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PubMed2005

A short-scheme protocol of gemeprost for midtrimester termination of pregnancy with uterine scar.

OBJECTIVE: The purpose of this study is to investigate the safety and effectiveness of a short-scheme protocol of gemeprost for second trimester induction of abortion in women with previous uterine surgery. STUDY DESIGN: Retrospective review of women who underwent second trimester medical termination of pregnancy (TOP) at our hospital in a 5-year period. A short regimen of gemeprost was used: over a 24-h period, 1 mg vaginal gemeprost was given every 3 h up to three doses after which, if abortion did not occur, another course at the same dosage schedule was administered up to 4 days. Induction failure was defined as women undelivered by 96 h. A homogeneous population was identified. Statistical analysis was performed with the chi(2) test or Fisher's Exact Test for categorical data and t test for continuous variables. RESULTS: Four hundred seventeen women underwent medical midtrimester TOP in the 5-year study period. Two hundred five patients were selected for this review, comparing 63 patients with scarred uterus to 142 women without uterine scars. There were no differences between the two groups in induction-to-abortion interval and number of pessaries given. The overall failure of induction rate was 1.5% and need for blood transfusion was 0.5%. No uterine rupture was reported. CONCLUSION: The regimen of gemeprost proposed seems to be as safe and effective in patients with uterine scars as in women with unscarred uteri with a very low incidence of complications.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

Patients' obstetric history in mid-trimester termination of pregnancy with gemeprost: does it really matter?

OBJECTIVE: The objective was to investigate the importance of previous obstetric history for termination of pregnancy in the second-trimester with gemeprost alone. STUDY DESIGN: A consecutive series of 423 mid-trimester inductions of abortion at our teaching hospital was reviewed. Termination of pregnancy was carried out with 1mg of vaginal gemeprost every 3h up to three doses over a 24-h period, repeated the following day if necessary. Failed induction was defined as women undelivered by 96 h. The study population was then stratified by gestational age, parity, gravidity and previous uterine scars. Main outcome parameters were failed induction and complication rates. Statistical analysis was performed using the chi(2) test or Fisher's exact test for categorical data, and the t-test and linear regression for continuous variables. RESULTS: No significant differences were found in the primary outcome parameters with regard to the obstetric parameters considered. The failed induction rate was 1.2% with an overall incidence of complications of 7.4%. Parity was the main factor that affected clinical response (time to abortion interval and number of pessaries). CONCLUSION: Patients' obstetric history does affect the clinical response to gemeprost, but its safety and effectiveness are preserved. These data provide clinicians with important information for correct counselling.

Abortifacient Agents, Nonsteroidal↗
PubMedDate not supplied

[Enterocele: clinical risk factors and association with others pelvic floor disorders (about 544 defecographies)].

OBJECTIVE: To study, by means of defecography, clinical risk factors of enterocele and association with others pelvic floor disorders. PATIENTS AND METHODS: Five hundred and forty-four consecutive female patients were investigated by colpocystodefecography with contrast medium in the small bowel. One hundred and thirty-six women with enterocele were compared to 408 women without enterocele. RESULTS: There were no significant differences in age, obstetrical history (parity, foetal macrosomia, instrumental extractions or perineal tear to delivery) between the two groups. More women with enteroceles had histories of hysterectomies (60% versus 24%) or cystopexies (29% versus 13%). Others pelvic floor disorders were associated in 91% of enterocele: rectocele (25%), cystocele (42%), uterine prolapse (28%), rectal intussusception (52%), rectal prolapse (4%) and abnormal perineal descent (30%). Stress urinary incontinence was significantly more frequent in women without enterocele. DISCUSSION AND CONCLUSIONS: The study has demonstrated that previous hysterectomy and cystopexy increased the risk of enterocele formation and that enterocele and others pelvic floor disorders are often concomitant. Enterocele may have a pessary effect on urinary disorders. Results of colpocystodefecography reinforce the notion of pelvic floor local disease.

Adult↗
PubMed2005

[Practicability of the vaginal prolapse surgery in the elderly woman].

OBJECTIVE: To evaluate the vaginal prolapse cure in the elderly woman. PATIENTS AND METHODS: A retrospective study is carried out on 38 patients of more than 80 years, operated for a vaginal genital prolapse cure between November 1997 and October 2004. The patients' general state of health, the type of analgesia, the operative type and time, the per- and postoperative complications and the evolution of the patients one month after the intervention, had been assessed. RESULTS: The average age of the patients was 84.2 (80-95). The patients' general state of health, according to the ASA classification was about 55.3% ASA II, and about 44.7% ASA III. The anaesthesia was general in 92.1% and spinal in 7.9%. The operating type was vaginal hysterectomy associated to a Marion-Kelly and a posterior perineorrhaphy in 68.4%; and a simple vaginal hysterectomy, associated more or less to the installation of a TVT in 13.1%; an intervention of Lefort, a case of Richter and a case of simple colpectomy in 10.5%. The average operative time is about 43 minutes. The peroperative complications can be summed up in a conversion in laparotomy due to haemorrhage, and a case of ligation of the right urethra. The transfer in an intensive care unit during 24 hours is necessary only for one case in 38. The postoperative complications are in one case death at eleventh day as a result of a pulmonary embolism, and a case of temporospatial disorientation and a prolapse relapse at 6 months. The duration of stay in hospital is about 7 days (2-18). The surgery did not affect the autonomy of the patients at one month. DISCUSSION AND CONCLUSION: Vaginal prolapse concerning the elderly woman is workable in quite common practice; it involves a good cooperation between anaesthetist and surgeon. The vital risk is really present but relative. This functional surgery must not be delayed by the installation of a pessary which must be used only for the inoperable patients.

Aged, 80 and over↗
PubMed2006

[Evaluation of controlled-release dinoprostone Propess for labor induction].

OBJECTIVE: To evaluate the efficacy of cervix ripening with vaginal controlled-release Propess. PATIENTS AND METHODS: A retrospective study of all women who underwent cervical ripening with Propess during the study period from 1(st) January 2002 to 31(st) December 2004 was carried out. A total of 130 patients who experienced Propess was compared with the next following patient who delivered spontaneously matched on gestational age. Modes of delivery, failure of labor, maternal morbidity were recorded. RESULTS: Indications for induction of labor were: post-term pregnancies in 18.5%, pre-eclampsia in 20.8%, oligohydroamnios in 18.5%, post-term pregnancy and oligohydramnios in 10.8%, intra-uterine fetal growth in 6.9%, premature rupture of membranes in 6.9%, diminution of fetal mobility in 6.1% and miscellaneous in 11.5%. Failure of cervical ripening was 21.2%. Patients in the Propess group had a 3.5 fold higher risk of Cesarean section [95% CI: 1.5-8.3; P < 0.04]. There was no case of maternal or fetal death. There was no difference in incidence of maternal complications, and post-partum haemorrhage. DISCUSSION AND CONCLUSION: Use of vaginal pessary Propess does not induce adverse maternal or fetal morbidity. However, it was associated with a higher incidence of Cesarean delivery.

Delayed-Action Preparations↗
PubMed2006

Use of Foley catheter for management of neonatal genital prolapse: case report and review of the literature.

Congenital vaginouterine prolapse is a rare condition occurring in neonates and is usually associated with spinal cord malformations in about 80% of cases. Several modalities of treatment have been described for neonatal genital prolapse (NGP). Conservative treatment in the form of simple digital reduction, usage of a pessary or other self-retaining device is usually sufficient to treat this condition, which is self-limiting and regressive. The authors report a new simple and effective method of conservative treatment that uses a Foley catheter to achieve permanent correction of this condition. A review of the literature regarding this uncommon condition is also provided.

Catheterization↗
PubMed2004

Health service utilization for perceived postpartum morbidity among poor women living in Karachi.

To explore traditional beliefs and practices, to assess puerperal morbidity, and to understand care-seeking behaviors, a qualitative and quantitative study was conducted in low socio-economic settlements of Karachi, Pakistan. Five focus group discussions and 15 in-depth interviews were conducted in July and August 2000. 525 Muslim women, who were 6-8 weeks post-partum, were then interviewed at home. Maternal care was relatively good-more than three-quarters of recent mothers sought antenatal care and more than half (267/525) delivered in a hospital or maternity home. Counseling to attend post-partum clinics among facility deliveries was 16% (43/267), of which only 26% (11/43) attended. Practices during the delivery and puerperium, such as massaging the vaginal walls with mustard oil during labor to facilitate delivery and inserting vaginal or rectal herbal pessaries to facilitate 'shrinkage of the uterus' and/or 'strengthening of the backbone', were pervasive. The core symptoms that are clinically significant during the puerperium are heavy vaginal bleeding and high fever, since they are potentially fatal symptoms if appropriate and timely care is not sought. About half of the study women (53.3%) reported at least one illness symptom, high fever (21.1%), heavy vaginal bleeding (13.9%), and foul smelling vaginal discharge (9.6%). Women did not know the underlying biologic cause of their perceived post-partum morbidity; weakness was frequently mentioned. Women sought care initially from close relatives or traditional healers and if they continued to suffer from their morbidity they finally approached a trained health care (allopathic) provider. The high prevalence of perceived post-partum morbidity illustrates the demand for post-partum community-based health care programs. We suggest promoting maternal health education that encourages women to seek appropriate and timely care by accessing public or private health services.

Adult↗
PubMed2006

Embryo production from superovulated sheep inseminated with sex-sorted ram spermatozoa.

An experiment was undertaken to assess the fertilizing capacity of sex-sorted, frozen-thawed ram spermatozoa, artificially inseminated into superovulated ewes, and the quality and survivability of the resultant pre-sexed embryos. Synchronized (intravaginal progestagen pessary and GnRH) donors were superovulated using PMSG and repeat ovarian stimulation with FSH before insemination. Ewes (n=67) were inseminated with either 30x10(6) or 15x10(6) motile non-sorted (control) or 15x10(6) motile sex-sorted (sorted) frozen-thawed spermatozoa (control: C30 or C15; sorted: S15, respectively) and the resultant embryos transferred immediately into synchronized recipients (n=160). The percentage of transferable embryos, pregnancy rate and embryo survival were similar (P>0.05) across all treatments. Oocyte cleavage rate was higher for ewes inseminated with S15 (172/230; 74.8%; P<0.05) than for C15 (97/151; 64.2%) or C30 (89/141; 63.1%) spermatozoa. Of the lambs resulting from embryos produced with sex-sorted spermatozoa, 86/93 (92.5%) were born of the predicted sex. This study demonstrated for the first time that pre-sexed offspring derived from superovulated sheep can be produced following transfer of embryos. Furthermore, sex-sorting by flow cytometry did not compromise the in vivo fertilizing capacity of ram spermatozoa in superovulated sheep, nor did it affect the quality or survivability of the resultant embryos.

Animals↗
PubMed1996

Diagnosis and assessment of sigmoidoceles.

OBJECTIVE: This study analyzed the clinical presentation, incidence, characteristics as demonstrated by defecating proctography, and surgical outcomes of sigmoidoceles. STUDY DESIGN: Defecating proctograms were obtained on all women with clinical evidence of pelvic floor defects between June 1, 1991, and June 30, 1995. The proctograms were retrospectively reviewed for the presence of a sigmoidocele and concomitant pelvic hernias. The distance between the maximum point of sigmoid descent with strain and the perineal body was measured. A chart review was performed to obtain clinical history, physical examination results, surgical treatment, and outcome. RESULTS: Nine sigmoidoceles (4.0%) were noted in 234 defecating proctograms. The leading edge of the sigmoid hernia ranged from 3.8 cm beyond the perineal body to 8 cm above the perineal body. All nine patients were found to have concomitant rectoceles by proctography, whereas only three were found to have enteroceles. Physical examination before proctography suggested that six patients had vaginal vault prolapse with enterocele, one patient had uterine prolapse with an enterocele, and two patients had rectoceles alone. Five of the seven patients clinically diagnosed with an enterocele showed no small bowel herniation on defecography. No sigmoidoceles were suspected by physical diagnosis alone. All rectoceles were diagnosed by clinical examination. All patients except one, who had concomitant rectal prolapse, complained of constipation. Two patients required manual pressure to the perineum or vagina to defecate. Seven of the nine patients underwent pelvic reconstructive surgery. The surgical procedure for sigmoidocele was determined by severity of constipation, degree of prolapse, and sigmoid redundancy at the time of surgery. Two patients underwent sigmoid resection with sigmoidopexy, one patient had sigmoidopexy alone, and four patients had Halban obliteration of the cul-de-sac. Two patients are successfully using pessaries. Follow-up from 4 months to 2 years (mean 12 months) showed no recurrence of an apical defect by clinical examination. One patient had a recurrent rectocele to the hymenal ring with strain. Five patients had no complaints of constipation, whereas two noted improvement but continued symptoms. Both these patients had Halban procedures only, and one had the recurrent rectocele. CONCLUSIONS: Sigmoidoceles are an uncommon but not rare finding with apical support defects. Physical examination alone does not make the diagnosis. All patients had a rectocele, which substantiates a posterior vaginal support defect. In these patients there was a strong association with constipation that responded to surgical correction, but the degree of anatomic distortion did not always correlate with functional impairment.

Aged↗
PubMed1998

Should sacrospinous ligament fixation for the management of pelvic support defects be part of a residency program procedure? The University of Miami experience.

OBJECTIVE: The objective of this article is to determine the safety and effectiveness of transvaginal sacrospinous ligament fixation as part of the management of pelvic support defects in a residency program. STUDY DESIGN: A retrospective chart review of patients undergoing sacrospinous ligament fixation at the Division of Gynecology, Jackson Memorial Hospital, University of Miami School of Medicine, between July 1990 and December 1995, was performed. Patients with vaginal vault prolapse and uterine prolapse with documented preoperative evaluation were included in this study. Data were obtained using a detailed predetermined flow sheet. RESULTS: A total of 160 patients was included in the study. All patients underwent right sacrospinous ligament fixation, anterior and posterior colporrhaphy, and perineorrhaphy. In addition, 31 (19%) underwent enterocele repair, 5 (3%) underwent trachelectomy, and 9 (6%) underwent Burch procedure. Complications included fever 13 (8.1%), urinary tract infection 16 (10%), blood loss requiring transfusion 7 (4.3%), sciatic neuralgia 2 (1.2%), and rectovaginal fistula 2 (1.2%). The mean follow-up was 40 months (range 18 to 78 months). The success of the operation was gauged by recurrence. Ninety-four percent of the patients had no evidence of vaginal vault prolapse on follow-up, and 85% had no recurrence of any pelvic support defect. Eleven of the 24 patients with recurrence underwent repeat surgery, whereas 13 opted for conservative management with pessaries. CONCLUSION: Transvaginal unilateral sacrospinous ligament fixation is a safe and successful operation for the treatment of pelvic support defect and should be an essential component in the training of gynecologic residents.

Adult↗
PubMed2000

Parity is a major determinant of success rate in medical abortion: a retrospective analysis of 3161 consecutive cases of early medical abortion treated with reduced doses of mifepristone and vaginal gemeprost.

The antiprogesterone mifepristone in combination with a suitable prostaglandin provides an effective method for induction of abortion in early pregnancy up to 63 days of gestation. The combination of 600 mg mifepristone followed by 1 mg of gemeprost vaginal pessary 48 h later is one of the standard regimens in practice, which is registered in several countries in Europe. In 1995, we reduced the doses for both mifepristone and gemeprost to 200 mg and 0.5 mg respectively, as this was shown to decrease significantly the incidence of side effects whilst maintaining a high efficacy. In this article, we report our experience with this regimen in routine clinical practice by analysing 3161 consecutive medical abortions retrospectively. Twelve case notes (0.4%) were not available, and for 310 (9.8%) women, the outcome was not known with certainty as they did not return for their follow up visit. Of the remaining 2839 women, 2732 (96.2%) had a complete abortion following their treatment. One-hundred-two (3.6%) women required an evacuation of the uterus: for incomplete abortion in 63 (2.2%) and ongoing pregnancy in 39 (1.4%). Three women had to undergo surgery for ectopic pregnancies. The surgical intervention rate was significantly higher at gestation of >49 days compared to < or = 49 days (5.7% vs. 2.6%, p = 0.002) and at >56 days than among those at < or = 56 days (6.7% vs. 3.1%; p <0.001). However, for incomplete abortion a significant increase was only seen at gestation >49 days compared to < or = 49 days (3% vs. 1.6%, p = 0.017). The incidence of ongoing pregnancies increased significantly only after 56 days of gestation compared to < or = 56 days (3.8% vs. 0.9%; p <0.001). Parity was related to the outcome with parous women having significantly more incomplete/ongoing abortions compared to nulliparous women (5.4% vs. 2.0%; p <0.001), although parous women did present earlier in pregnancy for termination than nulliparous women (p = 0.01). The incidence of complications was low: 165 (5.8%) women were given antibiotics for presumed genital infection and severe haemorrhage occurred in 11 (0.4%) women, of whom only two required blood transfusion. In summary, the recommended regimen with the reduced doses of mifepristone and gemeprost is highly effective, meeting the anticipated efficacy with a complete abortion rate of >95%. We have concluded from the data that gestation and parity are strong predictors for clinicians to anticipate the probability of a successful medical termination of pregnancy.

Abortifacient Agents, Nonsteroidal↗
PubMed1997

Oral mifepristone 600 mg and vaginal gemeprost for mid-trimester induction of abortion. An open multicenter study. UK Multicenter Study Group.

This open multicenter study was performed in 20 hospital gynecological units in the UK. The effects of 600 mg oral mifepristone as pretreatment to vaginal prostaglandin induction of second trimester abortion was studied in 267 women. The primary efficacy variable was the abortion induction interval, defined as the time taken to expel the fetus from the time of administration of the first prostaglandin pessary. Induction was commenced 36 to 48 hours following mifepristone intake. The mean abortion induction interval was 7 h. A total of 81.9% of women aborted within 12 h. There was a significant relationship between abortion induction interval and age of gestation, and a significant inverse relationship between abortion induction interval and parity. Vomiting, pelvic pain, and nausea were the most frequently reported adverse events. Two patients required transfusion and one patient with a uterine scar from a previous cesarean section suffered a ruptured uterus and hysterotomy.

Abortifacient Agents, Nonsteroidal↗
PubMed2002

Comparison of the efficacy and safety of two formulations of micronized progesterone (Ellios and Utrogestan) used as luteal phase support after in vitro fertilization.

OBJECTIVE: To compare the efficacy and the tolerability of two different vaginal formulations of micronized progesterone, Ellios and Utrogestan, used for luteal phase support after an in vitro fertilization (IVF) cycle. DESIGN: Cohort study. SETTING: Fertility center in a university hospital. PATIENT(S(: One hundred twenty-three women who underwent IVF/intracytoplasmic sperm injection (ICSI) stimulated cycles from October 1998 to March 2000, who had at least six follicles of > or =14 mm on the day of hCG administration. INTERVENTION(S): Patients received Ellios pessaries (2 times 200-mg pessary/day) or Utrogestan capsules (2 x 100-mg capsules, two times a day). Progesterone was administered from the day of oocyte pickup (day 0) until menses or up to 10 weeks in pregnant patients. MAIN OUTCOME MEASURE(S): Progesterone levels, pregnancy rate, and tolerability tested by patient questionnaire. RESULT(S): The progesterone levels on days 0, 9, 16 were not statistically different between the two formulations. The pregnancy rate were similar in groups 1 and 2 (25.5% vs. 18.6%), whereas tolerance was significantly better in group 1 versus group 2 (vaginal discharge: 43% vs. 82%). CONCLUSION(S): The efficacy of the two formulations of progesterone is comparable, although the patient tolerance for Ellios is better.

Administration, Intravaginal↗
PubMed1989

Circulating levels of placental protein 14 and progesterone following Mifepristone (RU38486) and Gemeprost for termination of first trimester pregnancy.

Ten patients underwent successful termination of first trimester pregnancies with RU38486 (Mifepristone, Roussel Laboratories Ltd., Broadwater Park, Uxbridge, Middlesex, United Kingdom) followed 2 days later by a prostaglandin (Gemeprost, May and Baker Ltd., Dagenham, Essex, United Kingdom) pessary. Four hours after administration of RU38486, the levels of progesterone (P) started to fall and continued to show a gradual decline until the abortion was completed, when a steep fall to follicular phase values was observed. Levels of placental protein 14 remained unaltered until 2 days after RU38486 administration, when levels were increased. The rise in placental protein 14 in association with falling P concentrations suggests that the decidual secretion of placental protein 14 might be independent of P. Fertil Steril 52:66, 1989.

Abortifacient Agents↗
PubMed1997

Age-related decline in fertility: a link to degenerative oocytes?

OBJECTIVE: To determine whether the age-related decline in fertility is due to degenerative oocytes or to aneuploidy. DESIGN: Retrospective. SETTING: Fertility center of a public and tertiary institution. PATIENT(S): One hundred fifty-one women (ages 24 to 44 years) undergoing 158 cycles of conventional IVF or IVF with intracytoplasmic sperm injection (ICSI) between January 1993 and December 1995 were divided into three age groups (group 1, < or = 34 years; group 2, between 35 and 39 years; and group 3, > or = 40 years). They were selected on the basis of available oocytes that remained unfertilized after IVF and that had analyzable chromosomes. INTERVENTION(S): Standard pituitary down-regulation and ovarian stimulation with FSH and hMG were done for both IVF and ICSI patients. In addition, all patients were given luteal phase support with P, administered orally, via pessaries, or by IM injections from the day of transfer. MAIN OUTCOME MEASURE(S): Fertilization rates and pregnancy rates (PRs), and cytogenetic analyses of unfertilized oocytes. RESULT(S): Although fertilization rates were not different among women in groups 1, 2, and 3 (50.9%, 49.3%, and 37.9%, respectively), PRs were significantly lower between groups 1 and 3 (43.2% versus 14.3%). A total of 383 oocytes were examined, of which 287 (75%) could be karyotyped. Of these, 201 oocytes showed a normal 23,X karyotype (70%), 40 (13.9%) were aneuploid, 24 (8.4%) were diploid, 12 (4.2%) had structural aberrations, and 13 (4.5%) had single chromatids only. No increase in the aneuploidy rate was detected between groups 1 and 2 (14.8% versus 12.4%). However, highly significant differences in the rate of oocyte chromosome degeneration, characterized by chromosomes splitting into unassociated chromatids, were observed with increasing age (group 1, 23.7%; group 2, 52.0%; and group 3, 95.8%). CONCLUSION(S): It seems that the age-related decline in fertility may be due more to degenerative oocytes than to aneuploidy. A decline in the number of oocytes retrieved with age may be of less importance than the decline in oocyte quality. Women in the older age group have a higher chance of achieving pregnancy from ovum-donation programs than by persisting in using their own aged oocytes, which have a very poor prognosis for success.

Adult↗
PubMed1997

Urogenital aging: solutions in clinical practice.

Urogenital aging, the most prevalent consequence of the menopause, affects at least 50% of postmenopausal women. It can lead to a lower quality of life, sexual problems, pain at intercourse/micturition and incontinence, but is yet an undertreated condition. The ideal treatment should relieve the vaginal symptoms of estrogen deficiency, have a localized effect, be convenient and easy to apply, safe to the endometrium and be without the unpleasant discharge produced by vaginal creams and pessaries. Vagifem, a new vaginal tablet containing 25 microg 17beta-estradiol, may fulfill many of the criteria required of an agent for the effective and efficient management of urogenital atrophy.

Administration, Intravaginal↗
PubMed1997

Bladder neck support prosthesis: a nonoperative treatment for stress or mixed urinary incontinence.

PURPOSE: We evaluated the usefulness and safety of a bladder neck support prosthesis in patients with stress or mixed incontinence. MATERIALS AND METHODS: A total of 57 women with stress and 20 with mixed incontinence completed a 12-week prospective clinical trial of a bladder neck support prosthesis. While indexes of incontinence episodes, leakage amounts and urgency along with a bothersome index were subjectively evaluated, a 60-minute pad test and urinary flow parameters were objectively evaluated. Three patients scheduled to undergo surgery for stress incontinence voluntarily used the device, and provided urodynamic data and cystourethrograms. Two prongs at 1 end of the ring, a type of elastic vaginal pessary, elevate the bladder neck against the pubic bone and facilitate pressure transmission around the bladder neck, resulting in urinary continence. RESULTS: Four subjective indexes significantly improved. There was no urinary flow obstruction. Urine loss decreased from 20.6 to 4.8 gm. per hour (p < 0.001) on the 60-minute pad test. Of the patients 22 (29%) reported complete continence and 39 (51%) had decreased severity of incontinence by more than 50%. Minor adverse effects occurred in 26% of the patients. Taking subjective evaluation, changes in objective parameters and adverse effects into consideration, 62 patients (81%) had some or maximum benefit according to the global usefulness rating. CONCLUSIONS: The bladder neck support prosthesis is safe, well tolerated and clinically effective for the treatment of stress or mixed incontinence.

Adult↗