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[Safety and acceptance of self application of cubic pessaries and urethral ring pessaries].

OBJECTIVE: Flexible cubic and ring pessaries with a suburethral thickening are devices for the treatment of genital prolapse and urinary stress incontinence. Threads attached to the pessary enable overnight self-removal and self-application. Little is known about the safety and women's acceptance of these devices. METHODS: Eighteen women (age 36-85 years), 9 of them with failed surgery, tried this therapy (cubic pessary n = 6; ring pessary n = 12). The size of the pessary was chosen clinically. All patients were seen after a week and then monthly. RESULTS: All women showed up after 1 week. Twelve of 18 women felt comfortable with these devices at that time. During follow-up, 5/18 women wanted surgical therapy within the first 2 months, 3/18 refused the device later, 1/18 was lost to follow-up and 9/18 patients continued pessary therapy for a mean duration of 11 months. During 107 treatment months, only 2 mild complications were observed without the need to intervention (mild vaginal erosion, spotting). CONCLUSIONS: Pessary therapy is safe but has a dropout rate of approximately 50%. It can be an efficient alternative method in motivated women.

Female↗

A survey of pessary use by members of the American urogynecologic society.

OBJECTIVE: To describe trends in pessary use for pelvic organ prolapse. METHODS: An anonymous survey administered to the membership of the American Urogynecologic Society covered indications, management, and choice of pessary for specific support defects. RESULTS: The response rate was 48% (359 of 748). Two hundred fifty surveys were received at the scientific meeting and 109 were returned by mail. Seventy-seven percent used pessaries as first-line therapy for prolapse, while 12% reserved pessaries for women who were not surgical candidates. With respect to specific support defects, 89% used a pessary for anterior defects, 60% for posterior defects, 74% for apical defects, and 76% for complete procidentia. Twenty-two percent used the same pessary, usually a ring pessary, for all support defects. In the 78% who tailored the pessary to the defect, support pessaries were more common for anterior (ring) and apical defects (ring), while space-filling pessaries were more common for posterior defects (donut) and complete procidentia (Gellhorn). Less than half considered a prior hysterectomy or sexual activity contraindications for a pessary, while 64% considered hypoestrogenism a contraindication. Forty-four percent used a different pessary for women with a prior hysterectomy and 59% for women with a weak pelvic diaphragm. Ninety-two percent of physicians believed that pessaries relieve symptoms associated with pelvic organ prolapse, while 48% felt that pessaries also had therapeutic benefit in addition to relieving symptoms. CONCLUSION: While there are identifiable trends in pessary use, there is no clear consensus regarding the indications for support pessaries compared with space-filling pessaries, or the use of a single pessary for all support defects compared with tailoring the pessary to the specific defect. Randomized clinical trials are needed to define optimal pessary use.

Adult↗

Survey of the characteristics and satisfaction degree of the patients using a pessary.

The objective of this study was to evaluate characteristics, satisfaction degree, and problems of patients using a pessary for pelvic organ prolapse. A total of 104 patients who had been fitted with a pessary and available for follow-up for pelvic organ prolapse management were enrolled. The patients answered questions on general characteristics, indications for pessary use, complications from pessary use, satisfaction degree, and frequency of removal. The results indicated that 76 (73.0%) patients had at least more than one medical illness and 86 (82.7%) patients complained of lower urinary symptoms such as incontinence, urgency, frequency, or nocturia. Eighty-four (80.7%) patients used pessaries as they were not surgical candidates due to poor medical status or old age. After using a pessary, 76 (73.1%) patients had symptoms such as bleeding, erosion, or foul odor; 70.2% of the women answered that they were satisfied or more than satisfied and 19.1% of the patients removed their pessaries, of whom 80.0% were unable to continue use due to repeated expulsion of the pessary and uncomfortable fitting. These data suggest that the pessary tends to be used for high-risk patients due to medical problems or old age. Despite the high frequency of complications from pessary use, it was seen that the frequency of removing the pessary was low and the satisfaction degree was high. Most of the complications were not thought to be serious. To decrease the frequency of complications, the regular follow-up visit and proper management of pessary use were thought to be needed. Further studies are warranted on tailor-fitting the pessary by variable use and relieving the symptoms associated with the lower urinary tract.

Age Factors↗

Risk factors associated with an unsuccessful pessary fitting trial in women with pelvic organ prolapse.

OBJECTIVE: Our purpose was to estimate the percentage of women with symptomatic pelvic organ prolapse who had a successful pessary fitting trial, to identify pelvic examination parameters that are associated with an unsuccessful pessary fitting trial, and to identify the most commonly used pessary for each stage of prolapse. STUDY DESIGN: In a prospective, observational study, 100 consecutive women with symptomatic pelvic organ prolapse were examined, staged, and fitted with either a ring or Gellhorn pessary. A successful pessary fitting trial occurred if a woman continued to use a pessary 1 week after being fitted. Women were then divided into two groups on the basis of whether they had a successful pessary fitting trial: group 1 was successful, and group 2 was unsuccessful. Pelvic examination parameters were evaluated as risk factors for an unsuccessful pessary fitting trial. RESULTS: Group 1 had 73 women, and group 2 had 27 women. A short vaginal length (< or =6 cm) and a wide vaginal introitus (4 fingerbreadths accommodated) were associated with group 2 (11% vs 0%, P=.02, and 22% vs 7%, P=.04, respectively). Ring pessaries were used more with stage II and III prolapse (100% and 71%, respectively), whereas Gellhorn pessaries were used more with stage IV prolapse (64%, P<.001). CONCLUSION: Seventy-three women (73%) with symptomatic pelvic organ prolapse had a successful pessary fitting trial. A short vaginal length and a wide vaginal introitus were risk factors for an unsuccessful pessary fitting trial. Gellhorn pessaries are more often needed with stage IV prolapse.

Adult↗

Sexual activity predicts continued pessary use.

OBJECTIVE: The purpose of this study was to determine which clinical variables predict continued pessary use. STUDY DESIGN: After IRB approval, charts of consecutive women at Loyola Women's Pelvic Medicine Center who bought a pessary from August 2000 to December 2002 were reviewed. Demographic information, length of pessary use, and reason for pessary discontinuation were recorded. Current pessary "users" were compared with "nonusers" (women who stopped wearing the pessary during the study period). RESULTS: Of the 136 study women, 82 (60%) were "users," and 54 (40%) were "nonusers." Women who were sexually active were more likely to continue pessary use (beta=2.204, P=.021). This was true regardless of indication for pessary placement. Women with prolapse were more likely than women with incontinence to continue with long-term pessary use (beta=2.031, P=.049). No other demographic characteristics predicted continued pessary use. CONCLUSION: Long-term pessary use is acceptable to sexually active women. Women being treated for pelvic organ prolapse are more likely to continue pessary use than women being treated for urinary incontinence. Additionally, the majority of women (60%) who accept a pessary for prolapse or urinary incontinence continue this treatment.

Adult↗

A simplified protocol for pessary management.

OBJECTIVE: To evaluate a simplified protocol for pessary management. METHODS: Women with symptomatic pelvic organ prolapse who opted for pessaries were enrolled in a prospective simplified protocol for pessary management. After the initial pessary fitting, they were seen at 2 weeks for reexamination and thereafter at 3- to 6-month intervals. RESULTS: One hundred ten women (mean age 65 years) were enrolled, and 81 (74%) of them were fitted successfully with a pessary. Life-table analysis showed that 66% of those who used a pessary for more than 1 month were still users after 12 months and 53% were still users after 36 months. The severity of pelvic prolapse did not predict the likelihood of pessary failure except in cases of complete vaginal eversion. Patients complaining of stress incontinence were less likely to have a successful pessary fitting and more likely to opt for surgery. Current hormone use and substantial perineal support do not predict greater likelihood of pessary fitting success. No serious complications from using the pessary were observed in the study sample. CONCLUSION: Stringent guidelines calling for frequent pelvic examinations during pessary use can be relaxed safely. Pessaries can be offered as a safe long-term option for the management of pelvic prolapse.

Adult↗

Pessary treatment of pelvic relaxation: factors affecting successful fitting and continued use.

OBJECTIVES: The aims of this study were to determine predictors of successful pessary fitting and continued pessary use in patients with pelvic relaxation. DESIGN: Retrospective observational study. SETTING AND SUBJECTS: The medical records of 130 consecutive patients evaluated for pessary treatment of pelvic relaxation by a single specially trained nurse practitioner (CRJ) at Kaiser Foundation Hospital, Harbor City, Calif, between May 1, 1997, and June 30, 2002, were retrospectively reviewed. INSTRUMENTS: Voiding diaries, data collection sheet, and questionnaires. METHODS: The medical records of the 130 patients were retrospectively reviewed, and data were recorded on data collection sheets. Patients using pessaries completed a questionnaire to assess treatment effectiveness. RESULTS: Coexisting stress urinary incontinence and previous prolapse and cystocele/rectocele repairs were each found to be independent predictors of unsuccessful pessary fitting. Fifty percent of successfully fitted patients had discontinued pessary use by 24 months. Current pessary users were more likely to have undergone prior pelvic reconstructive surgery (37% vs 13%, P = .02), less likely to require a space-filling pessary (13% vs 37%, P = .03), and more likely to recommend pessary to their friends or family (87% vs 50%, P = .007) compared to patients who discontinued pessary use. CONCLUSIONS: Prior pelvic reconstructive surgery is associated with an increased risk of unsuccessful pessary fitting; however, those patients who are successfully fitted tend to continue pessary use.

Aged↗

Pessaries for the treatment of incompetent cervix and premature delivery.

The purpose of this study was to review published articles about using pessaries in women with an incompetent cervix or who are at risk for preterm delivery. A MEDLINE search was performed from 1966 to 2000, with articles published before 1966 being extracted from the reference lists of articles obtained. Foreign articles were translated into English. Key words included pessary, incompetent cervix, and preterm labor. All studies that included patient data were included. A variety of studies suggest that pessaries can increase the percentage of full-term deliveries when used in women with an incompetent cervix or at risk for preterm delivery. When looking at women thought to have an incompetent cervix, the studies are mostly old case series. One prospective, randomized trial demonstrated no difference between women treated with a pessary and a cerclage. However, 27 weeks was the average gestational age at which therapy was started. In women at risk for preterm delivery, retrospective studies show an increase in full-term pregnancy rates with pessary use. One prospective, nonrandomized study also shows an increase in full-term pregnancy rate. However, in this study, lower risk patients received the pessary. Because of the poor nature of most of the studies, pessaries should not replace cerclage use at this time in women with an incompetent cervix. However, pessary use should be considered as adjuncts to cerclage or in women who are not candidates for cerclage. Also, pessary use may be considered in some women at risk for preterm delivery. Randomized perspective controlled trials are in progress to address the use of pessaries in these situations. Vaginal pessaries have been reported to be useful in women at risk for preterm delivery since 1959. Bedrest and cervical cerclage has become standard therapy in the United States for women with an incompetent cervix. However, cerclage is not without risk. Furthermore, advances in ultrasound have allowed us to identify women potentially at risk for preterm delivery by detecting cervical shortening before dilatation. This ability has raised questions concerning how to manage patients with subtle ultrasound changes. This article reviews the published literature concerning the use of pessaries in women with an incompetent cervix or at risk for early delivery.

Female↗

Gynecologists' patterns of prescribing pessaries.

OBJECTIVE: To determine how gynecologists in the United States prescribe pessaries. STUDY DESIGN: A 34-question (long) survey was sent to 2,000 gynecologists. Those who did not respond were then sent a five-question (short) survey. RESULTS: Nine hundred forty-seven (47.3%) long and short questionnaires were returned. Eighty-six percent of gynecologists prescribe pessaries. Most received minimal or no training in pessaries in their residencies. The most common pessaries used were the ring and doughnut. Uterine prolapse was treated most often with the Gellhorn and doughnut pessaries. The cube and Gellhorn pessaries were thought to be the most effective for vaginal vault prolapse. The Gehrung and ring pessaries were thought to be most effective for correction of cystocele. However, the ring pessary was considered the easiest to use. Follow-up visits were most often performed at one week, one month and then every three months. Estrogen was used in most cases. CONCLUSION: Most gynecologists prescribe pessaries. The ring pessary is used most often and is deemed the easiest to use. Pessaries are thought to work for all pelvic organ prolapse defects but are thought to be less effective for posterior defects. Follow-up of patients differs from manufacturers' recommendations.

Estradiol Congeners↗

Continence pessaries in the management of urinary incontinence in women.

OBJECTIVE: To evaluate the effectiveness of continence pessaries for the management of urinary incontinence in women. METHODS: A retrospective review of the records of 100 women who chose to try a pessary to treat their urinary incontinence. Demographic data, presenting symptoms, physical findings, results of objective testing (pad tests and urodynamics), and incontinence outcomes were abstracted. Factors such as age, pelvic prolapse, presenting symptoms, pessary type, and history of previous incontinence surgery were examined using the Student t-test, chi-square test, or Fisher exact test where appropriate. RESULTS: The mean age of the women was 56 years (range, 28-86 years) and mean parity was 2.5 (range, 0-13). Presenting complaints included stress incontinence in 41 women, mixed incontinence in 53 women, urge incontinence in 3 women, and combined prolapse and incontinence in 3 women. All 100 women returned for follow-up visits. Forty women had their pessary size or type adjusted at the first follow-up visit. At a mean follow-up time of 11 months (range, 2-42 months), 59 women continued to experience a complete resolution or decrease in their incontinence and chose to continue use of a pessary. Age, presenting symptoms, degree of pelvic prolapse, and type of pessary did not affect the success of pessary treatment. Women who had undergone incontinence surgery prior to pessary fitting had a higher failure rate, with relative risk (RR) of 1.6. CONCLUSION: Urinary incontinence pessaries are effective. More than 50% of women who try a continence pessary will continue to use it to manage their urinary incontinence.

Adult↗

Pessary placement and management.

Female pelvic organ prolapse is a common and aggravating condition that few women openly discuss. Fortunately, nonsurgical and surgical treatment options exist for this condition. Nonsurgical treatments include pessaries, which are used to reduce prolapse. The type of pessary depends on the direction and extent or grade of the protruding organ. The use of vaginal pessaries for urinary stress continence is a relatively new treatment option. Proper fit that is determined by trial is essential for effectiveness. Nurses at all levels now need to be familiar with the use of the vaginal pessary for pelvic organ prolapse and urinary stress incontinence. Nurses' roles regarding pessary use need to be clearly defined. Continence nurses should be familiar with the indications for pessary use, the types available for incontinence, and patient education regarding pessary care. Home health and long-term care nurses are frequently asked to periodically remove and insert pessaries. Skills and tips for making removal and insertion as easy as possible need to be disseminated. Advance practice nurses need skills for assessment of prolapse, fitting, and current outpatient pessary care routines. Increasing nurses' understanding of and comfort with pessary use might make a significant difference in the treatment of pelvic organ prolapse and urinary stress incontinence.

Clinical Competence↗

Patient characteristics that are associated with continued pessary use versus surgery after 1 year.

OBJECTIVE: The purpose of this study was to identify patient characteristics in women with symptomatic pelvic organ prolapse that is associated with continued pessary use versus surgery after 1 year. STUDY DESIGN: Fifty-nine women with symptomatic pelvic organ prolapse who were satisfied with their pessary at 2 months were evaluated prospectively at 1 year. Characteristics of women who continued to use a pessary were compared with women who underwent pelvic reconstructive surgery to identify predictors for continued pessary use versus surgery. RESULTS: Forty-three women (73%) continued pessary use, and 16 women (27%) underwent surgery. Characteristics that were associated with continued pessary use were older age (76 vs 61 years; p <.001) and poor surgical risk (26% vs 0%; P =.03). Characteristics that were associated with surgery were sexual activity (81% vs 26%; P <.001), stress incontinence (44% vs 16%; P =.03), stage III-IV posterior vaginal wall prolapse (44% vs 16%; P =.03), and desire for surgery at the first visit (63% vs 12%; P <.001). Age >or=65 years was the best cut-off value for continued pessary use, with sensitivity of 95% (95% CI, 84%, 99%) and a positive predictive value of 87% (95% CI, 74%, 94%). Logistic regression demonstrated that age >or=65 years ( P <.001), stage III-IV posterior vaginal wall prolapse ( P =.007), and desire for surgery ( P =.04) were independent predictors. CONCLUSION: Age >or=65 years was associated highly with continued pessary use. Desire for surgery and stage III-IV posterior vaginal wall prolapse were associated with discontinued pessary use and pelvic reconstructive surgery.

Adult↗

Factors which influence the short-term success of pessary management of pelvic organ prolapse.

OBJECTIVE: The purpose of this study was to identify patient criteria which may affect the outcome of a pessary trial. STUDY DESIGN: Records of 407 patients presenting with symptomatic pelvic organ prolapse who had a trial of pessary management were reviewed. Success was defined both by the initial fitting as well as by whether the patient was using the pessary at the 3-week follow-up visit. Outcomes were compared using chi-square test, 2-sample Student t test, or the Wilcoxon rank sum test, as appropriate. Statistical analysis was carried out at a significance of .05. RESULTS: One hundred sixty-eight patients (41%) were successfully fitted and continuing to use a pessary at the time of the 3-week follow-up visit. The likelihood of a successful pessary trial was significantly lower in subjects with a past history of hysterectomy (P<.001) or known reconstructive surgery for prolapse (P=.010). There was no association between the stage of prolapse and pessary trial outcome. There was no significance found in the relationship between the predominant location of support loss and the pessary trial outcome at the 3-week follow-up visit. CONCLUSION: The type and severity of pelvic organ prolapse do not influence the likelihood of a successful pessary fitting, and should not be used as a basis on which to select patients for pessary management.

Adult↗

[The Arabin cerclage pessary--an alternative to surgical cerclage].

During 1986-1988, the Arabin-cerclage pessary was used alternatively to surgical cerclage in 58 patients for prophylactic and in 44 cases of therapeutic indications. In 5 additional patients, the pessary was applied instead of emergency cerclage. The advantages of the cerclage pessary compared to other rigid pessary types, are based on its flexibility and adjustment to the anatomic conditions of vagina and cervix. The bowl-shaped pessary is inserted with the curvature upwards and the cervix is fixed in the central opening of the cerclage pessary. Thus a constriction, reconfiguration, and elongation of the incompetent cervix is obtained as evidenced by ultrasonography. The only side effect of the pessary treatment is an increase in cervical secretion and subsequent vaginal discharge. No infectious complications occurred. In 92% of the treated gravidae the cerclage pessary could be removed after the 36th week of gestation. Cerclage pessary can be recommended as a favourable alternative to surgical procedures as prophylactic or therapeutic approach, reducing surgical treatment significantly to less than 0.5%.

Cervix Uteri↗

An intravaginal controlled-release prostaglandin E2 pessary for cervical ripening and initiation of labor at term.

The purpose of this randomized, double-blind study was to evaluate the efficacy and safety of a new controlled-release hydrogel pessary for ripening the cervix and initiating labor. Subjects had an entry Bishop score of 4 or less and gestational age of 37 or more weeks. One hundred fourteen women received a placebo pessary and 101 received the hydrogel pessary, containing 10 mg of prostaglandin (PG) E2. Compared with the placebo group, those given the PGE2 pessary were more likely to have an increase in Bishop score of 3 or more (60 or 59% versus 21 or 18%; P less than .0001), change to a Bishop score of 6 or higher (59 or 58% versus 18 or 16%; P less than .0001), and active labor (68 or 67% versus 15 or 13%; P less than .0001). Including the crossover study, uterine hyperstimulation (28 of 182, 15%) and fetal heart rate abnormalities (18 of 182, 10%) in PGE2-treated subjects were reversed on removal of the pessary with no apparent harm to the mother or fetus. These temporary adverse effects appeared while the pessary was in place and after the onset of active labor. Oxytocin was unnecessary in 89 of 182 (49%) of the PGE2-treated cases and was used more often to augment than to induce labor. We conclude that the described controlled-release PGE2 vaginal pessary induces appreciable cervical ripening and frequently initiates active labor with little or no need for oxytocin. The pessary may cause uterine hyperstimulation or fetal heart rate abnormalities, but these would be expected to reverse on removal of the pessary.

Delayed-Action Preparations↗

Pessary test to predict postoperative urinary incontinence in women undergoing hysterectomy for prolapse.

OBJECTIVE: We sought to demonstrate that a positive pessary test could predict postsurgical stress urinary incontinence in women with severe pelvic organ prolapse and that performing tension-free vaginal taping (TVT) could effectively prevent its occurrence. METHODS: Among the 79 patients evaluated for severe pelvic organ prolapse without symptoms of stress urinary incontinence, all underwent meticulous urogynecologic evaluations and pessary testing. In group 1, 32 patients had positive pessary tests and underwent vaginal hysterectomy, anterior and posterior colporrhaphy, and TVT. In group 2, 47 patients (17 of whom had positive pessary tests and 30 of whom had negative pessary tests) underwent vaginal hysterectomy and anterior and posterior colporrhaphy alone. A comparison in terms of surgical outcome and clinical manifestations was made between these 2 groups of patients. RESULTS: After surgery, a small proportion of patients had de novo idiopathic detrusor overactivity (7.6%, n = 6), urinary tract infections (7.6%, n = 6), mild recurrent prolapse (5.1%, n = 4), and urinary retention (3.8%, n = 3). Eleven (64.7%) of 17 patients with positive pessary tests who did not undergo TVT had urine leakage after their hysterectomies in contrast with the 30 patients who had negative pessary test, none of whom developed symptomatic stress urinary incontinence after vaginal hysterectomy. Among the 32 patients with positive pessary tests who had TVT with their hysterectomies, 3 developed urine leakage later; the cure rate was 90.6%. CONCLUSION: Continent patients suffering from severe pelvic organ prolapse but with a positive pessary test are considered to be at high risk of developing postoperative symptomatic stress urinary incontinence. Among the patients in our medium-range study, TVT effectively prevented postsurgical urinary incontinence. LEVEL OF EVIDENCE: II-1

Female↗