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Journal of Gynecology Obstetrics and... Dec 2023Pelvic organ prolapse (POP) is a common condition affecting women, characterized by the descent of pelvic organs such as the vagina and uterus. While POP may not always...
Pelvic organ prolapse (POP) is a common condition affecting women, characterized by the descent of pelvic organs such as the vagina and uterus. While POP may not always cause symptoms, it can significantly impact a woman's quality of life. Diagnosis is typically made through clinical examination, and treatment options range from pelvic-floor physical therapy to surgery. Anterior sacrospinous ligament fixation (ASSLF) has emerged as a viable technique for treating apical prolapse vaginally. This procedure involves attaching the cervix or vaginal vault to the sacrospinous ligament, providing satisfactory results in the short term. Compared to the posterior approach, ASSLF shows similar efficacy, shorter operative time, and potentially fewer complications. Vaginal surgery offers advantages such as lower morbidity and cost, ability to address other pelvic conditions simultaneously, and suitability for managing recurrences. The presented case involves a 72-year-old woman with stage 3 cystocele, stage 3 hysterocele, stage 1 rectocele, and severe voiding dysfunction. After unsuccessful attempts with a pessary, surgical intervention becomes necessary. An instructive video article has been created to standardize the essential steps of ASSLF and facilitate resident education. The video demonstrates ten surgical steps, including installation/exposure, anterior vaginal wall infiltration, median anterior colpotomy, vesico-vaginal dissection, paravesical dissection, sacrospinous ligament suture, cystocele correction, colpotomy and vaginal wall repair, uterine anterior isthmus suture and sacrospinous ligament fixation, and colporrhaphy final closure. In conclusion, POP is a prevalent condition that can be effectively managed through techniques like ASSLF. Vaginal surgery offers several advantages, and proper training and standardization of surgical steps contribute to successful outcomes and resident education.
Topics: Female; Humans; Aged; Cystocele; Quality of Life; Pelvic Organ Prolapse; Vagina; Ligaments
PubMed: 37821046
DOI: 10.1016/j.jogoh.2023.102677 -
European Journal of Obstetrics,... Dec 2023To compare cesarean rates and maternal and neonatal morbidity according to the cervical ripening method used among obese pregnant women requiring induction of labor at...
Comparison of cesarean delivery rates after 3 methods of cervical ripening among obese women at or after 41 weeks - Secondary analysis of two French randomized controlled trials: MAGPOP and CYTOPRO.
OBJECTIVE
To compare cesarean rates and maternal and neonatal morbidity according to the cervical ripening method used among obese pregnant women requiring induction of labor at or after 41 weeks of gestation.
DESIGN
A secondary analysis of two multicenter randomized controlled trials conducted in French maternity units between 2015 and 2018.
PARTICIPANTS
336 women with a body mass index ≥30 kg/m, a pregnancy ≥41 weeks, and an induction of labor requiring cervical ripening.
INTERVENTIONS
Cervical ripening with a PGE2 dinoprostone pessary (Propess®), or low-dose vaginal PGE1 (misoprostol) or a double-balloon catheter.
MEASUREMENTS AND FINDINGS
The rates of cesarean delivery did not differ significantly according to the cervical ripening method (PGE2 pessary vs PGE1, RR: 1.18, 95% CI: 0.80-1.75; PGE2 pessary vs double balloon catheter: RR, 0.88, 95% CI: 0.60-1.29), p = 0.52; double balloon catheter vs PGE1, RR: 1.34, 95% CI: 0.77-2.32, p = 0.29). More oxytocin was required for women from the double-balloon group compared to those from both the PGE1 and PGE2 pessary groups (respectively, RR: 1.31, 95% CI: 1.08-1.58, p = 0.005; RR: 1.17, 95% CI: 1.03-1.32, p = 0.01). The risk of perineal tears or episiotomy was significantly lower for women induced with the PGE2 pessary than with PGE1 (0.85; 95% CI: 0.74-0.99), p = 0.03).
KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE
No cervical ripening method was associated with a lower cesarean rate in obese women who required cervical ripening from 41 weeks. Further trials are required among obese women to determine the cervical ripening method most efficacious for reducing the cesarean rate.
Topics: Infant, Newborn; Female; Pregnancy; Humans; Dinoprostone; Oxytocics; Alprostadil; Labor, Induced; Cervical Ripening; Randomized Controlled Trials as Topic; Obesity
PubMed: 37806026
DOI: 10.1016/j.ejogrb.2023.09.019 -
International Urogynecology Journal Feb 2024Pessary treatment for pelvic organ prolapse (POP) is effective and safe, but long-term continuation is low. Pain and vaginal discharge may play a role. This study was...
INTRODUCTION AND HYPOTHESIS
Pessary treatment for pelvic organ prolapse (POP) is effective and safe, but long-term continuation is low. Pain and vaginal discharge may play a role. This study was aimed at evaluating vaginal discharge and pain during pessary cleaning in an outpatient setting and in continuous pessary use.
METHODS
Women with POP who attended the outpatient clinic for pessary cleaning between January and October 2021 were included. Primary outcome was pain during removal and reinsertion of the pessary, measured by an 11-point numeric rating scale (NRS). Secondary outcome was vaginal discharge, measured by the NRS and Patient Global Impression of Change scale (PGI-C). Multiple linear regression analysis was used to identify associated variables for pain and discharge.
RESULTS
A total of 150 women were included. Mean NRS during pessary removal was 4.3 (± 2.7), with 25% of women scoring a 7 or higher. Mean NRS during reinsertion was 1.8 (± 2.0). A smaller genital hiatus and presence of vaginal atrophy or vulvar skin disease were associated with pain during pessary removal. Mean NRS for vaginal discharge was 2.5 (± 2.3). Twenty-five percent of women reported that their vaginal discharge was "(very) much worse" than before they used a pessary. Presence of vaginal erosions was associated with vaginal discharge in this study population.
CONCLUSIONS
Removing a pessary in an outpatient setting is a painful procedure for many women who use a pessary continuously. Moreover, 25% of these women experience an increase in vaginal discharge while using a pessary. Future research should focus on reducing these disadvantages.
Topics: Humans; Female; Pessaries; Outpatients; Vaginal Discharge; Pelvic Organ Prolapse; Pain
PubMed: 37796331
DOI: 10.1007/s00192-023-05648-5 -
Frontiers in Reproductive Health 2023Catamenial products like menstrual tampons for managing menses and vaginal pessaries for managing urinary incontinence and uterine prolapse are products that can be...
Catamenial products like menstrual tampons for managing menses and vaginal pessaries for managing urinary incontinence and uterine prolapse are products that can be inserted and removed from the vagina repeatedly over a woman's lifetime. In the United States (US), these products are considered to be medical devices and are regulated by the Center for Devices & Radiological Health (CDRH) of the Food and Drug Administration (FDA). As such, they are subject to both premarket and postmarket regulatory controls. Both tampons and pessaries have a long history of safe and effective use, and FDA applies a risk-based approach to both premarket entry as well as continued postmarket regulatory controls. Practicing clinicians are often the initial source of ideas for medical device improvements. This article is intended to help such clinicians to understand the regulatory challenges faced by development teams who seek to introduce these kinds of products to the US market. It explains FDA's risk-based classification of medical devices and the 510(k) premarket notification as the primary regulatory mechanism for market entry. It also highlights key FDA guidance documents and encourages early engagement with FDA when appropriate.
PubMed: 37795520
DOI: 10.3389/frph.2023.1224421 -
Cureus Sep 2023Pelvic organ prolapse (POP) is a common condition mainly affecting postmenopausal women, characterized by the descent of pelvic organs through the vaginal canal. While...
Pelvic organ prolapse (POP) is a common condition mainly affecting postmenopausal women, characterized by the descent of pelvic organs through the vaginal canal. While often asymptomatic, POP can manifest with various symptoms such as a painless bulge or pressure sensation, abdominal pain, urinary complaints, and discomfort during intercourse. Severe cases can lead to urinary tract obstruction, hydronephrosis, and renal dysfunction. This case study presents an elderly female with bilateral severe hydronephrosis and pyelonephritis due to undiagnosed POP. Imaging revealed obstructive uropathy resulting from bilateral ureteric compression caused by cystocele and uterine prolapse. The patient's condition improved with antibiotics and supportive management. A vaginal hysterectomy was performed, which led to the resolution of the urinary tract obstruction. This case emphasizes the importance of considering POP in elderly women with urinary symptoms and the need for proactive screening. It highlights the significance of appropriate management to prevent irreversible renal damage. Different treatment modalities, including surgery and pessaries, are discussed, to emphasize the significance of tailoring treatments to individual patient characteristics.
PubMed: 37790056
DOI: 10.7759/cureus.44513 -
JBRA Assisted Reproduction Sep 2023Does the use of 400mg pessaries of micronized progesterone provide comparable results as pessaries of 200mg x2, in terms of progesterone levels in hormonal replacement...
OBJECTIVE
Does the use of 400mg pessaries of micronized progesterone provide comparable results as pessaries of 200mg x2, in terms of progesterone levels in hormonal replacement cycles for embryo transfer?.
METHODS
Retrospective cohort study based on 299 embryo transfer treatments under artificial endometrial preparation carried out at Instituto Bernabeu. 131 patients received 1 pessary of 400 mg b.i.d. (group A) and 168 received 2 pessaries of 200 mg b.i.d. (group B).
RESULTS
Mean serum progesterone levels were similar between groups (A: 13.64±4.47ng/mL vs. B: 13.88±7.17ng/mL). There were no differences in suboptimal progesterone levels between groups (A: 11.5% vs. B: 16.8%). In terms of patients receiving additional progesterone supplementation, there were no differences between groups (A: 26% vs. B: 35.3%.). No differences between groups were observed in clinical outcomes: pregnancy rate (PR) (A: 55% vs. B: 54.8%), biochemical pregnancy loss rate (BPLR) (A: 13.4% vs. B: 17.6%), miscarriage rate (MR) (A: 17.9% vs. B: 19.8%) and ongoing pregnancy rate (OPR) (A: 36.5% vs. B: 34.1%).
CONCLUSIONS
One progesterone pessary of 400mg (Cyclogest®) twice daily appears to be non-inferior to the use of two-200mg pessaries twice daily in terms of progesterone levels in HRT cycles.
PubMed: 37768819
DOI: 10.5935/1518-0557.20230021 -
Human Reproduction (Oxford, England) Nov 2023Can supplementation with rectal administration of progesterone secure high ongoing pregnancy rates (OPRs) in patients with low serum progesterone (P4) on the day of...
Rectal progesterone administration secures a high ongoing pregnancy rate in a personalized Hormone Replacement Therapy Frozen Embryo Transfer (HRT-FET) protocol: a prospective interventional study.
STUDY QUESTION
Can supplementation with rectal administration of progesterone secure high ongoing pregnancy rates (OPRs) in patients with low serum progesterone (P4) on the day of blastocyst transfer (ET)?
SUMMARY ANSWER
Rectally administered progesterone commencing on the ET day secures high OPRs in patients with serum P4 levels below 35 nmol/l (11 ng/ml).
WHAT IS KNOWN ALREADY
Low serum P4 levels at peri-implantation in Hormone Replacement Therapy Frozen Embryo Transfer (HRT-FET) cycles impact reproductive outcomes negatively. However, studies have shown that patients with low P4 after a standard vaginal progesterone treatment can obtain live birth rates (LBRs) comparable to patients with optimal P4 levels if they receive additionalsubcutaneous progesterone, starting around the day of blastocyst transfer. In contrast, increasing vaginal progesterone supplementation in low serum P4 patients does not increase LBR. Another route of administration rarely used in ART is the rectal route, despite the fact that progesterone is well absorbed and serum P4 levels reach a maximum level after ∼2 h.
STUDY DESIGN, SIZE, DURATION
This prospective interventional study included a cohort of 488 HRT-FET cycles, in which a total of 374 patients had serum P4 levels ≥35 nmol/l (11 ng/ml) at ET, and 114 patients had serum P4 levels <35 nmol/l (11 ng/ml). The study was conducted from January 2020 to November 2022.
PARTICIPANTS/MATERIALS, SETTING, METHODS
Patients underwent HRT-FET in a public Fertility Clinic, and endometrial preparation included oral oestradiol (6 mg/24 h), followed by vaginal micronized progesterone, 400 mg/12 h. Blastocyst transfer and P4 measurements were performed on the sixth day of progesterone administration. In patients with serum P4 <35 nmol/l (11 ng/ml), 'rescue' was performed by rectal administration of progesterone (400 mg/12 h) starting that same day. In pregnant patients, rectal administration continued until Week 8 of gestation, and oestradiol and vaginal progesterone treatment continued until Week 10 of gestation.
MAIN RESULTS AND THE ROLE OF CHANCE
Among 488 HRT-FET single blastocyst transfers, the mean age of the patients at oocyte retrieval (OR) was 30.9 ± 4.6 years and the mean BMI at ET 25.1 ± 3.5 kg/m2. The mean serum P4 level after vaginal progesterone administration on the day of ET was 48.9 ± 21.0 nmol/l (15.4 ± 6.6 ng/ml), and a total of 23% (114/488) of the patients had a serum P4 level lower than 35 nmol/l (11 ng/ml). The overall, positive hCG rate, clinical pregnancy rate, OPR week 12, and total pregnancy loss rate were 66% (320/488), 54% (265/488), 45% (221/488), and 31% (99/320), respectively. There was no significant difference in either OPR week 12 or total pregnancy loss rate between patients with P4 ≥35 nmol/l (11 ng/ml) and patients with P4 <35 nmol/l, who received rescue in terms of rectally administered progesterone, 45% versus 46%, P = 0.77 and 30% versus 34%, P = 0.53, respectively. OPR did not differ whether patients had initially low P4 and rectal rescue or were above the P4 cut-off. Logistic regression analysis showed that only age at OR and blastocyst scoring correlated with OPR week 12, independently of other factors like BMI and vitrification day of blastocysts (Day 5 or 6).
LIMITATIONS, REASONS FOR CAUTION
In this study, vaginal micronized progesterone pessaries, a solid pessary with progesterone suspended in vegetable hard fat, were used vaginally as well as rectally. It is unknown whether other vaginal progesterone products, such as capsules, gel, or tablet, could be used rectally with the same rescue effect.
WIDER IMPLICATIONS OF THE FINDINGS
A substantial part of HRT-FET patients receiving vaginal progesterone treatment has lowserum P4. Adding rectally administered progesterone in these patients increases the reproductive outcome. Importantly, rectal progesterone administration is considered convenient, and progesterone pessaries are easy to administer rectally and of low cost.
STUDY FUNDING/COMPETING INTEREST(S)
Gedeon Richter Nordic supported the study with an unrestricted grant as well as study medication. B.A. has received unrestricted grant from Gedeon Richter Nordic and Merck and honoraria for lectures from Gedeon Richter, Merck, IBSA and Marckyrl Pharma. P.H. has received honoraria for lectures from Gedeon Richter, Merck, IBSA and U.S.K. has received grant from Gedeon Richter Nordic, IBSA and Merck for studies outside this work and honoraria for teaching from Merck and Thillotts Pharma AB and conference expenses covered by Merck. The other co-authors have no conflict of interest to declare.
TRIAL REGISTRATION NUMBER (25)
EudraCT no.: 2019-001539-29.
Topics: Female; Pregnancy; Humans; Adult; Progesterone; Pregnancy Rate; Prospective Studies; Administration, Rectal; Embryo Transfer; Estradiol; Abortion, Spontaneous; Hormone Replacement Therapy; Retrospective Studies
PubMed: 37759346
DOI: 10.1093/humrep/dead185 -
International Urogynecology Journal Nov 2023This manuscript from Chapter 2 of the International Urogynecology Consultation (IUC) on Pelvic Organ Prolapse (POP) reviews the literature involving the clinical... (Review)
Review
International Urogynecology consultation chapter 2 committee 3: the clinical evaluation of pelvic organ prolapse including investigations into associated morbidity/pelvic floor dysfunction.
INTRODUCTION AND HYPOTHESIS
This manuscript from Chapter 2 of the International Urogynecology Consultation (IUC) on Pelvic Organ Prolapse (POP) reviews the literature involving the clinical evaluation of a patient with POP and associated bladder and bowel dysfunction.
METHODS
An international group of 11 clinicians performed a search of the literature using pre-specified search MESH terms in PubMed and Embase databases (January 2000 to August 2020). Publications were eliminated if not relevant to the clinical evaluation of patients or did not include clear definitions of POP. The titles and abstracts were reviewed using the Covidence database to determine whether they met the inclusion criteria. The manuscripts were reviewed for suitability using the Specialist Unit for Review Evidence checklists. The data from full-text manuscripts were extracted and then reviewed.
RESULTS
The search strategy found 11,242 abstracts, of which 220 articles were used to inform this narrative review. The main themes of this manuscript were the clinical examination, and the evaluation of comorbid conditions including the urinary tract (LUTS), gastrointestinal tract (GIT), pain, and sexual function. The physical examination of patients with pelvic organ prolapse (POP) should include a reproducible method of describing and quantifying the degree of POP and only the Pelvic Organ Quantification (POP-Q) system or the Simplified Pelvic Organ Prolapse Quantification (S-POP) system have enough reproducibility to be recommended. POP examination should be done with an empty bladder and patients can be supine but should be upright if the prolapse cannot be reproduced. No other parameters of the examination aid in describing and quantifying POP. Post-void residual urine volume >100 ml is commonly used to assess for voiding difficulty. Prolapse reduction can be used to predict the possibility of postoperative persistence of voiding difficulty. There is no benefit of urodynamic testing for assessment of detrusor overactivity as it does not change the management. In women with POP and stress urinary incontinence (SUI), the cough stress test should be performed with a bladder volume of at least 200 ml and with the prolapse reduced either with a speculum or by a pessary. The urodynamic assessment only changes management when SUI and voiding dysfunction co-exist. Demonstration of preoperative occult SUI has a positive predictive value for de novo SUI of 40% but most useful is its absence, which has a negative predictive value of 91%. The routine addition of radiographic or physiological testing of the GIT currently has no additional value for a physical examination. In subjects with GIT symptoms further radiological but not physiological testing appears to aid in diagnosing enteroceles, sigmoidoceles, and intussusception, but there are no data on how this affects outcomes. There were no articles in the search on the evaluation of the co-morbid conditions of pain or sexual dysfunction in women with POP.
CONCLUSIONS
The clinical pelvic examination remains the central tool for evaluation of POP and a system such as the POP-Q or S-POP should be used to describe and quantify. The value of investigation for urinary tract dysfunction was discussed and findings presented. The routine addition of GI radiographic or physiological testing is currently not recommended. There are no data on the role of the routine assessment of pain or sexual function, and this area needs more study. Imaging studies alone cannot replace clinical examination for the assessment of POP.
Topics: Humans; Female; Pelvic Floor; Reproducibility of Results; Pelvic Organ Prolapse; Intussusception; Dysuria; Pain
PubMed: 37737436
DOI: 10.1007/s00192-023-05629-8 -
Urogynecology (Philadelphia, Pa.) Oct 2023The aim of the study was to compare 12-month subjective and objective outcomes between 3 approaches to apical pelvic organ prolapse (POP) surgery in patients presenting...
Twelve Month Outcomes of Pelvic Organ Prolapse Surgery in Patients With Uterovaginal or Posthysterectomy Vaginal Prolapse Enrolled in the Multicenter Pelvic Floor Disorders Registry.
OBJECTIVE
The aim of the study was to compare 12-month subjective and objective outcomes between 3 approaches to apical pelvic organ prolapse (POP) surgery in patients presenting with uterovaginal or posthysterectomy vaginal prolapse enrolled in the Pelvic Floor Disorders Registry for Research.
STUDY DESIGN
This was an analysis of a multicenter, prospective registry that collected both patient- and physician-reported data for up to 3 years after conservative (pessary) and surgical treatment for POP. Twelve-month subjective and anatomic outcomes for patients who underwent surgical treatment were extracted from the registry for analysis. Pelvic organ prolapse recurrence was defined as a composite outcome and compared between the 3 apical surgery groups (native tissue repair, sacrocolpopexy, colpocleisis) as well as the 2 reconstructive surgery groups (native tissue repair and sacrocolpopexy).
RESULTS
A total of 1,153 women were enrolled in the registry and 777 (67%) opted for surgical treatment, of whom 641 underwent apical repair and were included in this analysis (404 native tissue repair, 187 sacrocolpopexy, and 50 colpocleisis). The overall incidence of recurrence was as follows: subjective 6.5%, anatomic 4.7%, retreatment 7.2%, and composite 13.6%. The incidence of recurrence was not different between the 3 surgical groups. When baseline patient characteristics were controlled for, composite POP recurrence between the native tissue and sacrocolpopexy groups remained statistically nonsignificant. Concurrent perineorrhaphy with any type of apical POP surgery was associated with a lower risk of recurrence (adjusted odds ratio, 0.43; 95% confidence interval, 0.25-0.74; P = 0.002) and prior hysterectomy was associated with a higher risk (adjusted odds ratio, 1.77, 95% confidence interval, 1.04-3.03; P = 0.036).
CONCLUSION
Pelvic Floor Disorders Registry for Research participants undergoing native tissue apical POP repair, sacrocolpopexy, and colpocleisis surgery had similar rates of POP recurrence 12 months after surgery.
Topics: Humans; Female; Pregnancy; Uterine Prolapse; Pelvic Floor Disorders; Pelvic Organ Prolapse; Registries; Colpotomy
PubMed: 37733440
DOI: 10.1097/SPV.0000000000001410 -
Family Medicine Apr 2024Improving training and confirming the acquisition of gynecological procedure skills for family physicians (FPs) is crucial for safe health care delivery. The...
BACKGROUND AND OBJECTIVES
Improving training and confirming the acquisition of gynecological procedure skills for family physicians (FPs) is crucial for safe health care delivery. The objectives of this study were to (a) develop performance rating instruments for four gynecological procedures, and (b) pilot them to provide preliminary validity evidence using modern validity theory.
METHODS
Sixteen academic FPs and gynecologists participated in a modified Delphi technique to develop procedure-specific checklists (PSCs) for four procedures: intrauterine device insertion, endometrial biopsy, punch biopsy of the vulva, and routine pessary care. We modified a previously validated global rating scale (GRS) for ambulatory settings. Using prerecorded videos, 19 academic FPs piloted instruments to rate one first-year and one second-year family medicine resident's performance. They were blinded to the level of training. We compared the mean scores for PSCs and GRS for each procedure using paired samples t tests and Cohen's d to estimate effect sizes.
RESULTS
Consensus on items for the final PSCs was reached after two Delphi rounds. PSC and GRS scores were numerically higher for the second-year resident than the first-year resident for every procedure, with statistically significant differences for six of eight comparisons (P<.05). All comparisons demonstrated large effect sizes (Cohen's d>0.8). Both instruments received high scores for ease of use by raters.
CONCLUSIONS
We developed novel performance rating instruments for four gynecological procedures and provided preliminary validity evidence for their use for formative feedback in a simulation setting. This pilot study suggests that these instruments may facilitate the training and documentation of family medicine trainees' skills in gynecological procedures.
Topics: Humans; Pilot Projects; Clinical Competence; Female; Primary Health Care; Internship and Residency; Delphi Technique; Gynecology; Checklist; Family Practice; Educational Measurement
PubMed: 37725774
DOI: 10.22454/FamMed.2023.261011