Treatment outcome of women with urodynamic mixed urinary incontinence: an observational study.

INTRODUCTION AND HYPOTHESIS: Mixed urinary incontinence (MUI) is a common yet understudied condition. It remains a therapeutic challenge, with the presence of both stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). There is limited information on the optimal management for women with urodynamic MUI (urodynamic stress incontinence and detrusor overactivity). We assessed the treatment outcome of pelvic floor muscle training (PFMT), medical treatment and surgery for women who were diagnosed with urodynamic MUI. METHODS: A prospective observational study was carried out on women with urodynamic MUI from 2010 to 2018. All women underwent clinical assessment and standardised urodynamic evaluation. All women received PFMT from a specialised continence advisor as initial management. Antimuscarinics and/or continence surgery were considered according to the woman's response and symptoms after PFMT. Subjective outcome after each treatment modality was analysed. RESULTS: A total of 198 women were included for analysis. All women received PFMT, 104 (52.5%) showing improvement in urinary incontinence. Eighty-seven (43.9%) women were offered antimuscarinics, of whom 58 (29.3%) showed subjective improvement in both SUI and UUI, and 10 (5%) reported a reduction in UUI but persistent SUI. A total of 55 (27.7%) women received surgical treatment, with 20 receiving continence procedures. Sixteen out of twenty (80%) of them reported improvement in both SUI and UUI. None reported worsening of urgency or UUI. Overall, across all treatment modalities, 73.8% of women showed improvement in both SUI and UUI. CONCLUSION: Future analyses can help to inform which patients will have a higher success rate after each treatment modality and help focus treatment effort on those with a high risk of persistent symptoms. This will provide relevant data in counselling women, giving reasonable expectations and directing the management of women with urodynamic MUI.

Effect of additional acupuncture to pelvic floor exercise on urinary incontinence: A randomized controlled trial.

AIMS: To investigate the additional benefit of acupuncture to pelvic floor exercise (PFE) on the improvement of urinary incontinence (UI) and quality of life (QoL) in women. METHODS: This was a single-blinded randomized controlled trial in a tertiary university hospital. Women with UI in various severity and types were randomized to receive either a weekly course of acupuncture with PFE or PFE alone for 6 weeks and then followed up for 24 weeks in every 6 weeks. Investigators were blinded to group allocation in pre- and postintervention assessments. Primary outcome was subjective changes of UI symptoms at 24 weeks. Secondary outcomes were episodes and severity of UI from bladder diary, severity by Visual Analogue Scale, and QoL scores by validated Chinese short-form of Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7). RESULTS: One hundred seventy-nine women were screened while 137 were randomized. Significant subjective improvement in UI symptoms was demonstrated at all follow-up, latest at 24 weeks (odds ratio [OR]: 2.29, 95% confidence Interval [CI]: 1.02-5.12, respectively), with reduced episodes and severity of UI after (p < 0.05), and a trend of improvement in IIQ-7 score (p = 0.05). No major adverse events occurred. History of 2 years or longer duration of UI symptoms was associated with lower effectiveness of acupuncture (OR: 0.08, 95% CI: 0.01-0.68).

Efficacy and outcomes of transobturator tension-free vaginal tape with or without concomitant pelvic floor repair surgery for urinary stress incontinence: five-year follow-up.

OBJECTIVES: To compare the 5-year subjective and objective outcomes of transobturator tension-free vaginal tape alone versus the same procedure with concomitant pelvic floor repair surgery for pelvic organ prolapse in women with urinary stress incontinence. DESIGN: Prospective cohort study. SETTING: Urogynaecology unit at a university hospital in Hong Kong. PATIENTS: Of 218 women, 96 (44%) received transobturator tension-free vaginal tape alone and 122 (56%) received transobturator tension-free vaginal tape with concomitant pelvic floor repair surgery from September 2004 to December 2009. The women were followed up annually for up to 5 years after the operation. MAIN OUTCOME MEASURES: The 5-year subjective and objective cure rates were assessed. Subjective cure was defined as no urine loss during physical activity and objective cure was defined as no urine leakage on coughing during urodynamic study. RESULTS: Overall, 88 women receiving transobturator tension-free vaginal tape alone and 101 women receiving transobturator tension-free vaginal tape with concomitant pelvic floor repair surgery were followed up for 5 years after operation. The subjective and objective cure rates of the two groups were 70.5% versus 94.1% (P<0.01) and 80.3% versus 85.7% (P=0.58), respectively. CONCLUSIONS: Transobturator tension-free vaginal tape is an effective treatment for urinary stress incontinence in women who received it alone or with concomitant pelvic floor repair surgery for pelvic organ prolapse, providing high subjective and objective efficacy for up to 5 years after operation. Transobturator tension-free vaginal tape with concomitant pelvic floor repair surgery achieved similar, if not better, long-term outcome compared with transobturator tension-free vaginal tape alone.

Effect of levator ani muscle injury on primiparous women during the first year after childbirth.

INTRODUCTION AND HYPOTHESIS: To evaluate the effect of levator ani muscle (LAM) injury on pelvic floor disorders and health-related quality of life in Chinese primiparous women during the first year after delivery. METHODS: At 8 weeks and 12 months after delivery, 328 women were assessed for symptoms of pelvic floor disorders and quality of life using the standardised questionnaire, POP-Q; and translabial ultrasound to detect LAM injury. Descriptive analysis, independent sample t test, non-parametric testing, Chi-squared test and two-sided Fisher's exact test were used. RESULTS: At 8 weeks after delivery, 48 (19.0% [95% CI, 14.2-23.8%]) women with vaginal delivery had LAM injury; 38 women (79.2%) had persistent LAM injury at 12 months. At 8 weeks, LAM injury was associated with prolapse symptoms, descent at Pelvic Organ Prolapse Quantification (POP-Q) Aa and Ba points and a higher Pelvic Organ Prolapse Distress Inventory (POPDI) general and Urinary Distress Inventory (UDI) Obstructive subscale score. At 12 months, it was not associated with prolapse symptoms, Pelvic Floor Distress Inventory (PFDI) or Pelvic Floor Impact Questionnaire (PFIQ). There was also no association between stress urinary incontinence (SUI), urge urinary incontinence (UUI), mixed urinary incontinence (UI), faecal incontinence (FI) with LAM injury at both time points. CONCLUSIONS: Seventy-nine per cent of women who had LAM injury at 8 weeks after vaginal delivery had persistent LAM injury at 12 months. LAM injury was associated with prolapse symptoms, lower POP-Q Aa and Ba points at 8 weeks after delivery and a higher POPDI general and UDI Obstructive subscale scoring. However, we are not able to confirm the association between LAM injury and SUI, UUI, mixed UI, FI at 8 weeks or 12 months after delivery; or prolapse symptoms, PFDI or PFIQ scores at 12 months after delivery.

A pilot study of urine cytokines in ketamine-associated lower urinary tract symptoms.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to investigate urine cytokine and chemokine levels in symptomatic ketamine abusers compared with age-matched controls. METHODS: Midstream urine specimens were collected in a prospective study of 23 ketamine abusers and 27 controls who had never used ketamine. Their basic demographic and urinary symptoms were compared. The urine was analyzed by a multiplex panel screen for 19 cytokines/chemokines: EGF, GM-CSF, GRO, IL-1Ra, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12p40, IL-12p70, IP-10, MCP-1, MIP-1b, sCD40L, sIL-2Ra, VEGF, MCP-4, and TARC using Luminex™ xMAP® technology. Protein concentration values were normalized to urine creatinine concentrations. RESULTS: Mean age of the control group was 21.1 ± 4.3 years (n = 27) and of the ketamine group was 20.6 ± 3.7 years (n = 23). All participants were women. The urine cytokine analysis showed a significant elevation in EGF levels in the ketamine group with lower urinary tract symptoms (LUTS) compared with the control group (p < 0.005). Levels of the remaining 18 proteins tested were not different from control values. CONCLUSIONS: Urinary EGF levels were increased among symptomatic ketamine abusers. This suggests inflammation and epithelial repair may play a role in ketamine-associated LUTS, and this may in turn help in understanding the pathophysiology of this disease entity, leading to better treatment options.

Prevalence of urinary and fecal incontinence in Chinese women during and after their first pregnancy.

INTRODUCTION AND HYPOTHESIS: This study evaluated factors and their prevalence associated with urinary (UI) and fecal (FI) incontinence during and after a woman's first pregnancy. METHODS: Nulliparous Chinese women with no UI or FI before pregnancy were studied with a standardized questionnaire for UI and FI from early pregnancy until 12 months after childbirth. Maternal characteristics and obstetric data were analyzed using descriptive analysis, independent sample t test, chi-square test, and logistic regression. RESULTS: Three hundred and twenty-eight (74.2 %) women completed the study. The prevalence of antenatal UI increased with gestation. Overall, 192 (58.5 %), 60 (18.3 %), and 76 (23.1 %) had normal vaginal delivery, instrumental delivery, and cesarean section, respectively. Twelve months after delivery, prevalence of stress urinary incontinence (SUI) and urge urinary incontinence (UUI) was 25.9 % [95 % confidence interval (CI) 21.5-30.6] and 8.2 % (95 % CI 5.2-11.2), respectively. In those who delivered vaginally, the prevalence was 29.7 % and 9.1 %, respectively. Prevalence of FI was 4.0 % (95 % CI 1.9-6.1). On logistic regression, vaginal delivery [odds ratio (OR) 3.6], antenatal SUI (OR 2.8), and UUI (OR 2.4) were associated with SUI. Antenatal UUI (OR 6.4) and increasing maternal body mass index (BMI) at the first trimester (OR 1.2) were associated with UUI. Antenatal FI was associated with FI (OR 6.1). CONCLUSIONS: The prevalence of SUI, UUI, and FI were 25.9 %, 8.2 %, and 4.0 %, respectively, 12 months after delivery. Vaginal delivery, antenatal SUI, and UUI were associated with SUI; antenatal UUI and increasing maternal BMI at the first trimester were associated with UUI. Antenatal FI was associated with FI. Pregnancy, regardless of route of delivery and obstetric practice, had an effect on UI and FI.

Risk of malignancy in women who underwent hysterectomy for uterine prolapse.

AIMS: To evaluate the risk of missing a malignancy in surgical specimens following hysterectomy for uterine prolapse if routine pathological examination is not performed. Additionally, information on the risk of missing an hitherto unsuspected malignancy if uterine preservation is the preferred management option will be provided. MATERIALS AND METHODS: A retrospective study was performed on all cases of surgery performed for uterine prolapse in a tertiary referral institution from 2003 to 2011. Those with confirmed malignancy before operation were excluded. The study subjects had their clinical history, investigations, the type of operations and histopathology report analysed. They were classified into symptomatic or asymptomatic, depending on whether they reported symptoms that were suggestive of uterine malignancy. RESULTS: A total of 640 women were studied. Three cases of hitherto unsuspected uterine malignancy were found, giving an incidence of 0.47%. Among the 456 asymptomatic women, both pre- and postmenopausal, the risk of incidental malignancy was 0.22%. Within the postmenopausal group, risk of incidental malignancy was 0.26%. Another 3 cases of uterine premalignant conditions were identified, giving an overall risk of premalignant and malignant uterine condition of 0.94%. Five cases of cervical intra-epithelial neoplasia were found, contributing to a risk of 0.78%. CONCLUSIONS: The risk of missing an uterine malignancy in patients with uterine prolapse is low if appropriate investigations are carried out prior to surgery. If hysterectomy is to be performed, we recommend that all surgical specimens be subjected to histopathological examination.

Tension-free vaginal mesh for the treatment of pelvic organ prolapse in Chinese women.

OBJECTIVE: To assess perioperative and short-term outcomes after tension-free vaginal mesh repair of pelvic organ prolapse in local Chinese women. DESIGN: Case series. SETTING: The urogynaecology unit of a university teaching hospital in Hong Kong. PATIENTS: All women with stage III or more pelvic organ prolapse who underwent tension-free vaginal mesh repair with or without vaginal hysterectomy from May 2007 to June 2011. MAIN OUTCOME MEASURES: Perioperative and short-term outcomes. RESULTS: In all, 47 women underwent the procedure during the study period. The mean operating time was 94 minutes, the mean estimated blood loss was 163 mL, and the mean hospital stay was 4 days. Four patients had visceral injuries, all of which were identified and repaired during the operation; all four patients recovered uneventfully. The mean duration of follow-up was 25 (standard deviation, 13) months. Pelvic organ prolapse quantification improved significantly; nine (19%) of the patients had recurrent stage II prolapse but only one was symptomatic, six (13%) had postoperative mesh exposure, three of whom underwent mesh excision. There were five (11%) who had de-novo urodynamic stress incontinence, which was mostly mild and managed conservatively. Overall 91% (43/47) were satisfied with their operative outcome. CONCLUSIONS: The success rate of tension-free vaginal mesh repair for the treatment of pelvic organ prolapse in local Chinese women was comparable to rates reported internationally. There was a high degree of subjective satisfaction with the procedure. There were low rates of mesh exposure and de-novo stress incontinence that was mostly asymptomatic or mild.

Automated segmentation and measurement of the female pelvic floor from the mid-sagittal plane of 3D ultrasound volumes.

BACKGROUND: Transperineal ultrasound (TPUS) is a valuable imaging tool for evaluating patients with pelvic floor disorders, including pelvic organ prolapse (POP). Currently, measurements of anatomical structures in the mid-sagittal plane of 2D and 3D US volumes are obtained manually, which is time-consuming, has high intra-rater variability, and requires an expert in pelvic floor US interpretation. Manual segmentation and biometric measurement can take 15 min per 2D mid-sagittal image by an expert operator. An automated segmentation method would provide quantitative data relevant to pelvic floor disorders and improve the efficiency and reproducibility of segmentation-based biometric methods. PURPOSE: Develop a fast, reproducible, and automated method of acquiring biometric measurements and organ segmentations from the mid-sagittal plane of female 3D TPUS volumes. METHODS: Our method used a nnU-Net segmentation model to segment the pubis symphysis, urethra, bladder, rectum, rectal ampulla, and anorectal angle in the mid-sagittal plane of female 3D TPUS volumes. We developed an algorithm to extract relevant biometrics from the segmentations. Our dataset included 248 3D TPUS volumes, 126/122 rest/Valsalva split, from 135 patients. System performance was assessed by comparing the automated results with manual ground truth data using the Dice similarity coefficient (DSC) and average absolute difference (AD). Intra-class correlation coefficient (ICC) and time difference were used to compare reproducibility and efficiency between manual and automated methods respectively. High ICC, low AD and reduction in time indicated an accurate and reliable automated system, making TPUS an efficient alternative for POP assessment. Paired t-test and non-parametric Wilcoxon signed-rank test were conducted, with p < 0.05 determining significance. RESULTS: The nnU-Net segmentation model reported average DSC and p values (in brackets), compared to the next best tested model, of 87.4% (<0.0001), 68.5% (<0.0001), 61.0% (0.1), 54.6% (0.04), 49.2% (<0.0001) and 33.7% (0.02) for bladder, rectum, urethra, pubic symphysis, anorectal angle, and rectal ampulla respectively. The average ADs for the bladder neck position, bladder descent, rectal ampulla descent and retrovesical angle were 3.2 mm, 4.5 mm, 5.3 mm and 27.3°, respectively. The biometric algorithm had an ICC > 0.80 for the bladder neck position, bladder descent and rectal ampulla descent when compared to manual measurements, indicating high reproducibility. The proposed algorithms required approximately 1.27 s to analyze one image. The manual ground truths were performed by a single expert operator. In addition, due to high operator dependency for TPUS image collection, we would need to pursue further studies with images collected from multiple operators. CONCLUSIONS: Based on our search in scientific databases (i.e., Web of Science, IEEE Xplore Digital Library, Elsevier ScienceDirect and PubMed), this is the first reported work of an automated segmentation and biometric measurement system for the mid-sagittal plane of 3D TPUS volumes. The proposed algorithm pipeline can improve the efficiency (1.27 s compared to 15 min manually) and has high reproducibility (high ICC values) compared to manual TPUS analysis for pelvic floor disorder diagnosis. Further studies are needed to verify this system's viability using multiple TPUS operators and multiple experts for performing manual segmentation and extracting biometrics from the images.

The risk of preterm delivery prior to 34 weeks in women presenting with antepartum haemorrhage of unknown origin.

BACKGROUND: The management of antepartum haemorrhage of unknown origin (APHUO) remote from term remains controversial. AIM: To determine the rate and risk factors in predicting preterm delivery among women presenting with APHUO before 34 weeks of gestation. METHODS: All singleton pregnancies with the first episode of APHUO before 34 weeks of gestation who delivered between January 1995 and December 2004 were reviewed. The predictability of risk factors was assessed by both univariate and multivariate analysis. The cumulative rates of preterm delivery prior to 34 weeks were compared by using the Kaplan-Meier survival analysis and log-rank test between those with and those without risk factors. RESULTS: The rates of preterm delivery prior to 34 and 37 weeks of gestation were 7.3 and 17%, respectively. Uterine contractions, persistent bleeding, two or more episodes of APHUO and a history of spontaneous preterm deliveries were significant risk factors for preterm birth prior to 34 weeks in a multivariate logistic regression. Women with one risk factor had a hazard ratio of 5.5 (95% CI: 3.2-9.6) in having preterm delivery prior to 34 weeks compared with those without risk factors, whereas women with any two risk factors had a hazard ratio of 5.2 (95% CI: 2.1-12.9) compared with those with one risk factor. CONCLUSIONS: APHUO prior to 34 weeks of gestation is associated with three to fivefold increased risk of preterm delivery. Identification of several risk factors could further help to predict early preterm delivery and appropriate triage management.

Quality of life in women with urinary incontinence is impaired and comparable to women with chronic diseases.

OBJECTIVES: To evaluate the quality of life in women with urinary incontinence (categorised by urodynamic findings). DESIGN: Prospective cohort study on patients. SETTING: Urogynaecology unit of a university teaching hospital in Hong Kong. PATIENTS. Female patients presenting to our clinic from July 2008 to December 2009 and having their urinary incontinence categorised by urodynamic study. MAIN OUTCOME MEASURES: Patient's quality of life was assessed using the Medical Outcomes Study Short Form, Urogenital Distress Inventory Short Form, and Incontinence Impact Questionnaire Short Form. Their quality of life was compared according to their urodynamic category and a subgroup analysis was performed on patients having continence surgery for urodynamic stress incontinence. RESULTS: Among the 223 women studied, 46% had urodynamic stress incontinence, 18% had detrusor overactivity, 2% had both urodynamic stress incontinence and detrusor overactivity, and 34% had no urodynamic abnormality. In all, the Medical Outcomes Study Short Form scoring was lower than normal local population. The Medical Outcomes Study Short Form score in detrusor overactivity group was significantly lower than urodynamic stress incontinence group in vitality and mental health domains. Detrusor overactivity group also had higher scores in Incontinence Impact Questionnaire Short Form in travel, social and emotional health subscales and total score (46.3 vs 29.1; P<0.01). Women with urodynamic stress incontinence and required continence surgery had higher scores in Incontinence Impact Questionnaire Short Form. CONCLUSION: Women with urinary incontinence had impaired quality of life and it was comparable to other chronic medical diseases. Women with detrusor overactivity have more impaired quality of life than women with urodynamic stress incontinence. Severity of urodynamic stress incontinence did not correlate with quality of life. Women who opted for continence surgery had poorer quality of life.

Chinese validation of Urogenital Distress Inventory and Incontinence Impact Questionnaire short form.

INTRODUCTION AND HYPOTHESIS: UDI-6 and IIQ-7 are useful disease-specific questionnaires evaluating the impact of urinary incontinence on the QOL of women. We aim at validating them in Chinese language. METHODS: Both instruments were translated; 207 urinary incontinent women completed UDI-6 and IIQ-7, SF-36, bladder diary and urodynamic evaluation. The reliability and validity were assessed. RESULTS: There were high internal consistency (Cronbach's alpha for UDI-6 and IIQ-7 was 0.80 and 0.93) and test-retest reliability (Intraclass correlation coefficient was 0.72 and 0.75, P < 0.001). Scoring of UDI-6 and IIQ-7 was negatively correlated with SF-36 (P < 0.001); positively correlated with daytime urinary frequency and incontinent episodes (P < 0.001), and women's VAS (P < 0.001). Subscales of UDI-6 and IIQ-7 could discriminate women with different urodynamic diagnoses. CONCLUSIONS: The Chinese UDI-6 and IIQ-7 is reliable and valid. Study on the responsiveness to treatment is in progress. They are useful in assessing impact of the urinary incontinence in Chinese women.

The effect of time interval of vaginal ring pessary replacement for pelvic organ prolapse on complications and patient satisfaction: A randomised controlled trial.

OBJECTIVES: Limited data are available on the effect of the time interval of vaginal ring pessary replacement for pelvic organ prolapse (POP). This study investigated the effect of different replacement intervals on complications and patient satisfaction. STUDY DESIGN: A double-blinded, randomized controlled trial was conducted in a tertiary urogynecology center. Women with a vaginal ring pessary for POP (stage I to IV) were randomly allocated to two groups: 3-monthly or 6-monthly ring pessary replacement. All women were blinded to the replacement interval. Investigators were blinded during outcome assessment. Subjects were followed up for 6 months. MAIN OUTCOME MEASURES: The primary outcomes were the complication rates and patient satisfaction scores at 6 months. Secondary outcomes were the change in patient-reported symptoms and staging of POP. RESULTS: Of 101 women were screened from June 2016 to November 2017, 60 were recruited and randomly allocated: 30 to the 3-monthly replacement group and 30 to the 6-monthly replacement group. The overall complication rate in the 6-monthly group was higher than that in the 3-monthly group at the third visit (9 [30%] vs. 3[10.3%]; OR 3.71; 95%CI 0.89-15.58), but the difference was not statistically significant (p = 0.061). There were no statistically significant differences between groups in patient satisfaction scores, other prolapse-related symptoms or staging of POP. CONCLUSIONS: We provide evidence on the effect of replacement interval for a vaginal pessary on complications and patient satisfaction. A higher complication rate was found in the 6-monthly group than in the 3-monthly group, although the difference was not statistically significant. Patient satisfaction scores were similar in both groups.

Predictors for dislodgment of vaginal pessary within one year in women with pelvic organ prolapse.

OBJECTIVES: To identify clinical risk factors for dislodgment of vaginal pessary within one year in women with symptomatic pelvic organ prolapse. STUDY DESIGN: This was a prospective observational study which recruited consecutive women with symptomatic pelvic organ prolapse in a tertiary urogynecology center. Basic demographics, clinical symptoms and staging of pelvic organ prolapse were assessed. A vaginal pessary was offered where appropriate. MAIN OUTCOME MEASURES: Demographics and clinical parameters were compared between women who were able to use a vaginal pessary for one year and those whose pessaries were dislodged within one year. RESULTS: A total of 779 women were recruited and had a vaginal pessary inserted. Of them, 528 women, with a mean age of 64.7 (SD 10.1) years, returned for one-year follow-up; 177 (33.5%) had their pessary dislodged within one year and 351 (66.5%) had been able to retain the pessary. Stage III or IV prolapse (OR 1.76), prolapse predominant at the apical compartment (OR 2.14) and larger genital hiatus (OR 1.63) were factors associated with dislodgment of the vaginal pessary. Age, body mass index, previous hysterectomy and short vagina were not associated with dislodgment. Nevertheless, 47.6% of women with stage III/IV prolapse could still keep the pessary for one year. CONCLUSION: Higher staging of prolapse, larger genital hiatus and apical compartment prolapse are clinical predictors for dislodgment of a vaginal pessary. Despite this, nearly half of women with stage III/IV prolapse were able to use a vaginal pessary for one year. Therefore, a vaginal pessary should be offered despite their staging of prolapse.

Vaginal Pessary in Women With Symptomatic Pelvic Organ Prolapse: A Randomized Controlled Trial.

OBJECTIVE: To compare pelvic floor symptoms, quality of life, and complications in women with symptomatic pelvic organ prolapse (POP) with or without vaginal pessaries in addition to those who do pelvic floor exercises for 12 months. METHODS: This was a parallel-group, single-blind, randomized controlled trial with 12 months of follow-up. Women with symptomatic stage I to stage III POP were randomized to either pelvic floor exercises training (control group) or pelvic floor exercises training and insertion of a vaginal pessary (pessary group). The primary outcome was the change of prolapse symptoms and quality of life by using the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaires. Secondary outcomes included bothersome of prolapse symptoms, desired treatment, and any complications. RESULTS: From December 2011 through November 2014, 311 women were screened and 276 were randomized as follows: 137 to the control and 139 to the pessary group. One hundred thirty-two (95.0%) women in the pessary group and 128 (93.4%) in the control group completed the study. The Pelvic Organ Prolapse Distress Inventory of Pelvic Floor Distress Inventory and the Pelvic Organ Prolapse Impact Questionnaire of Pelvic Floor Impact Questionnaire scores decreased in both groups after 12 months, but the mean score differences were higher in the pessary group (Pelvic Organ Prolapse Distress Inventory: -29.7 compared with -4.7, P<.01; Pelvic Organ Prolapse Impact Questionnaire: -29.0 compared with 3.5, P<.01). Complication rates were low and similar in both groups. CONCLUSION: We provided further evidence in nonsurgical treatment for POP. Prolapse symptoms and quality of life were improved in women using a vaginal pessary in addition to pelvic floor exercises. CLINICAL TRIAL REGISTRATION: Centre for Clinical Research and Biostatistics-Clinical Trials Registry, https://www2.ccrb.cuhk.edu.hk/web/?page_id=746, ChiCTR-TRC-11001796.