RESUMO
BACKGROUND: Dyschezia is a defecatory disorder that places a heavy burden on a patient's quality of life. Biofeedback is the recommended treatment in most cases. OBJECTIVE: The objective of our study was to test whether a CO2-releasing suppository for patients with dyschezia could be effective in improving biofeedback training results. DESIGN: A randomized, double-blind, multicenter, placebo-controlled study was conducted in patients (18-75 years of age) with dyschezia defined according to the modified Rome III criteria. Patients were randomly assigned to either a CO2-releasing suppository or placebo suppository once per day for 21 days. SETTINGS: This was a multicenter trial. PATIENTS: A total of 122 patients were randomly assigned (62 intervention group and 60 placebo group). MAIN OUTCOME MEASURES: The primary end point was the change from day 0 to day 21 in intensity of symptoms on the basis of a self-assessed dyschezia using a visual analog scale (range, 0-100). Analyses were performed using intention-to-treat principles. RESULTS: A greater reduction from baseline to day 21 in symptom visual analog scale score was observed in the intervention group (-41.3 mm) than in the control group (-22.3 mm). Some secondary efficacy parameters improved more in the intervention group, including the percentage of patients who improved ≥50%, symptom intensity over 21 days, stool stains on underwear or pads, and need to practice manual maneuvers to facilitate defecation at day 21. At day 21, rectal sensitivity in the intervention group (31.4 mL) was lower than in the control group (39.1 mL). LIMITATIONS: There was a lower number of patients recruited than planned by the protocol. The sponsor stopped the trial before the inclusion of 306 participants, with no intermediate analysis. In addition, the main analysis conducted on the full analysis set population could have led to a statistical bias. CONCLUSIONS: The results of this multicenter trial demonstrate the added benefits of a CO2-releasing suppository in patients with dyschezia who were treated by anorectal biofeedback training.
Assuntos
Dióxido de Carbono/administração & dosagem , Constipação Intestinal/terapia , Retroalimentação Sensorial , Adolescente , Adulto , Idoso , Dióxido de Carbono/efeitos adversos , Constipação Intestinal/fisiopatologia , Método Duplo-Cego , Feminino , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Supositórios/efeitos adversos , Adulto JovemRESUMO
(1) Background: Pelvic organ prolapse (POP) can be managed using a vaginal pessary. However, the decision-making process whereby health professionals choose the right pessary is unclear. The objective of this study was to focus on the experience of experts in pessary use and to propose an algorithm. (2) Methods: A prospective study, based on face-to-face semi-directive interviews and group discussions, was conducted on a multidisciplinary panel of professional experts specialized in pessary prescriptions. A consensual algorithm was established, and its accuracy was assessed by expert and non-expert panels. The Consolidated Criteria for Reporting Qualitative Studies (COREQ) were used. (3) Results: 17 semi-directive interviews were conducted. The parameters involved in the decision-making process regarding the choice of vaginal pessaries were: desire for self-management (65%), associated urinary stress incontinence (47%), POP type (41%), and POP stage (29%). The algorithm was developed step by step (4 iterations) using the Delphi technique. Most of the expert panel (76%) rated the relevance of the algorithm as 7 or more out of 10 on a visual analog scale according to their own experience (reference activity). Finally, most (81%) of the non-expert panel (n = 230) rated the usefulness of this algorithm as 7 or more out of 10 on a visual analog scale. (4) Conclusions: This study provides an expert panel-based algorithm that may help in the prescription of pessaries for POP.
RESUMO
When a patient presents with symptoms suggestive of pelvic organ prolapse (POP), clinical evaluation should include an assessment of symptoms, their impact on daily life and rule out other pelvic pathologies. The prolapse should be described compartment by compartment, indicating the extent of the externalization for each. The diagnosis of POP is clinical. Additional exams may be requested to explore the symptoms associated or not explained by the observed prolapse. Pelvic floor muscle training and pessaries are non-surgical conservative treatment options recommended as first-line therapy for pelvic organ prolapse. They can be offered in combination and be associated with the management of modifiable risk factors for prolapse. If the conservative therapeutic options do not meet the patient's expectations, surgery should be proposed if the symptoms are disabling, related to pelvic organ prolapse, detected on clinical examination and significant (stage 2 or more of the POP-Q classification). Surgical routes for POP repair can be abdominal with mesh placement, or vaginal with autologous tissue. Laparoscopic sacrocolpopexy is recommended for cases of apical and anterior prolapse. Autologous vaginal surgery (including colpocleisis) is a recommended option for elderly and fragile patients. For cases of isolated rectocele, the posterior vaginal route with autologous tissue should be preferentially performed over the transanal route. The decision to place a mesh must be made in consultation with a multidisciplinary team. After the surgery, the patient should be reassessed by the surgeon, even in the absence of symptoms or complications, and in the long term by a primary care or specialist doctor.
Assuntos
Doenças dos Genitais Femininos , Prolapso de Órgão Pélvico , Feminino , Humanos , Idoso , Prolapso de Órgão Pélvico/cirurgia , Retocele , Vagina/cirurgia , Procedimentos Cirúrgicos em Ginecologia , Diafragma da Pelve/patologiaRESUMO
STUDY OBJECTIVE: To assess the feasibility and results of laparoscopic sacrocolpopexy (LSC) with two separate meshes along the anterior and posterior vaginal walls in correcting multicompartment pelvic organ prolapse (POP). DESIGN: Prospective study (Canadian Task Force classification I). SETTING: Tertiary care university-affiliated teaching hospital. PATIENTS: Forty-six consecutive women with radiologic diagnosis of multicompartment POP with or without genuine stress urinary incontinence and no history of surgery for either disorder. INTERVENTION: LSC with or without laparoscopic Burch colposuspension or tension-free vaginal tape procedure. MEASUREMENTS AND MAIN RESULTS: LSC was performed in 89% of patients. Mean operating and hospitalization times were 171 +/- 37 minutes and 4.0 +/- 2.1 days, respectively. Intraoperative complications were 7% of bladder injuries successfully treated by laparoscopic suture. The success rate for POP was 83%. The main recurrence was rectocele (12%), which occurred only among women undergoing LSC plus laparoscopic Burch colposuspension (P = 0.036). The LSC was effective in treating symptoms in 95% of women. Because of excessive mesh tension, one patient (2%) developed obstructed defecation, and two (5%) had de novo urinary incontinence. In no patient did occlusion or mesh infection and/or erosion in adjacent organs occur. CONCLUSION: LSC appears to be feasible and effective in treatment of multicompartment POP. Performing concomitant Burch colposuspension significantly enhances the risk of rectocele recurrence or development.