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PubMed2001

Mechanical methods for induction of labour.

BACKGROUND: Mechanical methods were the first methods developed to ripen the cervix or to induce labour. Devices which were used include various type of catheters and of laminaria tents, introduced into the cervical canal or into the extra-amniotic space. Mechanical methods were never completely abandoned, but were substituted by pharmacological methods during recent decades. Potential advantages of mechanical methods, compared with pharmacological methods, may include simplicity of preservation, lower cost and reduction of the side effects. However, special attention should be paid to contraindications (e.g. low-lying placenta), risk of infection and maternal discomfort when inserting these devices. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. OBJECTIVES: To determine the effects of mechanical methods for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment, prostaglandins (vaginal, intracervical, misoprostol) and oxytocin. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group Trials Register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched April 2001. SELECTION CRITERIA: The criteria for inclusion were the following: (1) clinical trials comparing mechanical methods used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate or unclear method for allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions. DATA COLLECTION AND ANALYSIS: A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. The initial data extraction was done centrally, and incorporated into a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. The data will be extracted from the primary reviews into a series of secondary reviews, arranged by category of woman. MAIN RESULTS: In total, 58 studies were considered; 45 studies have been included and 13 were excluded. Studies generally included women with unfavourable cervix and intact membranes. Comparing mechanical methods with placebo/no treatment, only one study with 48 participants reported on vaginal delivery not achieved in 24 hours (69% with mechanical methods versus 77% with placebo/no treatment; relative risk (RR) 0.90; 95% confidence interval (CI): 0.64-1.26). Hyperstimulation with fetal heart rate changes was not reported. The risk of caesarean section, reported in six studies including 416 women, was similar between groups (34%; RR 1.00; 95% CI: 0.76-1.30). There were no reported cases of severe neonatal and maternal morbidity. Comparing mechanical methods with vaginal PGE2, only one trial (109 women) reported on vaginal delivery not achieved in 24 hours (73% versus 42%; relative risk (RR) 1.74; 95% CI: 1.21-2.49). Compared with intracervical PGE2, only one trial (100 women) reported on vaginal delivery not achieved in 24 hours (68% versus 40%; relative risk (RR) 1.70; 95% CI: 1.15-2.51). Compared with with misoprostol, the effectiveness of mechanical methods was similar (34% versus 30%; relative risk (RR) 1.15; 95% CI: 0.80-1.66). The use of mechanical method reduced the risk of hyperstimulation with fetal heart rate changes when compared with prostaglandins: vaginal PGE2 (0% versus 6%; RR 0.14; 95% CI: 0.04-0.53), intracervical PGE2 (0% versus 1%; RR 0.21; 95% CI: 0.04-1.20) and misoprostol (4% versus 9%; RR 0.41; 95% CI: 0.20-0.87). There was no difference in the risk of caesarean section between mechanical methods and prostaglandins. Serious neonatal (three cases) and maternal morbidity (one case) were infrequently reported. When compared with oxytocin, use of mechanical methods reduced the risk of caesarean section (4 trials; 198 women; 17% versus 32%; RR 0.55; 95% CI: 0.33-0.91). The likelihood of vaginal delivery in 24 hours and of hyperstimulation with fetal heart rate changes was not reported. There were no reported cases of serious maternal morbidity and severe neonatal morbidity was not reported. These results are similar whatever specific mechanical method was used, except with extra-amniotic infusion. When comparing extra-amniotic infusion with any prostaglandins, women were more likely to not achieve vaginal delivery within 24 hours (57% versus 42%; RR 1.33; 95% CI: 1.02-1.75), the risk of caesarean section was increased (31% versus 22%; RR 1.48; 95% CI: 1.14-1.90), without a reduction of the risk of hyperstimulation. REVIEWER'S CONCLUSIONS: There is insufficient evidence to evaluate the effectiveness, in terms of likelihood of vaginal delivery in 24 hours, of mechanical methods compared with placebo/no treatment or with prostaglandins. The risk of hyperstimulation was reduced when compared with prostaglandins (intracervical, intravaginal or misoprostol). Compared to oxytocin in women with unfavourable cervix, mechanical methods reduce the risk of caesarean section. There is no evidence to support the use of extra-amniotic infusion.

Catheterization↗
PubMed2006

Mechanical devices for urinary incontinence in women.

BACKGROUND: Incontinence can have a devastating effect on the lives of sufferers with significant economic implications. Non-surgical treatments such as pelvic floor muscle training and the use of mechanical devices are usually the first line of management. The latter more so when a person did not want surgery or when considered unfit for surgery. Mechanical devices are inexpensive and do not compromise future surgical treatment. OBJECTIVES: To determine the effects of mechanical devices in the management of adult female urinary incontinence. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Trials Register (7 December 2005). The register contains trials identified from MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL and handsearching of journals and conference proceedings. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials of mechanical devices in the management of adult female urinary incontinence determined either by symptom classification or by urodynamic diagnosis. DATA COLLECTION AND ANALYSIS: Three reviewers assessed the identified studies for eligibility and methodological quality and independently extracted data from the included studies. Data analysis was performed using RevMan software (version 4.2). MAIN RESULTS: There were six trials involving a total of 286 women. Two small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment, the evidence for this was inconclusive. Five trials compared one mechanical device with another. Quantitative synthesis of data from these trials was not possible because different mechanical devices were compared in each trial using different outcome measures. Data from the individual trials showed no clear difference between devices, but with wide confidence intervals. There were no trials comparing a mechanical device with another type of treatment. AUTHORS' CONCLUSIONS: The place of mechanical devices in the management of urinary incontinence remains in question. Currently there is little evidence from controlled trials on which to judge whether their use is better than no treatment and a large well-conducted trial is required for clarification. There was also insufficient evidence in favour of one device over another and no evidence to compare mechanical devices with other forms of treatment.

Female↗
PubMed2006

Mechanical devices for urinary incontinence in women.

BACKGROUND: Incontinence can have a devastating effect on the lives of sufferers with significant economic implications. Non-surgical treatments such as pelvic floor muscle training and the use of mechanical devices are usually the first line of management. The latter more so when a person did not want surgery or when considered unfit for surgery. Mechanical devices are inexpensive and do not compromise future surgical treatment. OBJECTIVES: To determine the effects of mechanical devices in the management of adult female urinary incontinence. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Trials Register (7 December 2005). The register contains trials identified from MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL and handsearching of journals and conference proceedings. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials of mechanical devices in the management of adult female urinary incontinence determined either by symptom classification or by urodynamic diagnosis. DATA COLLECTION AND ANALYSIS: Three reviewers assessed the identified studies for eligibility and methodological quality and independently extracted data from the included studies. Data analysis was performed using RevMan software (version 4.2). MAIN RESULTS: There were six trials involving a total of 286 women. Two small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment, the evidence for this was inconclusive. Five trials compared one mechanical device with another. Quantitative synthesis of data from these trials was not possible because different mechanical devices were compared in each trial using different outcome measures. Data from the individual trials showed no clear difference between devices, but with wide confidence intervals. There were no trials comparing a mechanical device with another type of treatment. AUTHORS' CONCLUSIONS: The place of mechanical devices in the management of urinary incontinence remains in question. Currently there is little evidence from controlled trials on which to judge whether their use is better than no treatment and a large well-conducted trial is required for clarification. There was also insufficient evidence in favour of one device over another and no evidence to compare mechanical devices with other forms of treatment.

Female↗
PubMed2000

Weighted vaginal cones for urinary incontinence.

BACKGROUND: Pelvic floor muscle training has long been the most common form of conservative treatment for stress urinary incontinence. Many people have trouble identifying their pelvic floor, and thus difficulty training it. One aid to help with training the pelvic floor in women is weighted vaginal cones. These are inserted into the vagina and the pelvic floor is contracted to prevent them slipping out. OBJECTIVES: To evaluate the effects of weighted vaginal cones in the treatment of female stress urinary incontinence. SEARCH STRATEGY: We searched the Cochrane Incontinence Group trials register (to December 1999), MEDLINE (January 1966 to November 1999), EMBASE (January 1988 to November 1999) and reference lists of relevant articles. Date of the most recent searches: December 1999. SELECTION CRITERIA: The studies had to be randomised or quasi-randomised controlled trials. One arm of the study had to be the use of weighted vaginal cones. The women studied had to have stress urinary incontinence. DATA COLLECTION AND ANALYSIS: Reports were assessed by all three reviewers to see if they complied with the inclusion/exclusion criteria. Data was abstracted by one reviewer and cross checked by the others. Included data were processed as described in the Cochrane Handbook. MAIN RESULTS: Ten studies fitted the inclusion and exclusion criteria. Four of these have only been published as abstracts. All of the studies were small and in many the quality was hard to judge. The studies tested seven comparisons. There was variation between studies in the ways cones were used and in the ways comparison treatments were given. Cones alone were compared with control, pelvic floor muscle training (PFMT), electrostimulation, PFMT plus cones, and electrostimulation plus PFMT. Cones in conjunction with PFMT were compared with PFMT alone and electrostimulation. Two of the studies recruited women with symptoms of incontinence while the others required that the women had urodynamically proven genuine stress incontinence. Outcome measures differed between studies, making the results difficult to combine. Some studies reported high drop out rates with some of these being related to treatment with cones. Overall the dropout rate was not much different to that in the comparison treatments. Cones were better than control treatment (cure or improvement RR 0. 38; 95% CI 0.23 to 0.63), and similar to PFMT (RR 1.23; 95% CI 0.78 to 1.94) and electrostimulation (RR 1.35; 95% CI 0.82 to 2.21). Cones plus PFMT was no different to either cones alone or PFMT alone. These results held for both subjective and objective outcomes, but the confidence intervals were wide. REVIEWER'S CONCLUSIONS: This review provides limited evidence that weighted vaginal cones are beneficial in women with stress urinary incontinence. The limited data suggest that they are better than control treatments but similar to PFMT and electrostimulation. This conclusion must remain tentative until further larger high quality studies are carried out using similar relevant outcome measures. Some women treated with cones stop treatment early so cones may only be useful for those who find them acceptable.

Female↗
PubMed1996

Postpartum pelvic floor conditioning using vaginal cones: not only for prophylaxis against urinary incontinence and descensus.

Seventy-one women were examined 6-8 weeks after spontaneous delivery by pelvic floor (PF) palpation, inspection, manometry and gravimetry. Re-examination was performed in the same way after 4-6 weeks of daily cone training. Control groups included 20 women prior to and after conventional puerperal exercises, and 8 nulliparae prior to and after the same cone training, using a five-cone set. The number of puerperae not capable of voluntary PF contraction declined from 34% before to 6% after training. Optimum initial and post-training responses were exhibited by all nulliparae. Differences between cone and conventional exercise groups were of minor importance. Contractility increased from 5 to 10 mmHg on average in puerperae and from 15 mmHg to 21 mmHg in nulliparae. Cone nos. 1-3 were most frequently required at the beginning of training, and nos. 3-5 towards the end. Cone training works well as an alternative or complement to conventional postpartum exercises, and may therefore be recommended especially to puerperae who are not capable of holding vaginal cones of 20-70 g 6 weeks after delivery.

Adult↗
PubMed1995

Efficacy of progesterone vaginal suppositories in alleviation of nervous symptoms in patients with premenstrual syndrome.

PURPOSE: To further investigate the efficacy of progesterone in the treatment of the symptoms of premenstrual syndrome (PMS). MATERIALS AND METHODS: From an initial cohort of 25 subjects diagnosed with moderate to severe PMS, 17 reproductive age females completed the 7-month, double-blind, placebo controlled trial using 200-mg vaginal progesterone suppositories. Multiple modalities for evaluating symptoms were employed, including the Spielberger self-evaluation rating, the Beck depression inventory, and the Hamilton anxiety scale. In addition, each subject was interviewed by a psychiatrist on a monthly basis; ovulation was determined monthly using a basal body temperature chart; serum hormonal assays included beta endorphin, progesterone, follicle stimulating hormone, luteinizing hormone, estradiol, and prolactin. RESULTS: Hormonal assays confirmed no differences between treatment and control groups. Overall scores on all test vehicles were likewise not significantly different between the two groups; however, in the subcategory of nervous symptoms, a significant improvement was found in symptoms relating to tension, mood swings, irritability, anxiety and lack of control. CONCLUSIONS: Metabolites of progesterone (pregnanolone and allopregnanolone) may play a physiologic role as anxiolytic agents, perhaps modifying mood and anxiety; the current study confirms the utility of twice daily, 200-mg progesterone vaginal suppositories, in the alleviation of some PMS symptoms relating to anxiety and irritability. Further evaluation may be warranted to ascertain which patients in the known heterogeneous PMS population may be most likely to benefit from such treatment.

Adult↗
PubMed1989

Functional status of the pituitary-adrenal axis during treatment of RU486 for termination of early pregnancy in combination with PGs in Chinese women.

Six pregnant women (below 49 days of amenorrhea) desiring pregnancy termination received 600 mg RU486 orally in a single dosage and 1 mg PG-05 or ONO-802 as vaginal suppository 48 h afterward. Plasma cortisol, corticosterone, aldosterone and ACTH were monitored at -0.5, 1, 2, 4, 10, 24, 48, 72 h as well as during the first follow-up visit at the 8th day. Cortisol increased during the treatment and the values returned to the pretreatment level by the first follow-up visit. The changes of corticosterone were similar to those of cortisol. ACTH was also elevated within first 2 h and returned to the basal level at 48 h. There was no notable change in aldosterone during the treatment. The results suggest that a compensation of the pituitary-adrenal function occurred during the treatment, which is probably associated with a decreased negative feedback mechanism of cortisol due to the antiglucocorticosteroid activity of RU486 at the hypothalamus level.

Abortifacient Agents↗
PubMed1997

Use of a vaginal sponge during aerobic exercises in patients with stress urinary incontinence.

A newly marketed vaginal sponge intended to support the urethra was tested during aerobic exercise in a group of 6 women suffering from stress urinary incontinence. The patients performed half an hour of aerobic exercises on 2 consecutive days, with and without the vaginal sponge. A pad was worn during exercise and weighed before and after. Without the vaginal sponge the patients had a mean loss of 7 g (range 2-18 g) during exercise. With the vaginal sponge in situ there was no leakage. The sponge can be recommended for use during sports in patients with mild to moderate incontinence.

Adult↗
PubMed2003

The Contiform incontinence device - efficacy and patient acceptability.

A consecutive series of 59 women with urodynamic stress incontinence but no prolapse were offered treatment with Contiform (available in small/medium/large sizes). The 24-h pad test was the primary outcome measure. Of the 59 enrolled women, 41 (69%) completed the trial protocol. Median use was 21 days (IQR 10-24.5). Two severity groups were categorized based on pretreatment pad testing (mild <30 g/day n=24 patients, 59%) and moderate/severe >30 g/day, n= 17(41%). Overall, loss was reduced by a median of 72% (5-92), p<0.0001, with the greatest reduction seen in the moderate/severe group of 85% (75-100) p<0.0001. No significant benefit on pad testing was noted in the mild group. Both groups showed significant benefit on the Incontinence Impact Questionnaire. The insertion technique was quickly learnt and the device well tolerated. A medium-sized Contiform was used by 33 (80%) women. No serious adverse events occurred.

Adult↗
PubMed1999

Local treatment of urogenital atrophy with an estradiol-releasing vaginal ring: a comparative and a placebo-controlled multicenter study. Vaginal Ring Study Group.

Local estrogen substitution has been shown to be more appropriate than any systemic application for the treatment of urogenital symptoms of hormone deficiency. The efficacy, safety and acceptability of a new low-dose drug delivery system consisting of an estradiol-releasing silicone vaginal ring was studied in two multicenter trials. In an open-label comparative trial a total of 219 postmenopausal women were randomized to the estradiol-releasing vaginal ring or to estriol suppositories. In terms of efficacy both treatment arms were shown to be equivalent; however, significantly higher rates of acceptability were found for the vaginal ring. In a double-blinded placebo-controlled study a total of 84 patients were randomized to either treatment arm for a period of 24 weeks. The statistically significant improvement of the vaginal epithelial pH and maturation values demonstrated the efficacy of the estradiol-releasing vaginal ring compared to the placebo ring.

Adult↗
PubMed2000

Static and dynamic MRI of a urinary control intra-vaginal device.

The aim of this study was to describe by MRI, in dynamic conditions at rest and straining, the anatomical modifications induced by a commercially available intravaginal device (IVD) aimed at relieving female stress urinary incontinence. Ten female patients complaining of stress urinary incontinence (SUI) had pelvic MRI with static and dynamic sequences, without and with a self-inserted IVD. We studied positions and angulations of the IVD in the pelvis. Paired t-test allowed comparisons of: position of the bladder neck; urethral angulation with the pubis axis; position of the urethra; and posterior urethro-vesical angle (PUVA) without and with IVD. At rest, in ten of ten cases IVD laid cranial to the pubo-rectal muscle; with an average angulation of 95 +/- 10 degrees with the pubis axis, laterally tilted in three of ten cases. In maximum straining with IVD bladder neck descent was lower by an average of 5.2 +/- 3.1 mm (p = 0.001), pubo-urethral angle opening was smaller by an average of 22 +/- 20 degrees (p = 0.015), and bladder neck to pubis distance was shorter by an average of 5.7 +/- 4 mm. Posterior urethro-vesical angle was not significantly modified. Dynamic MRI allowed a non-invasive assessment of the mode of action of an IVD. The main modifications were a support of the bladder base and bladder neck, with a superior displacement of the urethra toward the pubis.

Adult↗