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Prolapse; Female clinical trials

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NCT ID: NCT06404931 Not yet recruiting - Prolapse; Female Clinical Trials

Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment

Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

This is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery. They will be randomly assigned in a ratio 1:1:1 to three different groups who will have assigned three different kinds of surgery. In the patients of the first group a classic vaginal hysterectomy with anterior colporrhaphy will be practised. Patients who belong to group two will undergo a vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors (hADM) for anterior reinforcement and sacrospinous fixation with Anchorsure® device (Neomedic trade mark (TM) International, Spain). Finally, patients from group three will have vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone . Patients will be followed-up at 4 weeks, 6 months, 12 months and annually till 36 months to evaluate relapses and possible complications.

NCT ID: NCT06352112 Completed - Clinical trials for Pelvic Floor Disorders

Effects of the Hypopressive Exercises in Women With Pelvic Organ Prolapse

Start date: March 15, 2023
Phase: N/A
Study type: Interventional

The aim of this study was compare home-based pelvic floor muscle training (PFMT) alone and home-based PFMT combined with hypopressive exercise (HE) in terms of pelvic floor muscle (PFM) activation and severity of pelvic floor dysfunction (PFD) in women with pelvic organ prolapse (POP) for eight weeks. For this purpose, the participants were randomly divided into two groups: [PFMT alone (n:15) and PFMT combined with HE(n:17)]. DuoBravo EMG device for evaluation of PFM activation and "Pelvic Floor Distress Inventory-20" was used to evaluate the severity of PFD. All evaluations were performed twice in total, at baseline and at week 8.

NCT ID: NCT06159777 Not yet recruiting - Constipation Clinical Trials

Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery

Start date: August 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to test the use of a laxative before surgery in women having surgery to fix pelvic prolapse that do not have constipation. The main question it aims to answer is: Does use of a laxative before surgery lessen the discomfort of bowel movements after surgery? Participants will be asked to complete questionnaires before and after surgery. Researchers will compare using the laxative before and after surgery versus only after surgery to see if there is less discomfort with bowel movements after surgery.

NCT ID: NCT06128291 Active, not recruiting - Prolapse; Female Clinical Trials

Concomitant Posterior Colporrhaphy on Bowel Functions in Pelvic Organ Prolapse Repair

Start date: March 3, 2023
Phase:
Study type: Observational

Compare the changes of preoperative and postoperative posterior colporrhaphy.

NCT ID: NCT05978414 Recruiting - Clinical trials for Endometriosis-related Pain

Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology

TMJ and Pelvis
Start date: November 14, 2023
Phase: N/A
Study type: Interventional

1 Recruitment. 2. Collection of written consents for the study. 3. Random assignment to groups with and without intervention. 4. Completion of questionnaires by study participants, postural pattern assessment, temporomandibular joint assessment, and platform assessment. 5. Performance of visceral therapy in the group with intervention, in the group without intervention placebo. Duration 5 weeks, treatment 1x per week at the same time of day and given day e.g. Mondays only. 6. Reassessment as in step 4. 7. Data collection, statistical analyses. 8. Interpretation of results for female participants. 9. Preparation of results for scientific publications.

NCT ID: NCT05836844 Recruiting - Prolapse; Female Clinical Trials

Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women

APAS
Start date: May 11, 2023
Phase:
Study type: Observational

Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most common types of prolapse. Treatment for apical prolapse ranges from observation, non-surgical treatment or surgical repair. An anchoring device can reduce dissection and operative time and is meant to provide strong fixation whilst minimizing potential postoperative pain by avoiding neurovascular injuries. These potential advantages must be evaluated in terms of performance and safety. This cohort study will be on patients undergoing sacrospinous fixation with the Anchorsure® system with a follow-up of 36 months.

NCT ID: NCT05760794 Recruiting - Prolapse; Female Clinical Trials

Barbed-suture Efficiency Study for Sacrocolpopexy

BEST
Start date: June 21, 2023
Phase: N/A
Study type: Interventional

Minimally invasive sacrocolpopexy (SCP) performed laparoscopically or with robotic assistance is associated with improved patient-centered outcomes such as faster recovery times, less pain, less bleeding, and shorter hospital stay, however at the expense of longer operating times. One of the time consuming parts of the procedure is vaginal mesh attachment.

NCT ID: NCT05750615 Recruiting - Prolapse; Female Clinical Trials

What Affects Willingness to Self-manage a Pessary?

Start date: August 25, 2022
Phase:
Study type: Observational

Pessary self-management is defined as the patient's ability to remove and reinsert their pessary themselves at home. Previous research has suggested that some women may prefer being able to remove and reinsert their pessary as they wish rather than wait for clinic appointments. At the moment, not enough is known about pessary self-management, particularly what makes someone more or less likely to try pessary self-management. The investigators would like to understand this better to try to help women overcome barriers they might face. This study aims to collect data via both questionnaires and interviews to explore willingness to self-manage a pessary. Using findings from the questionnaires and interviews, a group of women who use pessaries and healthcare professionals who provide pessary care will work together to develop a better way to support women to feel able and willing to manage their pessary in future.

NCT ID: NCT05633901 Recruiting - Prolapse; Female Clinical Trials

Impact of Preop Video on Patient Anxiety

Start date: December 7, 2022
Phase: N/A
Study type: Interventional

To determine whether a pre-operative educational video has an impact on the anxiety of patients undergoing vaginal prolapse surgery

NCT ID: NCT04880239 Recruiting - Prolapse; Female Clinical Trials

REDUCE Trial- Reducing Prolapse Recurrence

Start date: November 23, 2021
Phase: N/A
Study type: Interventional

This study will examine whether surgeons should add a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair.