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Prolapse clinical trials

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NCT ID: NCT04547816 Recruiting - Clinical trials for Functional Constipation

Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse

Start date: July 1, 2020
Phase: Phase 3
Study type: Interventional

This study is planned to evaluate the efficacy of complex conservative treatment (including tibial neuromodulation, biofeedback therapy, special pelvic floor training and diet modification) in women with pelvic organ prolapse

NCT ID: NCT04539782 Enrolling by invitation - Clinical trials for Pelvic Organ Prolapse

A Feasibility Study on the Value of Pelvic Floor Training After Pelvic Organ Prolapse Surgery

Start date: June 10, 2020
Phase: N/A
Study type: Interventional

The main objective is to assess the feasibility of a randomized controlled trial that investigates the effects of pelvic floor training on recurrence in pelvic organ prolapse surgeries. This will be achieved by measuring POP-Q stage and by a validated questionnaire before surgery and one year after. Women having POP surgery at Landspitali will be offered to participate if they meet the criteria of the research. Participants will be randomized into two groups, interventions and control group that gets standard care at the hospital. The intervention group will meet a physiotherapist 6 weeks post-op for targeted physiotherapy with pelvic floor training, conventional advice and support. Over 16 weeks period participants in intervention group will get physiotherapy four times and get two follow up phone calls. Pelvic floor activity will be measured with EMG and symptoms collected with questionnaire before surgery and year post-op. Recurrent surgeries are common problem shortly after the first one. POP symtoms can be bothersome for women and reduce their quality of life. More knowledge is needed to figure out if targeted physiotherapy with pelvic floor training can help reduce recurrency and bothersome symptoms.

NCT ID: NCT04537169 Recruiting - Congenital Ptosis Clinical Trials

Clinical Significance of Whitnall Ligament Structure

Start date: August 20, 2020
Phase:
Study type: Observational

Prospective clincal study to relate the structure of Whitnall ligament in cases of congenital ptosis to the severety of ptosis and the postoperative results.

NCT ID: NCT04525105 Completed - Clinical trials for Pelvic Organ Prolapse

SMAD2, SMAD3 AND TGF-β GENE EXPRESSION IN URGE URINARY INCONTINENCE

Start date: November 1, 2017
Phase:
Study type: Observational

Urge urinary incontinence (UUI) is a common health problem. Changes in collagen metabolism in pelvic support organs, such as uterosacral ligaments (USLs), might be responsible for the complex pathophysiology of UUI. The TGF-β pathway is involved in collagen synthesis and degradation. The Transforming Growth Family- β (TGF-β) superfamily has essential intracellular signaling components, such as newly identified SMAD family members. We evaluated the changes in the levels of TGF-β and SMAD gene and protein expression in the USL of patients with concomitant pelvic organ prolapse (POP) and UUI.

NCT ID: NCT04523298 Completed - Prolapse Clinical Trials

Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse

VELPOP
Start date: November 8, 2020
Phase: N/A
Study type: Interventional

This is a single center, investigator initiated study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE). Women with symptomatic prolapse (grade II-IV) who seek for a conservative treatment, with no history of previous POP-surgery will be randomised to either the laser-arm or the PFE-arm. There are 3 visits where vaginal application of laser will be performed, with a 4-weeks interval. Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators. The primary objective is to evaluate the effects of VEL treatment for reduction of prolapse symptoms and as a secondary outcome objective measurements. These endpoints are in line with the recommendations by Durnea et al., as being the most relevant and patient centered outcomes. The second goals are to register adverse events and to determine for how long the effects of laser are sustained, with a maximum of two years. To do so, the investigators will measure long term satisfaction with, and the longevity of the effect (measured by the need for repeat or alternative therapy) of laser therapy. Duration of follow-up per patient: max 27 months

NCT ID: NCT04508062 Completed - Clinical trials for Pelvic Organ Prolapse

Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms

Start date: August 6, 2020
Phase: N/A
Study type: Interventional

The investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.

NCT ID: NCT04491617 Completed - Postoperative Pain Clinical Trials

STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery Trial

STOP-PAIN
Start date: August 27, 2020
Phase: N/A
Study type: Interventional

Overprescribing opioids is considered a major contributor to the opioid crisis. Hill et al. demonstrated that within a general surgery practice, over 70% of the prescribed opioid pills were never taken. Disturbingly, 45% of patients who did not take opioids at all on their day of discharge were discharged with an opioid prescription (Chen et al). Recent initiatives have attempted to utilize restrictive opioid prescribing protocols for postoperative pain management in which patients were prescribed a limited number of opioid tablets (Hallway et al) or prescribed opioids only if they were used as an inpatient (Mark et al). These well-conducted studies show that restrictive opioid prescribing policies achieve the goal of reducing excess opioid exposure without causing undue harm, inconvenience or dissatisfaction among patients. The objective of this study is to determine if a restrictive opioid prescription protocol (in which patients are not prescribed postoperative opioids unless they request them) is acceptable to patients after ambulatory and major urogynecologic surgery, compared to standard opioid prescribing practices. The study investigators believe that physicians can capitalize on the new ability to electronically prescribe opioids for patients who require them, to prevent over-prescribing without impacting patient care. The study also intends to describe postoperative opioid use patterns in the urogynecologic population, including factors predictive of opioid use and non-use. The results of this research will have a significant and timely impact by helping to reduce opioid overprescribing and informing future prescribing guidelines in the field of urogynecology.

NCT ID: NCT04480671 Active, not recruiting - Clinical trials for Pelvic Organ Prolapse

Impact of Level III Support Procedure on Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy

MERIT
Start date: August 26, 2020
Phase: N/A
Study type: Interventional

This is a randomized controlled surgical trial evaluating the use of a concomitant posterior colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. The study's primary outcome is the proportion of women at 6 months postoperatively who still have an enlarged genital hiatus. An exploratory sub-aim (as of October 2021) of the study is to evaluate the levator hiatal area as compared with the genital hiatus by using preoperative and postoperative transperineal ultrasounds. Subjects will be invited to participate, but is not required for study participation.

NCT ID: NCT04478747 Recruiting - Clinical trials for Prolapse, Vaginal Vault

Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study

TVM vs LCSP
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

The main objective of the study is to compare subjective efficacy of trans vaginal mesh and laparoscopic colposakropexy (CSP) in women with an apical prolapse. The CSP group is further divided into two sub-groups; one where the mesh fixation is only at the apical part of the vagina, and another where the fixation is also extended to the levator plane. The secondary outcomes are safety (peri- and post-surgery complications, pain, erosion), objective efficacy (simplified POP-Q), and re-operation rate. Subjective outcome also includes the assessment of sexual satisfaction. Cost-effectiveness is studied by comparing both direct costs and QALYs.

NCT ID: NCT04474275 Active, not recruiting - Clinical trials for Pelvic Organ Prolapse

The Effect of the Mode of Delivery to the Pelvic Floor Function

Start date: June 1, 2020
Phase:
Study type: Observational

The childbirth is one of the risk factors for pelvic organ prolapse. In order to prevent the pelvic organ prolapse, the physicians do not routinely advice any exercises after deliveries. The investigators wondered if the mode of deliveries such as ceserean section, vaginal route delivery with episiotomy or vaginal route delivery without episiotomy effect the pelvic floor function differently or not. In order to evaluate this, the investigators are planning to measure the muscle tonus in primiparous women.