Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasms

Syndrome

Low Anterior Resection Syndrome

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Postoperative Complications

PTNS consists in the insertion of a small electrode above the medial malleolus adjacent to the posterior tibial nerve. An adhesive surface electrode is placed under th arch of the foot. Both electrodes are connected to the neurostimulator that generates electricity. A neuromodulation session lasts 30 minutes.

The treatment plan includes 12 weekly sessions, followed by two sessions at 2-week intervals and the last one after one month. Two additional sessions of reinforcement (top-up) are provided at intervals of 6 months or earlier in case of worsening of symptoms

PTNS

Dajana Cuicchi, MD PhD

The study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS) associated with conservative therapy (arm A) for the treatment of low anterior resection syndrome (LARS) compared with only conservative therapy (arm B).

The secondary aims are the evaluation of the following parameters:

* Effect of PTNS on manometric parameters
* Effect of PTNS on quality of life
* Effect of PTNS on the severity of fecal incontinence and / or obstructed defecation
* Safety of PTNS

The study is a prospective randomized clinical trial that compares two treatments in patients with LARS:

Arm A: PTNS + conservative treatment (based on predominant symptom) Arm B: only conservative treatment

The study is divided into two phases:

1. PRETREATMENT PHASE

   The patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer, will be submitted during the first visit of the study to :
   * Collection of personal data
   * Collection of medical records
   * Collection of data relating to the intervention of anterior resection of the rectum
   * Verification of the criteria for inclusion / exclusion
   * Collection of informed consent
   * Administration of the questionnaires European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Cancer 30 (EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Colorectal 38 (EORTC QLQ-CR38), Faecal incontinence severity index (FISI); Fecal incontinence quality of life questionnaire (FIQL), Obstructed defaecation syndrome (ODS) score questionnaire and Constipation-related quality of life questionnaire (CRQoL)
   * Endoanal ultrasound
   * Anorectal manometry
2. PHASE OF TREATMENT During the treatment phase, data related to the treatment and any treatment related-complications will be recorded on a special form Bowel function and quality of life will be assessed using the same questionnaires at the end of treatment. Even anorectal manometry will be repeated at the end of treatment.

It is expected to enroll approximately 12 patients.

Percutaneous Tibial Nerve Stimulation in the Treatment of Anterior Resection Syndrome After Rectal Cancer Surgery

The primary end point is the evaluation of the results of the two interventions in functional terms, by comparing the LARS score calculated first at the end and after 12 months of treatment, according to the following classification:

* No LARS: a score between 0 and 20
* LARS mild: score between 21:29
* LARS severe: a score between 30 and 42

Secondary objectives will be evaluated by the change of the questionnaires EORTC QLQ-CR38 performed before and after treatment.

Secondary objectives will be evaluated by the change of the questionnaires EORTC QLQ-C30 performed before and after treatment

Secondary objectives will be evaluated by the change of the questionnaires FISI examinations performed before and after treatment.

Secondary objectives will be evaluated by the change of the questionnaires FIQL performed before and after treatment.

Secondary objectives will be evaluated by the change of the questionnaires ODS score performed before and after treatment.

Secondary objectives will be evaluated by the change of the questionnaires CRQoL performed before and after treatment.

Functional outcome will be evaluated comparing manometric examinations performed before and after treatment.

registration of complications after each therapy session

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Dr Dajana Cuicchi MD PhD

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Constipation

Pelvic Floor Disorders

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Signs and Symptoms, Digestive

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Childhood Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Sham PTNS

Shucheng ZHANG

ZhengTong YU

Constipation is the most common complaint in childhood, affecting an estimated 20% of children globally. At present, the treatment of children's constipation is full of challenges, and treatment methods are diverse.

Studies have shown that pelvic floor dysfunction is a common cause of intractable constipation in children. Zhang et al. have confirmed the role of pelvic floor dysfunction in pediatric constipation. At present, the main methods for pelvic floor dysfunction include surface electromyography and anorectal manometry which have been widely used in children with constipation and they are helpful for the diagnosis of pelvic floor dysfunction in children with constipation.

Sacral nerve electrical stimulation combined with pelvic floor rehabilitation is an effective method for the treatment of pelvic floor dysfunction. It offers a novel approach for the treatment of intractable constipation with pelvic floor dysfunction . At present, there are many methods for sacral nerve regulation. Percutaneous tibial nerve stimulation (PTNS), another peripheral nerve electrical stimulation approved by the United States Food and Drug Administration, has the same effect as sacral nerve regulation, and has the advantages of small trauma, safety, and convenience. However, there is still a lack of evidence-based support for the treatment of childhood constipation by PTNS combine with PFR. Therefore, in this study, a randomized, controlled, double-blind clinical trial was designed to confirm the efficacy and safety of PTNS combine with PFR in the treatment of childhood constipation.

Constipation is the most common complaint in childhood, affecting an estimated 20% of children globally. At present, the treatment of childhood constipation is full of challenges, and treatment methods are diverse. For example, diet control, behavioral intervention and oral Laxative, bowl management, surgical treatment and other methods can be used for the treatment of childhood constipation. Therefore, a number of guidelines for constipation in children have been developed to regulate the treatment of constipation in children. Fiber intake and polyethylene glycol are recommended as the first line choice for constipation in North American and European guidelines. However, through clinical tests, the effectiveness of PEG3350 laxative and fiber does not last, or it does not work after long-term use. Therefore, additional treatment interventions are necessary. Zhang et al. applied traditional Chinese medicine to treat childhood constipation, which greatly improved the efficacy and reduced the recurrence rate, but there were still nearly 30% intractable constipation left, and other treatment methods were needed.

Studies have shown that secondary pelvic floor dysfunction is a common cause of intractable constipation in children. The incidence of pelvic floor dysfunction is high in children with constipation, and it has a great impact on the symptoms of constipation. Zhang et al. applied defecography to examine 76 children with constipation and found that there existed different pelvic floor dysfunction such as rectocele, puborectal muscle spasm, pelvic floor spasm syndrome and sigmoid hernia in the defecation of children with constipation. In addition, the pelvic floor dysfunction in children was mainly spastic, while in adults it was mainly flaccid. Although these results confirm the role of pelvic floor dysfunction in pediatric constipation, the pelvic floor function was not evaluated. At present, the main methods for pelvic floor function include surface electromyography and anorectal manometry.

Based on the above theory, Claire Zar-Kessler et al. completed a retrospective study of 69 children in which researchers compared the clinical outcome of patients who underwent pelvic floor physical therapy (n = 49) to control patients (n = 20) whom received only medical treatment (laxatives/stool softeners), determined by anorectal manometry and balloon expulsion testing and come to the conclusion that the new field of pelvic floor physical therapy is a safe and effective intervention for children with dyssynergic defecation causing or contributing to chronic constipation. In recent years, more and more studies have confirmed that childhood constipation is resulted from pelvic floor function.Also, it has been demonstrated that, after physical therapy, pelvic floor muscle was strengthened and it became fully continent of bowel in home and community settings. Therefore, constipation is one of the manifestations of pelvic floor dysfunction in children, surface electromyography assessment and anorectal manometry are helpful for the diagnosis of pelvic floor dysfunction in children.

Sacral nerve electrical stimulation combined with pelvic floor rehabilitation(PFR) is an effective method for the treatment of pelvic floor dysfunction. At present, there are many methods for sacral neuromodulation(SNM). Percutaneous sacral nerve stimulation is a effective method for sacral neuromodulation discovered in recent years. Studies have shown the efficacy of simultaneous SNM and PFR for the treatment of childhood constipation. This method is not only better than pelvic floor training and conventional treatment, but also safe and non-invasive. At present, there are many methods for SNM. Percutaneous tibial nerve stimulation (PTNS), another peripheral nerve electrical stimulation approved by the United States Food and Drug Administration, has the same effect as SNM, and has the advantages of small trauma, safety, and convenience. PTNS has become a very effective method for SNM in recent years. Carlo Vecchioli Scaldazza et al. demonstrates the effectiveness of PTNS in women with over active bladder, improving their pelvic floor function. The result suggests that percutaneous artificial stimulation combined with PFR can be used for the treatment of constipation, especially in those with secondary pelvic floor dysfunction.

Therefore, for the treatment of intractable constipation in children, it is also necessary to determine whether there is pelvic floor dysfunction involved. In the children with pelvic floor dysfunction, relieving the pelvic floor dysfunction is an important treatment principle for the treatment of constipation. PTNS in combination with PFR offers a novel approach for the treatment of pelvic floor dysfunction and intractable constipation. However, there is still a lack of evidence-based support for the treatment of childhood constipation by PTNS combine with PFR. In this study, a randomized, controlled, double-blind clinical trial was designed to confirm the efficacy and safety of PTNS combine with PFR in the treatment of childhood constipation.

Treatment group: PTNS and PFR treatment; Control group: ( Sham stimulation and PFR training)

PTNS and PFR in the Treatment of Childhood Constipation

Percutaneous Tibial Nerve Stimulation and Pelvic Floor Rehabilitation in the Treatment of Childhood Constipation

Rate of defecation without drugs or other auxiliary methods

Satisfaction with bowel function was collected from the parents and defined as the number of which were satisfied with bowel function after the treatment (yes or no).

Rate of bowel movements per week;Incidence of constipation.

The feelings of children during defecation;Rate of painful or hard bowel movements.

Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.

Rate of children who intentionally control or reduce the frequency of defecation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Percutaneous Tibial Nerve Stimulation in the Treatment of Anterior Resection Syndrome After Rectal Cancer Surgery	NCT02177084	Rectal Cancer Low Anterior Re...	PTNS	18 Years - 80 Years	IRCCS Azienda Ospedaliero-Universitaria di Bologna
PTNS and PFR in the Treatment of Childhood Constipation	NCT05059756	Constipation Childhood ALL Pelvic Floor Di...	PTNS Sham PTNS	10 Years - 14 Years	Shengjing Hospital

Spots Global Cancer Trial Database for ptns

Every month we try and update this database with for ptns cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ptns

Every month we try and update this database with for ptns cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ptns cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.