health Questionnaire (KHQ), and the 36-Item Short Form Health Survey (SF-36). For external validity, PISQ-IR subscales were compared to the clinical-measures Pelvic Organ Prolapse Quantification system (POP-Q) stage, pelvic floor muscle tone, and Oxford Grading Scale. Descriptive statistics, floor and ceiling effects, internal consistency using Cronbach's alpha coefficient, and Pearson correlations were calculated for all PISQ-IR subscales. RESULTS: The PISQ-IR was completed by 197 women, out of whom 66 (33.5 %) considered themselves not sexually active (NSA) and 131 (66.5 %) as sexually active (SA). Participants' mean age was 57 ± 12 years; 50 % were diagnosed with symptomatic POP, 74 % with urinary incontinence (UI) and 4 % with anal incontinence (AI). The PISQ-IR subscales were analyzed separately for SA and NSA women with Cronbach's alpha coefficients ranging from 0.64 to 0.94. Moderate to high correlations were observed between PISQ-IR subscales and related quality of life (QoL) scales and corresponding FSFI scales. CONCLUSION: Initial testing of the German PISQ-IR suggests it is an internally consistent and valid tool for use in clinical practice and research.

Levator ani trauma and pelvic organ prolapse - a comparison of three translabial ultrasound scoring systems.

INTRODUCTION: The study aimed to analyze the relation between the degree of puborectalis muscle trauma and subjective symptoms and objective findings of pelvic organ prolapse (POP), comparing two continuous scoring systems with a discrete scoring system for translabial ultrasound imaging. MATERIAL AND METHODS: In this retrospective observational study the records of patients attending a tertiary urogynecological unit between January 2012 and December 2014 were analyzed. POP assessment included a standardized interview, clinical examination using Pelvic Organ Prolapse Quantification and four-dimensional translabial ultrasound. Puborectalis muscle trauma was assessed with tomographic ultrasound imaging using two continuous scoring systems and a previously established discrete system. Receiver operating characteristics and adjusted odds ratios were used for comparison of scoring systems in predicting symptoms and signs of POP. RESULTS: Of 1258 women analyzed, 52.6% complained of prolapse symptoms. On ultrasound imaging, 65.7% of women had sonographically significant POP. Complete avulsion was diagnosed in 25.3% of women, being unilateral in 13.9% and bilateral in 11.4%. A maximum score in the 6-point and the 12-point tomographic ultrasound imaging scale increased the odds for a diagnosis of any significant POP on ultrasound by 4.4 and 4.8 times, respectively, compared with 4.6 times for the discrete diagnosis of bilateral avulsion. For all avulsion scoring systems the relation was strongest for cystocele and uterine prolapse. CONCLUSIONS: A continuous avulsion scoring system based on tomographic findings does not provide superior performance for the prediction of subjective symptoms and objective findings of prolapse compared with a discrete diagnostic system of unilateral or bilateral avulsion.

The "bother" of urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Patient reported measures are important for the evaluation of symptom-specific bother and the distinction between different types of urinary incontinence. The aim of the study was to assess the validity of physician administered visual analogue scales (VAS) for the bother from stress urinary incontinence (SUI) and urge urinary incontinence (UUI). METHODS: In this prospective cohort study based at a tertiary urogynecological unit, women attending for investigation of lower urinary tract symptoms (n = 504) were asked to indicate their subjective bother from SUI and UUI on a 10-cm VAS. Clinical assessment, including multichannel urodynamic testing and 4D translabial ultrasound was performed for clinical diagnosis. Linear regression was used to model the average increase in VAS bother score of SUI and UUI for each explanatory variable. RESULTS: 74 % (n = 375) reported symptoms of SUI, with mean bother of 5.7 out of 10 (SD 2.8), and 73 % (n = 370) symptoms of UUI, with a mean bother of 6.5 out of 10 (SD 2.6). Bother from UUI was positively associated with the symptoms of nocturia (p < 0.0001) and frequency (p = 0.002), and the urodynamic findings of detrusor overactivity (p < 0.0001). Bother from SUI was positively related to the urodynamic diagnosis of USI (p < 0.0001) and a low abdominal leak point pressure (ALPP) (p = 0.002), as well as to the ultrasound findings of cystourethrocele (p < 0.0001) and funnelling (p = 0.04). All univariate associations remained highly significant on multivariate analysis, controlling for age, BMI, parity, previous incontinence/prolapse surgery and previous hysterectomy. CONCLUSIONS: Physician-administered VAS are a valid, reliable and practicable tool to measure bother related to SUI and UUI.

Reasons for dissatisfaction ten years after TVT procedure.

INTRODUCTION AND HYPOTHESIS: The aim of the study was to assess the reasons for dissatisfaction 10 years after TVT placement. METHODS: Patients who underwent TVT surgery between 1999 and 2001 at two participating units were included. All patients who did not consider themselves to be cured were asked for their reasons. RESULTS: 141 out of 210 patients (81 %) were available for follow-up (median 116 months). In the group of 56 patients who did not consider themselves cured, the reasons were OAB symptoms in 29 patients (52 %), stress urinary incontinence in 13 patients (23 %), and complaints of mixed urinary incontinence in 8 patients (14 %). 85 % of all patients reporting urgency complaints at the time of follow-up and 66 % of patients with SUI at the time of follow-up did not consider themselves cured. CONCLUSIONS: In most cases overactive bladder symptoms were the reason for dissatisfaction. The results of this study support using composite outcomes to assess the results of surgery for urinary incontinence.

p16/Ki-67 dual-stained cytology testing may predict postpartum outcome in patients with abnormal papanicolaou cytology during pregnancy.

OBJECTIVE: To evaluate the use of a new immunocytochemical dual-staining protocol, which allows for the detection of coexpression of the p16(INK4a) (p16) and Ki-67 biomarkers in prenatal care. It was hypothesized that dual-staining cytology may predict postpartum outcome in patients with abnormal cervical Papanicolaou (Pap) smears during pregnancy. STUDY DESIGN: In this retrospective pilot study, 27 abnormal Pap smears collected from women during early pregnancy were destained and subsequently stained for p16/Ki-67. RESULTS were correlated with histologic outcome collected during postpartum follow-up. RESULTS: Fourteen of 20 abnormal Pap smears during pregnancy showed a positive p16/Ki-67 dual-stained cytology result, whereas 6 specimens tested negative. Seven cases were excluded due to technical reasons. All 14 patients who were positive for p16/Ki-67 dual stain had cervical intraepithelial neoplasia (CIN) on postpartum histology. In contrast, 5 out of 6 patients negative for p16/Ki-67 dual-staining had a negative histology postpartum and during follow-up, and the remaining patient showed a CIN1 (p < 0.001). CONCLUSION: p16/Ki-67 dual-stained cytology may provide a valuable novel approach to identify pregnant women with persistent or progressing CIN disease and may help improve the management of abnormal Pap cytology results during pregnancy.

Vaginal laser therapy versus hyaluronic acid suppositories for women with symptoms of urogenital atrophy after treatment for breast cancer: A randomized controlled trial.

BACKGROUND: Urogenital atrophy affects >50 % of women after breast cancer (BC) and there is reluctance to use local estrogen for this group. Hormone-free therapies like intravaginal laser therapy and hyaluronic acid suppositories have been shown to produce symptom relief in women with BC and urogenital atrophy, but have not been tested against each other. The aim of this study was to compare these nonhormonal modalities in women with urogenital atrophy after BC in a randomized fashion. STUDY DESIGN: We randomly assigned 43 women (aged 49-58 years, mean age 54 years) with urogenital atrophy and a history of BC to receive intravaginal laser therapy (2 courses within 1 month) or hyaluronic acid suppositories (3 times/week continuously for three months). The primary endpoint was score on the Vaginal Health Index after 3 months. Secondary endpoints were subjective bother on a numeric rating scale for all urogenital atrophy domains, quality of life, sexual health and pelvic organ prolapse symptoms using validated questionnaires. RESULTS: Of the 43 women who participated, 22 were randomized to intravaginal laser therapy, and 21 to vaginal suppositories. At 3 months score on the Vaginal Health Index had improved significantly in both groups (p = 0.001), without a significant difference between treatment groups (p = 0.232). Significant improvement was also seen in both groups for subjective bother of urogenital atrophy, quality of life and sexual health, without significant differences between laser or hyaluronic acid therapy. CONCLUSIONS: Both intravaginal laser therapy and hyaluronic acid suppositories are effective treatment options for women after BC suffering from urogenital atrophy. No difference was found between treatment regimens. CLINICALTRIALS: gov identifier: NCT03816735, https://clinicaltrials.gov/ct2/show/NCT03816735.

Does mode of delivery impact the course of cervical dysplasia in pregnancy? A review of 219 cases.

OBJECTIVE: The prevalence of cervical intraepithelial neoplasia (CIN) in pregnancy is about 1%. The aim of this study was to analyze the regression, persistence and progression rates of cervical dysplasia in pregnancy and the impact of delivery mode. STUDY DESIGN: In this retrospective study, data from pregnant patients with abnormal cytology findings, who presented to a colposcopic outpatient clinic of a university hospital within the last 10 years, were analyzed. Information on cytology, histology and Human Papillomavirus (HPV) status during pregnancy and postpartum and mode of delivery was collected. RESULTS: 219 women, who were assessed with cytology and /or biopsy antepartum and postpartum between January 2010 and July 2020, were included in the study. Antepartum patients presented with low grade squamous intraepithelial lesions (LSIL) in 37% and high grade squamous intraepithelial lesions (HSIL) in 53%. During pregnancy biopsy was performed in 78 patients (36%). Postpartum evaluation revealed an overall regression rate of 39%. Persistence rates were especially high in the HSIL group with 70 %. HSIL regressed in 28 %. Progression to invasive disease was rare and seen in two patients postpartum only. 141 women delivered vaginally (VD) and 51 received a cesarean section (CS). Regression rates were similar: 36 % and 47 %. There was no significant difference in progression or persistence rates. CONCLUSION: Our study demonstrates that mode of delivery does not influence the course of SIL. SIL show high rates of regression and persistence, progression to invasive disease is rare.

Ten-year follow-up after the tension-free vaginal tape procedure.

OBJECTIVE: The current study aimed to evaluate objective and subjective results 10 years after the tension-free vaginal tape procedure. STUDY DESIGN: Two hundred ten patients who underwent a tension-free vaginal tape procedure at the 2 participating units between 1999 and 2001 were invited for follow-up. Evaluation at 10 years included history, clinical examination, cystoscopy, urodynamics, a cough stress test, and the Incontinence Outcome Questionnaire. RESULTS: Interview data were available for 67%; full clinical investigation was performed in 56% of patients. At 10 years, the clinical stress test was negative in 84%, slightly positive in 8.5%, and strongly positive in 4.3%. Subjectively, 57% of patients considered themselves "cured," 23% "improved," 6.4% "unchanged," and 11% "worse." Eleven of 141 (7.8%) had been reoperated in the interim. The rate of de novo urgency was 20%. Obesity seemed to be a risk factor for failure. CONCLUSION: These data indicate satisfactory objective and subjective cure rates 10 years after tension-free vaginal tape procedure placement.

Patient-reported outcomes and urinary continence five years after the tension-free vaginal tape operation.

AIMS: To evaluate patient-reported outcomes and continence rates 5 years after the tension-free vaginal tape (TVT) operation and to compare these with subjective and objective cure rates. METHODS: A total of 101 patients underwent clinical and urodynamic assessment and completed the Incontinence Outcome Questionnaire (IOQ) 5 years after the retropubic TVT operation. The IOQ results were compared with the subjective and objective cure rates. RESULTS: At 5 years 85% of patients had a negative clinical stress test. Based on clinical stress test, stable cystometry to ≥300 ml and residual volume ≤100 ml, the physician assessment of cure was 80%. Patient-reported outcome showed improvement in incontinence symptoms in 86% of patients. Eighty-three percent of patients were satisfied with the results and 92% would recommend the operation to others. The results of the IOQ correlated more with patient-reported than with physician-assessed cure rates. CONCLUSION: Patient report high rates of satisfaction 5 years after the TVT operation.

Quality of life after periurethral injection with polyacrylamide hydrogel for stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The purpose of this observational study was to examine the effect of periurethral injections with polyacrylamide hydrogel (PAHG) on quality of life (QoL) in selected patients with stress urinary incontinence (SUI). METHODS: Fifty-four women with comorbidities or other reasons precluding other surgery received PAHG for SUI. Patient-reported outcomes were assessed with the "Incontinence Outcome Questionnaire" (IOQ) 9 months postoperatively. The IOQ is a 27-item, condition-specific instrument that assesses patient-reported outcomes after incontinence surgery. RESULTS: Forty-two women (78%) completed the questionnaire. Responses ranged from considerable (40%) and slight improvement (21%) to no change (29%) and worsening of symptoms (10%). CONCLUSION: Periurethral injections with PAHG are likely to provide relief of symptoms and improvement in QoL.