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Vaginal Fistula clinical trials

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NCT ID: NCT05444504 Recruiting - Fistula Clinical Trials

Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management

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

The investigators propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Two intervention models will be compared among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity.

NCT ID: NCT04676568 Completed - Clinical trials for Vesico Vaginal Fistula

Comparative Analysis of Outcome Between Extravesical and Transvesical Repair for Vesico-vaginal Fistula

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

In patients with vesicovaginal fistula, transvesical and extravesical repair will be compared in terms of operative time, complications and recurrence rates.

NCT ID: NCT04267757 Completed - Clinical trials for Recto Vaginal Fistula

Transperineal Repair of Primary Obstetric Rectovaginal Fistulas

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Introduction: A rectovaginal fistula (RVF) is an epithelium-lined abnormal tract between the rectum and the vagina and is often a challenging problem for both the patients and to the surgeons. In literature, there is still debate regarding the best treatment options for rectovaginal fistulas. Aim: To assess the results of the treatment of rectovaginal fistulas with incontinence and impaired anal tonus using fistulectomy, sphincteroplasty with or without bulbocavernosus muscle (Martius) flap. Materials and Methods: A total of 22 consecutive patients with simple RVFs were included and assigned to transperineal repair. The patients were divided into two groups , group1: with Martius flap; group2: without Martius flap .Postoperatively, patients were followed up for one year at the outpatient clinic or through telephone interviews with specific questionnaires to collect information on the status of fecal control, flatus, or fecal leakage from the vagina.

NCT ID: NCT04172389 Recruiting - Clinical trials for Vesico-vaginal Fistula

Treatment of Vesico-vaginal Fistula by a Robot Assisted Laparoscopy : Results of a Multicentric Series (FFVLARO)

FFVLARO
Start date: December 1, 2019
Phase:
Study type: Observational

Robot-assisted Vesico-Vaginal fistula (VVF) repair was described a few years ago as an alternative to the open approach to minimize the morbidity of this surgery. Very little series have reported the results of robotic VVF repair. The objective of this work was to evaluate the results of robotic VVF repair.

NCT ID: NCT03414060 Recruiting - Obstetric; Injury Clinical Trials

Feasibility of the Menstrual Cup for VVF

FMCVVF
Start date: August 8, 2016
Phase: N/A
Study type: Interventional

This study examines the feasibility and acceptability of the vaginal menstrual cup for short-term management of vesicovaginal fistula (VVF) among 11 women seeking treatment at a health facility in Ghana. The repeated measures design utilizes a 2-hr pad test to compare urinary leakage with and without the insertable cup, a questionnaire on acceptability and perceived effect is administered and a clinical exam is completed. Subsequently, semi-structured interviews will be carried out with up to 24 additional women seeking treatment at a health facility in Ghana. Interviews will cover women's experiences of living with fistula, including strategies for coping with urinary incontinence and resulting stigma, as well as user acceptability to the intervention.

NCT ID: NCT03236922 Active, not recruiting - Clinical trials for Vesicovaginal Fistula

Autologous Slings With Vesico-Vaginal Fistula Repair

Start date: June 2016
Phase: N/A
Study type: Interventional

It is clear from multiple accounts in the literature that patients with a vesico-vaginal fistula (VVF) involving the bladder neck and/or proximal urethra have a high likelihood of residual incontinence. Performing subsequent surgeries after the initial VVF repair risks additional complications. Therefore, placement of an autologous sling at the time of initial VVF repair would not only assist in covering the fistula, but would also imitate the physiologic support that would theoretically improve urethral function. A rectus fascia sling would most naturally provide this support and warrants testing against the success of the PC sling. Using the Goh scoring criteria, Goh class 3 and 4 VVF's are the type most involving the urethra. Therefore, this group of patients is the target population for this study. As there is currently no standard of care for repairing large urethral defects, this procedural technique combined with otherwise standardized fistula repair would not introduce any foreseeable harm to patients.

NCT ID: NCT03029130 Enrolling by invitation - Clinical trials for Vesico Vaginal Fistula

Catheter Extension Trial for Early Vesicovaginal Fistula Repair Failures

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

This study evaluates the use of extending time of continual urinary drainage (using transurethral foley catheter) for patients with early failures of vesicovaginal fistula repairs. Half of those included will be randomized to replacement of foley catheter for a length of 14 additional days, while the other half will be discharged (no intervention). Both groups will be examined for outcomes at 3 months post-repair.

NCT ID: NCT01864473 Completed - Vaginal Fistula Clinical Trials

Management of Vaginal Fistula by Kshar Sutra, a Minimally Invasive Treatment

Bhagandar
Start date: October 2010
Phase: N/A
Study type: Interventional

Background:Fistula-in-ano is described as Bhagandara in the classics of Ayurveda, is an ancient surgical problem. It was commonly described even in the Vedic period. The description of Bhagandara, with the full text of its managements, can be gathered from the Sushruta Samhita, which is supposed to have been written in the second century B.C. Fistula-in-ano is a tubular ulcer formed around the peri-anal region. It may also be found anywhere in the perineal region. Its ramifications can extend to the lower back, subscrotal region, vagina etc. Hypothesis:In Sushruta Samhita(2nd BC) Acharya Sushruta has advocated Kshar Sutra treatment due to probability of recurrence after surgery. The present treatment modality Kshar Sutra has been found effective and as adjuvant therapy by avoiding recurrence.

NCT ID: NCT01548092 Recruiting - Clinical trials for Recto-vaginal Fistula

Stromal Vascular Fraction (SVF) for Treatment of Recto-vaginal Fistula

HULPCIR
Start date: December 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of recto-vaginal fistula.

NCT ID: NCT01428830 Completed - Vaginal Fistula Clinical Trials

Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery

Start date: January 2012
Phase: N/A
Study type: Interventional

This facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown three months following urinary fistula repair surgery. The study will be conducted among 507 women with simple fistula presenting at 8 study sites in Sub-Saharan Africa for fistula repair surgery.